TOP-FLOR: This study is evaluating how safe and effective a new drug is when given in combination with targeted therapy, with or without additional immunotherapy, in people with follicular lymphomaTreatment Of Newly-diagnosed Follicular Lymphoma With CELMoD BMS-986369, Rituximab +/- Nivolumab: An Umbrella Bayesian Optimal Phase II Study.

Summary

Eligible participants will be randomly allocated to one of two experimental arms. In Experimental Arm A, participants will receive the investigational drug (called BMS-986369) plus targeted therapy (rituximab). Participants in this group will receive rituximab (375mg/m2) via intravenous (IV) infusion once every 4 weeks, plus BMS-986369 (0.4mg) via oral tablet on Days 1-14 of each cycle for 8 cycles. This will be followed by rituximab (375mg/m2) via IV infusion every 12 weeks in participants with CR/PR at the end of induction. In Experimental Arm B, participants will receive the investigational drug (BMS-986369) plus targeted therapy (rituximab) plus immunotherapy (nivolumab). Participants in this group will receive nivolumab (480mg) via IV infusion every 4 weeks, rituximab (375mg/m2) via IV infusion every 4 weeks and BMS-986369 (0.4mg) via oral tablet on Days 1-14 of each cycle for 8 cycles. This will be followed by rituximab (375mg/m2) via IV infusion every 12 weeks in participants with CR/PR at the end of induction.

Treatment Type

Radiotherapy