Table 1.
Ongoing clinical trials of immune checkpoint inhibitors in women with ovarian cancer.
| Intervention | NCT/Author | Phase | Enrollment | Primary Endpoint |
|---|---|---|---|---|
| Anti-CTLA4 | ||||
| Tremelimumab + Olaparib | NCT02571725 | 1/2 | ~50 patients with BRCA1/2-mutant ROC | RP2D, ORR |
| Tremelimumab + Olaparib | NCT04034927 | 2 | ~170 RPS OC | |
| Anti-PD-1 | ||||
| Nivolumab ± Ipilimumab | NCT03355976 | 2 | ~62 patients with ovarian or renal cell carcinoma | ORR |
| Intraperitoneal Nivolumab ± Ipiliumumab | NCT03508570 | 1b | ~48 patients with recurrent/high-grade gynecologic cancer with peritoneal metastases | RP2D |
| Nivolumab ± Ipiliumumab + CarboTaxol | NCT03245892 | 1 | ~40 patients with High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | DLT |
| Nivolumab + Bevacizumab ± Rucaparib | NCT02873962 | 2 | ~76 patients with ROC | ORR |
| Nivolumab + Poly-ICIC (a viral mimic) | NCT04024878 | 1 | ~30 patients with OC | Safety and Activity |
| Nivolumab + WT1 vaccine | NCT02737787 | 1 | ~11 patients with ROC | DLT |
| Durvalumab ± Tremelimumab + CarboTaxol | NCT03249142 | 1/2 | ~40 patients with Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma | DLT |
| Durvalumab + Tremelimumab + CarboTaxol | NCT03899610 | 2 | ~24 patients with treatment-naïve clinical stage IIIC/IV ovarian cancer | PFS |
| Sequential vs. combination Durvalumab + Tremelimumab | NCT03026062 | 2 | ~100 patients with RPR OC | irPFS |
| Olaparib + Tremelimumab + Durvalumab | NCT02953457 | 1/2 | ~36 patients BRCA1/2-mutant ROC | DLT and PFS |
| Anti-PD-L1 | ||||
| Avelumab ± PLD | NCT02580058 | 3 | 566 patients with RPR OC | OS and PFS |
RP2D, Recommended phase 2 dose; ORR, Overall response rate; RPS, recurrent platinum-sensitive; OC, ovarian cancer; PFS, Progression free survival; DLT, dose-limiting toxicity; irPFS, immune-related progression free survival; CarboTaxol, carboplatin and paclitaxel; ROC, recurrent ovarian cancer; PLD, pegylated liposomal doxorubicin; OS, overall survival.