Trials / Completed
CompletedNCT03194867
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The duration of the study for a patient will include a period for screening of up to 21 days and 3-month post treatment follow up. The cycle duration is 28 days. Patients will continue treatment until disease progression, unacceptable adverse events, consent withdrawal, or any other reason.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isatuximab SAR650984 | Pharmaceutical form: solution for infusion Route of administration: intravenous |
| DRUG | Cemiplimab REGN2810 | Pharmaceutical form: solution for infusion Route of administration: intravenous |
Timeline
- Start date
- 2018-02-21
- Primary completion
- 2023-04-05
- Completion
- 2023-04-05
- First posted
- 2017-06-21
- Last updated
- 2024-06-14
- Results posted
- 2024-06-14
Locations
30 sites across 10 countries: United States, Australia, Brazil, Canada, Czechia, France, Greece, Hungary, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03194867. Inclusion in this directory is not an endorsement.