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NCT03367819 · ClinicalTrials.gov registry record · Phase 1
Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT03367819: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT03367819 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03367819, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
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.
Primary Outcome
DLTs: adverse events occurring during 1st treatment cycle, unless due to disease progression/to cause obviously unrelated to investigational medicinal product (IMP) which included:hematological abnormalities: Grade(G) 4 neutropenia(N) for 7/more consecutive days, G3 to G4 N with fever (temperature greater than or equal to \[\>=\] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia with clinically significant bleeding.
Interventions
- DRUG Isatuximab SAR650984
- DRUG Cemiplimab REGN2810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-01-04 |
| Est. Completion | 2021-03-10 |
| Phase | Phase 1 |
Why NCT03367819 stopped before completion
NCT03367819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Isatuximab SAR650984 is the first listed.
NCT03367819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03367819 about?
NCT03367819 is a clinical study titled "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,...
What is the current status of trial NCT03367819?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2018-01-04. Estimated completion is 2021-03-10.
What interventions are being tested in trial NCT03367819?
The interventions under investigation include: Isatuximab SAR650984 (DRUG), Cemiplimab REGN2810 (DRUG).
Who is sponsoring clinical trial NCT03367819?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03367819's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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