Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Completed · Phase 1/Phase 2

Conditions studied: Plasma Cell Myeloma

In brief

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.

Key facts

Study ID

NCT03194867

Run by

Sanofi

People needed

109

Starts

2018-02-21

Expected to finish

2023-04-05

Last updated by the study team

2024-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:
• Serum M-protein ≥1 g/dL (≥0.5 g/dL in case of immunoglobulin A [IgA] disease), AND/OR
• Urine M-protein ≥200 mg/24 hours, OR
• In the absence of measurable M-protein, serum immunoglobulin free light chain ≥10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<0.26 or >1.65).
• Patients must have received prior treatment with an immunomodulatory drug (IMiD) (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (PI) (for ≥2 cycles or ≥2 months of treatment).
• Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line).
• Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).

You may not qualify if…

• Prior exposure to isatuximab or participated clinical studies with isatuximab.
• Prior exposure to any agent (approved or investigational) that blocks the programmed cell death-1 (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.
• Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
• Has allogenic haemopoietic stem cell (HSC) transplant.
• Prior treatment with idelalisib (a PI3K inhibitor).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
• Poor bone marrow reserve.
• Poor organ function.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• University of Colorado-Site Number:8400001 — Denver, Colorado, United States
• University of Kansas Medical Center-Site Number:8400003 — Kansas City, Kansas, United States
• Memorial Sloan-Kettering Cancer Center-Site Number:8400002 — New York, New York, United States
• Fox Chase Cancer Center-Site Number:8400004 — Philadelphia, Pennsylvania, United States
• Investigational Site Number :0360003 — Wollongong, New South Wales, Australia
• Investigational Site Number :0360002 — Richmond, Victoria, Australia
• Investigational Site Number :0360001 — West Perth, Western Australia, Australia
• Investigational Site Number :0760003 — Goiânia, Goiás, Brazil
• Investigational Site Number :0760001 — Porto Alegre, Rio Grande do Sul, Brazil
• Investigational Site Number :0760004 — São Paulo, São Paulo, Brazil
• Investigational Site Number :1240001 — Montreal, Quebec, Canada
• Investigational Site Number :1240005 — Montreal, Quebec, Canada
• Investigational Site Number :1240003 — Sherbrooke, Quebec, Canada
• Investigational Site Number :2030002 — Brno, Czechia
• Investigational Site Number :2030003 — Ostrava - Poruba, Czechia
• Investigational Site Number :2030001 — Prague, Czechia
• Investigational Site Number :2500004 — Lille, France
• Investigational Site Number :2500002 — Nantes, France
• Investigational Site Number :2500003 — Pierre-Bénite, France
• Investigational Site Number :2500001 — Villejuif, France
• Investigational Site Number :3000001 — Athens, Greece
• Investigational Site Number :3480002 — Budapest, Hungary
• Investigational Site Number :3800005 — Rozzano, Milano, Italy
• Investigational Site Number :3800003 — Brescia, Italy
• Investigational Site Number :3800001 — Torino, Italy

Full record on ClinicalTrials.gov

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