A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05328908
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab-relatlimab FDC — DRUG
    Specified dose on specified days
  • Regorafenib — DRUG
    Specified dose on specified days
  • TAS-102 — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.

Key Dates

Start date
Apr 28, 2022
Status verified
Aug 2025
Primary completion
Jul 14, 2025
Completion
Jul 14, 2025

Study Design

Enrollment
770 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC)
  • Active Comparator: Arm B: Investigator's Choice
    Treatment with Regorafenib or TAS-102

Primary Outcome Measure

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 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Local Institution - 0044SpringdaleArkansas72762-5328-
Local Institution - 0012Los AngelesCalifornia90089-0112-
Local Institution - 0117NorwichConnecticut06360-2753-
Local Institution - 0025MiamiFlorida33176-
Local Institution - 0031AtlantaGeorgia30342-
Local Institution - 0071BoiseIdaho83712-6267-
Local Institution - 0081Fort WayneIndiana46805-
Massachusetts General Hospital,BostonMassachusetts02214-
Local Institution - 0042Ann ArborMichigan48109-1382-
Local Institution - 0043East BrunswickNew Jersey08816-3340-
Local Institution - 0009DurhamNorth Carolina27710-
Local Institution - 0082CincinnatiOhio45220-
Local Institution - 0095ColumbusOhio43210-1240-
Local Institution - 0147PhiladelphiaPennsylvania19111-2434-
Local Institution - 0008CharlestonSouth Carolina29414-
Local Institution - 0096Sioux FallsSouth Dakota57104-
Local Institution - 0127NashvilleTennessee37203-2173-
Local Institution - 0097Fort WorthTexas76104-4611-
Local Institution - 0132RichmondVirginia23284-
Local Institution - 0005MadisonWisconsin53705-2275-

Related coverage on Hipa.ai

Find similar trials in Springdale, AR

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Local Institution - 0044· Springdale, ARLocal Institution - 0012· Los Angeles, CALocal Institution - 0117· Norwich, CTLocal Institution - 0025· Miami, FLLocal Institution - 0031· Atlanta, GALocal Institution - 0071· Boise, ID

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