Table 2.
Ongoing immunotherapy trials in gynecologic malignancies
| Trial | Study population | Phase | Intervention | Primary outcome | Status |
|---|---|---|---|---|---|
| Ovary | |||||
| NCT02580058 JAVELIN Ovarian 200 |
Platinum-resistant/refractory EOC | III | Arm 1: Avelumab Arm 2: avelumab + Doxil Arm 3: Doxil |
OS; PFS | Recruiting |
| NCT02839707 | Platinum-resistant EOC | II/III | Arm 1: Doxil + atezolizumab Arm 2: Doxil + atezolizumab + bevacizumab Arm 3: Doxil + bevacizumab |
DLTs, PFS | Recruiting |
| NCT02440425 | Platinum-resistant EOC | II | Weekly paclitaxel + pembrolizumab | PFS; AEs | Recruiting |
| NCT02608684 PemCiGem |
Platinum-resistant EOC | II | Gemcitabine + cisplatin + pembrolizumab | ORR | Recruiting |
| NCT02891824 ATALANTE |
Recurrent platinum-sensitive EOC | III | Arm 1: placebo + bevacizumab + platinum chemo Arm 2: atezolizumab + bevacizumab + platinum chemo |
PFS | Recruiting |
| NCT01928394 CheckMate 032 |
Advanced or metastatic solid tumors | I/II | Arm 1: nivolumab Arm 2: nivolumab + ipilimumab Arm 3: nivolumab + ipilimumab + cobimetinib |
ORR | Recruiting |
| NCT02498600 | Recurrent or persistent EOC | II | Arm 1: nivolumab + nivolumab maintenance Arm 2: nivolumab + ipilimumab + nivolumab maintenance |
ORR | Recruiting |
| NCT03026062 | Platinum-resistant and platinum refractory EOC | II | Arm 1: sequential tremelimumabfollowedby durvalumab Arm 2: combination tremelimumab + durvalumab |
irPFS | Recruiting |
| NCT02726997 | Advanced EOC with no prior treatment | I/II | Carboplatin + paclitaxel + durvalumab | Pharmacodynamics changes | Recruiting |
| NCT02520154 | Advanced EOC with no prior treatment | II | Neoadjuvant carboplatin + paclitaxel followed by interval TRS and adjuvant carboplatin + paclitaxel + pembrolizumab | PFS | Recruiting |
| NCT02834975 | Advanced EOC with no prior treatment | II | Neoadjuvant pembrolizumab + carboplatin + paclitaxel following by interval TRS and adjuvant pembrolizumab + carboplatin + paclitaxel | ORR | Recruiting |
| NCT03038100 IMagyn050 |
EOC with no prior treatment | III | Arm 1: carboplatin + paclitaxel + bevacizumab + atezolizumab Arm 2: carboplatin + paclitaxel + bevacizumab + placebo |
PFS; OS | Recruiting |
| NCT02718417 JAVELIN OVARIAN 100 |
Advanced EOC with no prior treatment | III | Arm 1: carboplatin + paclitaxel Arm 2: carboplatin + paclitaxel + avelumab maintenance Arm 3: carboplatin + paclitaxel + avelumab + avelumab maintanence |
PFS | Recruiting |
| Cervix | |||||
| NCT02628067 KEYNOTE 158 |
Advanced solid tumors | II | Pembrolizumab | ORR | Recruiting |
| NCT02488759 CheckMate 358 |
Squamous cell carcinomas of the cervix, vulva, and vagina plus other virus-associated malignancies | I/II | Arm 1: neoadjuvant/metastatic nivolumab Arm 2: nivolumab + ipililumab Arm 3: nivolumab + BMS-986016 Arm 4: nivolumab + daratumumab |
Safety and tolerability; ORR; rate of surgery delay | Recruiting |
| NCT01711515 | Advanced cervical cancer stage IB-IIB with positive PA nodes only and stage IIB/IIIB/IVA with positive nodes | I | Primary chemoradiation followed by ipilumumab | DLTs | Active, not recruiting |
| NCT02635360 | Locally advanced cervical cancer | Arm 1: chemoradiation followed by pembrolizumab Arm 2: chemoradiation with concurrent pembrolizumab |
Immune markers; DTLs | Recruiting | |
| NCT02866006 | Metastatic, progressive, or recurrent HPV 16/18 cervical cancer after failed standard therapy | I | BVAC-C vaccine | DTLs, AEs | Recruiting |
| NCT02128126 | Advanced, metastatic, or recurrent cervical cancer and HPV16positive | I/II | ISA101/ISA101b vaccine | HPV-specific immune response | Recruiting |
| Uterus | |||||
| NCT02549209 | Stage III/IV or recurrent endometrial cancer | II | Carboplatin + paclitaxel + pembrolizumab | ORR | Not yet recruiting |
| NCT02899793 | Recurrent endometrial cancer | II | Pembrolizumab | ORR; AEs | Recruiting |
| NCT02982486 | Non-resectable/metastatic sarcoma or high-grade endometrial cancer with MSI | II | Nivolumab + ipilimumab | ORR | Not yet recruiting |
EOC epithelial ovarian cancer, OS overall survival, PFS progression-free survival, AEs adverse events, ORR overall response rate, irPFS immune-related progression-free survival, TRS tumor reductive surgery, PA para-aortic, DLTs dose-limiting toxicities, MSI microsatellite instability