| Trial ID # | NCT02674061; KEYNOTE-100 |
| Phase | II |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-1 |
| Drug Name | Pembrolizumab |
| Alternate Drug Names | Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475 |
| Drugs in Trial | Pembrolizumab |
| Eligible Participant | Recurrent ovarian cancer; Cohort A: 1-3 prior therapies, 3-12 months Treatment Free Interval (TFI), Cohort B: 4-6 prior therapies, ≥3 months TFI |
| Patients Enrolled | 376; median 2 prior therapies |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | CBR, ORR, DCR, DoR, OS, evaluated per RECIST |
| Biomarkers | Exploratory: PD-L1 protein |
| Efficacy | ORR: 8.5% (7CR, 25PR, n=376) Exploratory analysis CPS<1 (n=141) vs CPS ≥1 (n=197) vs CPS ≥10 (n=82): |
| Clinically Significant Adverse Events | Serious AE: 2 treatment related deaths (1 Stevens-Johnson syndrome, 1 hypoaldosteronism) |
| Conclusion | Modest anti-tumor activity with acceptable safety profile |
| Reference | Matulonis UA et al. Antitumor Activity and Safety of Pembrolizumab in Patients with Advanced Recurrent Ovarian Cancer: Results from the Phase 2 KEYNOTE-100 Study. Ann Oncol (2019) 30: 1080-1087 Matulonis U et al. Final results from the KEYNOTE-100 trial of pembrolizumab in patients with advanced recurrent ovarian cancer. J Clin Oncol (2020) 38 (suppl; abstr 6005) |