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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 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 44 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03367819
The ClinicalTrials.gov registry entry for NCT03367819 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Isatuximab SAR650984 is the first listed.
NCT03367819 reports 0 study locations.
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.
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