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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

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    • 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:
      Stomach,Other Digestive Organ,Small Intestine

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CAPECITABINE PCS6422

      • 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 1b Study of the OxPhos Inhibitor ME-344 Combined with Bevacizumab in Previously Treated Metastatic Colorectal Cancer. - NCT05824559

    Primary Objective: To estimate progression-free survival (PFS) at 16 weeks of treatment in subjects with mCRC administered ME-344 in combination with bevacizumab. Secondary Objective: 1. To evaluate the preliminary efficacy of ME-344 administered in combination with bevacizumab in subjects with mCRC. 2. To determine the safety and tolerability of ME-344 administered in combination with bevacizumab. 3. To evaluate the pharmacokinetics (PK) of ME-344 administered in combination with bevacizumab. Exploratory Objective: To evaluate correlatives of mitochondrial metabolism.

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    • Protocol Number:
      072304

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Colon,Rectum

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB ME-344

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age ≥18 years
    • Histological or cytological documentation of adenocarcinoma of the colon or rectum that is metastatic (all other histological types are excluded)
    • Subjects who progressed or demonstrated intolerability to prior standard approved therapies which include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapies, cetuximab/panitumumab (if clinically indicated e.g., RAS wild-type tumors) PD-1 or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors in the metastatic setting.
    • Previous treatment with any investigational drug or anticancer treatment must be completed >28 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
    • Adequate bone marrow, liver, and renal function

    Exclusion Criteria:

    • Untreated brain metastases, spinal cord compression, or primary brain tumor
    • Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
    • Evidence of uncontrolled or unstable cardiovascular disease, myocardial infarction (within 6 months), unstable angina pectoris, congestive heart failure, serious arrhythmias requiring drug therapy
    • History of CNS disease
    • Bevacizumab or aflibercept therapy ≤ 3 weeks prior to starting study treatment
    • Peripheral neuropathy Grade ≥ 2
    • Uncontrolled hypertension or diabetes mellitus, active peptic ulcers, unhealed wounds, clinically significant disease or systemic infections
    • Known seropositive for, or active infection with hepatitis B or C virus
    • Symptomatic or uncontrolled infection with human T-cell leukemia virus
    • Venous thromboembolism (unless appropriately treated and stable on anticoagulant for at least 2 weeks).

    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 Basket Trial of Ulixertinib (BVD-523) in Combination with Hydroxychloroquine in Patients with Advanced Gastrointestinal Malignancies Harboring MAPK Pathway Mutations. - NCT05221320

    Primary Objective: - To assess the safety and tolerability of ulixertinib and hydroxychloroquine in patients with advanced, RAS, non-V600 BRAF, MEK1/2, or ERK1/2 mutated gastrointestinal (GI) malignancies. - To assess the efficacy of ulixertinib and hydroxychloroquine in patients with advanced, RAS, non-V600 BRAF, ERK1/2, or MEK1/2 mutated gastrointestinal malignancies. Secondary Objective: - To assess the duration of efficacy of ulixertinib and hydroxychloroquine in patients with advanced RAS, non- V600 BRAF, MEK1/2, or ERK1/2 mutated gastrointestinal malignancies. Exploratory Objective: - To evaluate the bioactivity of ulixertinib and hydroxychloroquine against ERK1/2, autophagy pathways, and pharmacodynamic biomarkers.

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    • Protocol Number:
      052216

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Anus,Small Intestine,Colon,Esophagus,Stomach,Rectum,Other Digestive Organ,Pancreas

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Ulixertinib (BVD-523) Hydroxychloroquine

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patient aged ≥ 18 years. 2. Histologically confirmed esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, extrahepatic cholangiocarcinoma, or colorectal adenocarcinoma harboring a MAPK-mutated GI malignancy: KRAS, NRAS, HRAS, BRAF non-V600, MEK 1/2 (MAP2K1/2), or ERK 1/2 (MAPK3/1). 3. Progression on or during standard lines of therapy:
    • Patients with intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, or extrahepatic cholangiocarcinoma must have progressed during or after receiving a first-line regimen of gemcitabine/cisplatin unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with pancreatic adenocarcinoma must have progressed during or after first-line therapy of FOLFIRINOX/ mFOLFIRINOX, gemcitabineab-paclitaxel unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with colorectal adenocarcinoma must have progressed during or after their first two lines of therapy, including FOLFOX ± Avastin and FOLFIRI ± Avastin, unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, or gastric adenocarcinoma must have progressed during or after their first two lines of therapy.
    • Acceptable first-line regimens: FOLFOX, 5-FU/Cisplatin, FOLFIRI, Paclitaxel/Cisplatin or Carboplatin, Docetaxel/Cisplatin, DCF (or modifications thereof), or ECF (or modifications thereof) unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Acceptable second-line regimens: Ramucirumab/Paclitaxel, Docetaxel, Paclitaxel, Irinotecan, Trifluridine/Tipiracil, or FOLFIRI, unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with deficient MisMatch Repair/High levels of MicroSatellite Instability (dMMR/MSI-H) tumors must have progressed during or after pembrolizumab. 4. Measurable disease by RECIST 1.1 criteria by computed tomography (CT) or magnetic resonance imaging (MRI). 5. Willing to provide a biopsy at the time points indicated on the Schedule of Activities. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 7. Adequate organ function as defined as: Hematologic:
    • Absolute neutrophil count (ANC) ≥ 1500/mm3
    • Platelet count ≥ 100,000/mm3
    • Hemoglobin ≥ 9 g/dL Hepatic:
    • Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
    • Asparate animotransferace /Alanine aminotransferase (AST(SGOT)/ALT(SGPT)) ≤ 3 × institutional ULN
    • Patients with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN. Renal:
    • Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula:
    • Males: (140-age) × weight [kg] / serum creatinine [mgdL] × 72
    • Females: ((140-age) × weight [kg] / serum creatinine [mgdL] × 72)×0.85 8. For female patients: Negative serum pregnancy test within 72 hours prior to first dose of study drugs for women of childbearing potential. The following definitions apply:
    • Women of childbearing potential, defined as a sexually mature woman:
    • Has not been naturally post-menopausal for at least 12 consecutive months (i.e., who has had menses anytime in the preceding 12 consecutive months).
    • Has not undergone menopause, surgical sterilization (bilateral oophorectomy or hysterectomy).
    • Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
    • Women not of childbearing potential:
    • Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, if any.
    • Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 9. Male and female patients of childbearing potential agree to use highly effective contraception throughout the study and at least 90 days after the last study treatment administration. 10. Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator. 11. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

    Exclusion Criteria:

      1. Received systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter. 2. Received radiotherapy ≤ 14 days prior to the first dose of study treatment. Note: Localized radiation therapy for the treatment of symptomatic bone metastasis is allowed during that timeframe. 3. Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not fully recovered from major surgery. 4. The diagnosis of another malignancy within ≤ 3 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). 5. Known uncontrolled brain metastases or cranial epidural disease. Note: Patients with stable brain metastases either treated or being treated with a stable dose of steroids (<20 mg of prednisone daily or equivalent) or anticonvulsants, with no dose change within 4 weeks before the first study drug dose, and no anticipated dose change, are eligible. In the event of steroid taper post-radiation therapy, taper must be complete within 2 weeks before Baseline. 6. History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity). 7. Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions: Cardiovascular disorders:
    • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
    • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
    • Duration of QT interval (QTc prolongation) defined as a QTcF > 500 ms.
    • Known congenital long QT.
    • Left ventricular ejection fraction < 50%. History of seizures Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome). Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [patients may not receive the drug through a feeding tube], social/ psychological issues, etc.) 8. Prior stomach or duodenal resection that in the opinion of the Principal Investigator and Medical Monitor would affect the breakdown and absorption of the study medications. A patient with a feeding tube should also be excluded, as ulixertinib capsules cannot be broken apart. 9. Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Patients on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial. 10. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C. Note: 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 positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 11. Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study. 12. Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3). 13. Patients taking prohibited medications as described in protocol. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur before the start of 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.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of CTX-009 in Adult Patients with Metastatic Colorectal Cancer who have received Two or Three Prior Systemic Chemotherapy Regimens. - NCT05513742

    Primary Objective: - To assess the efficacy of CTX-009 in patients with colorectal cancer (CRC) who have received two or three systemic therapies for advanced disease, as measured by Overall Response Rate (ORR). Secondary Objective: - To assess the efficacy of CTX-009 in patients with CRC as measured by Disease Control Rate (DCR). - To assess the efficacy of CTX-009 in patients with CRC as measured by Duration of Response (DOR). - To assess the efficacy of CTX-009 in patients with CRC as measured by Progression Free Survival (PFS). - To assess the efficacy of CTX-009 in patients with CRC as measured by Overall Survival (OS). - To evaluate the safety profile of CTX-009, including immunogenicity of CTX-009 in treated patients.

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    • Protocol Number:
      072301

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CTX-009

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. 18 years of age or older 2. Histologically or cytologically confirmed metastatic or recurrent colorectal cancers 3. The primary tumor must have been resected > 3 months prior to planned C1D1. 4. Patients who experienced progressive disease or relapse after receiving two or three prior lines of systemic therapy in the locally advanced or metastatic setting. Prior lines of systemic treatment must have included at least one fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab containing chemotherapy regimen (in any combination and may have been administered in the neoadjuvant setting). 1. Patients whose tumor is not right sided and RAS wild type must also have received an anti-epidermal growth factor receptor (EGFR) therapy. 2. Patients with tumors harboring mutations or other alterations for which there are available targeted therapies (e.g. BRAF V600E, HER2-positive, MSI-H/dMMR, etc.) must have also received the relevant approved targeted therapies. 3. If patient received peri-operative treatment (neoadjuvant and/or adjuvant), please consult the Sponsor Medical Monitor for review of prior treatment lines. 5. At least one lesion measurable as defined by RECIST v1.1 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 7. Predicted life expectancy of at least 12 weeks 8. Adequate hepatic and renal function within 14 days of C1D1 as described below: 1. Total bilirubin ≤ 1.5 X upper limit of normal (ULN) 2. Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 3.0 X ULN (≤ 5x ULN in case of hepatic metastasis) 3. Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault estimated creatinine clearance 4. Urine protein ≤ 1+ by spot urinalysis (or, if > 1+ then 24 hr urine protein <1.0 g/24 hr) 9. Female patients who are women of childbearing potential (WCBP) must have a negative pregnancy test (serum-human chorionic gonadotropin [hCG] or urine-hCG) at Screening within 14 days of C1D1 10. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commit to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment 11. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed

    Exclusion Criteria:

      1. From the time point of signed informed consent, 1. Less than 4 weeks have elapsed since patients had a surgery or major procedure 2. Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy 2. Prior to planned C1D1, 1. Less than 4 weeks have elapsed since patients had chemotherapy or targeted therapy for colorectal cancer 2. Less than 4 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment 3. A history of the following cardiovascular diseases in past 5 years may be exclusionary, as determined by the Sponsor Medical Monitor: 1. Congestive heart failure that corresponds to Class II or a higher class under New York Heart Association (NYHA) classification or less than 50% of left ventricular ejection fraction (LVEF) 2. Uncontrolled hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP] > 140/90 mmHg) (e.g., patient with SBP/DBP > 140/90 mmHg despite the best care including anti-hypertensive medications) 3. Patients with a history of hypertensive crisis or pre-existing hypertensive encephalopathy 4. Pulmonary hypertension 5. Myocardial infarction 6. Uncontrolled arrhythmia 7. Unstable angina 8. Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product 4. Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving) 5. A history of the following hemorrhage-related or gastroenterological disease: 1. Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor invasion into great arteries 2. History of clinically significant and active (within 6 months) gastroenterological disease, such as peptic ulcer, gastrointestinal (GI) bleeding, GI or non-GI fistula, perforation, abdominal abscess, clinical symptoms and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease. 6. Patients who received antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, direct thrombin inhibitors, etc.) within 2 weeks prior to C1D1, or are expected to need those drugs during the clinical study. 7. Patients requiring continuous treatment with systemic non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids (the following cases are permitted): 1. NSAIDs: Up to 3 consecutive days' use is permitted 2. Corticosteroids: Topical use of corticosteroid, such as topical intra-articular injection, intranasal administration, eye drops, inhaler, etc., or temporary systemic corticosteroid use for treatment and prevention of patient's contrast media allergy, or adverse event, is permitted 8. Severe infection requiring systemic antibiotics, antivirus drugs, etc., or other uncontrolled acute active infectious diseases 9. Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Inactive hepatitis B carriers who tested HBsAg positive may enroll provided that the patient's liver function values are normal. Also, patients with chronic HBV infection which has been controlled by the site's treatment guideline may enroll. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll 10. Patients with other severe diseases or uncontrolled illnesses that warrant the exclusion from the study (permitted only if medically controlled) including but not limited to: 1. Pre-existing hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to screening 2. Major, unhealed injury, active ulcer or untreated fracture 3. History of cerebrovascular incident (ischemic or hemorrhagic stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months prior to screening 4. Moderate to severe ascites and/or pleural effusion 11. Clinically significant abnormal electrocardiography (ECG) findings or history determined as clinically significant by the Investigator 12. QT interval (Fridericia's formula) (QTcF) interval > 450 msec at the time of screening

    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
    • Jersey City Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy Regimen. - NCT05506943

    Primary Objective: - To assess the efficacy of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with biliary tract cancers (BTC) who have received one systemic therapy for advanced disease, as measured by Overall Response Rate (ORR) assessed by an Independent Central Radiology (ICR) review. Secondary Objectives: - To assess the efficacy of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with BTC as measured by Disease Control Rate (DCR), assessed by an ICR review. - To assess the efficacy of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with BTC as measured by Duration of Response (DOR), assessed by an ICR review. - To assess the efficacy of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with BTC as measured by Progression Free Survival (PFS). - To assess the efficacy of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with BTC as measured by Overall Survival (OS). - To evaluate the safety profile of CTX-009 in combination with paclitaxel. - To assess the Quality of Life (QoL), as measured using the EORTC QLQ-C30 and BIL21, in patients with BTC treated with CTX-009 in combination with paclitaxel vs. paclitaxel alone.

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    • Protocol Number:
      072214

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Digestive Organ

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

    • Drugs Involved:
      PACLITAXEL CTX-009

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    INCLUSION CRITERIA 1. 18 years of age or older 2. Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma) 3. Patients must have radiologically documented progression after a prior gemcitabine and platinum containing chemotherapy regimen as first line therapy for locally advanced unresectable or metastatic disease. 1. Patients who received perioperative treatment (adjuvant and neoadjuvant) may be eligible, as determined by the Sponsor Medical Monitor. 2. Patients whose first line regimen was modified due to toxicity before disease progression, may be eligible, as determined by the Sponsor Medical Monitor. 4. At least one lesion measurable as defined by RECIST v1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 6. Predicted life expectancy of at least 12 weeks 7. No evidence of ongoing infection and adequate biliary excretion or patients whose adequate biliary excretion can be confirmed with the following procedures: 1. Patients who underwent endoscopic retrograde biliary drainage (ERBD) at least 1 week before the investigational drug treatment 2. Patients with endobiliary stents are eligible, provided there is no evidence of obstruction 3. Patients free of any signs of active or suspected uncontrolled infection after a drainage procedure 4. Patients free of any risk of hemorrhage and with incision completely healed 8. Adequate bone marrow, hepatic, and renal function within 14 days of randomization as described below. (Patient must be free of G-CSF treatment and blood transfusion within 14 days prior to the lab test): 1. Absolute neutrophil count (ANC) ≥ 1,500/mm3 2. Hemoglobin ≥ 9.0 g/dL 3. Platelet count ≥ 100,000/mm3 4. Total bilirubin ≤ 1.5 X ULN 5. AST/ALT ≤ 3.0 X ULN (≤5 X ULN in case of hepatic metastasis) 6. Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault 7. Urine protein ≤ 1+ by Dipstick (Only when urinalysis shows a protein dipstick result of > 1 positive (+), the total protein volume (<1.0 g/24hr) can be confirmed with a 24-hour urine test.) 8. Serum amylase and lipase level ≤ 3X ULN 9. Serum Albumin ≥ 3.0 g/dL 9. Female patients who are women of childbearing potential (WCBP) must have a negative pregnancy test (serum-hCG or urine-hCG performed at the Investigator's discretion) within 14 days of randomization 10. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commit to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, or any form of hormonal contraceptives) or abstinence for the duration of the study and for 6 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 6 months following the last dose of study treatment. 11. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed EXCLUSION CRITERIA 1. Patients who are eligible to be treated with a molecularly targeted therapy on a labelled regimen after receiving first-line chemotherapy. Patients who received a molecularly targeted therapy as part of their first line treatment may be eligible, as determined by the Sponsor Medical Monitor. 2. From the time point of screening, 1. Less than 4 weeks have elapsed since patients had a surgery or major procedure 2. Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy 3. Patients with percutaneous transhepatic biliary drains (PTBD) 4. Prior to the initial treatment of study drug, 1. Less than 2 weeks have elapsed since patients had chemotherapy or hormone therapy 2. Less than 2 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment 3. Less than 4 weeks since cryotherapy, radiofrequency ablation, anhydrous alcohol therapy, or photodynamic therapy, including TACE and TARE 5. A history of the following cardiovascular diseases (please, consult the Sponsor Medical Monitor for a case by case evaluation): 1. Congestive heart failure (CHF) that corresponds to Class II or a higher class under New York Heart Association (NYHA) classification, or less than 50% of left ventricular ejection fraction (LVEF) 2. Uncontrolled hypertension (SBP/DBP >140/90 mmHg) (e.g., patient with SBP/DBP >140/90 mmHg despite the best care including optimizing the anti-hypertensive medication regimen) 3. Patients with any history of hypertensive crisis or pre-existing hypertensive encephalopathy 4. Pulmonary hypertension 5. Myocardial infarction 6. Uncontrolled arrhythmia 7. Unstable angina 8. Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product 6. History of hypersensitivity reactions to any components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody drugs) or paclitaxel 7. Patients with contraindications to paclitaxel therapy 8. Patients with persistent, clinically significant toxicities (excluding hair loss) from previous anticancer treatment that corresponds to Grade 2 or a higher grade under NCI-CTCAE v5.0 9. Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis that have been treated with either surgery or radiation can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving) 10. A history of the following hemorrhage-related or gastroenterological disease: 1. Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor in great arteries 2. History of clinically significant gastroenterological disease, such as peptic ulcer, GI bleeding, GI or non-GI fistula, perforation, abdominal abscess, clinical symptoms, and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease (IBD) 11. Current or recent (within 10 days prior to study treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose will be excluded. a. Prophylactic (i.e., for the patency of venous access devices) use of low molecular weight heparin (i.e., enoxaparin 40 mg/day) is allowed if patient has INR < 2 or aPTT 81 mg/day), or other nonsteroidal anti-inflammatory drugs (NSAIDs), or other antiplatelets (i.e., dipyramidole, ticlopidine, clopidogrel, and cilostazol) will be excluded. 13. Severe infection requiring ongoing systemic antibiotics, antivirus drugs, etc., or other uncontrolled acute active infectious diseases 14. Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll. 15. Patients with other severe diseases or uncontrolled illnesses that warrant the exclusion from the study (permitted only if medically controlled) including but not limited to: 1. Pre-existing hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to screening 2. Major, unhealed injury, active ulcer, or untreated fracture 3. Pre-existing conditions of cerebrovascular incident (ischemic or hemorrhagic stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months prior to screening. 4. Moderate to severe ascites and/or pleural effusion. However, enrollment is permitted for patients with ascitic fluid as long as paracentesis is not required to improve the condition. 5. Interstitial lung disease or pulmonary fibrosis 16. Patients expected to require anticancer treatment other than the investigational product during the clinical study 17. Pregnant or lactating patients, or patients planning to become pregnant during the clinical study 18. A history of primary malignancy other than BTC will be excluded, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%). Prior malignancy history will be evaluated on a case-by-case basis by the Sponsor Medical Monitor. 19. Clinically significant abnormal ECG findings or history determined as clinically significant by the Investigator 20. QT interval (Fridericia's formula) (QTcF) interval > 450msec at the time of screening

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

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

  • A 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:
      Rectum,Colon

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

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

      • 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 (Class III or IV).
    • 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:
      Any Site,Stomach,Breast,Lung,Cervix

    • Therapies Involved:
      Chemotherapy multiple agents systemic

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

      • Contacts:

      • Rutgers University Prinicipal Investigator: Christian Hinrichs

    Read Inclusion & Exclusion Criteria

    1. 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 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.

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    • Protocol Number:
      072012

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Atezolizumab (MPDL3280A) BEVACIZUMAB

      • 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

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

    View All Details
    • Protocol Number:
      072213

    • Principal Investigator:
      Sharon Li

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

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

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Li

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • Jersey City Medical Center
    • 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 Objectives: (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 Objectives: (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 Surgery Chemotherapy (NOS)

    • 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:
      OXALIPLATIN FLUOROURACIL 5-Fluorouracil Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • Rutgers Cancer Institute of New Jersey
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