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Sponsor: Sanofi
Conditions: Lymphoma
Interventions: isatuximab SAR650984, cemiplimab REGN2810
Countries: France, Italy, Netherlands, Portugal, South Korea, Spain, Taiwan
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.
Sex: ALL
Age: 12 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * Participants greater than or equal to (\>=) 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 (cHL anti-programmed cell death protein 1/ligand 1 \[PD-1/PD-L1\] inhibitor naïve): Histologically confirmed advanced cHL that had relapsed or progressed after at least 3 lines of systemic therapy that included 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 had 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. * For Cohort B (diffuse large B-cell lymphoma \[DLBCL\]): Histologically confirmed advanced DLBCL that had relapsed or progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of systemic therapy for participants who were not eligible for auto-HSCT. * For Cohort C (peripheral T-cell lymphoma \[PTCL\]): Histologically confirmed advanced PTCL that had relapsed or progressed after either first-line chemotherapy and auto-HSCT as consolidation of first remission or first-line chemotherapy if participants were ineligible for auto-HSCT. * Body weight of greater than (\>) 45 kilograms for participants with age less than (\<)18 years. Exclusion criteria: * Prior exposure to agent that blocks CD38. * For participants 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, cytotic T-lymphocyte-associated protein 4 or LAG-3. * Evidence of other immune related disease/conditions. * Had 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
- Dijon, France
- Montpellier, France
- Nantes, France
- Pessac, France
- Villejuif, France
- Rozzano, Milano, Italy
- Bologna, Italy
- Brescia, Italy
- Amsterdam, Netherlands
- Maastricht, Netherlands
- Coimbra, Portugal
- Lisbon, Portugal
- Porto, Portugal
- Gangnam-gu, Seoul-teukbyeolsi, South Korea
- Seoul, Seoul-teukbyeolsi, South Korea
- Barcelona, Barcelona [Barcelona], Spain
- Barcelona, Barcelona [Barcelona], Spain
- L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain
- Madrid / Madrid, Madrid, Comunidad de, Spain
- Taichung, Taiwan