A Phase II Trial of Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma
H. Lee Moffitt Cancer Center and Research Institute
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 partici…
Interventions
- DrugPembrolizumab
Pembrolizumab Day 1 of each 21 day (3 week) cycle
- DrugOlaparib
Olaparib by mouth days 1-21 of each 21 day (3 week) cycle
Location
- Moffitt Cancer CenterTampa, Florida