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Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

Phase A Phase 2 Study Evaluating Response and Biomarkers in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Treated With Nivolumab in Combination With Relatlimab

NCT03642067•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with metastatic or locally advanced microsatellite stable (MSS) colorectal cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more 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.
+10 more criteria

Locations (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Key Dates

Start Date

February 12, 2019

Primary Completion Date

February 23, 2024

Completion Date

September 18, 2024

Last Updated

June 15, 2025

Enrollment

ACTUAL participants

Conditions

Microsatellite Stable (MSS) Colorectal AdenocarcinomasColorectal Adenocarcinoma

Interventions

Nivolumab

DRUG

Relatlimab

DRUG

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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RECRUITINGPHASE1

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

NCT04511039

Advanced Malignant Solid NeoplasmClinical Stage III Gastroesophageal Junction Adenocarcinoma+27 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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