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.
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)
Use of an investigational agent or an investigational device within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before administration of first dose of study drug.
Active, known or suspected autoimmune disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with PI approval.)
History of allergy or hypersensitivity to study drug components
History of organ transplant that requires use of immune suppressive agents
Single group
Dostarlimab
Drug300 mg Dostarlimb will be administered by IV, increasing to 1000 mg after cycle 4.
Niraparib
Drug200 mg Niraparib will be taken once daily by mouth days 1-21 of all cycles.
Overall Response Rate (ORR)
Overall response rate is defined as the number of patients with best overall response of complete response or partial response divided by total number of participants by immune Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1.
Progression Free Survival (PFS)
Progression free survival is defined as the duration of time from the start of treatment to the first documentation of tumor progression or death.
Overall Survival (OS)
Overall survival is defined as the duration of time from the start of treatment to death due to any cause.
Duration of Response (DOR)
Duration of response is defined as the time from the date of disease response to the date of disease progression. Participants who do not experience disease progression will be censored at the date of last follow up or last visit.
Overall Response Rate (ORR)
Overall response rate is defined as the number of participants with a best overall response of complete response or partial response per Response Evaluation Criteria in Solid tumors (RECIST)1.1 divided by the total number or participants.
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
GlaxoSmithKline
Collaborator
