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  • 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.

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    • 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 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 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
  • A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair. - NCT02912559

    Primary Objective: To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve DFS compared to FOLFOX alone in patients with stage III colon cancers and dMMR. Secondary Objectives: 1. To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve overall survival compared to FOLFOX alone in patients with stage III colon cancers and dMMR. 2. To assess the adverse events (AE) profile and safety of each treatment arm, using the CTCAE and PRO-CTCAE Quality of Life Objective: The quality of life objective will be to determine the impact of the addition of atezolizumab to FOLFOX on patient-reported neuropathy, health-related QOL, and functional domains of health-related QOL. The quality of life analysis will also access the efficacy of atezolizumab adjusting for baseline QOL and fatigue measurements. Potential Correlative Science Objectives: 1..Testing of banked specimens will not occur until an amendment to this treatment protocol (or separate correlative science protocol) is reviewed and approved in accordance with National Clinical Trials Network (NCTN) policies. 2. To determine if the Immunoscore can predict the efficacy of atezolizumab for disease free survival among patients with stage III colon cancer. 3. To assess whether circulating immune cell populations can predict the efficacy of atezolizumab as adjuvant therapy for stage III colon cancer. 4. To explore the associations of genomic alterations identified in cfDNA with DFS in patients treated with FOLFOX with or without atezolizumab. 5. To assess whether soluble markers of systemic inflammation in blood can predict the efficacy of atezolizumab as adjuvant therapy for stage III colon cancer. 6. To assess the relationship between baseline plasma 25(OH) D levels, change in 25(OH)D levels, and DFS and OS in patients with stage III colon cancer receiving FOLFOX +/- atezolizumab. 7..To determine the ability of using fecal microbiota and their metabolic products to predict survival benefit from anti-PD-L1 antibody therapy in dMMR colon cancer patients. 8. To determine if hypermutation or hyper-indel status is associated with response to atezolizumab. 9. To determine if unique mRNA expression signatures are predictive of disease-free survival among patients receiving adjuvant chemotherapy for stage III colon cancer. 10. To determine if the efficacy of atezolizumab differs among dMMR cancers due to germline MMR mutation (MLH1, MSH2, MSH6, PMS2) versus those with MLH1 hypermethylation and CIMP in patients with stage III colon cancer. 11. To identify overall mutational burden and number of putative tumor neoantigens in colon carcinoma specimens.

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    • Protocol Number:
      071808

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

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

    • Drugs Involved:
      Atezolizumab (MPDL3280A) mFOLFOX6

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C); tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve)
    • Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
    • Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)
    • Patients who are known to have Lynch syndrome, have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2), and have been shown to be dMMR by IHC are eligible to participate
    • Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon; near or positive radial margins are acceptable so long as en bloc resection was performed; proximal or distal margin positivity is not permitted
    • Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary; patients with more than one primary colon adenocarcinoma are eligible if the qualifying stage III tumor is confined to the colon, and not rectum, and the other cancers of lower stage are removed in the en bloc R0 resection
    • Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (included with distal), and further categorization will be as follows: cecum/ascending, transverse, descending, sigmoid colon, or rectosigmoid colon
    • No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible
    • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current colon cancer except for one cycle of mFOLFOX6
    • Performance Status:
    • Patients < 16 years of age: Lansky >= 50%
    • Patients 16 to < 18 years of age: Karnofsky >= 50%
    • Patients >= 18 years of age: Eastern Cooperative Oncology Group (ECOG) performance status =< 2
    • This study involves: 1) an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; and 2) an agent that has known genotoxic, mutagenic, and teratogenic effects; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)
    • Absolute neutrophil count (ANC) >= 1500 mm^3
    • Platelet count >= 100,000 mm^3; platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration
    • Creatinine =< 1.5 x upper limit of normal (ULN) or
    • Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation
    • Alternatively, for patients < 18 years of age, maximum serum creatinine =< the below age-gender-specific norms:
    • 12 years: 1.2 (male and female)
    • 13 to < 16 years: 1.5 (male), 1.4 (female)
    • 16 to < 18 years: 1.7 (male), 1.4 (female)
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
    • Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
    • No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency
    • No known active hepatitis B or C
    • Active hepatitis B can be defined as:
    • Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;
    • Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B
    • Persistent or intermittent elevation in ALT/AST levels
    • Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
    • Active hepatitis C can be defined as:
    • Hepatitis C antibody (AB) positive AND
    • Presence of hepatitis C virus (HCV) RNA
    • Excluded if known active pulmonary disease with hypoxia defined as:
    • Oxygen saturation < 85% on room air, or
    • Oxygen saturation < 88% despite supplemental oxygen
    • No grade >= 2 peripheral motor or sensory neuropathy
    • Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
    • A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests
    • No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
    • No systemic daily treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration
    • No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
    • No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation
    • No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin

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

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

    • Cooperman Barnabas Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • Alliance A021703: Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS). - NCT04094688

    Primary Objective: To compare the progression-free survival (PFS) of patients receiving high-dose vitamin D3 in combination with standard chemotherapy (FOLFOX or FOLFIRI) and bevacizumab versus those receiving standard-dose vitamin D3 in combination with standard chemotherapy and bevacizumab.

    View All Details
    • Protocol Number:
      072001

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      LEUCOVORIN IRINOTECAN FLUOROURACIL BEVACIZUMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed advanced/metastatic colorectal adenocarcinoma for which metastasectomy is not planned.
    • No known mismatch repair deficiency (dMMR) or high-frequency microsatellite instability (MSI-H) disease.
    • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
    • No prior systemic treatment for metastatic disease.
    • Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation. The last course of adjuvant therapy must have been completed > 12 months prior to colorectal cancer recurrence.
    • Patients may have received prior standard rectal cancer chemoradiation. Previous radiation therapy must have been completed >= 4 weeks prior to registration.
    • No continuous daily use of vitamin D supplements >= 2,000 IU per day for the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements >= 2,000 IU per day if total duration < 12 months in the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements < 2,000 IU per day for any duration prior to registration.
    • Patients must have completed any major surgery or open biopsy >= 4 weeks prior to registration and must have completed any minor surgery or core biopsy >= 1 week prior to registration. (Note: insertion of a vascular access device is not considered major or minor surgery.) Patients must have recovered from the effects of any surgery (e.g. wound is healed, no active infection, no drains, etc.) prior to registration.
    • Not pregnant and not nursing. This study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 14 days prior to registration is required.
    • Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
    • Absolute neutrophil count >= 1,500/mm^3.
    • Platelet count >= 100,000/mm^3.
    • Hemoglobin >= 9 g/dL.
    • Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (Calc.) creatinine clearance (CrCl) > 30 mL/min.
    • Calcium =< 1.0 x ULN. * Corrected for albumin level if albumin not within institutional limits of normal.
    • Total bilirubin =< 1.5 x ULN. * If Gilbert's disease, use direct bilirubin instead of total bilirubin; direct bilirubin =< 1.5 x ULN if patient to receive FOLFIRI; direct bilirubin =< 3.0 x ULN if patient to receive leucovorin, infusional fluorouracil, and oxaliplatin (modified [m]FOLFOX6).
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN. * AST/ALT < 5 x ULN if clearly attributable to liver metastases.
    • Urine protein to creatinine (UPC) ratio =< 1 mg/dL OR urine protein =< 1+. * If urine protein is above 1, then 24-hour urine must be ≤ 1 g/24 hours.
    • No resectable metastatic disease for which potentially curative metastasectomy is planned.
    • No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have been free of disease for >= 3 years.
    • No significant history of bleeding events or bleeding diathesis =< 6 months of registration unless the source of bleeding has been resected.
    • No history of arterial thrombotic events, including, but not limited to, transient ischemic attack, cerebrovascular accident, unstable angina, angina requiring surgical or medical intervention, or myocardial infarction =< 6 months of registration.
    • No history of clinically significant peripheral artery disease =< 6 months of registration.
    • No history of uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or greater.
    • No history of gastrointestinal (GI) perforation =< 12 months of registration except for GI perforation related to a primary colorectal tumor that has since been fully resected.
    • No history of malabsorption, uncontrolled vomiting or diarrhea, or any other disease significantly affecting GI function that could interfere with the absorption of oral agents.
    • No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study agents.
    • No uncontrolled hypertension (defined as blood pressure [BP] > 160/90).
    • No serious or non-healing wound, ulcer, or bone fracture.
    • No uncontrolled intercurrent illness, including, but not limited to, psychiatric illness/social situations that, in the opinion of the treating physician, may increase the risks associated with participation or treatment on the study or may interfere with the conduct of the study or interpretation of the study results.
    • Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
    • On effective anti-retroviral therapy
    • Undetectable HIV viral load by standard clinical assay =< 6 months of registration.
    • No known pre-existing hypercalcemia =< 6 months of registration.
    • No known active hyperparathyroid disease or other serious disturbance of calcium metabolism =< 5 years of registration.
    • No predisposing colonic or small bowel disorders in which symptoms are uncontrolled as indicated by > 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy are allowed per treating physician discretion.
    • No symptomatic genitourinary stones =< 12 months of registration.
    • Patients with treated brain metastases are eligible if follow-up imaging after central nervous system (CNS)-directed therapy shows no evidence of progression >= 28 days prior to registration.
    • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal 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 protocol-specified therapy after registration.
    • No uncontrolled seizure disorders.
    • No grade >=2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 regardless of causality.
    • Patients must be able to swallow oral formulations of the agent.
    • Concurrent use of supplemental calcium and/or vitamin D is not permitted. Patients must discontinue the supplement(s) at least 7 days prior to registration.
    • Concurrent use of thiazide diuretics (e.g. hydrochlorothiazide) is not permitted. Patients must discontinue the drug(s) or switch to an alternative anti-hypertensive agent at least 7 days prior to registration.
    • Chronic concomitant treatment with oral corticosteroids, lithium, phenytoin, quinidine, isoniazid, and/or rifampin are not permitted. Patients must discontinue the agent(s) at least 7 days prior to registration. Short-term use of corticosteroids as antiemetic therapy is acceptable.
    • Concurrent use of other anti-cancer therapy including chemotherapy, targeted, and/or biological agents is not permitted.

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

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

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer. - NCT04264702

    Primary Objectives: - Examine the impact of SIGNATERA on adjuvant treatment decisions - Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA Secondary objectives: - Molecular residual disease clearance as assessed by SIGNATERA -Percent of patients undergoing surgery for oligometastatic recurrence - Survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA negative test results - Overall survival - Patient satisfaction and cancer surveillance

    View All Details
    • Protocol Number:
      072004

    • Principal Investigator:
      Lyudmyla Berim

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Rectum,Colon

      • Contacts:

      • Rutgers University Prinicipal Investigator: Lyudmyla Berim

    Read Inclusion & Exclusion Criteria

    Inclusion criteria:

      1. 18 years of age or older. 2. Planning or undergone surgical resection of adenocarcinoma of the colon or rectum. 3. Diagnosis of Colorectal cancer that falls into one of the below categories: 1. Stage I to IV disease. 2. Stage IV with oligometastatic disease eligible for post-operative systemic therapy. 4. Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their routine practice. 5. ECOG performance status ≤ 2 6. Clinically eligible for post-operative systemic therapy. 7. Able to tolerate venipuncture for research blood draw(s). 8. Able to read, understand and provide written informed consent . 9. Willing and able to comply with the study requirements.

    Exclusion Criteria:

      1. Pregnant or breastfeeding. 2. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer 3. Has a known rare inherited genetic condition, with the exception of lynch syndrome 4. Has initiated post-operative systemic therapy. 5. Neuropathy > grade 2. 6. History of bone marrow or organ transplant. 7. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder . 8. Serious medical condition that may adversely affect ability to participate in the study.

      Control Arm Inclusion criteria:

        1. 18 years of age or older at time of diagnosis. 2. Diagnosis of Colorectal cancer that falls into one of the below categories: 1. Stage I to IV disease. 2. Stage IV with oligometastatic disease eligible for post-operative systemic therapy. 3. Were clinically eligible for chemotherapy at full recommended doses per Health Care Provider. 4. Received treatment no more than 3 years prior to study start date. 5. Have a minimum of least 2 years clinical follow-up data or reached a progression event. Control Arm Exclusion criteria: 1. Female patients that were pregnant or breastfeeding during historical control collection period. 2. Per investigator, was not clinically eligible for post-operative systemic therapy. 3. Had an ECOG performance status ≤ 2 at time of diagnosis.

    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
    • Community Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • Cancer treatment and survivorship experiences among Southern New Jersey residents.

    The primary objective of this project is to conduct a survey of cancer survivors to understand cancer burden, treatment outcomes, care needs, cancer prevention practices, health care access, and health information seeking behaviors of persons living in Southern New Jersey (Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, Mercer, Ocean, and Salem counties). To date, health needs of cancer survivors who are residents of these Southern New Jersey counties remain largely unexplored. Specific Aim 1: To determine the feasibility of conducting research on the access and needs of patients diagnosed with cancers who reside in the New Jersey counties outlined. Specific Aim 2: To characterize the cancer burden, quality of life characteristics, care needs, cancer prevention practices, health care access, survivorship care experiences, cancer surveillance, and health information seeking behaviors of patients diagnosed with cancers who reside in the New Jersey counties outlined.

    View All Details
    • Protocol Number:
      131803

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon,Breast - Female,Melanoma, Skin,Ovary,Lung,Rectum,Cervix,Other Female Genital,Thyroid,Prostate,Urinary Bladder

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey
  • COLOMATE: COlorectal Cancer Liquid BiOpsy Screening Protocol for Molecularly Assigned ThErapy - NCT03765736

    To perform blood-based genomic profiling on patients with treatment refractory metastatic CRC to facilitate accrual to molecularly assigned therapies. To facilitate clinically annotated genomic analyses

    View All Details
    • Protocol Number:
      072009

    • Principal Investigator:
      Patrick Boland

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
    • Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)
    • For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)
    • Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
    • At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
    • Life expectancy >= 3 months per estimation of investigator
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
    • Capable of understanding and complying with the protocol requirements and has signed the informed consent document
    • Satisfy at least one of the following two conditions:
    • Willing and able to provide blood sample for screening purposes
    • Guardant 360 testing completed =< 60 days prior to registration

    Exclusion Criteria:

    • Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of < 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
    • Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
    • History of solid organ transplantation
    • Pregnant or planning to become pregnant within the next 12 months

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

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

    • Monmouth Medical Center
    • Rutgers Cancer Institute of New Jersey
  • NRG-GI004: Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer. - NCT02997228

    Primary Objective: 1.1.1 To determine the efficacy, based on PFS, of mFOLFOX6/bevacizumab plus atezolizumab(combination) and atezolizumab (single agent) as compared to mFOLFOX6/bevacizumab(control). 1.2 Secondary Objectives: 1.2.1 To compare the overall survival. 1.2.2 To compare the objective response rates (ORR) per RECIST 1.1. 1.2.3 To determine the safety profiles of the combination of mFOLFOX6/bevacizumab/atezolizumab and atezolizumab monotherapy in patients with dMMR mCRC. 1.2.4 To compare the surgical conversion rate. 1.2.5 To compare disease control rate (CR + PR + SD) at 12 months. 1.2.6 To determine the duration of response and stable disease. 1.2.7 To determine the progression-free survival (PFS) by retrospective central independent scan review. 1.3 Exploratory Objectives: 1.3.1 To compare the health-related quality of life and patient-reported symptoms. 1.4 Translational Objectives: 1.4.1 To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.

    View All Details
    • Protocol Number:
      071807

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

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

    • Drugs Involved:
      Atezolizumab (MPDL3280A) BEVACIZUMAB mFOLFOX6

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    • Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer
    • Tumor determined to be mismatch-repair deficient (dMMR) by Clinical Laboratory Improvement Act (CLIA)-certified immunohistochemical (IHC) assay with a panel of all four IHC markers, including MLH1, MSH2, PMS2, and MSH6; alternatively, MSI-H diagnosed by polymerase chain reaction (PCR)-based assessment of microsatellite alterations (either Bethesda markers or Pentaplex panel) or by next-generation sequencing (NGS) are eligible
    • Documentation by positron emission tomography(PET)/computed tomography (CT) scan, CT scan, or magnetic resonance imaging (MRI) that the patient has measurable metastatic disease per RECIST 1.1
    • No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass
    • Absolute neutrophil count (ANC) must be >= 1500/mm^3 (obtained within 28 days prior randomization)
    • Platelet count must be >= 100,000/mm^3 (obtained within 28 days prior randomization)
    • Hemoglobin must be >= 8 g/dL (obtained within 28 days prior randomization)
    • Total bilirubin must be =< 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > 1.5 x ULN to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained within 28 days prior randomization); and
    • Alkaline phosphatase must be =< 2.5 x ULN for the lab with the following exception: patients with documented liver metastases or bone involvement - alkaline phosphatase must be =< 5 x ULN (obtained within 28 days prior randomization); and
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be =< 3 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be =< 5 x ULN (obtained within 28 days prior randomization)
    • Serum creatinine =< 1.5 x ULN for the lab or measured (24 hour urine collection) or calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior randomization)
    • A urine sample tested for proteinuria by either the dipstick method, urinalysis (UA), or a urine protein creatinine (UPC) ratio:
    • The dipstick method must indicate 0-1+ protein; if dipstick reading is >= 2+, a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours
    • A urine protein creatinine (UPC) ratio must be < 1.0; if the UPC ratio is >= 1.0 a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours
    • Urinalysis must indicate < 30 mg/dl. If urinalysis >= 30 mg/dl, a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours
    • International normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history, regardless of PT/INR results
    • Pregnancy test done within 14 days prior randomization must be negative (for women of childbearing potential only); pregnancy testing should be performed according to institutional standards; administration of atezolizumab or mFOLFOX6/bevacizumab/atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; 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
    • Women of child-bearing potential and men must agree to use adequate contraception methods that result in a failure rate of < 1% per year during the treatment period (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, and 6 months after the last dose of mFOLFOX6; a woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; men must refrain from donating sperm during this same period

    Exclusion Criteria:

    • Patients with central nervous system (CNS) metastases are excluded, with the following exceptions:
    • Patients with asymptomatic untreated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following:
    • Evaluable or measurable disease outside the CNS
    • No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
    • No history of intracranial hemorrhage or spinal cord hemorrhage
    • No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.
    • No neurosurgical resection or brain biopsy within 28 days prior to randomization
    • Patients with asymptomatic treated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following:
    • No radiographic demonstration and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
    • No stereotactic radiation or whole-brain radiation within 28 days prior to randomization
    • Screening CNS radiographic study >= 28 days from completion of radiotherapy and >= 14 days from discontinuation of corticosteroids
    • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, fluoropyrimidines, folic acid derivatives or oxaliplatin
    • Uncontrolled high blood pressure defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP 90 mmHg with or without anti-hypertensive medication; patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria
    • Any of the following cardiac conditions:
    • Documented New York Heart Association (NYHA) class III or IV congestive heart failure
    • Myocardial infarction within 6 months prior to randomization
    • Unstable angina within 6 months prior to randomization
    • Symptomatic arrhythmia
    • Serious or non-healing wound, skin ulcer, or bone fracture
    • History of transient ischemic attack (TIA), cerebrovascular accident (CVA), gastrointestinal (GI) perforation or arterial thrombotic event within 6 months prior to randomization, symptomatic peripheral ischemia, or other medical condition in the opinion of the treating oncologist that makes the risk of cardiovascular or bleeding complications with bevacizumab use unacceptably high
    • Other malignancies are excluded unless the patient has completed therapy for the malignancy >= 12 months prior to randomization and is considered disease-free; patients with the following cancers are eligible if diagnosed and treated within the past 12 months: in situ carcinomas or basal cell and squamous cell carcinoma of the skin
    • Known DPD (dihydro pyrimidine dehydrogenase) deficiency
    • Symptomatic peripheral sensory neuropathy >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0)
    • Prior treatment with oxaliplatin chemotherapy within 6 months prior to randomization
    • Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents; patients who have received prior treatment with anti-CTLA-4 may be enrolled provided the following requirements are met:
    • Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose to randomization
    • No history of severe immune-related adverse effects (CTCAE Grade 3 and 4) from anti-CTLA-4
    • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier are excluded; however, the following therapies are allowed:
    • Hormone-replacement therapy or oral contraception
    • Herbal therapy > 7 days prior to randomization (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization)
    • Palliative radiotherapy for bone metastases > 14 days prior to randomization
    • Treatment with systemic immunostimulatory medications (including, but not limited to interferon [IFN]-alpha or interleukin [IL]-2 within 42 days prior to randomization
    • Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization; however,
    • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea; or chronic daily treatment with corticosteroids with a dose of =< 10 mg/day methylprednisolone equivalent) may be enrolled
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
    • Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
    • Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g., denosumab) who cannot discontinue it before treatment with atezolizumab
    • Treatment with any other investigational agent within 4 weeks prior to randomization
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease; however,
    • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible if polymerase chain reaction (PCR) for HBV RNA is negative per local guidelines
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA) per local guidelines
    • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; however,
    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
    • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
    • Rash must cover less than 10% of body surface area (BSA)
    • Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
    • No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
    • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
    • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    • Patients with known active tuberculosis (TB) are excluded
    • Severe infections within 28 days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
    • Signs or symptoms of infection within 14 days prior to randomization
    • Received oral or intravenous (IV) antibiotics within 14 days prior to randomization; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
    • Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab; Note: influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 28 days prior to randomization or at any time during the study
    • Psychiatric illness/social situations that would limit compliance with study requirements
    • Pregnant women are excluded from this study because atezolizumab is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding should be discontinued if the mother is treated with atezolizumab; these potential risks may also apply to other agents used in this study; (Note: pre

    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.

    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • NRG-GI005 Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA) - NCT04068103

    Primary Objectives: 1.1.1 Primary Objective Phase II To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer. 1.1.2 Primary Objective Phase III To compare recurrence-free survival (RFS) in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer.

    View All Details
    • Protocol Number:
      071915

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      LEUCOVORIN OXALIPLATIN FLUOROURACIL CAPECITABINE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon (T3, N0, M0) with at least 12 lymph nodes examined at the time of surgical resection.
    • Appropriate for active surveillance (i.e., no adjuvant chemotherapy) at the discretion of and as documented by the evaluating oncologist based on current practice patterns.
    • The distal extent of the tumor must be >= 12 cm from the anal verge on pre-surgical endoscopy (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). If the patient did not undergo a pre-surgical endoscopy, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination or pre-operative imaging.
    • The patient must have had an en bloc complete gross resection of tumor (curative resection) as definitive surgical cancer treatment within 14 to 60 days of study randomization. Patients who have had a two-stage surgical procedure to first provide a decompressive colostomy and then, in a later procedure, to have the definitive surgical resection, are eligible.
    • Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
    • Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 28 days before randomization).
    • Platelet count must be >= 100,000/mm^3 (within 28 days before randomization); and
    • Hemoglobin must be >= 9 g/dL (within 28 days before randomization).
    • Total bilirubin must be =< ULN (upper limit of normal) for the lab (within 28 days before randomization) unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert?s disease or similar syndrome involving slow conjugation of bilirubin; and
    • Alkaline phosphatase must be < 2.5 x ULN for the lab (within 28 days before randomization); and
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 1.5 x ULN for the lab (within 28 days before randomization).
    • Serum creatinine =< 1.5 x ULN for the lab or measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 28 days before randomization).
    • Pregnancy test (urine or serum according to institutional standard) done within 14 days before randomization must be negative (for women of childbearing potential only).
    • Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of international normalized ratio (INR) if they are randomized to Arm 2 and receive capecitabine.

    Exclusion Criteria:

    • Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
    • Pathologic, clinical, or radiologic evidence of overt metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected (including the presence of satellite nodules constituting N1c disease in the absence of lymph node involvement).
    • Tumor-related bowel perforation.
    • History of prior invasive colon malignancy, regardless of disease-free interval.
    • History of organ transplantation.
    • Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary rectal adenocarcinomas for which treatment with neoadjuvant chemoradiation is warranted are not permitted).
    • Other invasive malignancy within 5 years before randomization. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ including those of the cervix and breast (DCIS).
    • Synchronous primary rectal and/or colon cancers.
    • Antineoplastic therapy (e.g., chemotherapy, targeted therapy, or immunotherapy) within 5 years before randomization. (For the purposes of this study, hormonal therapy is not considered chemotherapy.).
    • Uncontrolled cardiac disease, in the opinion of the treating medical oncologist, that would preclude the use of any of the drugs included in the GI005 treatment regimen. This includes but is not limited to:
    • Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker.
    • Ventricular tachycardia or supraventricular tachycardia that requires treatment with class Ia antiarrhythmic drugs (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
    • Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker.
    • Complete left bundle branch block (LBBB) unless treated with a permanent pacemaker.
    • Sensory or motor neuropathy >= grade 2, according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
    • Active seizure disorder uncontrolled by medication.
    • Active or chronic infection requiring systemic therapy.
    • Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.
    • Pregnancy or lactation at the time of randomization.
    • Co-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).
    • Prior testing with any available ctDNA test as part of the management of colon cancer.

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

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

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Community Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
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