A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy
H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Provide written, informed consent to participate in the study and follow the study procedures * Histologically confirmed stage III (unresectable) or stage IV penile cancer, as per American Joint Committee on Cancer (AJCC) staging system. * Life expectancy \>12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 (ECOG performance status 2 can be included after discussion with PI) * Measurable disease per iRECIST * Participants who have progressed or had tolerance problems to no more than one prior line of therapy in the locally advanced setting…
Interventions
- DrugDostarlimab
300 mg Dostarlimb will be administered by IV, increasing to 1000 mg after cycle 4.
- DrugNiraparib
200 mg Niraparib will be taken once daily by mouth days 1-21 of all cycles.
Locations (2)
- Moffitt Cancer CenterTampa, Florida
- MD Anderson Cancer CenterHouston, Texas