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  • A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma - NCT02954094

    Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC

    View All Details

    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

      • Contacts:

      • Robert Wood Johnson Medical School Prinicipal Investigator: Vinod Rustgi MD, MBA

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

    Exclusion Criteria:

      1. Inability to provide written informed consent

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers - NCT05639972

    Primary Objective: - To determine the feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC Secondary Objectives: - To determine the objective tumor response rate at 6-weeks after treatment - To assess 2-year and 5-year disease free survival (DFS) - To collect biospecimens for exploratory translational research

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    • Protocol Number:
      192104

    • Principal Investigator:
      Christian Hinrichs

    • Phase:
      Phase I

    • Scope:
      Local

    • Applicable Disease Sites:
      Breast,Stomach,Cervix,Other Male Genital,Lip, Oral Cavity and Pharynx,Other Female Genital

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      TCR-T Cell infusion

      • Contacts:

      • Rutgers University Prinicipal Investigator: Christian Hinrichs

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol. 2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. 3. HLA-A*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis. 4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST. 5. Age > 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy tests is not required for women who have had a bilateral oophorectomy or hysterectomy. 8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a women become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 9. Seronegative for HIV antibody, hepatitis B surface antigen (sAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative. 10. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/Mantle cell lymphoma (mcL) 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum aspartate aminotransferase (AST) (SGOT)/ alanine transaminase (ALT)(SGPT) < 2.5 x upper limit of normal (ULN) 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. international normalized ratio (INR) or activated partial thromboplastin time ( aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage. 11. Participants must be able to understand and be willing to sign the written informed consent document. 12. Participants must agree to participate in protocol CINJ 192103 (Pro2021002307) for gene therapy long term follow up and in protocol Cancer Institute of New Jersey (CINJ) 192002 (Pro2021000281) for biospecimen collection study.Note: Patients may have undergone minor surgical procedures with the past three weeks, aslong as all toxicities have recovered to Grade 1 or less.

    Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from

      participation in this study: 1. Prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. 2. Current treatment with another investigational agent. 3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study. 4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 5. Subjects with HLA-A*02:01 damaging mutation or allele loss or other molecular resistance detected by research or clinical sequencing will not be eligible. 6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations: 1. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or 2. Age > 50 years old 7. Participants with baseline screening pulse oxygen level of <92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated. 8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study. 9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications). 11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible. 12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to: 1. Carcinoma in situ 2. Cutaneous skin cancers requiring only local excision 3. Low grade non-muscle invasive bladder cancer 4. Low grade prostate cancer 13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible. 14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination with Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination with mFOLFIRINOX in Participants with Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression. - NCT05365581

    To evaluate the safety and tolerability of ASP2138 as monotherapy and in combination with pembrolizumab and mFOLFOX6, ramucirumab and paclitaxel and mFOLFIRINOX only. To determine the MTD and/or the RP2D regimen(s) of ASP2138 as monotherapy and in combination with pembrolizumab and mFOLFOX6, ramucirumab and paclitaxel and mFOLFIRINOX only.

    View All Details

    • Protocol Number:
      072305

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Pancreas

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      ASP2138

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
    • Female participant is not pregnant, confirmed by serum pregnancy test and medical evaluation by interview and at least 1 of the following conditions apply:
    • Not a woman of childbearing potential (WOCBP)
    • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.
    • Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after the final study intervention administration.
    • Female participant must not donate ova starting at screening and throughout the study period and for 6 months after the final study intervention administration.
    • Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after the final study intervention administration.
    • Male participant must not donate sperm during the treatment period and for 6 months after the final study intervention administration.
    • Male participant with pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study intervention administration.
    • Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.
    • Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention.
    • Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
    • Participant has QT interval by Fredericia (QTcF) =< 470 msec.
    • Participant agrees not to participate in another interventional study while receiving study Intervention in the present study.
    • Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Participant has predicted life expectancy >= 12 weeks.
    • Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study Intervention. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained >= 2 weeks after any blood transfusion.Monotherapy Disease specific Criteria: Gastric/GEJ Cancer
    • Participant has histologically confirmed gastric/gastroesophageal junction (GEJ) adenocarcinoma.
    • Escalation: Participant with gastric/GEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
    • Unique to South Korea: Participant with gastric/GEJ adenocarcinoma who has refused standard approved therapies is not allowed.
    • Expansion: Participant with gastric/GEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.Monotherapy Disease specific Criteria: Pancreatic Cancer
    • Participant has histologically or cytologically confirmed pancreatic adenocarcinoma.
    • Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
    • Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.
    • Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment.For all participants in combination therapy administration:
    • If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.Combination Therapy Disease specific Criteria: ASP2138 in Combination with Pembrolizumaband mFOLFOX6 as First-line Therapy in Gastric/GEJ Cancer
    • Participant has histologically confirmed diagnosis of gastric/GEJ adenocarcinoma.
    • Participant has metastatic or locally advanced unresectable gastric/GEJ adenocarcinoma.
    • Participant with gastric/GEJ adenocarcinoma has progressed and must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.
    • Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor per local testing.Combination Therapy Disease Specific Criteria: ASP2138 in Combination with Ramucirumaband Paclitaxel as Second-line Therapy in Gastric/GEJ Cancer
    • Participant has histologically confirmed diagnosis of gastric/GEJ adenocarcinoma.
    • Participant has metastatic or locally advanced unresectable gastric/GEJ adenocarcinoma.
    • Participant with gastric/GEJ adenocarcinoma must have previously received 1 line of systemic chemotherapy treatment (i.e., documented objective radiological or clinical disease progression during or within 4 months of the last dose of first line platinum and fluoropyrimidine doublet or disease progression during or after perioperative fluorouracil, leucovorin, oxaliplatin and docetaxel [FLOT]).Combination Therapy Disease specific Criteria: ASP2138 in Combination with mFOLFIRINOX asFirst-line Therapy in Pancreatic Cancer
    • Participant has histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
    • Participant has confirmed metastatic or locally advanced unresectable pancreatic adenocarcinoma.
    • Participant has pancreatic adenocarcinoma, has progressed and must not have received prior systemic anticancer therapy for their advanced disease.

    Exclusion Criteria:

    • Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration.
    • Participant has any condition which makes the participant unsuitable for study participation.
    • Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.
    • Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.
    • Participant weighs < 40 kg.
    • Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.
    • Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
    • Participant has significant gastric bleeding and/or untreated gastric ulcers that exclude the participant from participation.
    • Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
    • Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts >= 350 cells/µL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for human immunodeficiency virus (HIV) infection should be conducted per local requirements.
    • Participant is known to have active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted per local requirements.
    • For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test will be performed and if positive the participant will be excluded.
    • Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.
    • Participant treated for HCV with undetectable viral load results are eligible
    • Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.
    • Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.
    • Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.
    • Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
    • Participant has psychiatric illness or social situations that would preclude study compliance.
    • Participant has had a major surgical procedure 28 days before start of study intervention and has not fully recovered.
    • Participant has received radiotherapy metastatic or for locally advanced unresectable gastric/GEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of study intervention and has NOT recovered from any related toxicity.
    • Participant has another malignancy for which treatment is required.
    • Participant who has received CLDN18.2-targeted therapy (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of study intervention administration is not eligible for dose escalation cohorts. However, a participant who has received CLDN18.2-targeted therapy greater than 28 days or 5 half-lives (whichever is longer) prior to first dose study intervention administration is eligible for dose expansion cohorts only, with the exception of participants who have experienced Grade >= 3 gastrointestinal toxicity after receiving an CLDN18.2-targeted therapy.
    • Participant has a history or complication of interstitial lung disease.China Specific:Participant who has received treatment with herbal medications that have known antitumoractivity within 28 days prior to first dose of study treatment.For all participants in combination therapy administration:
    • Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab and mFOLFOX6 [all components], ramucirumab and paclitaxel or mFOLFIRINOX [all components]).
    • For 5 FU (fluorouracil): Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements).
    • Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded; however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of combination therapy administration) are allowed.
    • Participant is known to have HIV infection.
    • NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells/µL and no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.
    • NOTE: Screening for HIV infection should be conducted per local requirements.
    • Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention.
    • Participant has a history of ascites requiring drainage more than twice in the past 7 days.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase 1/Randomized Phase 2 Study of M3814 (peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma - NCT04172532

    Primary Objectives: Phase 1: To evaluate the safety and tolerability of M3814 (peposertib) in combination with hypofractionated radiotherapy in patients receiving treatment for locally advanced pancreatic adenocarcinoma (LAPC). Phase 2: To determine the difference in progression free survival (PFS) between patients with LAPC treated with hypofractionated radiotherapy in combination with M3814 (peposertib) as compared to patients treated with hypofractionated radiotherapy alone. Secondary Objectives: Phase 1 - To observe and record anti-tumor activity. Although the clinical benefit of this drug has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be monitored for response and survival outcomes in addition to safety and tolerability. - To evaluate plasma pharmacokinetic (PK) profiles of M3814 (peposertib) in patients receiving hypofractionated radiotherapy. Phase 2 - To compare the 2-year overall survival (OS) rate of patients treated with hypofractionated radiotherapy plus M3814 (peposertib) to that of those treated with hypofractionated radiotherapy alone. - To compare the objective response rate (ORR) by imaging of patients treated with hypofractionated radiotherapy plus M3814 (peposertib) to that of those treated with hypofractionated radiotherapy alone. - To compare the disease control rate in patients treated with hypofractionated radiotherapy plus M3814 (peposertib) as compared to those patients treated with hypofractionated radiotherapy alone. - To explore gene signature patterns in baseline patient tumor tissues that may suggest response to the combination of M3814 (peposertib) and radiotherapy, as identified on whole exome sequencing and RNA seq.

    View All Details

    • Protocol Number:
      072403

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Pancreas

    • Therapies Involved:
      Radiotherapy Chemotherapy single agent systemic

    • Drugs Involved:
      M3814 (peposertib)

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Matthew Deek

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must have pathologically confirmed pancreatic adenocarcinoma
    • Received 4-6 months of induction chemotherapy with either fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX) or gemcitabine/Abraxane, as per standard of care
    • Patients must have locally advanced pancreatic cancer according to National Comprehensive Cancer Network (NCCN) Guidelines (version 1.2020) on pancreas protocol CT scan performed within 21 days of registration. Locally advanced disease is defined as any of the following:
    • For head or uncinate process tumors:
    • Solid tumor contact with superior mesenteric artery > 180 degrees
    • Solid tumor contact with the celiac axis > 180 degrees
    • Solid tumor contact with the common or proper hepatic arteries > 180 degrees or
    • For pancreatic body or tail tumors:
    • Solid tumor contact of > 180 degrees with the superior mesenteric artery or celiac axis
    • Solid tumor contact with the celiac axis and aortic involvement or
    • Unreconstructible superior mesenteric vein or portal vein due to tumor involvement or occlusion (can be due to tumor or bland thrombus)
    • The determination of locally advanced pancreatic cancer and plan for non-operative treatment on this clinical trial must be confirmed through local multi-disciplinary review
    • Measurable disease per response evaluation criteria in solid tumors (RECIST) version (v)1.1
    • Age >= 18 years. Because no dosing or adverse event data are currently available on the use of M3814 (peposertib) in combination with hypofractionated radiation in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
    • Leukocytes >= 4,000/mcL
    • Absolute neutrophil count >= 1.5 x 10^9/L.
    • Hemoglobin >= 9 g/dL
    • Platelets >= 100 x 10^9/L
    • Total bilirubin =< 2.0 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional ULN
    • Creatinine =< 1.5 x institutional ULN
    • Glomerular filtration rate (GFR) >= 51 mL/min/1.73 m^2
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
    • Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female patients of childbearing potential and male patients must be willing to use an adequate method of contraception for the course of the study through 12 weeks after the last dose of study medication.
    • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function. To be eligible for this trial, patients should be American Heart Association Stage B (people without current or previous symptoms of heart failure but with either structural heart disease, increased filling pressures in the heart or other risk factors) or better and New York Heart Association Functional Classification II (slight limitation of physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain), or better
    • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible

    Exclusion Criteria:

    • Patients who have completed induction chemotherapy less than 2 weeks or more than 8 weeks prior to study enrollment
    • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia and neuropathy grade =< 2
    • Patients who are receiving any other investigational agents
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to M3814 (peposertib)
    • Evidence of distant metastatic disease
    • More than 1 line of chemotherapy for the treatment of localized pancreatic cancer
    • Prior abdominal radiation
    • Active inflammatory bowel disease or connective tissue disease
    • Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
    • History of anaphylactic reaction to iodinated intravenous (IV) contrast required for radiation simulation. Patients with mild reactions may be enrolled, but must receive premedications for contrast allergy prior to imaging
    • Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4/5, CYP2CP, and CYP2C19. Concomitant use of CYP1A2, CYP2B6, and CYP3A4/5 substrates with a narrow therapeutic index are also excluded. Patients may confer with the study doctor to determine if alternative medications can be used. The following categories of medications and herbal supplements must be discontinued for at least the specified period of time before the patient can be treated:
    • Strong inducers of CYP3A4/5, CYP2C9 and CYP2C19: >= 3 weeks prior to study treatment
    • Strong inhibitors of CYP3A4/5, CYP2C9 and CYP2C19: >= 1 week prior to study treatment
    • Substrates of CYP1A2, CYP2B6, and CYP3A4/5 with a narrow therapeutic index: >= 1 day prior to study treatment
    • Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
    • Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs). Patients may confer with the study doctor to determine if such medications can be discontinued. These must be discontinued >= 5 days prior to study treatment. Patients do not need to discontinue calcium carbonate. H2 blockers and antacids are allowed.
    • Patients who have received a live attenuated vaccine within 30 days of dosing with M3814 (peposertib)
    • Patients with uncontrolled intercurrent illness
    • Patients with psychiatric illness/social situations that would limit compliance with study requirements
    • Pregnant women are excluded from this study because M3814 (peposertib) is a DNA-protein kinase (PK) inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M3814 (peposertib), breastfeeding should be discontinued if the mother is treated with M3814 (peposertib)
    • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Cancers of the Stomach, Breast, Lung and Cervix. - NCT05483491

    To determine the maximally tolerated dose of KK-LC-1 TCR T cells plus aldesleukin for the treatment of metastatic KK-LC-1 positive epithelial cancers.

    View All Details

    • Protocol Number:
      192004

    • Principal Investigator:
      Christian Hinrichs

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Stomach,Breast,Lung,Cervix

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      FLUDARABINE CYCLOPHOSPHAMIDE KK-LC-1 TCR Interleukin-2 (Aldesleukin)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Christian Hinrichs

    Read Inclusion & Exclusion Criteria

    1. Inclusion Criteria: Subjects must meet all the following criteria to participate in

      this study. 1. Signed, written informed consent obtained prior to any study procedures. 2. Age > 18 years at the time of informed consent. 3. Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers, screening will focus on gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by the Rutgers Cancer Institute, Department of Biorepository Services. 4. HLA-A*01:01 allele by HLA haplotype test. 5. Measurable disease per RECIST Criteria Version 1.1 at time of enrollment. 6. Prior treatment with cancer type-specific standard of care systemic cancer therapy is required. Standard treatment options must be considered and declined. Documentation of rationale is required if a subject is deemed unsuitable for standard therapy. 7. Subjects with < 3 brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 9. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy tests is not required for women who have had a bilateral oophorectomy or hysterectomy. 10. Women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for 12 months after treatment. Should a women become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 11. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/mcL 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum AST (SGOT)/ALT (SGPT) < 2.5 x ULN 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. INR or a PTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or PTT within therapeutic range and no history of severe hemorrhage. 12. Serology:
    • HIV antibody negative
    • Hepatitis B antigen negative
    • Hepatitis C antibody negative or HCV RNC negative (i.e., no current HCV infection) 13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the KK-LC-1 TCR T cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability and meet the eligibility criteria for the protocol. 14. Oxygen saturation ≥ 92% on room air. 15. Left ventricular ejection fraction ≥45% by echocardiogram or MUGA for patients 50 years of age or older.

    Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from

      participation in this study: 1. Current treatment with another investigational agent. 2. History of severe allergic reactions to compounds of similar chemical or biologic composition to agents in used in study. 3. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 4. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with KK-LC-1 TCR T cells, breastfeeding should be discontinued if the mother is treated with KK-LC-1 TCR cells. The potential risks may also apply to other agents used in this study. 5. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 6. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications). 7. Subjects with HLA-A*01:01 damaging mutation or allele loss or other molecular resistance detected by clinical or research genomic profiling will not be eligible. 8. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible. 9. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to: 1. Carcinoma in situ 2. Cutaneous skin cancers requiring only local excision 3. Low grade non-muscle invasive bladder cancer 4. Low grade prostate cancer Participants with prior or concurrent malignancy that do not meet the above criteria are excluded. 10. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible. 11. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies. - NCT04068194

    Primary Objective: Phase I: (1) To determine the safety and tolerability and recommended phase 2 dose (RP2D) of M3814 in combination with hypofractionated radiation and avelumab in patients with advanced/metastatic solid tumors. Phase II: (1) To determine the efficacy of the combination of hypofractionated radiation, M3814, and avelumab as compared to the combination of hypofractionated radiation and avelumab in patients with advanced/metastatic hepatobiliary tumors by objective response rate (ORR) in non-irradiated lesions. All lesions (target and non-target) except the one or two lesions that were irradiated are to be included in the assessment of overall response using RECIST v1.1. Secondary Objective(s): Phase I: (1) To observe and record anti-tumor activity. Although the clinical benefit of this combination has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Specifically, to determine efficacy of the combination by measurement of disease control rate (DCR), duration of response (DOR), progression free survival (PFS), PFS outside the irradiated field, and overall survival (OS) in patients with advanced/metastatic solid tumors. (2) To characterize the pharmacokinetic (PK) profile of M3814 in combination with avelumab. Phase II: (1) To determine the efficacy and safety of the combination of hypofractionated radiation, M3814, and avelumab as compared to hypofractionated radiation and avelumab by measurement of DCR, DOR, PFS, PFS outside the irradiated field, and OS in patients with advanced/metastatic hepatobiliary tumors. (2) To determine if baseline DNA repair defects inherent to some cholangiocarcinomas correlate with a more dramatic response to radiation compared to those without as measured by H2AX pNBS1 multiplex IFA assay. (3) To characterize the pharmacokinetic (PK) profiles of M3814 and avelumab.

    View All Details

    • Protocol Number:
      052002

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver,Any Site,Other Digestive Organ

    • Therapies Involved:
      Chemotherapy multiple agents systemic Radiotherapy Chemotherapy single agent systemic

    • Drugs Involved:
      M3814 Avelumab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Salma Jabbour M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • PHASE 1: Patients must have a histologically confirmed metastatic or locally advanced unresectable solid tumor that has progressed on or after available standard of care therapy or for which no acceptable standard of care therapy exists, or in which the patient declines standard of care therapy (each patient that declines standard of care therapy will be documented in the case report form)
    • PHASE 2: Patients must have a histologically confirmed metastatic or locally advanced unresectable cholangiocarcinoma/gallbladder carcinoma that has progressed on at least 1 prior standard of care therapy or for which no acceptable standard of care therapy exists, or in which the patient declines standard of care therapy (each patient that declines standard of care therapy will be documented in the case report form)
    • Age >= 18 years
    • Because no dosing or adverse event data are currently available on the use of M3814 in combination with avelumab in patients < 18 years of age
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
    • Patients with at least 1 index lesion to irradiate for whom palliative radiation treatment is indicated (including but not limited to pain and/or symptom control, prevention of disease -related complications, and preservation of organ function). Lung and liver lesions are preferred, though alternate lesions may be considered after discussion with trial principal investigator (PI). Up to 2 lesions may be considered for irradiation provided at least 1 lesion will receive the study treatment of total of 60 Gy and all prescribed irradiation will be completed within the radiation window
    • Patients with at least 1 Response Evaluation Criteria in Solid Tumors (RECIST) measurable lesion (to be unirradiated) (defined as those accurately measured in at least one dimension, with the longest diameter to be recorded for non-nodal lesions and the shortest diameter for nodal lesions). Measurable is defined as at least 10 mm in longest diameter for solid tumors, at least 15 mm in shortest diameter for lymph nodes
    • Patients must be willing to undergo fresh biopsies at baseline (as opposed to using archival tissue), in the event their baseline tissue was obtained > 12 months prior to study consent and/or they are randomized to the gamma H2AX pNBS1 multiplex IFA assay
    • Absolute neutrophil count (ANC) >= 1,500/mcL
    • Platelet count >= 100,000/mcL
    • Hemoglobin >= 9.0 g/dL
    • Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated serum creatinine clearance (glomerular filtration rate [GFR] can be used in place of creatinine or creatinine clearance) >= 60 mL/min for participants with creatinine levels > 1.5 x institutional ULN
    • Calculate serum creatinine clearance using the standard Cockcroft-Gault formula
    • Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for participants with total bilirubin > 1.5 x ULN
    • Patients with known Gilbert disease with serum bilirubin level =< 3 x ULN are eligible
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN or =< 5.0 x ULN for patients with hepatobiliary tumors/liver metastases
    • Albumin >= 2.8 g/L
    • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) =< 1.5 x ULN
    • This applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose
    • Participants must have the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
    • Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The effects of M3814 and avelumab on the developing human fetus are unknown and there is the potential for teratogenic or abortifacient effects. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 6 months after completion of M3814 and avelumab administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M3814 and avelumab, breastfeeding should be discontinued if the mother is treated with M3814 and avelumab
    • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) and/or family member available will also be eligible

    Exclusion Criteria:

    • PHASE I: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents
    • PHASE II: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents with the following exceptions:
    • Patients who have only received previous durvalumab (anti-PD-L1) in combination with gemcitabine +/- cisplatin as part of first line therapy (TOPAZ-1 regimen) are eligible
    • Patients who have only received previous pembrolizumab (anti-PD-1) in combination with gemcitabine +/- cisplatin as part of first line therapy (KEYNOTE-966 regimen) are eligible
    • Patients who have had chemotherapy, definitive radiation, biological cancer therapy, or investigational agent/device within 21 days of first planned dose of study therapy (within 14 days for palliative radiation). Previously irradiated lesions may be re-irradiated provided there is disease progression in the irradiated lesion and the prescribed radiation dosage can safely be re- administered
    • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Common Terminology Criteria for Adverse Events [CTCAE] grade 1) with the exception of alopecia
    • Patients with untreated/uncontrolled central nervous system (CNS)/leptomeningeal disease. Patients with asymptomatic, treated CNS disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy and the following criteria are met:
    • Radiographic demonstration of clinical stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study done >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids
    • No stereotactic radiation or whole-brain radiation within 28 days prior to randomization
    • Patients with active autoimmune disease requiring systemic corticosteroids greater than the equivalent of prednisone 10 mg daily including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, colitis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis, with the following exceptions:
    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only who require only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) are eligible
    • Patients receiving treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 6 weeks must discontinue these medications prior to starting M3814 and avelumab on day 7, with the exception of:
    • Patients with active autoimmune disease managed with systemic corticosteroids less than the equivalent of prednisone 10 mg daily
    • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea)
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension and adrenocortical insufficiency
    • Patients who have undergone prior solid organ or bone marrow transplant with the exception of patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection
    • Patients with uncontrolled intercurrent illness (e.g., including but not limited to uncontrolled hypertension [HTN] [systolic blood pressure (BP) > 150, diastolic BP > 100], symptomatic congestive heart failure [CHF], unstable angina pectoris, ischemic myocardial infarction [MI] within 6 months, cardiac arrhythmia, recent transient ischemic attack [TIA or cerebrovascular accident (CVA)]) within 6 months
    • Patients with serious active infection (e.g. requiring hospitalization and/or intravenous [IV] antibiotics) within 4 weeks prior to starting M3814 and avelumab, or signs/symptoms of infection or receiving oral or IV antibiotics for the treatment of active systemic infection within 2 weeks prior to starting M3814 and avelumab. Patients receiving prophylactic antibiotics are eligible
    • Patients with known chronic hepatitis B virus (HBV) infection must have an undetectable viral load on suppressive therapy if indicated. Patients with known chronic hepatitis C (HCV) infection must have been treated and cured. Patients who are currently on curative treatment are eligible if they have an undetectable HCV viral load
    • Patients with known human immunodeficiency virus (HIV) are allowed on study provided they have:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infection
    • A CD4 count above 250 cells/mcL
    • An undetectable HIV viral load on standard polymerase chain reaction (PCR)-based testing
    • Patients with history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    • Patients with known concurrent malignancy that is expected to require active treatment within two years, or may interfere with the interpretation of the efficacy and safety outcomes of this study in the opinion of the treating investigator. Superficial bladder cancer, nonmelanoma skin cancers, and low-grade prostate cancer not requiring cytotoxic therapy should not exclude participation in this trial. Patients with chronic lymphocytic leukemia (CLL) may be enrolled if they do not require active chemotherapy and their hematologic, renal and hepatic function meets criteria previously mentioned
    • Patients with psychiatric illness/social situations that would limit compliance with study requirements
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to M3814 or avelumab
    • Patients unable to discontinue medications or substances that are potent inhibitors, inducers or sensitive substrates of CYP3A4/5 or CYP2C19 prior to starting M3814 and avelumab are ineligible. Medications or substances that are strong inhibitors of CYP3A4/5 or CYP2C19 must be discontinued at least 1 week prior to first M3814 dose. Strong inducers of CYP3A4/5 or CYP2C19 must be stopped at least 3 weeks prior to the first dose. Drugs mainly metabolized by CYP3A with a narrow therapeutic index as judged by the investigator must stop at least 1 day prior to first M3814 dose. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. The primary elimination mechanism of avelumab is proteolytic degradation, thus there are no contraindicated medications with respect to avelumab
    • Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs) prior to starting M3814 and avelumab. These must be discontinued >= 5 days prior to starting M3814 and avelumab. Patients do not need to discontinue calcium carbonate. H2 blockers are allowed provided they are taken at least 2 hours after M3814 dose
    • Patients receiving sorivudine or any chemically related analogues (such as brivudine) and not able to discontinue prior to starting M3814 and avelumab are excluded
    • Pregnant and lactating women are excluded from this study because M3814 and avelumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M3814 and avelumab, breastfeeding should be discontinued if the mother is treated with M3814 and avelumab
    • Patients who have received live vaccination within 30 days before starting M3814 and avelumab

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors. - NCT05724108

    Primary: To evaluate the overall response rate (ORR) by RECIST 1.1 of combination triapine + Lutetium Lu 177 Dotatate and standard of care Lutetium Lu 177 Dotatate alone. Secondary: To evaluate progression-free survival (PFS) in study and control arm. Exploratory: - To evaluate plasma hPG80 as a biomarker of treatment response. - To evaluate plasma deoxyribonucleosides as a biomarker of triapine resistance. - Collect plasma for circulating DNA (ctDNA) assessment.

    View All Details

    • Protocol Number:
      072310

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Rectum,Prostate,Small Intestine

    • Therapies Involved:
      Radiotherapy

    • Drugs Involved:
      177Lu-PSMA-I&T TRIAPINE

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Matthew Deek

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must have metastatic, histologically confirmed well-differentiated neuroendocrine tumor with positive gallium 68 DOTATATE or copper 64 DOTATATE scan. Lesions on dotatate scan will be considered positive if the standardized uptake volume maximum (SUVmax) of target lesion is > 2 times standardized uptake value (SUV) mean of normal liver parenchyma. Patients with lung neuroendocrine tumors (NETs) are excluded from the trial
    • Patients must have progressive disease based on RECIST criteria, version 1.1 evidenced with CT scans/MRI obtained within 24 months from enrollment
    • Patients must have measurable disease per RECIST 1.1
    • Failure of at least one prior systemic cancer treatment with somatostatin analogs
    • No prior exposure to peptide receptor radionuclide therapy
    • Recovered from adverse events of previously administered therapeutic agents (i.e., to grade 2 or less toxicity) according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0
    • Age >= 18 years
    • Because no dosing or adverse event data are currently available on the use of triapine in combination with lutetium Lu 177 dotatate in patients < 18 years of age, children are excluded from this study
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
    • Absolute neutrophil count >= 1,500/mcL
    • Platelets >= 100,000/mcL
    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
    • Serum creatinine =< 1.5 x institutional ULN. Creatinine > 1.5 ULN will require a measured creatinine clearance (CrCl) > 50 ml/min to qualify
    • Hemoglobin > 5.0 mmol/L (> 8.0 g/dL)
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
    • Patients with treated brain metastases and off steroids are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 4 weeks prior to enrollment in the study. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to enrollment in the study
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
    • Pregnancy precaution: Men and women should avoid pregnancy for seven months after the date of their last treatment with lutetium Lu 177 dotatate. It is noteworthy that beta-human chorionic gonadotropin (beta-HCG) may be secreted by a small percentage of NETs, such that, in addition to being a pregnancy marker, it also is a tumor marker. Consequently, NET female patients with positive beta-HCG (> 5 mIU/mL) at baseline can be eligible to enter the study and receive treatment if pregnancy can be excluded by lack of expected doubling of beta-HCG and negative pelvic ultrasound. Normally, in pregnant subjects beta-HCG doubles every 2 days during the first 4 weeks of pregnancy and every 3.5 days by weeks 6 to 7. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral ovariectomy) or is not postmenopausal (defined as amenorrhea > 12 consecutive months, and for women on hormone replacement therapy, only with a documented plasma follicle-stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral, implanted, or injected contraceptive hormones, an intrauterine device (IUD), or barrier methods (diaphragm, condoms, spermicidal) to prevent pregnancy, are practicing abstinence or where the partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential. Postmenopausal women who have fertilized eggs implanted are also considered to be of childbearing potential. Acceptable methods of contraception may include total abstinence at the discretion of the Investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception (hormonal or barrier method of birth control; abstinence) should be maintained throughout the study and for 7 months after study treatment discontinuation. All men and women of childbearing potential and male partners must use a double-barrier method of birth control or practice continuous abstinence from heterosexual contact throughout the study and for seven months after the end of the last treatment
    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • Patients who have not recovered from adverse events of previously administered therapeutic agents (i.e., have residual toxicities > grade 2) according to CTCAE 5.0, with the exception of alopecia
    • Patients who are receiving any other investigational agents
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine or lutetium Lu 177 dotatate
    • Patients with uncontrolled intercurrent illness
    • Uncontrolled congestive heart failure (New York Heart Association [NYHA] III, IV)
    • Pregnant women are excluded from this study because triapine is a ribonucleotide reductase (RNR) inhibitor and lutetium Lu 177 dotatate is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine and lutetium Lu 177 dotatate, breastfeeding should be discontinued if the mother is treated with triapine and lutetium Lu 177 dotatate and for 2.5 months following the last treatment
    • Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
    • Patients with any other significant condition, currently uncontrolled by treatment, which may interfere with completion of the study

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab. - NCT05199285

    The objectives of the study are to: To investigate the confirmed objective response rate (ORR) of nivolumab and ipilimumab in patients with hepatocellular carcinoma (HCC) who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To determine the overall survival (OS) in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment . To determine the progression free survival (PFS) in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To determine the disease control rate in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To assess the frequency and severity of adverse events in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment.

    View All Details

    • Protocol Number:
      072213

    • Principal Investigator:
      Sharon Li

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Opdivo (Nivolumab) IPILIMUMAB (MDX-010)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Li

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age >= 18 years.
    • HCC diagnosis confirmed by histology/cytology or clinically by American Association for Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
    • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
    • Locally advanced, metastatic, or unresectable disease.
    • Child Pugh class A.
    • Barcelona clinic liver cancer (BCLC) stage B (not amenable to liver directed therapy) or stage C.
    • Prior treatment with atezolizumab and bevacizumab combination with radiographic progression that necessitates change in treatment per treating physician. Patients with rapid progression on atezolizumab and bevacizumab (defined as patients who progressed radiographically in the first restaging scan that necessitates change in treatment) are excluded.
    • Washout period >= 4 weeks prior to registration is required since last atezolizumab and bevacizumab dose.
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. (Form is available on the Academic and Community Cancer Research United [ACCRU] website).
    • Absolute neutrophil count (ANC) >= 1000/mm ^ 3 (obtained =< 28 days prior to registration).
    • Platelet count >= 60,000/mm^3 (obtained =< 28 days prior to registration).
    • Hemoglobin >= 8.5 g/dL (obtained =< 28 days prior to registration).
    • Total bilirubin =< 3 x upper limit of normal (ULN) (obtained =< 28 days prior to registration).
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 5 x ULN (obtained =< 28 days prior to registration).
    • International normalized ratio (INR) =< 2.3 or Prothrombin time (PT) =< 6 seconds above control OR if patient is receiving anticoagulant therapy and INR is within target range of therapy creatinine =< 1.5x ULN (obtained =< 28 days prior to registration).
    • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only.
    • Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    • Provide informed written consent =< 28 days prior to registration.
    • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
    • Note: During the active monitoring phase of a study (i.e., active treatment), participants must be willing to return to the consenting institution for follow-up.
    • Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes.

    Exclusion Criteria:

    • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
    • Pregnant persons
    • Nursing persons
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
    • Major surgery =< 4 weeks prior to registration.
    • Liver directed therapy (transarterial chemoembolization [TACE], Y-90, liver directed radiation) =< 28 days prior to registration. Prior liver directed therapy > 28 days prior to registration is allowed as long as patient has at least one measurable untreated lesion by RECIST v1.1.
    • Patients with rapid progression on atezolizumab and bevacizumab (who progressed radiographically in the first restaging scan that necessitates change in treatment) are excluded.
    • Prior treatment =< 4 weeks prior to registration with anti-CTLA-4 antibody for HCC.
    • Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
    • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
    • Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
    • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection excluding hepatitis C virus (HCV)
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Unstable cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements.
    • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients with chronic HBV infection as evidenced by detectable HBV surface antigen or HBV deoxyribonucleic acid (DNA) are eligible if on antiviral therapy and have HBV DNA < 100 IU/mL. Patients with active or resolved hepatitis C (HCV) infection as evidenced by detectable HCV ribonucleic acid (RNA) or antibody are eligible.
    • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 4 weeks prior to registration.
    • Other active malignancy =< 2 years prior to registration. Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
    • History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
    • History of allogenic organ transplantation.
    • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
    • Patients with vitiligo or alopecia
    • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
    • Any chronic skin condition that does not require systemic therapy
    • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
    • Patients with celiac disease controlled by diet alone
    • History of leptomeningeal carcinomatosis.
    • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
    • Current or prior use of immunosuppressive medication =< 14 days prior to registration. The following are exceptions to this criterion:
    • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
    • Receipt of live attenuated vaccine =< 30 days prior to registration; Note: Patients, if enrolled, should not receive live vaccine whilst on study treatment and up to 30 days after the last dose of study treatment.
    • Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
    • History of grade 3 or 4 immunotherapy related toxicity NCI CTCAE v5.0 due to prior regimen attributed to atezolizumab.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute
  • A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE). - NCT05332002

    Hypothesis: We hypothesize that the use of sFOLFOXIRI in gastroesophageal cancer (GEC) will increase response rates beyond that expected with FOLFOX while maintaining acceptable tolerability. Primary Objective: - To determine the clinical efficacy of treatment regime in terms of objective response rate (ORR). Secondary Objectives: - To determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). - To characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.

    View All Details

    • Protocol Number:
      072204

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Esophagus,Stomach

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      OXALIPLATIN FLUOROURACIL 5-Fluorouracil Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically and/or cytologically confirmed metastatic or unresectable adenocarcinoma of esophageal, gastroesophageal junction or gastric origin
    • Tumor is HER2 negative by standard local testing methodology
    • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2
    • Measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1
    • No prior systemic therapy for the present cancer given in the metastatic setting and > 6 months from administration of peri-operative chemotherapy, if applicable o Note: up to two prior cycles of mFOLFOX6 for the present illness is permitted if patients otherwise qualify for the study with adequate baseline imaging
    • At least 18 years of age
    • Adequate bone marrow and organ functions as defined by:
    • Absolute neutrophil count ≥ 1500 cells/ μL
    • Hemoglobin ≥ 8 g/ dL
    • Platelets > 100,000 / μL
    • Creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
    • Total bilirubin ≤ ULN
    • Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) < 2.5 x ULN, unless with liver metastases and then must be <5 x ULN of normal
    • Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately.
    • Ability to understand the nature of this study protocol and give written informed consent.
    • Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures.

    Exclusion Criteria:

    • Receipt of any investigational agents at the time of registration
    • Known, untreated brain metastases
    • Grade two or greater peripheral neuropathy
    • Presence of any additional active malignancy within the past three years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments
    • For those patients who are going to receive nivolumab
    • No active use of systemic corticosteroids at the time of enrollment, at a dose equivalent of 10 mg/day or prednisone
    • Clinically significant autoimmune disease which is active or has required systemic immunosuppression within the last two years
    • Prior organ transplant or bone marrow transplant
    • History of interstitial lung disease or pneumonitis
    • Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure, unstable angina or active arrhythmia
    • Major surgery within the four weeks prior to initiation of study treatment
    • A history of allergy or hypersensitivity to any of the study drugs
    • Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • Rutgers Cancer Institute
  • A Phase II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers. - NCT05686226

    The primary objective of this trial is to determine the objective tumor response rate (CR+PR) and duration of response for treatment of recurrent/refractory or metastatic HPV-associated cancers with E7 TCR-T cells.

    View All Details

    • Protocol Number:
      192204

    • Principal Investigator:
      Christian Hinrichs

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Other Male Genital,Larynx,Other Female Genital,Cervix,Anus,Lip, Oral Cavity and Pharynx

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      E7 TCR T cell

      • Contacts:

      • Rutgers University Prinicipal Investigator: Christian Hinrichs

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer. 2. Tumor with HPV16 genotype as determined by testing performed in a CLIA certified laboratory. 3. HLA-A*02:01 allele as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis. 4. Measurable disease as assessed by RECIST Criteria Version 1.1. 5. Age ≥ 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening. 7. Must have received prior first line standard therapy or have declined standard therapy. 8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII). 9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery. 10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy tests is not required for women who have had a bilateral oophorectomy or hysterectomy. 11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a women become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 12. Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for Hepatitis C (HCV) RNA must be negative. 13. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/microliter (mcL) 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum aspartate transferase (AST) (SGOT)/alanine transaminase (ALT) (SGPT) < 2.5 x upper limit of normal (ULN) 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. international normalized ratio (INR) or activated partial thromboplastin time ( aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage. 14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells.. Adverse events from prior therapy must have resolved to ≤grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol. 15. Participants must be able to understand and be willing to sign the written informed consent document. 16. Participants must agree to participate in protocol Cancer Institute of New Jersey (CINJ) 192103 (Pro2021002307) for gene therapy long term follow up and in protocol CINJ 192002 (Pro2021000281) for biospecimen collection study.Note: Participants may have undergone minor surgical procedures with the past threeweeks, as long as all toxicities have recovered to Grade 1 or less.

    Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from

      participation in this study: 1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study. 3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test. 4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations: 1. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or 2. Age > 50 years old 5. Participants with baseline screening pulse oxygen level of < 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated. 6. Subjects with HLA-A*02:01 damaging mutation or allele loss or other molecular resistance detected by clinical or research genomic profiling will not be eligible. 7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study. 8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications). 10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible. 11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to: 1. Carcinoma in situ 2. Cutaneous skin cancers requiring only local excision 3. Low grade non-muscle invasive bladder cancer 4. Low grade prostate cancer Participants with prior or concurrent malignancy that do not meet the above criteria are excluded. 12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible. 13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase II Trial of Tislelizumab Consolidation after Liver-Directed Therapy for Hepatocellular Carcinoma. - NCT05366829

    Primary Objective: To determine if consolidation therapy with Tislelizumab following local therapy improves 1-year progression-free survival in patients with locally advanced, unresectable HCC. PFS is defined as the time from registration until the criteria for disease progression is met by mRECIST and RECIST v1.1 or death as a result of any cause. Secondary Objectives: 1.To determine if consolidation therapy with Tislelizumab after definitive therapy improves time to metastatic disease and overall survival (OS) and local control in subjects with localized, inoperable HCC. 2.To assess objective response rate, disease control rate, duration of response with consolidation therapy with Tislelizumab after local therapy in subjects with localized, inoperable HCC. 3.To assess the safety profile of Tislelizumab after definitive therapy. 4. To assess biomarker response as measured by Alpha fetoprotein (AFP), should the patient s tumor produce AFP. Exploratory Objectives: 1.To determine the strength by which the tumor molecular profile from NGS tissue prior to initiation of therapy correlates with treatment response. 2.To analyze ctDNA as a biomarker of response to therapy and early detection of disease progression.

    View All Details

    • Protocol Number:
      072105

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Tislelizumab (BGB-A317)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Salma Jabbour M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Each patient eligible to participate in this study must meet all the following criteria: 1. Written informed consent 2. Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted 3. Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5 4. Eastern Cooperative Oncology Group performance status score of 0-2 5. Age>/=18 years 6. Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation 7. No extrahepatic metastasis detected on CT chest with or without IV contrast, abdomen and pelvis with IV and oral contrast (triphasic-if feasible based on kidney function), or MRI abdomen/liver and chest CT. 8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 6 months after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days of first dose of study drug 9. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 6 months after the last dose of tislelizumab. Males must agree not to donate or bank sperm during treatment with tislelizumab and for > 6 months after treatment stop. 10. Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1. 11. Demonstrate adequate bone marrow and organ function as defined below: 1. Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL 2. Renal - Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN
    • Calculate serum creatinine clearance using the standard Cockcroft-Gault formula. Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment *Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours 3. Hepatic - Serum total bilirubin ≤ 3 mg/dL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN *This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.

    Exclusion Criteria:

      1. Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields 2. Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time 3. Severe, active co-morbidity as per investigator 4. More than five discrete intrahepatic parenchymal foci of definite HCC or left/right or main portal vein thrombus 5. Direct tumor extension into the stomach, duodenum, small bowel or large bowel 6. Measurable common or main branch biliary duct involvement with HCC 7. Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions). Note: benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm. 8. Prior liver transplant 9. HIV positive 10. Immunodeficiency requiring chronic systemic therapy or that may relapse 11. Participants who have received prior immunotherapy. 12. Participants with clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control a. Note: Participants with ascites who require pharmacologic intervention (e.g. diuretics) to maintain symptomatic control and who have been on stable doses of diuretics for two months days prior to the first dose of study treatment are eligible. 13. Participants with clinically meaningful encephalopathy 14. Participants who have undergone prior solid organ or bone marrow transplant except for patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection. 15. Patients must have documented hepatitis virology status. a. Participants with active hepatitis B virus (HBV) infection must have a viral load < 500 IU/mL within 28 days prior to start of Tislelizumab and be on suppressive therapy (per local standard of care) for a minimum of fourteen days prior to start of study treatment and for the length of the study. b. Participants with co-infection with HBV and hepatitis C virus (HCV) are excluded. c. Participants with a history of HCV infection but with negative HCV RNA by PCR are considered non-infected with HCV and can enroll. 16. Participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible. 17. Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible. 18. Participants with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only are eligible provided: 1) rash covers < 10% of body surface area (BSA), disease is well controlled at baseline and requires only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%). 19. Any malignancy ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g. resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast). 20. Treatment with a live, attenuated vaccine within four weeks prior to initiation of study treatment with Tislelizumab. 1. Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed. 21. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug a. Note: Participants who are currently or have previously been on any of the following steroid regimens are not excluded: i. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) ii. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption iii. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non- autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen) 22. With uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before first dose of study drug 23. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc. 24. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. 25. Severe infections within 4 weeks before first dose of study drug, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 26. Received therapeutic oral or intravenous antibiotics within two weeks before first dose of study drug 27. Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug 28. Any of the following cardiovascular risk factors: a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before first dose of study drug e .Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug 29. Has received any herbal medicine used to control cancer within fourteen days of the first study drug administration 30. Participants with toxicities (because of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities) 31. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study c conduct. 32. Concurrent participation in another therapeutic clinical study.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Community Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
  • A Phase II, open-label, multi-cohort, multicenter study in patients with unresectable HEPATOCELLULAR CARCINOMA and CHILDPUGH B7 and B8 Cirrhosis - NCT06096779

    Primary objective: To evaluate the safety of the study treatments in Cohorts A and B Secondary Objectives: To evaluate the efficacy of the study treatments in Cohorts A and B To evaluate patient-reported tolerability of the study treatments in Cohorts A and B from the participant s perspective Exploratory Objective: To identify biomarkers as follows: Those associated with response to atezolizumab + bevacizumab or atezolizumab monotherapy Those that are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers) OR Those that can increase the knowledge of disease biology and drug safety in Cohorts A and B

    View All Details

    • Protocol Number:
      072309

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      Atezolizumab (MPDL3280A) BEVACIZUMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    General Inclusion Criteria:

    • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients
    • Disease that is not amenable to curative surgical and/or locoregional therapies
    • No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
    • Measurable disease (at least one untreated target lesion) according to RECIST v1.1
    • ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment
    • Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
    • Adequate hematologic and end-organ function
    • Life expectancy of at least 12 weeks
    • Female participants of childbearing potential must be willing to avoid pregnancy and egg donation

    General Exclusion Criteria:

    • Pregnancy or breastfeeding
    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies
    • Treatment with investigational therapy within 28 days prior to initiation of study treatment
    • Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
    • Treatment with systemic immunostimulatory agents
    • Treatment with systemic immunosuppressive medication
    • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
    • Inadequately controlled hypertension
    • Active or history of autoimmune disease or immune deficiency
    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    • Patients who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation.
    • Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
    • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
    • Prior allogeneic stem cell or solid organ transplantation
    • Listed for liver transplantation
    • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
    • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
    • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
    • Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
    • History of hepatic encephalopathy requiring hospitalization or treatment escalation within 6 months prior to study treatment, or any continued symptoms of encephalopathy despite medical management
    • History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS)
    • History of ascites requiring therapeutic paracentesis over the last 3 months
    • History of spontaneous bacterial peritonitis within last 12 months

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
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