At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 25 target
Drug / intervention
Dostarlimab +1 moredrug
Likely dose
Dostarlimab 300 mgfrom record
Key inclusion· 11
- ✓Histologically confirmed stage III (unresectable) or stage IV penile cancer per AJCC
- ✓Life expectancy greater than 12 weeks
- ✓ECOG performance status 0 or 1 (ECOG 2 possible after PI discussion)
- ✓Measurable disease per iRECIST
Key exclusion· 15
- ✕Investigational agent or device within 4 weeks or 5 half-lives (whichever shorter) before first dose
- ✕Active or suspected autoimmune disease requiring systemic treatment in past 2 months
- ✕Allergy or hypersensitivity to study drug components
- ✕History of organ transplant requiring immunosuppressive agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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·interventional·Posted Sep 2, 2022·Updated Dec 4, 2025
In Brief
A Phase 2 clinical trial evaluating Dostarlimab and Niraparib for Penile Carcinoma. Currently recruiting, targeting 25 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPenile Carcinoma
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 2Recruiting
20232024202520262027
First PostedSep 2022
Enrollment StartDec 2022
TodayJul 2026
Primary CompletionNov 2026
Study CompletionNov 2027
First PostedSep 2, 2022
Enrollment StartDec 28, 2022
Primary CompletionNov 1, 2026
Study CompletionNov 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 3.8 years agoPrimary completion in 4 months
Interventions
Dostarlimabdrug
300 mg Dostarlimb will be administered by IV, increasing to 1000 mg after cycle 4.
Niraparibdrug
200 mg Niraparib will be taken once daily by mouth days 1-21 of all cycles.