Last updated on December 2019

A Study of Isatuximab-based Therapy in Participants With Lymphoma


Brief description of study

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] nave 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 patients 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.

Detailed Study Description

The total study duration per patient is up to 28 months, including an up to 28-day screening period, an up to 96-week treatment period, and a 90-day safety follow up period.

Clinical Study Identifier: NCT03769181

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