Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03194867 · ClinicalTrials.gov registry record · Phase 1
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
NCT03194867 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 109 participants.
The verdict
NCT03194867, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
Study Summary
Primary Objectives: * To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma. * To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria. Secondary Objectives: * To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS). * To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination. * To assess the immunogenicity of isatuximab and cemiplimab when given in combination.
Interventions
- DRUG Isatuximab SAR650984
- DRUG Cemiplimab REGN2810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2023-04-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03194867
The ClinicalTrials.gov registry entry for NCT03194867 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 109 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.
NCT03194867 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03194867 about?
NCT03194867 is a clinical study titled "Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients". Primary Objectives: * To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma. * To compare the overall response of the combination of isatuximab and cemiplimab ve...
What is the current status of trial NCT03194867?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2018-02-21. Estimated completion is 2023-04-05.
What interventions are being tested in trial NCT03194867?
The interventions under investigation include: Isatuximab SAR650984 (DRUG), Cemiplimab REGN2810 (DRUG).
Who is sponsoring clinical trial NCT03194867?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.