Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies
Status:
Completed
Trial end date:
2021-03-10
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- To characterize the safety and tolerability of isatuximab in combination with REGN2810
in patients with metastatic, castration-resistant prostate cancer (mCRPC) who are naïve
to anti-programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PD-L1)-containing
therapy, or non-small cell lung cancer (NSCLC) who progressed on
anti-PD-1/PD-L1-containing therapy, and to confirm the recommended Phase 2 dose (RP2D).
- To assess the response rate of isatuximab in combination with REGN2810 in patients with
either mCRPC who are anti-PD-1/PD-L1 therapy naive, or NSCLC who progressed on
anti-PD-1/PD-L1 therapy, or of isatuximab as single agent in patients with mCRPC.
Secondary Objectives:
- To evaluate the safety of the combination of isatuximab with REGN2810 or isatuximab
monotherapy.
- To evaluate the immunogenicity of isatuximab and REGN2810.
- To characterize the pharmacokinetic (PK) profile of isatuximab single agent or in
combination with REGN2810, and to characterize the PK of REGN2810 in combination with
isatuximab.
- To assess overall efficacy of isatuximab in combination with REGN2810 or as a single
agent.