Last updated on August 2019

Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

Brief description of study

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 nave 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.

Detailed Study Description

The total study duration per patient is up to 28 months including an up to 28 days screening period, an up to 24 months treatment period, and a 3 months safety follow up period.

Clinical Study Identifier: NCT03367819

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