Dostarlimab and Niraparib for Advanced Penile Cancer
This study is testing a combination of two drugs, dostarlimab and niraparib, for men with advanced penile cancer that has returned or is hard to treat. Dostarlimab is given through an IV, and niraparib is a pill taken by mouth. The goal is to see how many patients respond to this treatment (Overall Response Rate) over 24 months. To join, you must have stage III or IV penile cancer, be at least 18 years old, and have a life expectancy of more than 12 weeks. The study is currently unclear about its recruitment status and plans to enroll 25 participants.
- Study design
- This is an interventional study with a planned enrollment of 25 participants. The phase of the study is not specified.
- What's involved
- You would receive dostarlimab through an IV and take niraparib by mouth once daily for 21 days of each cycle. The study will measure your response to treatment for up to 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05526989
Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~25 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:DostarlimabNiraparib
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over Up to 24 months
Conditions
Where it's being run
2 sites across 2 statesFlorida1
Texas1
Study leadership
- Juskaran Chadha, DO · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
Measurable disease per iRECIST
Participants who have progressed or had tolerance problems to no more than one prior line of therapy in the locally advanced setting or post platinum-based chemotherapy, including in a neoadjuvant or adjuvant setting or in combination with radiation therapy.
Participants must not have received any prior immune-oncology regimens, including but not limited to checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies
Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation
Clinically significant toxic effect(s) of the most recent prior chemotherapy must be Grade 1 or resolved (except alopecia and sensory neuropathy that may be Grade 2).
If the participant received major surgery or radiation therapy of \> 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
Participants and their female partners of childbearing potential must agree and commit to use a highly effective form of contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months (female participants) and 3 months (male participants and their female partners), respectively, following the last dose of study drug. Female partner may use either an intrauterine device or hormonal contraception and continue until 3 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy 90 days months before signing the informed consent form (ICF) or a penectomy.
Participants must not have known active brain metastases.
Participants with treated brain metastases are eligible if they have neurologically returned to baseline (except for residual signs or symptoms related to the cns treatment) for at least 4 weeks prior to the first dose of study drug(s).
Participant cannot be receiving any chronic systemic steroids (prednisone or equivalent) \> 20 mg daily, for at least 4 weeks prior to the first dose of study drug(s).
Participants with small, untreated, asymptomatic central nervous system (CNS) metastases without associated edema, shift, or requirement for steroids are eligible after discussion with the Medical Monitor, i.e. the Principal Investigator.
No stereotactic radiation or craniotomy within 4 weeks of Cycle 1 Day 1
No new central nervous system lesions on repeat radiographic imaging 4 weeks or more from last treatment
No clinically significant symptoms secondary to brain metastases
Participants must also consent to allow acquisition of existing formalin-fixed paraffin-embedded (FFPE) material (archival tumor tissue), either a block or unstained slides for planned correlative studies.
Exclusion
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
Current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.
Prior surgery or radiotherapy encompassing \>20% of the bone marrow within 14 days of therapy. Patients must have recovered from all radiation-related toxicities.
Active infection requiring systemic therapy; a known history of active tuberculosis.
Has known active hepatitis B virus (HBV) infection (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C virus (HCV) infection (e.g., HCV ribonucleic acid \[RNA\] qualitative is detected)
Has known immunodeficiency or active human immunodeficiency virus (HIV-1/2 antibodies) with CD 4 count \< 400 for in the past 6 months.
Prolonged corrected QT interval (QTcF) \> 450 ms for men
History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
Systolic BP \>140 mmHg or diastolic BP \>90 mmHg that has not been adequately treated or controlled. Need for \> 2 antihypertensive medications for management of hypertension (excluding diuretics)
Must not have received a transfusion (platelets or red blood cells) ' 4 weeks prior to initiating protocol therapy.
Must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
Has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment.
Must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Has experienced a Grade 3 or greater immune-related Adverse Event with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
Has received a live vaccine within 30 days of initiating protocol therapy
What this trial measures
- Overall Response Rate (ORR)Up to 24 months
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.