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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2021-03-10

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random assignment used only for allocation to Cohort A-1 or A-2

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1: mCRPC/NSCLC

Isatuximab dose 1 and REGN2810 predefined dose

Group Type EXPERIMENTAL