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

NCT ID: NCT03194867

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-21
• Study Completion Date: 2023-04-05

Brief 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

Plasma Cell Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Isatuximab/cemiplimab (Regimen 1)

Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.

Cemiplimab on Days 1 and 15 in 28-day cycle up to disease progression.

Group Type: EXPERIMENTAL

Isatuximab SAR650984

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Cemiplimab REGN2810

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Isatuximab/cemiplimab (Regimen 2)

Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.

Cemiplimab on Day 1 in 28-day cycle up to disease progression.

Group Type: EXPERIMENTAL

Isatuximab SAR650984

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Cemiplimab REGN2810

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Isatuximab

Isatuximab on Days 1, 8, 15 and 22, then Day 1 and 15 in 28-day cycles up to disease progression.

Group Type: ACTIVE_COMPARATOR

Isatuximab SAR650984

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Interventions

Isatuximab SAR650984

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

Cemiplimab REGN2810

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

Other Intervention Names

Sarclisa

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Investigational Site Number :7240003

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :7240004

Badalona, Catalunya [Cataluña], Spain

Investigational Site Number :7240002

Barcelona, Catalunya [Cataluña], Spain

Investigational Site Number :7240005

Valencia, Valenciana, Comunidad, Spain

Investigational Site Number :7240006

Madrid, , Spain

Countries

United States; Australia; Brazil; Canada; Czechia; France; Greece; Hungary; Italy; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-001431-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1189-4706

Identifier Type: OTHER

Identifier Source: secondary_id

TCD14906

Identifier Type: -

Identifier Source: org_study_id