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.
Checked against the public recordLast updated May 16, 2022 · Source: ClinicalTrials.gov
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
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.
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.