81 results
Page of 7
  • 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

    • Principal Investigator:
      Matthew Deek

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Pancreas

    • Therapies Involved:
      Chemotherapy single agent systemic Radiotherapy

    • Drugs Involved:
      M3814 (peposertib)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must have pathologically confirmed pancreatic adenocarcinoma
    • Received 4-6 months of induction chemotherapy with fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), fluorouracil, liposomal irinotecan, luecovorin, oxaliplatin (NALIRIFOX), 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, unless the change in treatment was made only for toxicity
    • 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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Rutgers Cancer Institute
  • A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. - NCT06385080

    Primary: - To assess anti-tumor activity of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. Secondary: - To further assess anti-tumor activity of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor - To characterize safety and tolerability of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. - To characterize PK of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.

    View All Details
    • Protocol Number:
      032405

    • Principal Investigator:
      Missak Haigentz

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Lip, Oral Cavity and Pharynx

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

    • Drugs Involved:
      Amivantamab CARBOPLATIN PACLITAXEL Pembrolizumab (MK-3475)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies. Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (a) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (b) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (c) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (c) Participants must provide local testing results of PD-L1 status
    • Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1
    • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes [any grade], Grade less than or equal to [<=]2 peripheral neuropathy and Grade <=2 hypothyroidism stable on hormone replacement)
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    • Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test.Participants should have: a) Hemoglobin >=9 grams per deciliter (g/dL); b) Neutrophils>=1.5 x 10^3/mcg; c) Platelets >=100 x 10^3/mcg

    Exclusion Criteria:

    • Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
    • Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
    • Participant with a history of clinically significant cardiovascular disease
    • Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
    • Received radiotherapy for palliative purposes within 7 days of the first administration of study 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.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute
  • A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE). - NCT05563220

    Phase I - Primary Objective: Determine the recommended Phase 2 dose (RP2D) of elacestrant in combination with each of the other study drugs. Phase I - Secondary: - Characterize the safety of elacestrant in combination with each of the other study drugs. Describe the plasma (blood for everolimus) pharmacokinetics (PK) of elacestrant and each of the combination drugs and their major metabolites and explore any potential drug-drug interactions. - Evaluate the efficacy of elacestrant in combination with each of the other study drugs for overall response rate (ORR) as per RECIST v. 1.1, duration of response (DoR), clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS). Phase II-Primary Objective: - Evaluate the efficacy of elacestrant in combination with each of the other drugs for PFS. Phase II - Secondary Objectives: - Evaluate the efficacy of elacestrant in combination with each of the other drugs for additional efficacy endpoints. - Further, characterize the safety of elacestrant in combination with each of the other study drugs.

    View All Details
    • Protocol Number:
      042305

    • Principal Investigator:
      Mridula A George

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Alpelisib Elacestrant Palbociclib RAD001 (Everolimus)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Patient has signed the informed consent before all study specific activities are conducted. 2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female patients may be of any menopausal status.
    • Postmenopausal status is defined by: 1. Age ≥60 years 2. Age <60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or a follicle-stimulating hormone (FSH) value >40 mIU/mL and an estradiol value<40 pg/mL (140 pmol/L) or in postmenopausal ranges per local reference ranges 3. Documentation of prior surgical sterilization (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, at least 1 month before first dose of trial therapy).
    • Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist initiated at least 4 weeks before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment.
    • For perimenopausal women to be considered of non-childbearing potential, FSH levels must be >40 mIU/ml. 3. Histopathological or cytological confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists(CAP) guidelines (Allison et al, 2020, Wolff et al, 2018). Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without PGR positivity. . 4. At least 1 not previously irradiated measurable lesion as per RECIST version 1.1 and/or at least 1 lytic or mixed (lytic +sclerotic) bone lesion with identifiable soft tissue components meeting the definition of measurability by RECIST version 1.1 that can be evaluated by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible. 5. ECOG performance status of 0 or 1. 6. Patient has adequate bone marrow and organ function, as defined by the following laboratory values: 1. Absolute neutrophil count (ANC) ≥1.5 × 10^9/L 2. Platelets ≥100 × 10^9/L 3. Hemoglobin ≥9.0 g/dL 4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE grade ≤1 5. Creatinine is ≤ 1.5 x ULN or if creatinine is > 1.5 x ULN, then creatinine clearance must be ≥50 mL/min based on the Cockcroft-Gault formula. Note: C-G formula:
    • Creatinine clearance (male) = ([140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72)
    • Creatinine clearance (female) = (0.85 × [140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72) 6. Serum albumin ≥3.0 g/dL (≥30 g/L) 7. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN. If the patient has liver metastases, ALT and AST ≤ 5 × ULN 8. Total serum bilirubin <1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.

    Exclusion Criteria:

      1. Active or newly diagnosed CNS metastases, including meningeal carcinomatosis. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be ≤2.0 mg/day of dexamethasone or equivalent. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. 2. Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement >50%. 3. Prior chemotherapy or elacestrant in the advanced/metastatic setting. 4. Patients with known germline BRCA mutation without prior treatment with a PARP inhibitor before study entry. 5. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERM), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysis-targeting chimeras (PROTACs), in the metastatic setting. Prior treatment with fulvestrant is not exclusionary as it is an approved medication. 6. Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy. Other malignancies with low risk of recurrence may be considered eligible with Sponsor approval. 7. Uncontrolled significant active infections. • Patients with HBV and/or HCV infection must have undetectable viral load during screening. • Patients known to be HIV+ are allowed if they have undetectable viral load at baseline. 8. Documented pneumonitis/ILD prior to Cycle 1 Day 1. 9. Major surgery within 28 days before starting trial therapy. 10. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug. 11. Known intolerance to elacestrant or any of its excipients. 12. Pregnant and breast-feeding women are excluded from the study. In addition, women of childbearing potential are excluded who: • Within 28 days before starting trial therapy, did not use a highly effective method of contraception. • Do not agree to use a highly effective method of contraception (Appendix F) or abstain from heterosexual intercourse throughout the entire study period and for 120 days after trial therapy discontinuation. 13. Men or women who do not agree to abstain from donating sperm or ova, or to use a highly effective method of contraception, during the course of the treatment period and for 120 days after the last dose of study treatment. 14. Patient is currently receiving or received any of the following medications prior to first dose of trial therapy: • Anti-cancer therapy within 14 days (28 days for anticancer antibody based treatment) or 5 half-lives, whichever is shorter. Please note: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2). • Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter, (refer to http://medicine.iupui.edu/clinpharm/ddis/ or https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-inter actions-table-substrates-inhibitors-and-inducers). • Herbal preparations/medications within 7 days. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. • Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to randomization. 15. Evidence of ongoing alcohol or drug abuse as assessed by the investigator. 16. Any severe medical or psychiatric condition that, in the Investigator's opinion, would preclude the patient's participation in a clinical study.Additional Eligibility for the Alpelisib Combination (Phase 1b and Arm A)

      Inclusion:

        In general, the SmPC of the respective combination drug should be consulted forinstructions/restrictions with respect to interactions with concomitant medications. 1. PIK3CA mutation by local laboratory assessment. 2. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.Exclusion: 1. Prior therapy with alpelisib or any other PI3K inhibitor. 2. Type 1 diabetes or uncontrolled type 2 diabetes (fasting plasma glucose level of >140 mg/dL [7.7 mmol/L], or glycosylated hemoglobin [HbA1c] level of >6.4%). 3. Known intolerance to alpelisib or any of its excipients. 4. Patient is currently receiving or received drugs known to be a BCRP inhibitor within 14 days or 5 half-lives, whichever is shorter, prior to first dose of trial therapy 5. Patient has ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumabAdditional Eligibility for the Everolimus Combination (Phase 1b and Arm B)

        Inclusion:

          1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.Exclusion: 1. Prior therapy with everolimus. 2. Known intolerance to everolimus or any of its excipients.Additional Eligibility for the Abemaciclib Combination (Arm C)

          Inclusion:

            1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.Exclusion: 1. Prior therapy with abemaciclib in the advanced or metastatic setting. Adjuvant therapy with abemaciclib is exclusionary if the patient relapsed within the past 12 months. 2. Known intolerance to abemaciclib or any of its excipients.Additional Eligibility for the Ribociclib Combination (Phase 1b and Arm C)

            Inclusion:

              1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.Exclusion: 1. Prior therapy with ribociclib in the metastatic setting. Prior adjuvant therapy with ribociclib is also exclusionary if the patient relapsed within the past 12 months. 2. Known intolerance to ribociclib or any of its excipients. 3. QTcF values ≥450 msec. 4. Patients who already have or who are at significant risk of developing QTc prolongation, including patients with:
            • Long QT syndrome
            • Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
            • Electrolyte abnormalities 5. Patient is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.Additional Eligibility for the Palbociclib Combination (Phase 1b)

              Inclusion:

                1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.Exclusion: 1. Prior therapy with palbociclib in the metastatic setting. 2. Known intolerance to palbociclib or any of its excipientsAdditional Eligibility for the Palbociclib Combination (Arm D)

                Inclusion:

                  1. One or up to two prior hormonal therapies in the advanced or metastatic setting.Exclusion: 1. Prior therapy with a CDK4/6i in the metastatic setting. 2. Known intolerance to palbociclib or any of its excipients.Additional Eligibility for the Abemaciclib Combination (Arm D)

                  Inclusion:

                    1. One or up to two prior hormonal therapies in the advanced or metastatic setting.Exclusion: 1. Prior therapy with any CDK4/6i in the metastatic setting. 2. Known intolerance to abemaciclib or any of its excipients.Additional Eligibility for Ribociclib Combination (Arm D)

                    Inclusion:

                      1. One or up to two prior hormonal therapies in the advanced or metastatic setting.Exclusion: 1. Prior therapy with a CDK4/6i in the advanced or metastatic setting. 2. Known intolerance to ribociclib or any of its excipients. 3. QTcF values ≥450 msec. 4. Patients who already have or who are at significant risk of developing QTc prolongation, including patients with:
                    • Long QT syndrome
                    • Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
                    • Electrolyte abnormalities 5. Patient is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.

    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
    • Monmouth Medical Center
    • Community Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
  • A Phase 2, Open-Label Study of PCS6422 with Capecitabine in Patients with Advanced or Metastatic Breast Cancer. - NCT06568692

    Primary: - To assess the antitumor activity of PCS6422 administered with Cap in patients with advanced or metastatic breast cancer - To assess the safety and tolerability of PCS6422 administered with Cap in patients with advanced or metastatic breast cancer - To determine the optimal dosage regimen of PCS6422 administered with Cap in patients with advanced or metastatic breast cancer for use in a pivotal study - To To further characterize and evaluate the exposure-AE relationships of PCS6422 with Cap - To further characterize and evaluate the exposure-efficacy relationships of PCS6422 with Cap Secondary: - To further assess the antitumor activity of PCS6422 administered with Cap in patients with advanced or metastatic breast cancer - To assess survival benefits of PCS6422 administered with Cap - To evaluate the incidence of adverse events of special interest (AESIs) - To characterize the effect of PCS6422 on DPD activity during Cap dosing and the pharmacokinetic (PK) profiles of Cap, 5-FU, and the quantifiable main metabolite (FBAL) - To characterize the PK of PCS6422

    View All Details
    • Protocol Number:
      042407

    • Principal Investigator:
      Mridula A George

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CAPECITABINE PCS6422

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Aged ≥18 years at Screening 2. Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included: 1. Patients with triple-negative breast cancer, advanced or metastatic 2. Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer 3. Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1 4. Other therapies are not indicated (eg, resistant or intolerant to taxanes and/or an anthracycline-containing regimen) for treatment of advanced or metastatic breast cancer 5. Has a life expectance of at least 24 weeks 6. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening 7. Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before C1D1 (Note: labs will also be repeated pre-dose on C1D1 to confirm eligibility): a. Hemoglobin ≥9 g/dL (≥90 g/L) b. Adequate renal function by estimated glomerular filtration rate (eGFR) defined as a creatinine clearance >50 mL/min (>0.84 mL/s) (Cockcroft-Gault equation) and normalized to body surface area c. Peripheral absolute neutrophil count (ANC) of ≥1.5×109/L d. Platelet count of ≥100×109/L without growth factor/transfusion e. Total bilirubin <1.5× upper limit of normal (ULN); or ≤3×ULN if the patient has Gilbert's disease f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5×ULN, with liver metastasis <5×ULN g. International normalized ratio (INR) <1.5 and prothrombin time (PT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant h. Activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or PTT is within therapeutic range of intended use of anticoagulants

    Exclusion Criteria:

      1. Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization 2. Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization 3. Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1 4. Received DPD inhibitor within 4 weeks prior to C1D1 5. Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity 6. Cardiac: 1. Has history or presence of clinically significant abnormal 12-lead electrocardiogram (ECG) results, in the Medical Monitor or Investigator's opinion 2. Has prolonged QTc (with Fridericia's correction) of >480 msec performed at Screening 3. Has a history of prolonged QTc interval, ventricular tachycardia/fibrillation or significant ventricular arrhythmia, or Torsades de Pointes, or a history of ventricular ablation for arrhythmia 4. Has congenital long QT syndrome or a family history of long QT syndrome 5. Has other clinically significant cardiac disease including, but not limited to, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery ≤12 months prior to randomization, congestive heart failure
    • Class II per the New York Heart Association, or history of myocarditis 7. Is pregnant or breastfeeding

    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
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • RWJ University Hospital Somerset
    • Trinitas Regional Medical Center – Williamson Street Campus
  • A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. - NCT05498428

    Primary Objective: To assess the anti-tumor activity of amivantamab SC-CF (Cohorts 1, 2, and 3) in combination treatment.. Secondary Objectives: - To characterize the safety of amivantamab SC-CF (Cohorts 1, 2, and 3). - To assess additional measures of anti-tumor activity of amivantamab SC-CF (Cohorts 1, 2, and 3). - To assess amivantamab PK (Cohorts 1, 2, and 3). Exploratory Objectives: - To assess the relationship between PK or immunogenicity and selected endpoints including but not limited to efficacy and safety. - To assess the immunogenicity to rHuPH20 in participants treated with amivantamab SC-CF (Cohorts 1, 2, and 3).

    View All Details
    • Protocol Number:
      032212

    • Principal Investigator:
      Missak Haigentz

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

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

    • Drugs Involved:
      Amivantamab CARBOPLATIN Lazertinib PEMETREXED

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
    • All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy
    • May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
    • Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions
    • Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
    • Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment
    • A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility

    Exclusion Criteria:

    • Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis
    • Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort
    • Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary
    • For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1
    • Other clinically active liver disease of infectious origin
    • Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan
    • Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone or equivalent) for at least 2 weeks prior to treatment allocation

    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
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute
  • A Phase 2b, Open-Label, Two-Cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-Line Treatment for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. - NCT06667076

    The primary objective of this study is to assess the antitumor activity of amivantamab SC and lazertinib (Cohort 1), and amivantamab SC and chemotherapy (Cohort 2) in participants with EGFRm NSCLC. Overall safety and tolerability will be assessed as a secondary objective. Secondary Objective is to assess the safety and tolerability of amivantamab SC (Cohorts 1 and 2) and lazertinib (Cohort 1 only) in EGFRm NSCLC patient populations.

    View All Details
    • Protocol Number:
      032409

    • Principal Investigator:
      Missak Haigentz

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Amivantamab Lazertinib

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
    • Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
    • Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
    • Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia [any grade], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)
    • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

    Exclusion Criteria:

    • Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
    • Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
    • Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
    • Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
    • Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

    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
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Somerset
    • Trinitas Regional Medical Center – Williamson Street Campus
  • A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants with Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1) - NCT06356129

    Primary: To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the Investigator. Secondary (efficacy): To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the IRAC. To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to OR as assessed by the Investigator. To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to CMR as assessed by the Investigator To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS24. To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to DoR. To evaluate the efficacy of treatment with golcadomide plus R-CHOP vs placebo-RCHOP on overall survival in participants with untreated high-risk large B-cell lymphoma with respect to PFS2. To evaluate the exposure of CHOP cytotoxic components (cyclophosphamide, doxorubicin, vincristine) in golcadomide plus R-CHOP vs placebo plus R-CHOP in participants with untreated high-risk large-B-cell lymphoma with respect to relative dose intensity (RDI). To compare the disease symptoms, functioning, and overall HRQoL of golcadomide plus R-CHOP vs placebo-RCHOP in participants with untreated high-risk large B-cell lymphoma as measured by the EORTC QLQ-C30 and the FACT-LymS Secondary (Safety): To evaluate the safety of golcadomide plus RCHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma.

    View All Details
    • Protocol Number:
      012407

    • Principal Investigator:
      Yun Kyoung Tiger

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Golcadomide

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinalcenter B-cell (GCB) and activated B-cell (ABC) types]ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2double-hit lymphomas)iii) High-grade B-cell lymphoma, not otherwise specifiediv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)v) Epstein-Barr virus + DLBCL
    • International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) > 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
    • Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
    • Must have Ann Arbor Stage II-IV disease.

    Exclusion Criteria:

    • Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
    • Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
    • Documented or suspected central nervous system (CNS) involvement by lymphoma.
    • Other protocol-defined Inclusion/Exclusion criteria apply.

    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
    • Monmouth Medical Center
    • Community Medical Center
  • A Phase 3, Randomized, Open-Label, Controlled Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination with Physician's Choice Chemotherapy, for the Treatment of Participants with Metastatic HER2-Positive Breast Cancer. - NCT06435429

    Primary: Compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy Secondary: Further compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy

    View All Details
    • Protocol Number:
      042406

    • Principal Investigator:
      Coral Omene

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      TRASTUZUMAB Zanidatamab

    Read Inclusion & Exclusion Criteria

    Participants are eligible to be included in the study only if all of the followingcriteria apply: 1. Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent. 2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a central laboratory 3. Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment. 4. Has measurable disease per RECIST version 1.1. 5. Is eligible to receive one of the chemotherapy options listed in the physician's choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine). 6. Participants with history of treated or clinically inactive CNS metastases are eligible as specified in the protocol. 7. Has a life expectancy of at least 6 months, in the opinion of the investigator. 8. Has adequate hematologic parameters as defined in the protocol. 9. Has adequate hepatic function as specified in the protocol. 10. Has creatinine clearance ≥ 30 mL/minute as calculated per local institutional guidelines. 11. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4 weeks before the first dose of study intervention. 12. Has ECOG performance status of 0 or 1. 13. Participant agrees to the following based on sex assigned at birth. 1. Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer:
    • Refrain from donating fresh unwashed semen.
    • Use contraception as follows as specified in the protocol 2. Female participants:
    • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
    • Is a women of nonchildbearing potential OR
    • Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), with low user dependency during the study intervention period and for at least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer.
    • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 3 days before the first dose of study intervention.
    • Additional requirements for pregnancy testing during and after study intervention are provided in the protocol.
    • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. 14. Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.Participants are excluded from the study if any of the following criteria apply:Medical Conditions 1. Has known or suspected leptomeningeal disease. 2. Has uncontrolled or significant cardiovascular disease. 3. Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1, with exceptions as stated in the protocol. 4. Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 5. Has known HIV infection. 6. Has active hepatitis B or C infection. 7. Has an active SARS-CoV-2 infection. Participants with prior infection that has resolved per local institutions' requirements and screening guidance are eligible. 8. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab. 9. Is unable to receive trastuzumab treatment due to medical contraindications. 10. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site. 11. Has any condition that would prevent treatment with the physician's choice of chemotherapy. 12. Has any issue or condition that in the opinion of the investigator would contraindicate the participant's participation in the study or confound the results of the study. Prior/Concomitant Therapy 13. Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation. 14. Was treated with any local or systemic antineoplastic therapy (including hormonal therapies for breast cancer) or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization. 15. Has a history of trauma or major surgery within 4 weeks prior to randomization. Other Exclusions 16. Has a known hypersensitivity to any components of the study drugs, including chemotherapy. 17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.

    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
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Trinitas Regional Medical Center – Williamson Street Campus
  • 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:
      IPILIMUMAB (MDX-010) Opdivo (Nivolumab)

    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
  • A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer. - NCT05467891

    Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer (EBC). Secondary Objectives: - To estimate distant metastasis-free survival - To estimate overall survival (OS). - To evaluate safety and tolerability - To identify predictors of loco-regional recurrence. Exploratory Objectives: - To explore prognostic and predictive biomarkers of treatment with ribociclib and ET. - To explore potential molecular mechanisms of resistance to study treatment. - To explore the correlation of molecular landscape of recurrence with clinical endpoints (e.g., PIK3CA mutations, ESR1 mutations).

    View All Details
    • Protocol Number:
      042208

    • Principal Investigator:
      Coral Omene

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Ribociclib (KISQALI)

    Read Inclusion & Exclusion Criteria

    Eligibility Criteria to Collect Optional Correlative Blood and Tissue at Local Recurrence
    • Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
    • Male or female age ≥ 18 years at the time of consent.
    • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
    • Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.
    • Patient has locoregional recurrence of breast cancer: locoregional recurrence is defined as invasive recurrence in the ipsilateral breast, axilla, regional nodes, or chest wall.

      Inclusion Criteria for Treatment Phase:

        Subject must meet all of the following applicable inclusion criteria to participate inthis study:
      • Written informed consent (stage II/ main consent) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
      • Male or female age ≥ 18 years at the time of consent. NOTE: Both pre- and post-menopausal women are eligible. Post-menopausal status is defined as:
      • Prior bilateral oophorectomy
      • Age ≥60
      • Age <60 and amenorrhea for the last 12 or more months(in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range.
      • ECOG Performance Status of 0-1 within 28 days prior to registration.
      • If patient is receiving tamoxifen or toremifene, a washout period of 5 half-lives (i.e. 35 days) prior to registration is required (during that period the participant can take AI).
      • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
      • Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.
      • Patients have had adequate local treatment for locoregional recurrence (LRR) of breast cancer.
      • Locoregional recurrence is defined as recurrence in the ipsilateral breast, axilla, regional lymph nodes, or chest wall.
      • Local treatment is defined as either surgery, radiation therapy, or a combination of both if indicated.
      • Adequate local therapy is surgery with negative microscopic margins. Radiation therapy is mandated for patients with microscopically involved margins and recommended for all patients who had not received radiotherapy as part of their primary treatment.
      • Patients who have distant metastatic disease will not be eligible.
      • Prior treatment with neoadjuvant and adjuvant chemotherapy and ET is allowed.
      • Patients must enroll within 6 months of the last local treatment, either local surgery or radiation; or systemic chemotherapy (if patient is receiving chemotherapy), whichever occurred last. Chemotherapy after local therapy is allowed. ET for recurrent disease is allowed for up to 12 months prior to enrollment.
      • Patient has no contraindication to the adjuvant ET in the trial and is planned to be treated or continue treatment with ET.
      • Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
      • Hematological
      • Absolute Neutrophil Count (ANC): ≥ 1.5 x 109/L
      • Platelets: ≥ 100 x 109/L
      • Hemoglobin (Hgb): ≥ 9.0 g/dL
      • Renal
      • --Estimated glomerular filtration rate (eGFR): ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula
      • Hepatic
      • Bilirubin: ≤ upper limit of normal (ULN) except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN
      • Aspartate aminotransferase (AST): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the AST is < 5 × ULN
      • Alanine aminotransferase (ALT): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the ALT is < 5 × ULN
      • Coagulation
      • --International Normalized Ratio (INR) : ≤ 1.5 × ULN (unless is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug)
      • Electrolytes ---Potassium, Magnesium, and Total Calcium (corrected for serum albumin): Within normal limits or corrected to within normal limits with supplements.
      • Standard 12-lead ECG values defined as
      • QTcF interval at screening < 450 msec (QT interval using Fridericia's correction)
      • Resting heart rate 50-90 bpm (determined from the ECG)
      • Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration and must be willing to use a highly effective method of contraception that does not contain estrogen and/or progesterone. See the protocol for definition of childbearing potential.
      • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
      • Ability to swallow and retain oral medication.

      Exclusion Criteria for Treatment Phase:

        Subjects meeting any of the criteria below may not participate in the study:
      • Patient with a known hypersensitivity to any of the excipients of ribociclib.
      • Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
      • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
      • Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
      • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.
      • Patients with distant metastases of breast cancer beyond regional lymph nodes as defined by AJCC (8th edition).
      • Treatment with any investigational drug within 30 days prior to registration or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. Enrollment or planned enrollment in another study that does not involve an investigational drug will be allowed at the discretion of the treating investigator.
      • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
      • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, HIV, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). Testing to be done at investigator's discretion.
      • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
      • History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry
      • Documented cardiomyopathy
      • History of Left Ventricular Ejection Fraction (LVEF) < 50%
      • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
      • Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
      • Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug)
      • Inability to determine the QTcF interval
      • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
      • Systolic Blood Pressure (SBP) >160 or <90 mmHg
      • Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:
      • Concomitant medications, herbal supplements, and/or fruits (e.g., grapefruit, pummelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5,
      • Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
      • Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: a short duration (<5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
      • Patient with an uncontrolled psychiatric condition that, in the investigator's judgment, may cause unacceptable safety risks, impede research integrity and compliance, or interfere with the objectives 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.

    • Cooperman Barnabas Medical Center
  • A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients with Unresectable Heptocellular 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 participants perspective. Exploratory Objectives: 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

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

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

    • Drugs Involved:
      Atezolizumab (MPDL3280A) BEVACIZUMAB

    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 participants
    • 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
    • Absolute neutrophil count ≥1.0 x 109/L (≥1000/μL) without granulocyte colony-stimulating factor support
    • Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
    • Hemoglobin ≥ 80 g/L (8 g/dL) AST and ALT ≤ 5 × upper limit of normal (ULN)
    • Serum bilirubin ≤ 3 × ULN
    • Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
    • Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
    • INR ≤2.3

    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
    • Participants 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.
    • Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded.
    • 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
    • Actively 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
    • Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment
    • History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B.
    • Diagnostic Paracentesis is allowed. Therapeutic Paracentesis within 3 months is an exclusion criteria
    • Participants with ascites controlled on diuretics are allowed.
    • 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.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute
  • A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-ZZFX (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma. - NCT05256225

    Primary: Phase II: Progression Free Survival To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed progression free survival (PFS) as assessed by RECIST 1.1. The two experimental arms (Arms 2 and 3) will be compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other. Phase III: Overall Survival To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed overall survival (OS). The two experimental arms (Arms 2 and 3) will be compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other. Secondary: - To evaluate the overall response rate (ORR) in patients with measurable disease. The ORR will be defined as the binomial proportion of evaluable patients with a best overall response of CR or PR (by RECIST 1.1) within 12 months of initiating maintenance therapy. - To evaluate the duration of objective response in patients with measurable disease as assessed by RECIST 1.1. - To determine the nature, frequency and degree of toxicity as assessed by CTCAE v.5.0 for each treatment arm. - To compare QOL, as measured by FACT-En-TOI, in the experimental versus control arms. - To compare patient-reported treatment-associated symptoms (diarrhea and rash) as measured with the PRO -CTCAE, patient-reported fatigue as measured with the PROMIS-Fatigue short form, and worry concerning side effects of treatment as measured by the item bothered by side effect , in the FACT-En TOI, respectively, in the experimental and control arms. - To assess the correlation of HER2 IHC expression and ISH amplification with clinical outcome and response to HER2 targeted therapies. Exploratory Objectives: To explore time to sustained deterioration in quality of life, as measured by a drop in the FACT-En-TOI by 6 or more points lasting for more than one PRO time point, in the experimental and control arms.

    View All Details
    • Protocol Number:
      102301

    • Principal Investigator:
      Eugenia Girda

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CARBOPLATIN Hyaluronidase-oysk PACLITAXEL Pertuzumab TRASTUZUMAB

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IVB, non-recurrent, chemotherapy (chemo)-naive, HER2-positive endometrial cancer. The following endometrial cancer types are eligible:
    • Serous
    • Other endometrial cancers (including clear cell, endometrioid, mixed epithelial, dedifferentiated/undifferentiated)
    • Carcinosarcoma
    • NOTE: Endometrial cancers that are mismatch repair deficient (dMMR) by IHC are not eligible
    • Histologic confirmation of the original primary tumor is required. Submission of surgical pathology report (or endometrial biopsy pathology report in patients who never undergo hysterectomy) is required
    • Patients must be within 8 weeks of primary surgery (or endometrial biopsy in patients who never undergo hysterectomy) at the time of study registration
    • Patients may have measurable disease, non-measurable disease, or no measurable disease. In patients with measurable disease, lesions will be defined and monitored by RECIST v 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by CT or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
    • For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium. Any amount of myoinvasion is acceptable for eligibility. Patients with non-invasive disease, endometrial intraepithelial carcinoma alone, or disease confined to a polyp will be excluded
    • All patients must have tumors that are HER2 positive as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 Breast Cancer guidelines (https://documents.cap.org/documents/algorithim-evaluation-her2.pdf.) IHC and ISH testing will be done locally, at each participating institution and interpreted by local pathologists. In general HER2 positivity is defined as any of the following:
    • 3+ immunohistochemistry (IHC),
    • 2+ IHC with positive in situ hybridization (ISH) Alternatively, patients could be eligible if next generation sequencing (NGS) demonstrates HER2 (ERBB2) amplification. NGS testing can be performed through any designated labs as per the National Cancer Institute (NCI) MATCH/NCI Combo-MATCH trial (https://ecog-acrin.orgci-match-eay131-designated-labs).Pathology report showing results of institutional HER2 testing (or NGS testing results)must be submitted.Sites must submit all results available (IHC, ISH, and NGS)
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    • Age >= 18
    • Platelets >= 100,000/mcl (within 14 days prior to registration)
    • Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration)
    • Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) or estimated Glomerular filtration rate (eGFR) >= 50 mL/min using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR) (within 14 days prior to registration)
    • Total serum bilirubin level =< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled) (within 14 days prior to registration)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to registration)
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
    • Although the uterus will have been removed in the vast majority of patients, for patients of child-bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. Patients will be considered of non-reproductive potential if they are either:
    • Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR
    • Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to registration
    • Have a congenital or acquired condition that prevents childbearing
    • 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 evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load 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 are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

    Exclusion Criteria:

    • Prior Therapy:
    • Patients must NOT have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma
    • Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation includes external beam pelvic radiation therapy, external beam extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy
    • NOTE: Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment. Planned use of vaginal brachytherapy must be declared at time of registration
    • Patients may have received prior hormonal therapy for treatment of endometrial carcinoma. All hormonal therapy must be discontinued at least one week prior to registration
    • Patients may not have a planned interval cytoreduction or hysterectomy, prior to documentation of progression, after study registration
    • Patients may not have planned external beam radiotherapy, prior to documentation of progression, after study registration
    • Significant cardiovascular disease including:
    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications
    • Myocardial infarction or unstable angina within 6 months prior to registration
    • New York Heart Association functional classification II, III or IV
    • Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate
    • Significant lung disease: dyspnea at rest grade 2 or greater (resulting from extensive tumor involvement or other causes), pneumonitis grade 2 or greater, interstitial lung disease grade 2 or greater, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)
    • Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), uncontrolled interstitial lung disease, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
    • Treatment with strong CYP2C8 or CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to registration
    • Women who are unwilling to discontinue nursing

    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
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
Page of 7