| Trial ID # | UMIN000005714 |
| 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 | Nivolumab |
| Eligible Participant | Platinum resistant or refractory ovarian cancer with ≥ 2 prior therapies, no prior anti-PD-1 Ab |
| Patients Enrolled | 20 (15 serous, 3 endometrioid, 2 clear cell) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, PFS, OS, evaluated per RECIST |
| Biomarkers | Exploratory: PD-L1 protein |
| Efficacy | ORR (1mg/kg): 10% (1PR, n=10) |
| Clinically Significant Adverse Events | Serious AE: 10% |
| Conclusion | Encouraging anti-tumor activity with acceptable safety profile |
| Reference | Hamanishi et al. Safety and Antitumor Activity of Anti-PD-1 Antibody, Nivolumab, in Patients With Platinum-Resistant Ovarian Cancer. J Clin Oncol (2015) 33(34):4015-22 |