Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma
This is a prospective phase II multi-center trial of the combination of the PARP inhibitor olaparib with the immune checkpoint inhibitor pembrolizumab in advanced uveal melanoma.
| Condition(s) | Uveal Melanoma, Ocular Melanoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a prospective phase II multi-center trial of the combination of the PARP inhibitor olaparib with the immune checkpoint inhibitor pembrolizumab in advanced uveal melanoma. |
| Who can participate | Inclusion Criteria: * Male or female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic uveal melanoma will be enrolled in this study. Prior hepatic directed therapy for metastatic uveal melanoma is permitted. * Male participants: A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 200 days after the last dose of study treatment and refrain from donating sperm during this period. * Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: (a) Not a woman of childbearing potential (WOCBP) as de |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Locations | Tampa, Florida, United States |
| Start date | 2022-10-11 |
| NCT ID | NCT05524935 |
| Official listing | https://clinicaltrials.gov/study/NCT05524935 |