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

NCT05526989 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-04

No results posted yet for this study

Summary

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

  • Penile Carcinoma

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.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Juskaran Chadha, DO · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-28
Primary Completion
2026-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526989 on ClinicalTrials.gov