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A Study of Isatuximab-based Therapy in Participants With Lymphoma

NCT03769181 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-09-23

Study results available
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Summary

Primary Objectives:

Phase 1

-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D).

Phase 2

* Cohort A1 (anti-programmed cell death protein 1/ligand 1 \[PD-1/PD-L1\] naïve cHL): To assess the complete remission (CR) rate of isatuximab in combination with cemiplimab.
* Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): To assess the objective response rate (ORR) of isatuximab in combination with cemiplimab.

Secondary Objectives:

* To evaluate the safety of the RP2D of the combination of isatuximab with cemiplimab.
* To evaluate the safety of the combination of isatuximab with cemiplimab and radiotherapy in participants with cHL.
* To evaluate the immunogenicity of isatuximab and cemiplimab when given in combination.
* To characterize the pharmacokinetic (PK) profile of isatuximab and cemiplimab when given in combination.
* To assess overall efficacy of isatuximab in combination with cemiplimab and isatuximab in combination with cemiplimab and radiotherapy.

Conditions

Interventions

DRUG

isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

cemiplimab REGN2810

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2022-11-08
Completion
2022-11-08
FDA Drug
Yes

Countries

  • France
  • Italy
  • Netherlands
  • Portugal
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769181 on ClinicalTrials.gov