Study on Combining Dostarlimab and Niraparib for Patients with Penile Cancer

Inclusion Criteria

• Agree to participate in the study and follow the study procedures.
• Have stage III (unremovable) or stage IV penile cancer confirmed by medical tests.
• Have a life expectancy of more than 12 weeks.
• Be in good overall health with a performance status score of 0 or 1 (score of 2 may be considered after discussion with the study doctor).
• Have measurable cancer as defined by specific criteria.
• Have had no more than one previous treatment for advanced cancer or after platinum-based chemotherapy.
• Must not have received any previous immune-oncology treatments, such as certain checkpoint inhibitors or cancer vaccines.
• Have adequate organ function as determined by specific medical tests within 28 days before starting treatment.
• Any side effects from previous chemotherapy must be mild or resolved, except for hair loss and mild nerve damage.
• If you had major surgery or radiation therapy over 30 Gy, you must have recovered from any side effects.
• Agree to use effective birth control during the study and for a specified time after the last dose of study drug.
• Must not have active brain cancer spread.
• If you have treated brain cancer spread, you must have returned to normal for at least 4 weeks before starting the study drugs.
• Must not be taking more than 20 mg of steroids daily for at least 4 weeks before starting the study drugs.
• If you have small, untreated, symptom-free brain cancer spread, you may be eligible after discussion with the study doctor.
• No brain radiation or surgery within 4 weeks of starting the study.
• No new brain cancer spread on scans 4 weeks or more after last treatment.
• No significant symptoms from brain cancer spread.
• Agree to provide existing tumor tissue samples for research purposes.

Exclusion Criteria

• Have used an experimental drug or device within 4 weeks or less than 5 half-lives of the drug before starting the study.
• Have an active or suspected autoimmune disease needing treatment within the past 2 months or a history of severe autoimmune disease needing steroids or immunosuppressive drugs (exceptions apply).
• Have a history of allergy to study drug components.
• Have had an organ transplant needing immune-suppressing drugs.
• Have active lung inflammation or a history of lung disease needing steroids.
• Have had surgery or radiation affecting more than 20% of bone marrow within 14 days of starting the study.
• Have an active infection needing treatment or a history of active tuberculosis.
• Have active hepatitis B or C infection.
• Have an immune deficiency or active HIV with a low CD4 count in the past 6 months.
• Have a prolonged QT interval on an ECG.
• Have unstable heart disease within the past 6 months.
• Have high blood pressure not controlled with medication.
• Have received a blood transfusion within 4 weeks before starting the study.
• Have received certain growth factors within 4 weeks before starting the study.
• Have had severe blood cell issues from previous chemotherapy lasting more than 4 weeks.
• Have a history of certain blood disorders or leukemia.
• Have had severe immune-related side effects from previous immunotherapy.
• Have received a live vaccine within 30 days before starting the study.