RecruitingPhase 2NCT05526989

Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

25 participants

Start Date

Dec 28, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — dostarlimab (an immunotherapy checkpoint inhibitor) and niraparib (a PARP inhibitor) — in men with advanced or metastatic penile cancer that has come back or progressed after prior treatment. **You may be eligible if...** - You are a man with confirmed stage III (unresectable) or stage IV penile cancer - Your cancer has progressed after or you could not tolerate up to one prior line of therapy - You have measurable disease on imaging - Your life expectancy is more than 12 weeks - You are in good functional health (ECOG 0–1, or possibly 2 with investigator approval) **You may NOT be eligible if...** - You have previously received immunotherapy (checkpoint inhibitors like anti-PD-1 or anti-CTLA-4 drugs) - Your cancer has spread to the brain and is active/untreated - You have significant side effects remaining from prior treatment - Your organ function is not adequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Tampa, Florida, United States

MD Anderson Cancer Center

Houston, Texas, United States

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NCT05526989


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