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

• Status: Completed
• Trial end date: 2021-03-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cemiplimab

Criteria

Inclusion Criteria:

• Patients must have a known diagnosis of either metastatic castration-resistant prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC) with evidence of measurable disease.

• Failure of, inability to, or refusal to receive standard of care.

• ≥18 years of age.

Exclusion Criteria:

• Prior exposure to isatuximab or participation in clinical studies with isatuximab.

• For patients with mCRPC, prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.

• Evidence of other immune related disease /conditions.

• History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.

• Has received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.

• Prior solid organ or hematologic transplant.

• Eastern Cooperative Oncology Group performance status (PS) ≥2.

• Poor bone marrow reserve.

• Poor organ function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.