Spots Global Cancer Trial Database for A Study of Isatuximab-based Therapy in Participants With Lymphoma
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Trial Identification
Brief Title: A Study of Isatuximab-based Therapy in Participants With Lymphoma
Official Title: A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab in Combination With Other Anti-cancer Therapies in Participants With Lymphoma
Study ID: NCT03769181
Conditions
Study Description
Brief 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.
Detailed Description: The total study duration per participant was 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.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number :2500005, Dijon, , France
Investigational Site Number :2500004, Montpellier, , France
Investigational Site Number :2500002, Nantes, , France
Investigational Site Number :2500007, Pessac, , France
Investigational Site Number :2500001, Villejuif, , France
Investigational Site Number :3800003, Rozzano, Milano, Italy
Investigational Site Number :3800002, Bologna, , Italy
Investigational Site Number :3800006, Brescia, , Italy
Investigational Site Number :4100001, Gangnam-gu, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :5280002, Amsterdam, , Netherlands
Investigational Site Number :5280001, Maastricht, , Netherlands
Investigational Site Number :6200002, Coimbra, , Portugal
Investigational Site Number :6200004, Lisboa, , Portugal
Investigational Site Number :6200003, Porto, , Portugal
Investigational Site Number :7240003, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240005, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240002, Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number :7240004, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number :1580002, Taichung, , Taiwan
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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