| Trial ID # | NCT02498600 |
| 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 | Partially platinum sensitive, resistant or refractory ovarian cancer, 1-3 prior therapies, no prior immune checkpoint inhibitor |
| Patients Enrolled | 100; 62% Pt-R |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | ORR, PFS, OS, evaluated per RECIST |
| Efficacy | Ipi+Niv (n=51) vs Niv (n=49): ORR: 31.4 (3CR, 13PR) vs 12.2% (3CR, 3PR)(p=0.034) |
| Clinically Significant Adverse Events | Niv+Ipi vs Niv: |
| Conclusion | Encouraging anti-tumor activity of nivolumab and ipilimumab combination with favorable benefit over risk |
| Reference | Zamarin D et al. Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study. J Clin Oncol (2020) 38(16):1814-1823 |