| Trial ID # | NCT02598960 |
| Phase | IIa |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-1 |
| Drug Name | Nivolumab |
| Alternate Drug Names | BMS-936558, ONO-4538, MDX-1106, Anti-PD-1 human mab MDX-1106, Opdivo |
| Drugs in Trial | BMS-986156, Nivolumab |
| Eligible Participant | Advanced solid tumors |
| Patients Enrolled | 258; median 2 prior therapies (44 ovarian) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, evaluated per RECIST |
| Efficacy | 37 evaluable ovarian (expansion: 240 mg BMS-986156+ 240 mg nivolumab): |
| Clinically Significant Adverse Events | Serious AE: all (2.7%) |
| Conclusion | Nivolumab+BMS-986156 is safe and has efficacy comparable to historical data reported for nivolumab monotherapy |
| Reference | Heinhuis KM et al. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor–Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol (2019) 6(1):1-8 |