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

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

    View All Details
    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

      1. Inability to provide written informed consent

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

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

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

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

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    • Protocol Number:
      072104

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase I

    • Scope:
      National

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

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      PCS6422 CAPECITABINE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

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

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

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    • Protocol Number:
      072110

    • Principal Investigator:
      Lyudmyla Berim

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon,Rectum

      • 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 no more than 1 cycle of first-line treatment in the metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab
    • Measurable and unresectable 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 or equivalent for patients 12 to 17 years of age
    • Patient has adequate organ function in opinion of investigator
    • 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 5 months after last investigational study treatment.

    Exclusion Criteria:

    • Patients with microsatellite instability-high disease
    • 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 or prior to study treatment, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure
    • Pregnant, planning to become pregnant, or nursing.

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Study of MK-4280A (coformulated favezelimab [MK-4280] plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD L1 Positive Colorectal Cancer. - NCT05064059

    Primary: To compare MK-4280A to standard of care (regorafenib or TAS-102) with respect to overall survival. Hypothesis (H1): MK-4280A is superior to standard of care with respect to overall survival. Secondary: To compare MK-4280A to standard of care with respect to progression free survival per RECIST 1.1 as assessed by BICR. Hypothesis (H2): MK-4280A is superior to standard of care with respect to progression free survival per RECIST 1.1 by BICR. To compare MK-4280A to standard of care with respect to objective response rate per RECIST 1.1 as assessed by BICR Hypothesis (H3): MK-4280A is superior to standard of care with respect to ORR per RECIST 1.1 by BICR. To assess the efficacy of MK-4280A and standard of care with respect to duration of response per RECIST 1.1 by BICR. To determine the safety and tolerability of MK-4280A and standard of care. To compare the change from baseline in global health status/QoL, physical functioning, appetite loss and bloating for MK-4280A versus standard of care. To compare the time to deterioration in global health status/QoL, physical functioning, appetite loss and bloating for MK-4280A versus standard of care.

    View All Details
    • Protocol Number:
      072106

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Regorafenib (Stivarga) Favezelimab (MK4280A) TAS-102

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
    • Has measurable disease per RECIST 1.1 as assessed by the local site investigator.
    • Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
    • Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
    • Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
    • Has a life expectancy of at least 3 months, based on the investigator assessment.
    • Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
    • Has adequate organ function.

    Exclusion Criteria:

    • Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
    • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
    • Has a history of acute or chronic pancreatitis.
    • Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
    • Has urine protein greater than or equal to 1g/24h.
    • A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
    • Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
    • Has previously received regorafenib or TAS-102.
    • Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
    • Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
    • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    • Has an active autoimmune disease that has required systemic treatment in past 2 years.
    • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
    • Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).
    • Has a known history of human immunodeficiency virus (HIV) infection.
    • Has known history of Hepatitis B or known active Hepatitis C virus infection.
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
    • Has had an allogenic tissue/solid organ transplant.

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

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

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

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

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    • Protocol Number:
      052105

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      OBI-3424

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria (all subjects):

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

      Dose Escalation Phase Subjects Only (Inclusion Criteria):

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

        Expansion Phase Subjects Only (Inclusion Criteria):

          12. Available tumor tissue, either archival or fresh (fresh preferred). 13. For treatment, an AKR1C3 IHC H-score of ≥ 135 using a validated IHC assay in one of the following tumor types to be enrolled in the respective cohort: 1. Cohort A: Pancreatic Adenocarcinoma 2. Cohort B: Basket (any solid tumor type other than pancreatic adenocarcinoma)

        Exclusion Criteria:

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

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

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

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

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

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    • Protocol Number:
      071702

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Stomach

    • Therapies Involved:
      Radiotherapy Chemotherapy (NOS) Surgery

    • Drugs Involved:
      Pembrolizumab (MK-3475) CAPECITABINE

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

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

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

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    • Protocol Number:
      072204

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Esophagus,Stomach

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

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

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

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    • Protocol Number:
      071914

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB IRINOTECAN TAS-102

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • Monmouth Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2). - NCT03847428

    Primary: (1). To assess the efficacy of Arm B vs Arm C. Secondary: (1). To assess the efficacy of Arm A vs Arm C. (2). To assess the efficacy of Arm A vs Arm B (for descriptive purposes only) (3). To assess the efficacy of Arm A vs Arm C and Arm B vs Arm C (4). To investigate the relationship between a patient s baseline PD-L1 expression and efficacy outcomes with durvalumab by comparing Arm A vs Arm C and Arm B vs Arm C.

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    • Protocol Number:
      071912

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      MEDI4736 (Durvalumab) BEVACIZUMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
    • Imaging to confirm disease-free status within 28 days prior to randomization
    • ECOG 0-1 at enrolment
    • Child-Pugh score of 5 or 6
    • Adequate organ and marrow function.

    Exclusion Criteria:

    • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
    • Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
    • History of hepatic encephalopathy within 12 months prior to randomization
    • Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
    • Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
    • Active co-infection with HBV and HDV.
    • Receipt of prior systemic anticancer therapy for HCC
    • Those on a waiting list for liver transplantation

    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 Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy - NCT04793958

    Primary Objective: To compare the efficacy of MRTX849 in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation. Secondary Objectives: 1. To evaluate secondary efficacy endpoints in the study population. 2. To evaluate the safety and tolerability in the study population. 3. To evaluate the pharmacokinetics (PK) of MRTX849 administered in combination with cetuximab. 4. To evaluate health-related quality of life (HRQOL) and cancer-related symptoms in the study population.

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    • Protocol Number:
      072102

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      MRTX849 mFOLFOX6 CETUXIMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
    • Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

    Exclusion Criteria:

    • Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
    • Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
    • Active brain metastasis

    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 Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery. - NCT05296681

    PRIMARY ENDPOINT: Dose Intensity of Irinotecan administered (mg/m2/week) SECONDARY ENDPOINTS: 1. Reduction in % Patients Needing Dose Modification for Diarrhea 2. Toxicity Grade of diarrhea 3. Response Rate 4. Time to Progression-free survival EXPLORATORY ENDPOINTS: 1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome 2. Short chain fatty acids analysis (promotion of acetic and butyric acid production) 3. Markers for gut inflammation such as fecal lipocalin 2 4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.

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    • Protocol Number:
      072201

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy (NOS)

    • Drugs Involved:
      NBT-NM108 IRINOTECAN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Biopsy proven and metastatic colon cancer
    • Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w. Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseline consistency.
    • Performance Status (PS) 0-1
    • Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) >1500/uL; Creatinine < 1.5 x Upper Limit of Normal (ULN); Transaminases < 5x ULN; Bilirubin < 1.5 x ULN; Albumin > 3.0 g/dL
    • No known UGTA1A* genotype

    Exclusion Criteria

    • Grade two diarrhea or greater (4-6 movements per day over baseline)
    • Inability to take oral supplements
    • Current antibiotic therapy
    • Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection.
    • History of the following infections and/or disease which could lead to diarrhea:
    • History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool.
    • History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.

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

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

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants with Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975). - NCT04210115

    Primary Objectives: 1. To compare definitive chemoradiotherapy (dCRT) + pembrolizumab to dCRT + placebo with respect to OS in participants with ESCC, in participants whose tumors express PD-L1 Combined Positive Score (CPS) ≥10, and in all participants. 2. To compare dCRT + pembrolizumab to dCRT + placebo with respect to event-free survival (EFS) per BICR or biopsy in participants with ESCC, in participants whose tumors express PD-L1 CPS ≥10, and in all participants. Secondary Objectives: To evaluate the safety and tolerability profile of dCRT + pembrolizumab.

    View All Details
    • Protocol Number:
      072109

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Esophagus

    • Therapies Involved:
      Chemotherapy multiple agents systemic Radiotherapy

    • Drugs Involved:
      pembrolizumab/placebo Pembrolizumab (MK-3475) FOLFOX

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Has histologically or cytologically confirmed diagnosis of CTX N+ M0 or cT2-T4a NX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only
    • Is deemed suitable for dCRT
    • Is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist
    • Is not expected to require tumor resection during the course of the study
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment.
    • Has adequate organ function
    • Male participants must use adequate contraception (a male condom plus partner use of an additional contraceptive method) unless confirmed to be azoospermic (vasectomized or secondary to medical cause) and refrain from donating sperm during the study treatment period and through 90 days after the last dose of chemotherapy.
    • Female participants who are a Woman of Childbearing Potential (WOCBP) must use contraception that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the study treatment period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agree not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
    • Female participants must not be pregnant or breastfeeding

    Exclusion Criteria:

    • Has direct invasion of tumor into adjacent organs such as the aorta or trachea or has radiographic evidence of >90 degree encasement or invasion of a major blood vessel, or of intratumoral cavitation.
    • Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipates the need for major surgery during study treatment; participants with gastric or esophageal fistulae are excluded
    • Has had weight loss of >20% in the previous 3 months
    • Has had prior chemotherapy or radiotherapy for esophageal cancer
    • Has had a myocardial infarction within the past 6 months
    • Has symptomatic congestive heart failure
    • Has received prior therapy with an anti-programmed cell death-1 (anti PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
    • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
    • Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents
    • Has not recovered from all adverse events (AEs) due to previous non-anticancer therapies to ≤Grade 1 or Baseline
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded from the study. Participants with localized prostate cancer that has undergone potentially curative treatment can be enrolled in the study.
    • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients
    • Has an active autoimmune disease that has required systemic treatment in past 2 years
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection
    • Has a known history of Hepatitis B or known active Hepatitis C virus infection
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment (180 days for participants receiving cisplatin who are breastfeeding)
    • Has had an allogenic tissue/solid organ transplant

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

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

    • Rutgers Cancer Institute of New Jersey
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