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Phase Ib/II Study of Neoadjuvant Pembrolizumab With Gemcitabine-Cisplatin (Cisplatin-Eligible) or Gemcitabine (Cisplatin-Ineligible) in Subjects With T2-4aN0M0 Urothelial Cancer: HCRN GU14-188

Study on Pre-surgical Treatment for Muscle Invasive Bladder Cancer

Recruiting
18 years and older
All
Phase N/A

This study investigates treatments for muscle invasive bladder cancer, which is a type of cancer affecting the bladder muscle. The purpose is to explore the effects of different treatments before surgery in patients who are candidates for neoadjuvant therapy. Neoadjuvant therapy is treatment given before the main treatment, which is often surgery, to shrink a tumor.

Participants in this study will undergo various medical tests and procedures to evaluate the effects of the investigational treatment. This could include imaging tests, blood tests, and providing tumor samples for analysis. The study aims to understand how these treatments work on the cancer cells and their impact on the body before surgery.

  • Who can participate: Adults with muscle invasive bladder cancer or urothelial cancer who are candidates for pre-surgical therapy can participate. They must have a specific cancer stage, adequate organ function, and no active infections.
  • Study details: Participants will receive an investigational treatment before their scheduled surgery. They may undergo tests to monitor health and treatment effects, and a placebo may be used, which is an inactive substance that looks like the investigational medicine.
Study details
    Bladder cancer
    Urothelial cancer

TX5636

19 February 2024

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