Related Experiment Video

Updated: Jan 12, 2026

Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment
07:29

Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment

Published on: April 22, 2019

12.1K

Phase 2 study of dostarlimab plus niraparib in stage III-IV recurrent or refractory Penile squamous cell carcinoma

Firas Hatoum1, Gabriel Roman Souza1, Jeff Johnson1

  • 1Genitourinary Oncology Department, H. Lee Moffitt Cancer Center, Tampa, FL, USA.

Future Oncology (London, England)
|October 30, 2025
PubMed

Insights

This trial investigates combining PARP inhibitor niraparib with PD-1 inhibitor dostarlimab for advanced penile squamous cell carcinoma. The combination shows potential as a novel treatment strategy for refractory cases.

Area of Science:

  • Oncology
  • Immunotherapy
  • Genitourinary Cancers

Background:

  • Penile squamous cell carcinoma (PSCC) management is challenging with limited options.
  • Preclinical data suggest synergistic antitumor effects from combining PD-1 and PARP inhibitors.

Purpose of the Study:

  • To evaluate the efficacy and safety of niraparib plus dostarlimab in patients with recurrent or refractory stage III-IV PSCC.
  • To determine the objective response rate (ORR) as the primary endpoint.

Main Methods:

  • Phase II clinical trial enrolling patients with advanced PSCC.
  • Combination therapy with niraparib (PARP inhibitor) and dostarlimab (PD-1 inhibitor).
  • Primary endpoint: ORR by iRECIST; Secondary endpoints: PFS, OS, safety.

Main Results:

  • The study is currently enrolling patients in two stages.
  • The first stage will enroll 15 patients, with expansion to 10 more if ORR exceeds 13%.

Conclusions:

  • This combination therapy may offer a new treatment approach for advanced, platinum-refractory PSCC.
  • Further results are pending patient enrollment and data collection.
Keywords:
Penile NeoplasmsPoly(ADP-ribose) polymerase inhibitorscombinationdostarlimabdrug therapyimmune checkpoint inhibitorsniraparibphase II clinical trials

More Related Videos

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts10:27

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Published on: July 25, 2020

7.8K
Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer04:04

Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer

Published on: February 12, 2017

10.9K

Related Concept Videos

Treatment Resistant Cancers02:56

Treatment Resistant Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
3.7K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K