A Study of Isatuximab-based Therapy in Participants With Lymphoma
Status:
Active, not recruiting
Trial end date:
2022-10-24
Target enrollment:
Participant gender:
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 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.