A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Relapsed or Refractory B-Cell Malignancies
Johns Hopkins Kimmel Cancer Center in Baltimore
The study will evaluate safety and tolerability, as well as a risk/benefit profile of anti-LAG-3 antibody (BMS-986016)in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) and lymphomas.
Male and female adult subjects with histologic or cytologic confirmation of CLL, Hodgkin lymphoma, or non-Hodgkin lymphoma (including T-cell and B-cell lymphomas) who have relapsed following prior treatment or been refractory to prior treatment and who meet all entry criteria will be eligible to participate.
This is a Phase 1, open-label study of BMS-986016 administered as a single agent to subjects with relapsed or refractory CLL and lymphomas. The study will be conducted in 2 parts. Part A consists of a 3 + 3 + 3 dose escalation design in subjects with relapsed or refractory CLL, HL, and NHL. Part B consists of cohort expansion in 4 disease-restricted populations. Treatment in Part B will be initiated when the MTD for Part A has been determined. In Part A (dose escalation), BMS-986016 will be administered at doses of 20, 80, 240, and 800 mg once every 2 weeks, in 8-week cycles, for up to 12 cycles of study therapy. In Part B, cohort expansion will be carried out at the dose selected from dose escalation (not to exceed the maximum tolerated dose [MTD], or maximum administered dose [MAD] if an MTD is not established). Study therapy will be administered once every 2 weeks, in 8-week cycles, for up to 12 cycles.
09/24/2016 05:03 AM