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

Sanofi

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer; Prostate Cancer

Treatments: Drug: Cemiplimab REGN2810; Drug: Isatuximab SAR650984

Study type: Interventional

Funder types: Industry

Identifiers

NCT03367819

U1111-1197-7792 (Other Identifier)

2017-002846-61 (EudraCT Number)

ACT15319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must had 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.
• Greater than or equal to (>=) 18 years of age.

Exclusion criteria

• Prior exposure to isatuximab or participation in clinical studies with isatuximab.
• For participants 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.
• Had received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus were 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 6 patient groups

Phase 1: mCRPC/NSCLC

Experimental group

Description:

Isatuximab dose 1 and REGN2810 predefined dose

Treatment:

Drug: Cemiplimab REGN2810

Drug: Isatuximab SAR650984

Cohort A-1: mCRPC, isatuximab and REGN2810 combination

Experimental group

Description:

Participants with mCRPC will be given isatuximab dose determined in Phase 1 arm of study and REGN2810 predefined dose

Treatment:

Drug: Cemiplimab REGN2810

Drug: Isatuximab SAR650984

Cohort A-2: mCRPC, isatuximab monotherapy

Experimental group

Description:

Participants with mCRPC will be given isatuximab dose 2

Treatment:

Drug: Isatuximab SAR650984

Phase 2 Cohort B: NSCLC

Experimental group

Description:

Participants with NSCLC will be given isatuximab dose determined in Phase 1 arm of study and REGN2810 predefined dose

Treatment:

Drug: Cemiplimab REGN2810

Drug: Isatuximab SAR650984

Possibly Phase 2 Cohort C: mCRPC

Experimental group

Description:

Isatuximab dose 3 will be given in combination with REGN2810 predefined dose or isatuximab dose 3 will be given as monotherapy in participants with mCRPC

Treatment:

Drug: Cemiplimab REGN2810

Drug: Isatuximab SAR650984

Possibly Phase 2 Cohort D: NSCLC

Experimental group

Description:

Isatuximab dose 3 will be given in combination with REGN2810 predefined dose

Treatment:

Drug: Cemiplimab REGN2810

Drug: Isatuximab SAR650984