Actively Recruiting
Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-04
25
Participants Needed
2
Research Sites
252 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants
- Histologically confirmed stage III (unresectable) or stage IV penile cancer
- Life expectancy greater than 12 weeks
- ECOG performance status of 0 or 1 (status 2 allowed after discussion with investigator)
- Measurable disease according to iRECIST criteria
- Progressed after or intolerance to no more than one prior line of therapy including platinum-based chemotherapy
- No prior immune-oncology treatments such as checkpoint inhibitors or other immune-related therapies
- Adequate organ function within 28 days before treatment
- Toxic effects from prior chemotherapy must be Grade 1 or resolved (except alopecia and sensory neuropathy up to Grade 2)
- Recovered from major surgery or radiation therapy complications
- Participants and female partners of childbearing potential must agree to use effective contraception during and after the study
- No active brain metastases; treated brain metastases allowed if stable for at least 4 weeks
- No chronic systemic steroids above 20 mg prednisone daily for at least 4 weeks before treatment
- Consent to provide archival tumor tissue for research
You will not qualify if you...
- Use of investigational drugs or devices within 4 weeks or less than 5 half-lives before treatment
- Active or severe autoimmune disease requiring systemic treatment recently or historically, with some exceptions
- Allergy or hypersensitivity to study drugs
- History of organ transplant requiring immunosuppressive drugs
- Active pneumonitis, interstitial lung disease, or radiation pneumonitis requiring steroids
- Prior surgery or radiotherapy affecting more than 20% of bone marrow within 14 days before treatment
- Active infections requiring treatment or known active tuberculosis
- Known active hepatitis B or hepatitis C infections
- Known immunodeficiency or active HIV with low CD4 count
- Prolonged corrected QT interval over 450 ms for men
- Recent unstable or worsening cardiac disease including unstable angina, heart failure class III/IV, or uncontrolled arrhythmias
- High blood pressure not adequately controlled or requiring multiple medications
- Recent blood transfusions or colony stimulating factors use within 4 weeks before treatment
- Severe blood cell count abnormalities lasting more than 4 weeks from prior chemotherapy
- History of myelodysplastic syndrome or acute myeloid leukemia
- Severe immune-related adverse events from prior immunotherapy
- Receipt of live vaccines within 30 days before treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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