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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

    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.

    • Robert Wood Johnson University Hospital
    • Rutgers Cancer Institute
  • A bilingual virtually-based intervention (PEDALL) for the prevention of weight gain in childhood ALL patients considering key genetic and sociodemographic risk factors - NCT05963971

    Primary Objective To prevent the development of overweight and obesity (OW/OB) during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL. Exploratory Objectives To assess the effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors. To examine the modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL. To examine the modifying effect of multi-level sociodemographic factors on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL. To understand the effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines. To understand contextual factors that shaped the recruitment and retainment of participants and to identify strategies that may hinder or support implementation within routine care at their site including resource, training and technological needs using a one-time, brief structured survey at the end of the study with study site designate. To understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.

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    • Protocol Number:
      112307

    • Principal Investigator:
      Peter D. Cole

    • Phase:
      N/A

    • Scope:
      National

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age: 5-21 years old at enrollment
    • Diagnosis and Treatment: Plan to receive or are receiving maintenance or continuation chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia.
    • Timing: Patient is eligible for entry only if it is feasible to start the study intervention during the first month of the maintenance phase of ALL therapy.
    • Language: Fluency in English or Spanish
    • Weight Status: Healthy weight at baseline as determined by BMI z-score < 1.04 and >-1.04 for those under 5-18, and BMI between 19 and 25 for those >18.
    • Ethnicity: Hispanic or Non-Hispanic of any race.

    Exclusion Criteria:

    • Patients on nutrition support (enteral or parenteral nutrition)
    • Patients with a history of eating disorder

    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 Digital Intervention to Improve Skin Self-Examination Among Melanoma Survivors. - NCT05373823

    Aim 1. To enhance MSS by collaborating with multi-level stakeholders. We will collaborate with stakeholders in enhancing MSS through qualitative interviews and usability testing of potential enhancements. Enhancements are based on empirically validated behavior change techniques (BCTs) and our prior study. We will utilize an iterative process that includes: (1) key informant interviews with survivors, providers, and professional organizations regarding proposed enhancements; (2) conversion to an enhanced mobile-based delivery platform; (3) usability testing, and; (4) iterative program refinements. Aim 2. To evaluate the effects of enhanced MSS on thorough SSE in an RCT and examine its impact on the diagnosis of new/recurrent melanomas (N= 300). We will conduct a RCT comparing MSS and a non-interactive educational webpage with 300 survivors to test its effects on SSE. We propose that MSS participants will be more likely to perform thorough SSE over the 18-month follow-up. We will explore the impact of MSS on new/recurrent melanomas. We propose that there will be more earlier stage melanomas diagnosed in MSS as compared with UC. Aim 3. To assess selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation. We will use mixed methods to assess implementation outcomes and explore perspectives from survivors, care providers, and professional organizations about how to best disseminate and implement MSS on a broad scale. The sub-aims are: 3a) To estimate program costs and assess cost-effectiveness of MSS relative to control. We hypothesize that MSS costs will be higher than UC. We expect that MSS will be a more cost-effective strategy, given its greater effectiveness to increase SSE and identify new or recurrent melanoma. If our findings support this as expected, exploratory cost-effectiveness analyses from the health care and societal perspectives will be conducted using simulation models of melanoma-related costs, disease progression, and survival over 5- and 10-year analysis horizons. 3b) To examine MSS reach, adoption, engagement, acceptability, appropriateness, feasibility, and maintenance. For reach, we predict that demographic variables will not differ from the general population of melanoma survivors. For adoption, we propose that the proportion of contacted/eligible survivors randomized to MSS who consent, complete the baseline, and log into MSS will be equal or greater than the efficacy trial. For engagement, we propose that 80% of MSS participants will log in. For acceptability, we predict MSS will be rated as highly acceptable. 3c) To identify and describe contextual factors from multilevel stakeholders as key to scale-up and widespread implementation of MSS, including consideration of potential delivery settings, timing of delivery, and needed resources to promote its implementation and sustainability.

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    • Protocol Number:
      132202

    • Principal Investigator:
      Sharon Manne

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
    • Three months to five years post-surgery
    • No current evidence of cancer
    • Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
    • ≥ 18 years old
    • Internet access
    • Able to speak/read English
    • Able to provide informed consent

    Exclusion Criteria:

    • Children

    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 ,Cervix ,Lip, Oral Cavity and Pharynx ,Other Female Genital ,Other Male Genital ,Stomach

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      TCR-T Cell infusion

    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 First-in-Human Study of Mutant-Selective PI3K Alpha Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer. - NCT05216432

    RLY-2608 Single Agent Arm: Primary Objectives: - To determine the MTD and/or RP2D of RLY-2608 as a single agent - To determine the safety and tolerability of RLY-2608 as a single agent RLY-2608 + Fulvestrant Arm: Primary Objectives: - To determine the MTD and/or RP2D of RLY-2608 in combination with fulvestrant - To determine the safety and tolerability of RLY-2608 in combination with fulvestrant Triple Combination Arms: Primary Objectives: - To determine the MTD and/or RP2D of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib or ribociclib) and fulvestrant - To determine the safety and tolerability of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib, ribociclib) and fulvestrant

    View All Details
    • Protocol Number:
      042402

    • Principal Investigator:
      Mridula A George

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      RLY-2608

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria

      Patient has ECOG performance status of 0-1One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor perlocal assessment
    • Other potentially oncogenic PIK3CA mutations may be considered but must be approved by the Sponsor prior to enrollment.Part 1 - Ability to provide archived tumor tissue or be willing to undergo pretreatmenttumor biopsy to assess PIK3CA status retrospectively Part 2 - Submit tumor tissue priorto study drug initiation for determination of PIK3CA mutation retrospectively.Key Inclusion for RLY-2608 Single Agent Arm
    • [For Part 1]: Evaluable disease per RECIST v1.1
    • [For Part 2]: Measurable disease per RECIST v1.1
    • Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy.
    • Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
    • Part 2 - Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types:Group 1: clear cell ovarian cancer Group 2: head and neck squamous cell carcinoma Group3: cervical cancer Group 4: other solid tumors, excluding colorectal, clear cell ovarian,head and neck squamous cell, and cervical cancers Group 5: unresectable or metastaticsolid tumors with PIK3CA double mutations In addition, the SRC (with Sponsor approval)may choose to open additional group(s) of 20 participants to study the clinical activity,safety, and PK/PD in other specified solid tumor types.Key Inclusion for Combination Arms
    • [For Part 1 and Part 2]: Evaluable disease per RECIST v1.1
    • [For Part 1 and Part 2]: Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy. Females may be postmenopausal, premenopausal, or perimenopausal. Premenopausal or perimenopausal females must have a histologically or cytologically confirmed diagnosis of HR+ HER2- advanced or metastatic breast cancer that is not amenable to curative therapy and must have been previously treated with GnRH agonist at least 4 weeks prior to start of study drug
    • [For Part 1 and Part 2]: Had previous treatment for breast cancer with: 1. ≤1 line of chemotherapy in the metastatic setting 2. ≥1 CDK4/6 inhibitor in either the adjuvant and/or metastatic setting 3. ≥1 antiestrogen therapy in either adjuvant and/or metastatic setting, including, but not limited to, selective estrogen-receptor degraders (eg, fulvestrant), selective estrogen receptor modulators (eg, tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane), and 4. ≥1 PARP inhibitor, if appropriate, if documented germline BRCA1/2 mutation Note: Systemic local, loco-regional, or adjuvant treatment with chemotherapy and PARP inhibitors is not to be included in enumeration or previous treatment[For RLY-2608 + fulvestrant arm; Part 2, Group 2]: Received prior treatment with a PI3Kαor AKT inhibitor and discontinued the inhibitor due to intolerance and not diseaseprogression, where intolerance is defined as treatment discontinuation due to treatmentrelated AE (eg. hyperglycemia, rash, diarrhea, stomatitis) other than severehypersensitivity reaction and/or life-threatening reactions, such as anaphylaxis andStevens-Johnson syndrome.[For triple combination arms; Part 1 only]: Participants who had previous treatment forbreast cancer with PI3Kα or AKT inhibitors will be considered.[For triple combination arms with ribociclib or palbociclib; Part 1 only]: endometrialcancer may be enrolled.

    Key Exclusion Criteria

      Prior treatment with PI3Kα, AKT, or mTOR inhibitors (except for RLY-2608 + fulvestrantarm, Part 2, Group 2; and triplet combinations, Part 1).Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasmaglucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.History of hypersensitivity to PI3K inhibitors. For combination arms only:hypersensitivity to fulvestrant, palbociclib, ribociclib, and/or PF-07220060, asappropriate for the combination.Past medical history of or ongoing ILD, or pneumonitis requiring intervention.Participants with past history of resolved Grade 1 pneumonitis may be considered, exceptin triple combination arms.Any of the following cardiac criteria:
    • Mean resting corrected QT interval (QTc) >470 msec. For triple combination arm with ribociclib: Mean QTcF ≥450 msec.
    • Patient has a history of prolonged QT syndrome or torsades de pointes. Patient has a familial history of prolonged QT syndrome.
    • Clinically significant, uncontrolled cardiovascular diseaseCNS metastases or primary CNS tumor that is associated with progressive neurologicsymptoms

    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 First-in-Human, Open-Label, Phase 1/2 Dose-Escalation with Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects with Advanced Solid Malignancies. - NCT06028074

    Primary Objective Part A and B: - To characterize the safety and tolerability of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1) programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have a Food and Drug Administration (FDA) approval for anti-PD-1/PD-L1 therapy at time of recruitment. Primary Objectives Dose Expansion (Part B): - To identify a recommended dose for future studies (RP2D) - To assess the anti-tumor activity of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have FDA approval for anti-PD-1/PD-L1 therapy at time of recruitment. Secondary Objectives: - To assess safety and tolerability (Part B only) - To characterize the pharmacokinetic (PK) profile of GIM-122 (Part A and Part B) - To assess the emergence and persistence of anti-drug antibodies (ADA) and the mpact on GIM-122 exposure (Part A and Part B) - To assess the change from baseline in tumor tissue markers as potential predictors of efficacy of GIM-122 (Part A and Part B) - To evaluate the preliminary anti-tumor activity of GIM-122 (Part A only)

    View All Details
    • Protocol Number:
      052401

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      GIM-122

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      General
    • Written informed consent
    • ECOG performance status 0-1.
    • Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
    • Recommended Double methods of contraception 90-days post treatment Cancer Specific
    • Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
    • Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
    • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
    • Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
    • No other lines of therapy that are available

    Exclusion Criteria:

      General
    • Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
    • Women who are pregnant or breastfeeding
    • History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
    • Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
    • Current second malignancy at other sites
    • Leptomeningeal disease
    • Spinal cord compression
    • Symptomatic or new or enlarging central nervous system (CNS) metastases

    Treatment-specific Exclusion Criteria

    • Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
    • Has undergone a major surgery < 1 month prior to administration of GIM-122
    • Has received radiation therapy within 2 weeks prior to administration of GIM-122
    • Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
    • Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
    • Prior treatment with other immune modulating agents within < 4 weeks prior to the first dose of GIM-122.
    • Has a diagnosis of immunodeficiency, either primary or acquired
    • Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
    • Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
    • Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
    • Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date > 30 days prior to administration of GIM-122).

    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 First-in-Human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects with Advanced Solid Tumors. - NCT04485013

    Primary Objective: To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule. Secondary Objectives(s): (1) To characterize the single-dose and/or multiple-dose pharmacokinetics (PK) of TTX-080 following intravenous (IV) administration in subjects with advanced solid tumors. (2) To evaluate the immunogenicity of TTX-080 in subjects with advanced solid tumors. (3) To evaluate the preliminary antitumor activity of TTX-080 in subjects with advanced solid tumors. Exploratory Objective: To assess the effects of TTX-080 on pharmacodynamic biomarkers relating to mechanism of action and immune responses.

    View All Details
    • Protocol Number:
      052006

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CETUXIMAB Folfiri Pembrolizumab (MK-3475) TTX-080

    Read Inclusion & Exclusion Criteria

    Abbreviated Inclusion Criteria:

      1. Subject with histological diagnosis of advanced/metastatic cancer 2. Age 18 years or older, is willing and able to provide informed consent 3. Evidence of measurable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks

    Abbreviated Exclusion Criteria:

      1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody 2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

    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.

  • A Long-Term Study for Participants Previously Treated With Ciltacabtagene Autoleucel. - NCT05201781

    To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.

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    • Protocol Number:
      012204

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
    • Participants who have provided informed consent for this 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 Multicenter, Open Label, Phase III Extension Trial to Study the Long-Term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial. - NCT03486873

    Primary Objective: To estimate the OS. Secondary Objectives: - To estimate the DOR and DOCR per evaluation criteria used in the parent trial by investigator assessment for participants who have received or are receiving First Course Phase trial treatment with pembrolizumab or a pembrolizumabbased combination. - To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase trial treatment.

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    • Protocol Number:
      051804

    • Principal Investigator:
      Eugenia Girda

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      Pembrolizumab (MK-3475)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
    • Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.Additional eligibility criteria for participants who enter Second Course Phase once theyare enrolled on MK-3475-587:
    • Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Demonstrates adequate organ function.
    • Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
    • A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.Additional eligibility criteria for participants who enter dosing with Lenvatinib:
    • Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications.
    • For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
    • Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.

    Exclusion Criteria:

    • There are no exclusion criteria to participate in MK-3475-587.Participants are excluded from entering Second Course trial treatment once they areenrolled on MK-3475-587 if any of the following criteria applies:
    • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
    • Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.
    • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
    • Has known active central nervous system metastases and/or carcinomatous meningitis.
    • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
    • Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
    • Has an active infection requiring systemic therapy.
    • Has a known history of human immunodeficiency virus (HIV) infection.
    • Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
    • Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
    • Has hepatic decompensation (Child-Pugh score >6 [class B and C]).
    • Has uncontrolled thyroid dysfunction.
    • Has uncontrolled diabetes mellitus.
    • Has had an allogeneic tissue/solid organ transplant.
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis).Additional exclusion criteria for participants who enter dosing with Lenvatinib:
    • Has had major surgery within 3 weeks prior to first dose of study intervention(s).
    • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
    • Has urine protein ≥1 g/24 hours.
    • Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
    • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
    • Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to >480 ms.
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
    • Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
    • Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
    • Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.

    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 Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRC1 Carriers. - NCT04251052

    Primary Objective: - To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germline mutations. Secondary Objectives: - To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACT-ES subscale compared to women in the BSO arm. To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients. - To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice. - To assess adverse events, graded using CTCAE v5.0.

    View All Details
    • Protocol Number:
      102005

    • Principal Investigator:
      Eugenia Girda

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Individuals 35-50 years of age, inclusive
    • Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
    • At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
    • Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
    • Patients may be premenopausal or menopausal
    • Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) and CA-125 within 180 days of registration
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
    • Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future

    Exclusion Criteria:

    • Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.
    • Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
    • Patients medically unfit for the planned surgical procedure
    • Patients with abnormal screening tests (pelvic ultrasound, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days
    • An abnormal pelvic ultrasound is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary
    • An abnormal CA-125 is defined as a level > 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals

    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.

    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
  • A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer. - NCT05226507

    Primary Objective: - To identify the MTD and dose for Part B by: Evaluating the safety profile of escalating doses and different schedules of NXP800. Identification of DLTs. Secondary Objective: - To evaluate the PK profile of NXP800. Exploratory Objectives: - To describe the antitumor activity of NXP800 in various tumor types. - To describe the effect of NXP800 on tumor markers (where applicable). - To describe the treatment effect of NXP800 on pharmacodynamic markers.

    View All Details
    • Protocol Number:
      052306

    • Principal Investigator:
      Eugenia Girda

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      NXP800

    Read Inclusion & Exclusion Criteria

    Part A Inclusion Criteria:

    • Provide written informed consent.
    • 18 years old or older.
    • Life expectancy of at least 12 weeks.
    • Histologically- or cytologically-confirmed, advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator (in Part B, subjects with specific cancer types will be enrolled; Specific criteria will be introduced in a protocol amendment).
    • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
    • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

    Part A Exclusion Criteria:

    • Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
    • Ongoing toxic manifestations of previous treatments > Grade 2.
    • Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 28 days after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
    • Female subjects who can become pregnant (or are already pregnant or lactating).
    • Male subjects with partners of childbearing potential (unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence).

      Part B Inclusion Criteria:

      • Provide written informed consent.
      • 18 years old or older.
      • Subjects with the following ARID1a mutated, ovarian/fallopian tube/primary peritoneal cancer histologies (ARID1a mutation status determined by a DNA-based Next Generation Sequencing test):
      • Clear cell ovarian carcinoma (≥ 50% clear cell carcinoma with no serous differentiation)
      • Endometrioid ovarian carcinoma
      • Subjects must have disease progression within 6 months (182 days) from completion of platinum-based therapy (6 months should be calculated from the date of the last administered dose of platinum therapy to the date of radiographic imaging showing progression)
      • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
      • Subjects with a BRCA mutation must have received prior treatment with a PARP inhibitor.
      • Subjects must have received at least 1 but not more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab.
      • Adjuvant + neoadjuvant are considered one line of therapy
      • Maintenance therapy (i.e., bevacizumab, PARP inhibitors) will be considered as part of the preceeding line of therapy and are not counted independently.
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
      • Subjects must have a sufficient archival Formalin-Fixed Paraffin-Embedded (FFPE) tissue specimen, or be willing to consent to a fresh tissue biopsy during the study.

      Part B Exclusion Criteria:

      • Subjects with disease that did not respond to, or has progressed during or within 4 weeks of the last dose of first-line platinum containing chemotherapy.
      • Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800.
      • Ongoing toxic manifestations of previous treatments > Grade 2, with the exception of alopecia.
      • Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 12 weeks while off corticosteroids after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
      • Female subjects who can become pregnant (or are already pregnant or lactating).

    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 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkins Lymphoma. - NCT06393738

    Primary Objective: To evaluate the safety and tolerability of ARV-393, determine MTD if necessary, and identify the RP2D(s) and dosing schedule. Secondary Objective: - To characterize the pharmacokinetic profile of ARV-393 in plasma, - To assess the preliminary anti-tumor activity of ARV-393.

    View All Details
    • Protocol Number:
      012406

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      Early Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      ARV-393

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Eligible participants aged ≥18 years.
    • Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 prior systemic therapies, or histologically confirmed AITL that has recurred or progressed following institutional standard-of-care therapy.
    • Participants must also have ≥1 measurable lesion at study entry
    • Eastern Cooperative Oncology Group performance status of 0 or 1,
    • Freshly biopsied or archival tumor tissue available,
    • Participants with adequate organ function,
    • Participants must accept and follow pregnancy prevention guidance.

    Exclusion Criteria:

    • No prior allogeneic stem cell transplant or solid organ transplantation, Autologous stem cell transplant, must not have occurred ≤100 days, previous CAR T-cell therapy ≤60 days, radiotherapy ≤ 2 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, prior to ARV-393 treatment initiation.
    • Participants must not have significant acute or chronic medical illness, including hypereosinophilic syndrome, active interstitial lung disease or pneumonitis, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
    • Participants with an inability to comply with listed prohibited treatments.

    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.

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