New treatments for muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates various neoadjuvant therapies for patients with muscle-invasive bladder cancer (MIBC) who cannot receive or refuse cisplatin-based chemotherapy. It aims to evaluate the effectiveness of antibody-drug conjugates, specifically Sacituzumab govitecan, alone and in combination with pembrolizumab, to improve patient outcomes. The study also focuses on developing a biomarker program to better understand the biology of MIBC and identify which patients may benefit from these therapies. Participants will be those enrolled in related clinical trials or candidates for radical cystectomy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Inclusion in NureCombo (NCT04876313), SURE-01 (NCT05226117), and SURE-02 (NCT05535218) clinical trials or candidates to radical cystectomy as per routine clinical practice.

  2\. Histopathologically-confirmed urothelial carcinoma (UC). 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Clinical stage T2-T4N0M0, muscle-invasive bladder cancer (MIBC)

Exclusion Criteria:

1. Refusal to partecipate to the above studies
2. Unavailability of baseline tumor and blood samples

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Andrea Necchi, MD
• Email: necchi.andrea@hsr.it
• Phone: +390226435789

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

• BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy

  This trial tests whether T-bren can help people with HER2-expressing metastatic urothelial cancer who progressed after anti-PD-(L)1 therapy, compared with standard platinum-based chemotherapy.

  Recruiting at 2 sites Phase 3 SystImmune Inc. · Macon, Georgia and 1 other locations · NCT07869836

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Personalized 3D Tumoroids from Your Tumor to Test Treatments

  Researchers are using patient tumor tissue and blood to grow personalized 3D, vascularized tumoroids with autologous immune cells to help tailor treatments for kidney, bladder, and prostate cancers.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07820566

• Irreversible Electroporation for Recurrent Pelvic Tumors

  This study tests whether using irreversible electroporation (IRE) is safe and helps control recurrent pelvic tumors in adults who can’t have other local treatments.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT07782164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.