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Program Status Clinical trial’s patient recruitment status
Phase Phase of the clinical trial that is recruiting (I, II, or III)
Immunotherapy-centered Trial A flag to indicate whether the trial is an immunotherapy trial
Prior Immunotherapy Allowed Whether the clinical trial is open to patients who have received prior immunotherapy
CRC-directed Trial A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Drugs Therapeutics used in the clinical trial
Tags
Comments
Anti PD-1 + anti-LAG-3 monoclonal antibody BMS – 986016 (Relatlimab) Inclusion criteria Must have received at least one chemotherapy regimen. No prior anti PD-1 allowed Similar to other trials, other locations, with Relatlimab.
Inclusion Criteria
Inclusion Criteria:
Age ≥18 years. ECOG performance status 0 or 1 Have metastatic or locally advanced microsatellite stable (MSS) colorectal adenocarcinoma. Cohort A: Primary lesion has a composite PD-L1/Mucin (CPM) score ≥ 15%. Cohort B: Primary lesion has a composite PD-L1/Mucin (CPM) score < 15%. Cohort C: Prior surgical resection of primary tumor. Prospective biomarker evaluation not required. Must have received at least one chemotherapy regimen. Patients with the presence of at least one measurable lesion using RECIST 1.1. Patients must have available archival tissue from the surgical resection of their primary tumor. Patient's acceptance of tumor biopsies. Life expectancy of greater than 3 months. Patients must have adequate organ and marrow function defined by study - specified laboratory tests. Documented LVEF ≥ 50% - 6 month prior to drug administration. Must use acceptable form of birth control while on study. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
Exclusion Criteria:
Known history or evidence of brain metastases. Patients with previously treated brain metastases may participate if they are stable for 4 weeks prior to beginning treatment, have no new or enlarging brain metastases, and are not using steroids for at least 1 week prior to initiation of study treatment. Require any antineoplastic therapy. History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or anti-Lag-3 antibodies. Had chemotherapy, radiation, or steroids within 14 days prior to study treatment. Had any cytotoxic drug within 4 weeks prior to initiation of study treatment. Hypersensitivity reaction to any monoclonal antibody. Has uncontrolled intercurrent acute or chronic medical illness. Has an active known or suspected autoimmune disease. Has a diagnosis of immunodeficiency. Prior tissue or organ allograft or allogeneic bone marrow transplantation. Requires daily supplemental oxygen History of interstitial lung disease. Requires daily supplemental oxygen. Significant heart disease History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. Infection with HIV or hepatitis B or C at screening. Has an active infection. Unable to have blood drawn. Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Woman who are pregnant or breastfeeding.
NCT ID Trial ID number from clinicaltrials.gov or other database
Date Trial Added Date on which the clinical trial was added to the clinicaltrials.gov website
Updated Date Date on which the clinical trial was updated on the clinicaltrials.gov website