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

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

    View All Details
    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

      1. Inability to provide written informed consent

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1b Dose-Escalation Study of the Safety and Pharmacokinetics of Fixed-Dose PCS6422 with Escalating Doses of Capecitabine Administered Orally to Patients with Advanced, Refractory Gastrointestinal Tract Tumors. - NCT04861987

    Primary Objectives: 1. To evaluate the safety, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of capecitabine administered to patients with advanced, refractory gastrointestinal tract (GI) tumors using a 7 days on + 7 days off capecitabine regimen ~24 hours after a single, fixed, oral 40 mg dose of PCS6422. 2. To characterize the PK profiles of capecitabine, 5-FU, and the quantifiable main metabolites FBAL in plasma. Secondary Objectives: 1. To characterize the PK profile of PCS6422 and its major metabolite 5-acetyluaracil. 2. To evaluate the DPD enzyme activity over time after a single dose of PCS6422 by using the ratio of dihydrouracil to uracil as a surrogate to enzyme activity or an analytical method for DPD activity still to be developed. 3. To evaluate the effect of PCS6422 on QT corrected for heart rate (QTc) 4. To evaluate the incidence of adverse events of special interest (AESI), including the incidence of hand-foot syndrome (HFS).

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    • Protocol Number:
      072104

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Small Intestine,Stomach,Other Digestive Organ

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      PCS6422 CAPECITABINE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Has advanced, metastatic or unresectable GI tract tumors that are refractory or intolerant to existing available therapies and for whom the investigator recommends fluoropyrimidine monotherapy. 2. Has measurable disease in accordance with Respond Evaluation Criteria in Solid Tumors (RECIST) guidelines (Version 1.1). 3. Is aged ≥18 years 4. Has not received treatment with intravenous (IV) 5 FU or oral 5 FU analogs in the 4 weeks preceding enrollment 5. Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at study entry 6. Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment: 1. peripheral ANC of ≥1.5 × 109/L 2. platelet count of ≥75 × 109/L without growth factor/transfusion 3. hemoglobin ≥8.5 g/dL without growth factor/transfusion 4. estimated glomerular filtration rate >50 mL/min 5. total bilirubin <2 × upper limit of normal (ULN); <5 × ULN if patient has liver metastases, biliary tract cancer; or ≤3 × ULN if the patient has Gilbert's disease 6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN, with liver metastasis <5 × ULN 7. international normalized ratio (INR) <1.5 7. Has a life expectancy of at least 12 weeks 8. Female patients of childbearing potential and male patients with partners capable of reproduction must agree to use an effective contraceptive method from the time of Screening through 60 days after the last dose of capecitabine 9. Females of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test result 10. Willingly provides written, informed consent. 11. Has resolution or stabilization of acute toxicity from prior therapy to Grade <2 - except Grade 2 neuropathy 12. If patient has human immune deficiency virus (HIV) infection, it is controlled with undetectable viral load with antiretroviral treatment. 13. If patient has hepatitis C infection and received antiviral treatment, has a negative viral load at Screening 14. If patient has chronic hepatitis B infection and is receiving antiviral treatment, has a negative viral load at Screening. 15. Is willing and able to comply with all protocol required visits and assessments

    Exclusion Criteria:

      1. Is unable to take oral medication or malabsorption syndromes potentially interfering with medication absorption (e.g., short bowel syndrome or chronic, partial bowel obstruction) 2. Has history or presence of clinically significant abnormal 12 lead ECG results, in the investigator's opinion 3. Has current brain metastasis 4. Has prolonged QTc (with Fridericia's correction) of >480 msec in men and women performed at Screening 5. 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 6. Has congenital long QT syndrome or a family history of long QT syndrome 7. Has other clinically significant cardiac disease including, but not limited to, uncontrolled angina, myocardial ischemia or infarction within 6 months, congestive heart failure >Class II per the New York Heart Association, or history of myocarditis 8. Has an electrolyte disturbance, such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, or hypocalcemia. Patients can be enrolled following successful correction of an electrolyte disturbance. 9. Is currently using any drugs included in the prohibited medications list in the protocol (including those that can prolong QTc) that cannot be discontinued 10. Has known hypersensitivity to any of the components of study treatments 11. Has other primary cancer requiring treatment within the last 3 years, except for cervical intraepithelial neoplasia, ductal carcinoma in situ, or completely excised squamous or basal cell carcinoma 12. Is a pregnant or lactating female 13. Had major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to the first dose of study treatment 14. Is receiving or has received any investigational treatment within 4 weeks prior to study entry, or participating in another clinical study 15. Has known DPD deficiency

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Metastatic Colorectal Cancer. - NCT05141721

    Primary Objectives: To characterize the antitumor activity of maintenance therapy with GRT-C901/GRT-R902 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab as assessed by molecular response based on change in ctDNA in patients with metastatic colorectal cancer (CRC) whose disease has not progressed during induction chemotherapy with fluoropyrimidine/oxaliplatin/bevacizumab. Secondary Objectives: - To evaluate PFS based on RECIST and iRECIST criteria, as assessed by the Investigator, of patients treated with maintenance therapy GRT-C901/GRTR902 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab in patients with metastatic CRC whose disease has not progressed during induction chemotherapy with fluoropyrimidine/oxaliplatin/bevacizumab - To assess the safety and tolerability of GRT-C901/GRT-R902 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab. - To assess OS in patients treated with GRT-C901/GRT-R902 in combinationwith checkpoint inhibitors and fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab. - To evaluate measures of clinical activity of GRT-C901 and GRT-R902 in combination with checkpoint blockade and fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab via RECIST v1.1 and iRECIST-based assessment of: - Objective response rate (ORR) - Duration of response (DOR) - Clinical benefit rate (CBR) - Deepening of response for patients who achieved stable disease (SD) or better response to routine therapy. - To determine the feasibility of manufacturing a patient-specific vaccine.

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    • Protocol Number:
      072110

    • Principal Investigator:
      Lyudmyla Berim

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon,Rectum

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

    • Drugs Involved:
      BEVACIZUMAB GRT-R902 GRT-C901 IPILIMUMAB (MDX-010) Atezolizumab (MPDL3280A)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Lyudmyla Berim

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received <30 days of first-line treatment in the metastatic setting with FOLFOX/bev, CAPEOX/bev, FOLFOXIRI/bev, or CAPOXIRI/bev per SOC
    • Measurable and unresectable metastatic disease according to RECIST v1.1
    • Availability of formalin-fixed paraffin-embedded (FFPE) tumor specimens.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Patient has adequate organ function per defined criteria
    • If women of childbearing potential (WCBP), must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 150 days after last investigational study treatment.

    Exclusion Criteria:

    • Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype
    • Patient has a known tumor mutation burden <1 non-synonymous mutations/megabase
    • Known DNA Polymerase Epsilon mutations
    • Patients with known BRAFV600E mutations
    • Bleeding disorder or history of significant bruising or bleeding following IM injections or blood draws
    • Immunosuppression anticipated at time of study treatment
    • History of allogeneic tissue/solid organ transplant
    • Active or history of autoimmune disease or immune deficiency
    • Patient with symptomatic or actively progressing central nervous system (CNS) metastases, carcinomatous meningitis, or has been treated with whole brain radiation
    • History of other cancer within 2 years with the exception of neoplasm that has undergone potentially curative therapy
    • Any severe concurrent non-cancer disease that, in the judgment of the Investigator, would make the patient inappropriate for the current study
    • Active tuberculosis or recent (<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV
    • History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)
    • Myocardial infarction within previous 3 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure
    • Pregnant, planning to become pregnant, or 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.

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

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

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    • Protocol Number:
      192004

    • Principal Investigator:
      Christian Hinrichs

    • Phase:
      Phase I

    • Scope:
      National

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

    • Therapies Involved:
      Chemotherapy multiple agents systemic

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

      • Contacts:

      • Rutgers University Prinicipal Investigator: Christian Hinrichs

    Read Inclusion & Exclusion Criteria

    1. Signed, written informed consent obtained prior to any study procedures. 2. Age > 18 years at the time of informed consent. 3. Metastatic solid tumor with ≥ 25% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers, screening will focus on gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by the Rutgers Cancer Institute of New Jersey, Department of Biorepository Services. 4. HLA-A*01:01 allele by HLA haplotype test. 5. Measureable disease per RECIST Criteria Version 1.1 at time of enrollment. 6. Prior treatment with cancer type-specific stand of care systemic cancer therapy is required. Standard treatment options must be considered and declined. Documentation of rationale is required if a subject is deemed unsuitable for standard therapy. 7. Subjects with < 3 brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 9. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy tests is not required for women who have had a bilateral oophorectomy or hysterectomy. 10. Women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a women become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 11. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/mcL 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum AST (SGOT)/ALT (SGPT) < 2.5 x ULN 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. INR or a PTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or PTT within therapeutic range and no history of severe hemorrhage. 12. Serology:
    • HIV antibody negative
    • Hepatitis B antigen negative
    • Hepatitis C antibody negative or HCV RNC negative (i.e., no current HCV infection) 13. More than four weeks must have elapsed since any prior systemic therapy or radiotherapy at the time the patient receives the KK-LC-1 TCR T cells. Adverse events from prior therapy must have resolved to≤ grade 1 according to CTCAE Version 5 or have demonstrated clinical stability and meet the eligibility criteria for the protocol. 14. Oxygen saturation ≥ 92% on room air. 15. Left ventricular ejection fraction ≥45% by echocardiogram or MUGA for patients 50 years of age or older.

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors. - NCT03592264

    Primary Objectives: Dose Escalation and Expansion Phases: 1. To evaluate the safety and tolerability of single agent OBI-3424 when administered intravenously (IV) Dose Escalation Phase: 1. To determine the DLTs, MTD, and RP2D of OBI-3424 administered as a single agent 2. To determine the PK of OBI-3424, OBI-2660, and related metabolites in plasma and urine. Expansion Phase: 1. To make a preliminary assessment of the activity of OBI-3424 as determined by the objective response rate (ORR) in patients whose tumors have moderate to high AKR1C3 expression. The study will include patients with pancreatic adenocarcinoma (Cohort A) and a basket cohort of solid tumors with other histologic subtypes (Cohort B). Secondary Objectives: 1. To determine the duration of response (DOR) and progression-free survival (PFS) 2. To explore the association between tumor AKR1C3 expression as determined by IHC and clinical activity 3. To determine impact of OBI-3424 on immune cell populations relevant for immune response to tumors as determined by lymphocyte immunophenotyping (performed in the Dose Escalation Phase only) 4. To investigate by a population analysis the PK of OBI-3424 and OBI-2660 in the target population, including the influence of covariates and to provide post-hoc estimates of exposure.

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    • Protocol Number:
      052105

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      OBI-3424

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria (all subjects):

      1. At least 18 years of age 2. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 3. Recovered from toxicities of prior therapy to Grade 0 or 1 4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Acceptable liver function: 1. Bilirubin ≤1.5 × institutional ULN 2. AST and ALT ≤3.0 × ULN, or ≤5.0 × ULN for subjects with liver involvement 7. Acceptable renal function: a. Creatinine clearance >30 mL/min according to the Cockcroft-Gault formula 8. Acceptable hematologic status (without hematologic support, other than red blood cell transfusion): 1. ANC ≥1500 cells/μL 2. Platelet count ≥100,000/μL 3. Hemoglobin ≥9.0 g/dL (prior packed red blood cell transfusion or erythropoietin support is allowed). 9. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation.

      Dose Escalation Phase Subjects Only (Inclusion Criteria):

        10. Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective 11. Tumor progression after most recent therapy

        Expansion Phase Subjects Only (Inclusion Criteria):

          12. Available tumor tissue, either archival or fresh (fresh preferred). 13. For treatment, an AKR1C3 IHC H-score of ≥ 100 using a validated IHC assay in one of the following tumor types to be enrolled in the respective cohort: 1. Cohort A: Pancreatic Adenocarcinoma 2. Cohort B: Basket (any solid tumor type other than pancreatic adenocarcinoma)

        Exclusion Criteria:

          1. Prior radiotherapy to more than 25% of the bone marrow 2. Symptomatic brain metastases, unless previously treated and well controlled for at least 4 weeks after central nervous system (CNS)-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the Screening Period. Patients with known leptomeningeal disease are excluded. 3. Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study 4. Patients with hepatocellular carcinoma (applies to Expansion Phase only) 5. Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery 6. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 7. Treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 3 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C) 8. Concomitant use of strong CYP3A4 inhibitors/inducers 9. Concomitant use of naproxen within a 48-hour window before and after OBI-3424 dosing 10. Females who are pregnant or breast-feeding 11. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study 12. Unwillingness or inability to comply with the study protocol for any reason

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study (with Safety Run-In) of ALX148 in Combination with Cetuximab and Pembrolizumab in Patients with Refractory Microsatellite Stable Metastatic Colorectal Cancer. - NCT05167409

    Primary Objectives: 1. To determine the recommended dose (RD) of ALX148 in combination with cetuximab and pembrolizumab. 2. To determine the objective response rate (ORR), defined as partial response or complete response, with ALX148, cetuximab, and pembrolizumab using RECIST v1.1 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed on at least two lines of standard therapy. Secondary Objectives: 1. To determine the disease-control rate (DCR), defined as stable disease, partial response, or complete response with ALX148, cetuximab, and pembrolizumab using RECIST v1.1. 2. To determine the duration of response (DOR) with ALX148, cetuximab, and pembrolizumab, defined as the time from response (partial or complete) to progression using RECIST v1.1 or death from any cause. 3. To determine the progression-free survival (PFS) with ALX148, cetuximab, and pembrolizumab, defined as the time from enrollment to the first observation of progression using RECIST v1.1 or death from any cause. 4. To determine the overall survival (OS) with ALX148, cetuximab, and pembrolizumab, defined as the time from enrollment to death from any cause. 5. To determine the first cycle dose-limiting toxicities (DLT) of ALX148, cetuximab, and pembrolizumab in stage 1. 6. To evaluate the safety and tolerability of ALX148, cetuximab, and pembrolizumab, defined and graded according to the NCI CTCAE v5.0.

    View All Details
    • Protocol Number:
      072205

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Pembrolizumab (MK-3475) CETUXIMAB ALX148

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      To be eligible to participate in this study, an individual must meet all of the following criteria:
    • Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease
    • Have microsatellite stable disease
    • Adequate hematologic and end organ function

    Exclusion Criteria:

      An individual who meets any of the following criteria will be excluded from participation in this study:
    • Patients with known MSI-high status or known mismatch repair deficiency (dMMR)
    • Patients in whom both mismatch repair and microsatellite stability status are unknown
    • History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
    • Left-sided (at or distal to the splenic flexure) RAS/BRAF wild-type metastatic colorectal cancer who are EGFR inhibitor naïve.
    • Prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47, or anti-SIRPα agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of Atezolizumab and Bevacizumab in Child-Pugh B7 Hepatocellular Carcinoma (The AB7 Trial). - NCT04829383

    Primary Objective: To estimate the safety of the combination of atezolizumab and bevacizumab in patients with advanced/metastatic HCC and Child-Pugh B7 liver dysfunction by grade 3-5 adverse event rate. Secondary Objectives: To estimate the efficacy of the combination in this patient population by overall response rate (ORR), disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS). Exploratory Objectives: 1) To correlate tumor molecular signature from NGS tissue analysis with clinical outcomes and treatment response. 2) To correlate tumor molecular signature from NGS tissue analysis with ctDNA. 3) To correlate levels of ctDNA with clinical outcomes and treatment response.

    View All Details
    • Protocol Number:
      072012

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB Atezolizumab (MPDL3280A)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Subject must meet all of the following applicable inclusion criteria to participate in this study:
    • Written informed consent and HIPAA authorization for release of personal health information must be obtained either from the subject or their representative. See protocol. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
    • Age ≥ 18 years at the time of consent.
    • ECOG Performance Status of 0-1.
    • Locally advanced, metastatic, or unresectable hepatocellular carcinoma that has not received prior systemic therapy. Note: if no prior histologic diagnosis exists, prefer fresh biopsy if it is both safe and feasible. If fresh biopsy is not safe and feasible, imaging criteria may be used for diagnosis as per AASLD criteria in cirrhotic patients (please see www.aasld.org for up to date guidelines).
    • Child Pugh Class B7 or B8 liver dysfunction or cirrhosis with the following limitations:
    • Bilirubin ≤ 3 mg/dL
    • Albumin ≥ 2.8 g/dL
    • INR ≤ 1.7
    • Absent to slight [CP=1 to 2] (no moderate [CP=3]) ascites (Also see exclusion criteria).
    • No clinically significant encephalopathy (Also see exclusion criteria).
    • At least 1 untreated measurable lesion according to RECIST 1.1.
    • Willingness to undergo fresh tumor biopsy at baseline if safe and feasible. Note: archival tissue may be used at baseline provided histologic diagnosis was made and sufficient tissue is available for NGS analysis.
    • NGS analysis must be requested from archival tissue or fresh biopsy (if applicable) as per standard of care. Foundation One CDX is the preferred platform. Prior NGS sequencing results (including from another platform) will be accepted if NGS sequencing was previously obtained (please see protocol).
    • Demonstrate adequate bone marrow and organ function as defined below:
    • Hematologic
    • Absolute neutrophil count (ANC) ≥ 1,000/mcL
    • Lymphocyte count ≥ 0.5 x 10^9/L (500uL)
    • Hemoglobin ≥ 90 g/L (9 g/dL)
    • Platelet count ≥ 70,000/mcL
    • Renal
    • Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5 x ULN OR ≥ 30 mL/min for participants with creatinine levels > 1.5 x institutional ULN *calculate serum creatinine clearance using the standard Coccroft-Gault formula
    • Urine protein: Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment *Patients with with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours.
    • Hepatic
    • AST (SGOT) and ALT (SGPT) ≤ 8 x ULN
    • Alkaline phosphastase (ALP) ≤ 8 x ULN
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, or 6 months after the last dose of bevacizumab. See also the protocol for definition of childbearing potential.
    • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive measures. Men with female partners of childbearing potential must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of bevacizumab. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of bevacizumab to avoid exposing the embryo. See also the protocol for additional information.
    • As determined by the enrolling physician or protocol designee, ability of the subject to understand a written informed consent document, and ability and willingness to comply with study procedures for the entire length of the study. Patients with impaired decision-making capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) and/or family member available are also eligible.

    Exclusion Criteria:

      Subjects meeting any of the criteria below may not participate in the study:
    • Histologic diagnosis of fibrolamellar or sarcomatoid HCC or mixed cholangiocarcinoma-HCC.
    • Patients who have had chemotherapy, definitive radiation, biological cancer therapy, or investigational agent/device within 21 days of first planned dose of study therapy (within 14 days for palliative radiation). Patients who have had major surgery within 4 weeks of start of study therapy or anticipation of need for a major surgical procedure during the study.
    • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > CTCAE Grade 1) with the exception of alopecia or neuropathy.
    • Patients who have received prior systemic therapy for HCC.
    • Patients who have received prior immunotherapy.
    • Patients with clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control within 3 months prior to the first dose of study treatment. Note: Patients with ascites meeting eligibility criteria who require pharmacologic intervention (e.g. diuretics) to maintain symptomatic control and who have been on stable doses of diuretics for 2 months prior to the first dose of study treatment are eligible.
    • Patients with clinically meaningful encephalopathy, defined as a history of hepatic encephalopathy within 6 months prior to first dose of study treatment or requirement for medications to prevent or control encephalopathy (e.g. lactulose, rifaximin).
    • Any of the following additional high-risk features:
    • Patients with untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding. Note: Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to enrollment. Patients who have undergone an EGD with appropriate management of varices (if applicable) within 6 months of prior to initiation of study treatment do not need to repeat the procedure.
    • History of esophageal and/or gastric hemorrhage within 3 months prior to study treatment.
    • History of hemoptysis (< 2.5 mL of bright red blood per episode) within 1 month prior to study treatment.
    • History of intracranial hemorrhage within 1 month prior to study treatment.
    • History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment. Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure.
    • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture within 30 days prior to start of study treatment.
    • Metastatic disease that involves major airways or blood vessels. Patients with vascular invasion of the portal or hepatic veins may be enrolled.
    • Significant vascular disease (e.g. aortic aneurysm requiring surgical repair) or vasculitis within 6 months prior to initiation of study treatment.
    • History of arterial thrombotic event (e.g. myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months prior to initiation of study treatment.
    • Chronic or recent (within 10 days of first dose of study treatment) use of aspirin > 325 mg/day, dipyramidaole, ticlopidine, clopidogrel, or dilostazol. Note: Use of aspirin < 325 mg/day is allowed.
    • History of venous thromboembolic event (e.g. deep vein thrombosis, pulmonary embolism, portal vein thrombosis, or any other significant thromboembolism) must be on a stable dose of anticoagulation for 1 month prior to initiation of study treatment and must have completely treated varices.
    • Use of Coumadin-like products or full dose oral or parenteral anticoagulants. Use of prophylactic low dose anticoagulation, unfractionated heparin or LMWH is allowed.
    • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
    • Core biopsy or other minor surgical procedure within 3 days prior to the first dose of bevacizumab.
    • History of intestinal obstruction. Note: Patients with previous intestinal obstruction may be enrolled if they have received definitive treatment for symptom resolution.
    • History of inflammatory process within 6 months prior to start of study treatment including but not limited to active peptic ulcer disease, diverticulitis or colitis.
    • Significant traumatic injury within 4 weeks prior to start of study treatment.
    • Uncontrolled pleural effusion or pericardial effusion requiring frequent drainage procedures (> once monthly). Patients with indwelling catheters (e.g. PleurX®) are allowed.
    • History of nephrotic or nephritic syndrome.
    • Uncontrolled hypertension defined as systolic pressure ≥ 150/90 in spite of maximum anti-hypertensive therapy.
    • Patients with untreated/uncontrolled CNS/leptomeningeal disease. Note: Patients with asymptomatic, treated CNS disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy and the following criteria are met:
    • No evidence of interim progression between the completion of CNS-directed therapy and the start of study enrollment.
    • No stereotactic radiation or whole-brain radiation within 28 days prior to randomization.
    • No evidence of intracranial hemorrhage or spinal cord hemorrhage.
    • Patients with active autoimmune disease requiring systemic corticosteroids greater than the equivalent of prednisone 10 mg daily or other systemic immunosuppressive medications including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, colitis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis, with the following exceptions:
    • Patients with a history of autoimmune hypothyroidism on thyroid replacement hormone are eligible.
    • Patients with Type 1 diabetes mellitus on an insulin regimen are eligible.
    • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only are eligible provided: 1) rash covers < 10% of body surface area (BSA), 2) disease is well controlled at baseline and requires only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%).
    • See protocol for a more comprehensive list of autoimmune diseases and immune deficiencies.
    • Patients receiving treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 6 weeks must discontinue these medications prior to starting protocol therapy, with the exception of:
    • Patients with active autoimmune disease managed with systemic corticosteroids less than the equivalent of prednisone 10 mg daily.
    • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea).
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension and adrenocortical insufficiency.
    • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
    • Patients who have undergone prior solid organ or bone marrow transplant with the exception of patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection.
    • Patients with serious active infection within 2 weeks prior to enrollment (e.g. requiring hospitalization and/or intravenous [IV] antibiotics) infection within 2 weeks prior to enrollment, or currently receiving oral or IV antibiotics for the treatment of infection. Patients receiving prophylactic antibiotics are eligible.
    • Patients must have documented hepatitis virology status.
    • Patients with active hepatitis B virus (HBV) infection must have a viral load < 500 IU/mL within 28 days prior to start of study treatment and be on suppressive therapy (per local standard of care) for a minimum of 14 days prior to start of study treatment and for the length of the study.
    • Patients with co-infection with HBV and hepatitis C virus (HCV) are excluded. Patients with a history of HCV infection but with negative HCV RNA by PCR are considered non-infected with HCV.
    • Patients with known human immunodeficiency virus (HIV) are allowed on study provided they have:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent concurrent antibiotics or antifungal agents for the prevention of opportunistic infection
    • A CD4 count above 250 cells/mcL
    • An undetectable HIV viral load on standard PCR-based testing
    • Patients with uncontrolled intercurrent illness (e.g., including but not limited to uncontrolled HTN [systolic BP ≥ 150, diastolic BP ≥ 100 despite optimal medical management or history of hypertensive crisis or hypertensive encephalopathy], symptomatic congestive heart failure [CHF], uncontrolled cardiac arrhythmia, or other within 3 months prior to start of study treatment or psychiatric illness/social situations or other conditions that would limit compliance with study requirements or substantially increase risk of incurring AEs in the opinion of the treating investigator.
    • Patients with known concurrent malignancy that is expected to require active treatment within two years or may interfere with the interpretation of the efficacy and safety outcomes of this study in the opinion of the treating investigator. Note: Superficial bladder cancer, nonmelanoma skin cancers, and low-grade prostate cancer not requiring cytotoxic therapy should not exclude participation in this trial. Patients with CLL may be enrolled if they do not require active chemotherapy and their hematologic, renal and hepatic function meets criteria previously mentioned.
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications in the opinion of the treating investigator.
    • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment.
    • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins or know hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab infusion.
    • Uncontrolled tumor-related pain. NOTE: Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
    • Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN)
    • Active tuberculosis
    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

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

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

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

    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)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Li

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of Preoperative Pembrolizumab for Mismatch Repair Deficient, Epstein-Barr Virus Positive and/or PD-L1 Positive Gastric Cancer followed by Chemotherapy and Chemoradiation with Pembrolizumab. - NCT03257163

    Primary Objective To assess efficacy (disease-free survival) of operable gastric cancer treated with PD-1 blockade using pembrolizumab Secondary Objective(s) (1) To characterize the safety and tolerability of pembrolizumab in the preoperative setting and postoperative setting with chemoradiation (2) To evaluate recurrence rates and patterns of recurrence/metastasis (3) To characterize adverse events (AE) of pembrolizumab in combination with radiation therapy and capecitabine (4) To evaluate overall survival rates Exploratory Objective (1) To assess T cell responses and pathological responses in the tumor specimen (2) To correlate PD-L1 expression in tumor tissue and stroma with tumor tissue response (3) To evaluate RNA expression via Nanostring technology with tumor tissue response

    View All Details
    • Protocol Number:
      071702

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Stomach

    • Therapies Involved:
      Radiotherapy Chemotherapy (NOS) Surgery

    • Drugs Involved:
      Pembrolizumab (MK-3475) CAPECITABINE

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Written informed consent for the trial
    • Must have operable gastric adenocarcinoma, T2-T4a, N0-N3, M0
    • Staging evaluation within 42 days of enrollment consisting of staging laparoscopy, computed tomography (CT) scan of the abdomen and pelvis, and positron emission tomography (PET) scan will be acquired; also endoscopic ultrasound (EUS) tumor and nodal staging will be required
    • Mismatch repair deficiency as identified by immunohistochemistry or other institutional standard, or Epstein-Barr virus positivity as determined by in situ hybridization or other institutional standard
    • Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 10 weeks (70 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen (if available from prior biopsy) only upon agreement from the sponsor
    • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
    • Absolute neutrophil count (ANC) >= 1,500 /mcL
    • Platelets >= 100,000 / mcL
    • Hemoglobin >= 7 g/dL or >= 5.6 mmol/L with transfusion or erythropoietin (EPO) dependency
    • Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
    • Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN
    • Albumin >= 2.5 mg/dL
    • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
    • Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    • Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days of enrollment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
    • Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
    • Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

    Exclusion Criteria:

    • Presence of metastatic disease is not allowed; subjects must be evaluated with imaging consisting of CT scan and PET scan prior to enrollment for protocol therapy to exclude metastatic disease
    • Prior chemotherapy, adjuvant therapy, or radiotherapy for gastric cancer
    • Prior radiotherapy that overlaps with planned radiotherapy portal
    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
    • Has a known history of active TB (Bacillus tuberculosis)
    • Hypersensitivity to pembrolizumab or any of its excipients
    • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
    • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
    • Note: subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
    • Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
    • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
    • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
    • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
    • Evidence of interstitial lung disease
    • Has an active infection requiring systemic therapy
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
    • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
    • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
    • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus (HCV) RNA [qualitative] is detected)
    • Has received a live vaccine within 30 days of planned start of study therapy; Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE). - NCT05332002

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

    View All Details
    • Protocol Number:
      072204

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Esophagus,Stomach

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Opdivo (Nivolumab) OXALIPLATIN FLUOROURACIL

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pretreated Metastatic Colorectal Cancer. - NCT04109924

    Primary: Determine the median progression free survival (PFS) benefit of FOLFIRI naive patients treated with TAS-102 + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab. Secondary: Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile.

    View All Details
    • Protocol Number:
      071914

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB IRINOTECAN TAS-102

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Advanced colorectal cancer (metastatic or unresectable): Histologically or cytological proven adenocarcinoma of the colon or rectum which is metastatic or otherwise incurable
    • Prior treatment with a fluoropyrimidine (5-fluorouracil [5-FU] or capecitabine) and oxaliplatin in the metastatic/unresectable setting OR, recurrence within 12 months of adjuvant therapy with a regimen that included oxaliplatin
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Hemoglobin >= 9 g/dL
    • Absolute neutrophil count >= 1500/mm^3
    • Platelet count >= 100,000/mm^3
    • Creatinine < 1.5 upper limit of normal (ULN) or if >= 1.5 x ULN creatinine clearance (CRCL) >= 30 mL/min (by Cockcroft-Gault)
    • Bilirubin < 1.5 x ULN
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN or =< 5 x ULN if with hepatic metastases
    • Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
    • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
    • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

    Exclusion Criteria:

    • Prior treatment with TAS-102 or irinotecan
    • Anti-cancer therapy within 2 weeks of the planned first dose of study medication
    • Unresolved toxicities from prior therapy of > grade 1, excluding alopecia or similar toxicities which are not deemed to be clinically significant or put the participant at greater risk. Grade 2 neuropathy is permitted
    • Major surgery within 4 weeks of anticipated start of therapy
    • Uncontrolled hypertension: systolic blood pressure >= 150, diastolic blood pressure >= 100
    • Unstable angina, symptomatic congestive heart failure or cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers and digoxin are allowed)
    • Arterial or venous thrombotic or embolic events within 3 months of study initiation, unless well controlled on stable anti-coagulation for >= 2 weeks. This excludes uncomplicated catheter associated venous thrombosis
    • History of cerebrovascular or myocardial ischemia within 6 months of initiation
    • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 grade 3 or greater hemorrhage within the past 4 weeks
    • Proteinuria >= 2+, unless 24 hour urine collection demonstrates =< 1 g of protein OR spot protein: creatinine demonstrates a ratio of =< 1
    • Untreated brain metastases
    • History of abnormal glucuronidation of bilirubin (Gilbert's syndrome)
    • History of second primary malignancy within 3 years prior to enrollment, excluding in-situ cervical carcinoma, non-melanoma skin cancer or malignancy of equivalent risk which is highly unlikely to require systemic treatment in the next 2 years
    • Have known active infection which would heighten the risk of complications
    • Pregnant or nursing female participants
    • Unwilling or unable to follow protocol requirements
    • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

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

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

    • Monmouth Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study to Evaluate the Efficacy of Liposomal Irinotecan in Combination with Oxaliplatin, Leucovorin, and 5-Fluorouracil for Patients with Locally Advanced Pancreatic Carcinoma. - NCT03861702

    Primary Objective: Determine the disease control rate (DCR) of liposomal irinotecan (nalIRI) in combination with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) for treatment of locally advanced pancreatic carcinoma. Secondary Objectives: 1. Describe the objective response rate (ORR) at 8 weeks, 16 weeks, and 24 weeks following starting FOLFOX-nal-IRI. 2. Describe the stable disease rate (SDR) at 8 weeks, 16 weeks, and 24 weeks following starting FOLFOX-nal-IRI. 3. Describe the proportion of subjects able to undergo surgical resection of tumor. 4. Describe the response of serum CA 19-9 every 2 cycles (every 4 weeks) following starting FOLFOX-nal-IRI. 5. Determine progression-free survival (PFS). 6. Determine overall survival (OS). 7. Describe safety and tolerability of FOLFOX-nal-IRI. 8. Describe the quality of life every 4 cycles (every 8 weeks) following starting FOLFOX-nal-IRI.

    View All Details
    • Protocol Number:
      072008

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Pancreas

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      OXALIPLATIN LEUCOVORIN FLUOROURACIL nal-Irinotecan

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
    • Age ≥ 18 years at the time of consent.
    • ECOG Performance Status of 0-1 within 28 days prior to registration.
    • Histological or cytological confirmation of pancreatic carcinoma.
    • Measurable disease according to RECIST v1.1 within 28 days prior to registration.
    • Previously untreated pancreatic carcinoma considered as locally advanced unresectable according to NCCN guidelines.
    • Demonstrate adequate organ function as defined in the table below; All screening labs to be obtained within 14 days prior to initiation of study treatment.
    • Hematological
    • Absolute Neutrophil Count (ANC): >/=1500/uL
    • Hemoglobin (Hgb): >/=8 g/dL with blood transfusion permitted
    • Platelet (Plt): >/=100,000/uL
    • Renal
    • Serum creatinine:
    • Calculated creatinine clearance using the Cockcroft-Gualt formula: >/=50 mL/min for subjects with creatinine levels >1.5 ULN
    • Hepatic
    • Total bilirubin:
    • Aspartate aminotransferase (AST):
    • Alanine aminotransferase (ALT):
    • Albumin: >/=3.0 g/dL
    • Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT):
    • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days of study registration and within 72 hours of Cycle 1 Day 1. NOTE: Female subjects are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
    • Female subjects of childbearing potential and males must be willing to abstain from behaviors that could lead to pregnancy (heterosexual activity, sperm donation, in vitro fertilization, etc.) or to use 2 forms of effective methods of contraception from the time of informed consent until 9 months (females) or 6 months (males) after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.
    • 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. The subject should be able to understand the purpose and risks of the study and provide a signed and dated informed consent form.

    Exclusion Criteria:

    • Known hypersensitivity to irinotecan liposome, other liposomal products, oxaliplatin, 5-fluorouracil, leucovorin, or any ingredients in those preparations.
    • Pre-existing peripheral neuropathy (Grade 3 or 4) during screening.
    • Major surgery within 4 weeks of starting treatment.
    • Active uncontrolled cardiac arrhythmia or congestive heart failure (class 3 or 4 as defined by the New York Heart Association Functional Classification); or history of myocardial infarction, unstable angina; or acute coronary syndrome within 6 months prior to enrollment.
    • Known history of human immunodeficiency virus (HIV), or hepatic cirrhosis caused by active infection with hepatitis B virus (HBV, as defined by HBsAg positivity or positive DNA). Testing is not required for study entry if there is no clinical suspicion. Note: hepatic cirrhosis caused by other factors (ex. alcoholic cirrhosis) may be considered on a case-by-case basis if, in the opinion of the treating investigator, the disease is unlikely to compromise the subject's safety or put the study outcomes at unnecessary risk.
    • Any medical condition, life-threatening illness, or organ dysfunction, which in the investigator's opinion, can compromise the subject's safety or put the study outcomes at unnecessary risk.
    • Uncontrolled active systemic infection.
    • Concomitant medications that are prohibited in this study and they cannot be switched to alternative medications.
    • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
    • Known additional malignancy that is active and/or progressive requiring treatment within 2 years of screening for this study; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, low-grade prostate cancer, or other cancer for which the subject has been disease-free for at least five years. Additional exceptions could be considered if agreed by sponsor-investigator and site investigator assuming the disease is considered extremely unlikely to confound evaluation of disease status.
    • Treatment with any investigational drug within 30 days prior to registration, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing of this study.

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

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

    • Rutgers Cancer Institute of New Jersey
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