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Sponsor: Sanofi
Conditions: Prostate Cancer, Non-small Cell Lung Cancer
Interventions: Isatuximab SAR650984, Cemiplimab REGN2810
Countries: United States, France, Italy, Taiwan, United Kingdom
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Birmingham, Alabama, United States
- Atlanta, Georgia, United States
- Hackensack, New Jersey, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Bordeaux, France
- Villejuif, France
- Rozzano, Milano, Italy
- Orbassano, Torino, Italy
- Naples, Italy
- Padova, Italy
- Verona, Italy
- Tainan, Taiwan
- Taipei, Taiwan
- Sutton, Surrey, United Kingdom
- Newcastle upon Tyne, United Kingdom