Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 16, 2022 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Sanofi
- Interventions being studied
- Drug: Isatuximab SAR650984; Drug: Cemiplimab REGN2810
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Investigational Site Number 8400003Birmingham, Alabama
- Investigational Site Number 8400007Atlanta, Georgia
- Investigational Site Number 8400002Hackensack, New Jersey
- Investigational Site Number 8400005Nashville, Tennessee
- Investigational Site Number 8400004Houston, Texas
- Investigational Site Number 2500002Bordeaux
- Investigational Site Number 2500001Villejuif
- Investigational Site Number 3800003Rozzano, Milano
- Investigational Site Number 3800001Orbassano, Torino
- Investigational Site Number 3800006Naples
- Investigational Site Number 3800004Padova
- Investigational Site Number 3800005Verona
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 16, 2022. Always confirm current availability with the study team.