NCT05526989 is a Phase 2 clinical trial of Dostarlimab in Penile Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Who is sponsoring NCT05526989?

NCT05526989 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What drugs are being tested in NCT05526989?

Interventions in NCT05526989: Dostarlimab, Niraparib.

What condition does NCT05526989 study?

NCT05526989 studies Penile Carcinoma.

Is NCT05526989 still recruiting?

NCT05526989 is currently recruiting now. Last updated 3 December 2025.

Last reviewed 2025-12-03 · How we verify

NCT05526989

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy

Recruiting now Phase 2 Last updated 3 December 2025

What this trial tests

Phase 2 trial testing Dostarlimab in Penile Carcinoma in 25 participants. Currently enrolling.

Timeline

28 December 2022

Primary endpoint
1 November 2026

1 November 2027

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	28 December 2022
Primary completion	1 November 2026
Estimated completion	1 November 2027
Sites	2 locations across United States

Drugs / interventions tested

Dostarlimab (DOSTARLIMAB) — full drug profile →
Niraparib (niraparib) — full drug profile →

Conditions studied

Penile Carcinoma — all drugs for Penile Carcinoma →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, male only, with Penile Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own 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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic Targets in Advanced Penile Cancer: From Bench to Bedside.
Pagliaro LC, Tekin B, Gupta S, Herrera Hernandez L. · · 2024 · cited 9× · PMID 38893204 · DOI 10.3390/cancers16112086
The mechanism and clinical application of DNA damage repair inhibitors combined with immune checkpoint inhibitors in the treatment of urologic cancer.
Xie D, Jiang B, Wang S, Wang Q, et al · · 2023 · cited 7× · PMID 37305685 · DOI 10.3389/fcell.2023.1200466
New Therapeutic Horizons for Advanced or Metastatic Penile Cancer.
Simon N, Atiq S, Sonpavde G, Apolo A. · · 2024 · cited 3× · PMID 38925739 · DOI 10.1016/j.ucl.2024.03.005
Treatment approaches in advanced penile cancer: targeted therapies and immunotherapy.
Benjamin DJ, Hsu RC. · · 2024 · cited 2× · PMID 39882447 · DOI 10.3389/fonc.2024.1457006
Evaluating the Evolving Treatment Landscape of Systemic Therapies in Penile Cancer.
Jaime-Casas S, Barragan-Carrillo R, Eskenazi F, Dugarte JP, et al · · 2025 · cited 1× · PMID 41008800 · DOI 10.3390/cancers17182956
Phase 2 study of dostarlimab plus niraparib in stage III-IV recurrent or refractory Penile squamous cell carcinoma.
Hatoum F, Souza GR, Johnson J, Miller J, et al · · 2025 · PMID 41163621 · DOI 10.1080/14796694.2025.2577632
Immunotherapy in the Management of Penile Cancer-A Systematic Review.
Taghizadeh H, Fajkovic H. · · 2025 · PMID 40075730 · DOI 10.3390/cancers17050883

Verify or expand the search:

Other trials of Dostarlimab

Trials testing the same drug.

NCT07408063 — A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Res · Phase 2 · not yet recruiting
NCT07381777 — XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Lo · Phase 2 · not yet recruiting
NCT06405230 — Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Or · Phase 1, PHASE2 · recruiting
NCT07336147 — Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine · Phase 2 · recruiting
NCT07108270 — A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recur · Phase 2 · recruiting

Other recruiting trials for Penile Carcinoma

Currently open trials in the same condition.

NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting
NCT05999396 — FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer · Phase 1 · recruiting
NCT02496208 — Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors · Phase 1 · active not recruiting

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

NCT05041335 — Wet Heparinized Suction for Abdominal Cancer · NA · not yet recruiting
NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs · NA · recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors · Phase 1 · recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma · Phase 2 · recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05526989 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 3 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05526989.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing