Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Conditions
Brief summary
1/Part A- Dose-limiting toxicities (DLTs), Maximum Tolerated Dose/Recommended Phase 2 Dose; (MTD/RP2D), and incidences of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths and laboratory abnormalities, 2/Part A- maximum observed serum concentration (Cmax), trough observed concentration (Ctrough), time to maximum concentration (Tmax), and area under the curve within a dosing interval (AUC(TAU)) for relatlimab, 3/Part B- Complete Metabolic Response (CMR) rate
Detailed description
1/Part B: Incidences of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities, 2/Part B: Overall Response Rate (ORR)
Interventions
DRUGRelatlimab
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1/Part A- Dose-limiting toxicities (DLTs), Maximum Tolerated Dose/Recommended Phase 2 Dose; (MTD/RP2D), and incidences of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths and laboratory abnormalities, 2/Part A- maximum observed serum concentration (Cmax), trough observed concentration (Ctrough), time to maximum concentration (Tmax), and area under the curve within a dosing interval (AUC(TAU)) for relatlimab, 3/Part B- Complete Metabolic Response (CMR) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1/Part B: Incidences of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities, 2/Part B: Overall Response Rate (ORR) | — |
Countries
France, Italy, Netherlands, Spain
Outcome results
None listed