Study of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Multiple Myeloma

Official Title

An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma- CheckMate 602: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 602

Summary:

This is a phase 3 multicentre, randomized, open label study designed to evaluate the clinical benefit and safety of the combination therapy of Nivolumab, pomalidomide, and dexamethasone (N-Pd the investigational arms, when compared to pomalidomide and dexamethasone (Pd; the control arm) in subjects with relapsed and refractory multiple myeloma (rrMM). The study includes a third arm evaluating the clinical benefit and the safety of the combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone (NE-Pd, the exploratory arm) in the same patient population. Subjects in the control arm (Pd) are allowed to cross-over to the exploratory arm (EN-Pd) at the time of progression.

Trial Description

Primary Outcome:

  • Objective response rate (ORR) by Independent Review Committee (IRC)
  • Progression free survival (PFS) by IRC
Secondary Outcome:
  • Time to objective response (TTR)
  • Duration of objective response (DOR)
  • Investigator-assessed PFS
  • Investigator-assessed ORR

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society