NCT05526989 · H. Lee Moffitt Cancer Center and Research Institute
Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
What this study is about
The purpose of the study is to evaluate the effectiveness and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.
View original scientific description
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.
Interventions
DRUG
Dostarlimab
300 mg Dostarlimb will be administered by IV, increasing to 1000 mg after cycle 4.
DRUG
Niraparib
200 mg Niraparib will be taken once daily by mouth days 1-21 of all cycles.
Primary outcome measures
Overall Response Rate (ORR)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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-stimu
Where
- Tampa, Florida
- Houston, Texas
Collaborators
GlaxoSmithKline
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations