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Clinical Trials List

Protocol NumberCA224-123
NCT Number(ClinicalTrials.gov Identfier)NCT05328908
Active

2022-07-01 - 2028-05-31

Phase III

Recruiting5

ICD-10C18.3

Malignant neoplasm of hepatic flexure

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9153.0

Malignant neoplasm of hepatic flexure colon

A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 饒坤銘 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴冠銘 未分科
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳鴻華 Division of Colorectal Surgery
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Colorectal Neoplasms

Objectives

The purpose of this trial is to learn the safety and effectiveness of relatlimab and nivolumab (also called "investigational drugs") in people with colorectal cancer (CRC) that has come back and spread (metastasized) after previous chemotherapy. The efficacy and safety of the trial drug will be compared with current conventional chemotherapy drugs (regorafenib or TAS-102) in patients with metastatic colorectal cancer that has progressed during prior chemotherapy treatment.

Test Drug

BMS-986213 (Relatlimab-Nivolumab FDC)

Active Ingredient

Relatlimab
Nivolumab

Dosage Form

Injection

Dosage

480 mg
480 mg

Endpoints

Comparison of relatlimab-nivolumab FDC with standard of care therapy of the trial sponsor's choice (regorafenib or TAS-102) in participants with advanced metastatic colorectal cancer, including all randomized participants and those with PD-L1 CPS ≥ 1

Inclution Criteria

Inclusion Criteria

Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry.
Participants must have:.

i) 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;.

ii) 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.

Exclusion Criteria

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    700 participants

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