Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT03367819
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isatuximab SAR650984 — DRUG
    Pharmaceutical form: solution for infusion Route of administration: intravenous
  • Cemiplimab REGN2810 — DRUG
    Pharmaceutical form: solution for infusion Route of administration: intravenous

Study Details

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.

Key Dates

Start date
Jan 4, 2018
Status verified
Apr 2022
Primary completion
Mar 10, 2021
Completion
Mar 10, 2021

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: mCRPC/NSCLC
    Isatuximab dose 1 and REGN2810 predefined dose
  • Experimental: Cohort A-1: mCRPC, isatuximab and REGN2810 combination
    Participants with mCRPC will be given isatuximab dose determined in Phase 1 arm of study and REGN2810 predefined dose
  • Experimental: Cohort A-2: mCRPC, isatuximab monotherapy
    Participants with mCRPC will be given isatuximab dose 2
  • Experimental: Phase 2 Cohort B: NSCLC
    Participants with NSCLC will be given isatuximab dose determined in Phase 1 arm of study and REGN2810 predefined dose
  • Experimental: Possibly Phase 2 Cohort C: mCRPC
    Isatuximab dose 3 will be given in combination with REGN2810 predefined dose or isatuximab dose 3 will be given as monotherapy in participants with mCRPC
  • Experimental: Possibly Phase 2 Cohort D: NSCLC
    Isatuximab dose 3 will be given in combination with REGN2810 predefined dose

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 days) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Investigational Site Number 8400003BirminghamAlabama35249-
Investigational Site Number 8400007AtlantaGeorgia30322-
Investigational Site Number 8400002HackensackNew Jersey07601-
Investigational Site Number 8400005NashvilleTennessee37203-
Investigational Site Number 8400004HoustonTexas77030-

Find similar trials in Birmingham, AL

By condition
Lung cancerProstate cancer
By specialty
OncologyLung oncologyLung diseaseProstate oncologyMen's healthUrology
By research site
Investigational· Birmingham, ALInvestigational· Atlanta, GAInvestigational· Hackensack, NJInvestigational· Nashville, TNInvestigational· Houston, TX

Related Studies