A Phase 3, Randomized, Open-label Study for Participants with Later-lines of Metastatic Colorectal Cancer by Bristol-Myers Squibb

JRCT ID: jRCT2031220232

Registered date:31/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: microsatellite stable (MSS) metastatic colorectal cancer (mCRC)
• Date of first enrollment: 23/08/2022
• Target sample size: 60
• Countries of recruitment: US,Japan
• Study type: Interventional

Intervention(s)

Experimental: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC(BMS-986213), Specified dose on specified days)
Active Comparator: Arm B: Investigator's Choice
Treatment with Regorafenib or TAS-102 (Specified dose on specified days)

Outcome(s)

Primary Outcome

1. Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) >- 1 [ Time Frame: Up to 5 years after last participant randomized ]
2. OS in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]

Secondary Outcome

1. Objective response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in randomized participants with PD-L1 CPS >- 1 [ Time Frame: Up to 5 years after last participant randomized ]
2. ORR by BICR per RECIST v1.1 in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]
3. Progression-free survival (PFS) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS >- 1 [ Time Frame: Up to 5 years after last participant randomized ] etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry
-Must have historically or locally confirmed tumor microsatellite stability (stable) (MSS) / proficient mismatch repair (pMMR) status
-Participants must have:

1. 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), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if KRAS wild-type), if approved in the respective country, or;
2. 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

Exclude 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
Other protocol-defined inclusion/exclusion criteria apply

Related Information

• Primary Sponsor: Marimuthu Sathiya