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

Stopped early · Phase 1/Phase 2

Conditions studied: Prostate Cancer, Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03367819

Run by

Sanofi

People needed

44

Starts

2018-01-04

Expected to finish

2021-03-10

Last updated by the study team

2022-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 8400003 — Birmingham, Alabama, United States
• Investigational Site Number 8400007 — Atlanta, Georgia, United States
• Investigational Site Number 8400002 — Hackensack, New Jersey, United States
• Investigational Site Number 8400005 — Nashville, Tennessee, United States
• Investigational Site Number 8400004 — Houston, Texas, United States
• Investigational Site Number 2500002 — Bordeaux, France
• Investigational Site Number 2500001 — Villejuif, France
• Investigational Site Number 3800003 — Rozzano, Milano, Italy
• Investigational Site Number 3800001 — Orbassano, Torino, Italy
• Investigational Site Number 3800006 — Naples, Italy
• Investigational Site Number 3800004 — Padova, Italy
• Investigational Site Number 3800005 — Verona, Italy
• Investigational Site Number 1580002 — Tainan, Taiwan
• Investigational Site Number 1580001 — Taipei, Taiwan
• Investigational Site Number 8260001 — Sutton, Surrey, United Kingdom
• Investigational Site Number 8260002 — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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