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

Titre officiel

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

Sommaire:

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 late-line microsatellite stable (MSS) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.

Description de l'essai

Primary Outcome:

  • Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1
  • OS in all randomized participants
Secondary Outcome:
  • Objective response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in randomized participants with PD-L1 CPS ≥ 1
  • ORR by BICR per RECIST v1.1 in all randomized participants
  • Progression-free survival (PFS) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1
  • PFS by BICR per RECIST v1.1 in all randomized participants
  • Duration of response (DoR) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1
  • DoR by BICR per RECIST v1.1 in all responders
  • Number of participants with adverse events (AEs)
  • Number of participants with serious adverse events (SAEs)
  • Number of participants with immune-mediated adverse events (IMAEs)
  • Number of participants with AEs leading to discontinuation
  • Number of participants with clinical laboratory abnormalities
  • DeFS-QoL: The time from randomization to death or at least a 15-points worsening from baseline in the EORTC QLQ-C30 GHS/QoL scale, with no subsequent improvement above the 15-point worsening from baseline score
  • DeFS-PF: The time from randomization to death or at least a 10-points worsening from baseline in the EORTC QLQ-C30 physical function scale, with no subsequent improvement above the 10-point worsening from baseline score

Voir cet essai sur ClinicalTrials.gov

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