OncoMatch

OncoMatch/Clinical Trials/NCT05526989

Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

Is NCT05526989 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dostarlimab and Niraparib for penile carcinoma.

Phase 2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT05526989Data as of May 2026

Treatment: Dostarlimab · NiraparibThe 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.

Check if I qualify

Extracted eligibility criteria

Cancer type

Penile Carcinoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line

Must have received: platinum-based chemotherapy — locally advanced or neoadjuvant/adjuvant or in combination with radiation therapy

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.

Cannot have received: immune-oncology therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, cytokine therapies)

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

Lab requirements

Blood counts

Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation

Kidney function

Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation

Liver function

Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation

Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Moffitt Cancer Center · Tampa, Florida
  • MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify