A Study of Isatuximab-based Therapy in Participants With Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-10-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cemiplimab

Criteria

Inclusion criteria:

• Participants must be ≥ 12 years of age inclusive, at the time of signing the informed consent

• Disease location amenable to tumor biopsy at baseline

• Measurable disease

• For Cohort A1 (classic Hodgkin's lymphoma [cHL] anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] inhibitor naïve): Histologically confirmed advanced cHL that has relapsed or progressed after at least 3 lines of systemic therapy that may include autologous hematopoietic stem cell transplant (auto-HSCT) or auto-HSCT and brentuximab vedotin (BV)

• For Cohort A2 (cHL anti-PD-1/PD-L1 inhibitor progressor): Histologically confirmed advanced cHL which has relapsed or progressed after one previous anti-PD-1/PD-L1 containing regimen as the most recent prior therapy but no more than 4 lines of previous chemotherapy including the anti-PD-1/PD-L1 containing regimen and documentation of benefit during or after the anti-PD-1/PD-L1 containing regimen within 4 months prior to initiation of investigational medicinal product (IMP)

• For Cohort B (diffuse large B-cell lymphoma [DLBCL]): Histologically confirmed advanced DLBCL that has relapsed or progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of systemic therapy for participants who are not eligible for auto-HSCT

• For Cohort C (peripheral T-cell lymphoma [PTCL]): Histologically confirmed advanced PTCL that has relapsed or progressed after either first-line chemotherapy and auto-HSCT as consolidation of first remission or first-line chemotherapy if participants are ineligible for auto-HSCT

• Body weight of > 45 kg for patients with age <18 years

Exclusion criteria:

• Prior exposure to agent that blocks CD38

• For patients with cHL (PD-1/PD-L1 naïve), DLBCL or PTCL prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1, PD-L2, CD137, CTLA-4 or LAG-3

• Evidence of other immune related disease/conditions

• Has received a live-virus vaccination within 28 days of planned treatment start; seasonal flu vaccines that do not contain live virus are permitted

• 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.