drugset / Trial / NCT03357952

A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma

NCT03357952

Phase 2/3 Completed 10 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).

Timeline

Start
2017-11-16
Primary completion
2018-10-24
Completion
2021-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetrelimab Monoclonal antibody 240 mg Intravenous
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous

Indications