NCT03367819

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

A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab (SAR650984) in Combination With REGN2810, or Isatuximab Alone, in Patients With Advanced Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: * To characterize the safety and tolerability of isatuximab in combination with REGN2810 in participants with metastatic, castration-resistant prostate cancer (mCRPC) who were 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 participants with either mCRPC who were 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 participants 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 description

The total study duration per participant was 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.

Conditions

• Prostate Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Isatuximab SAR650984	Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUG	Cemiplimab REGN2810	Pharmaceutical form: solution for infusion Route of administration: intravenous

Timeline

• Start date: 2018-01-04
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2017-12-11
• Last updated: 2022-05-16
• Results posted: 2022-05-16

Locations

16 sites across 5 countries: United States, France, Italy, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study