| Trial ID # | NCT03355976; BrUOG 354 |
| Phase | II |
| 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 | Ipilimumab, Nivolumab |
| Eligible Participant | Recurrent clear cell ovarian and gynecologic cancer |
| Patients Enrolled | 44, median 1 prior therapies (1-7); 36 OCCC |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | ORR, DoR, PFS, OS, evaluated per RECIST |
| Efficacy | Ipi+Niv (n=30) vs Niv (n=14): ORR: 33.3 (4CR, 6PR) vs 14.3% (2PR) |
| Clinically Significant Adverse Events | Ipi+Niv vs Niv: |
| Conclusion | Ipillimumab+nivolumab demonstrates important, meaningful, and durable activity in people with previously treated ovarian and gynecologic clear cell cancer |
| Reference | Dizon D et al. Final results of BrUOG 354: a randomized phase II trial of nivolumab alone or in combination with ipilimumab with ovarian and extra-renal clear cell carcinomas. J Clin Oncol 2024; 42 (suppl 17):LBA5500. |