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Clinical trial’s patient recruitment status
Phase of the clinical trial that is recruiting (I, II, or III)
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
A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Therapeutics used in the clinical trial
Phase III trial for MSS CRC that includes immunotherapy in one of the arms.
Relatlimab (anti-LAG-3 antibody, immunotherapy) in combination with nivolumab (anti PD-1, immunotherapy, Opdivo) for the treatment of late-line MSS mCRC participants who failed at least 1 but no more than 4 prior lines of therapy, versus standard of care (Stivarga or Lonsurf).
Trial is randomized (patients may be assigned to any of the two arms).
No prior treatment with either an immunotherapy or with regorafenib or with TAS-102 are allowed.
Anti-LAG-3 antibody relatlimab, combined with anti PD-1, has resulted in clinical activity for melanoma patients who were resistant to anti PD-1 monotherapy.
Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry
Participants must have:
progressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;
been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures
Must have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements
Must have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
Prior treatment with either an immunotherapy or with regorafenib or with TAS-102
Untreated central nervous system (CNS) metastases, participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment)
History of refractory hypertension not controlled with anti-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, Class II congestive heart failure (as per the New York Heart Association Functional Classification), interstitial lung disease/pneumonitis or an active, known or suspected autoimmune disease
Confirmed tumor microsatellite instable high/deficient mismatch repair (MSI-H/dMMR) status as per local standard testing; MSI/MMR test results from initial diagnosis are acceptable.
Other protocol-defined inclusion/exclusion criteria apply
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
Date on which the clinical trial was updated on the clinicaltrials.gov website
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