Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

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

In this Phase 3 study, participants with nonmetastatic, muscle-invasive bladder cancer who are either ineligible for radical cystectomy or choosing bladder preservation will receive sacituzumab tirumotecan plus pembrolizumab alongside standard chemoradiation. The goal is to see if this combination improves progression-free survival compared with chemoradiation alone. The study also monitors safety and how well patients tolerate the regimens. Enrollment is limited to sites in Taiwan and Ukraine, with Merck as the lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1)
* Has clinically nonmetastatic bladder cancer (N0-N1M0)
* Is either ineligible for radical cystectomy or has opted for bladder preservation and is planned to receive chemoradiotherapy (CRT)
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has received prior pelvic/local radiation therapy for any reason or any systemic antineoplastic treatment for MIBC
* Has not recovered to Grade ≤1 or baseline from AE associated with anticancer therapy before randomization
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments

Where it's running

• Chang Gung Memorial Hospital at Kaohsiung ( Site 2702)
  Kaohsiung City, Taiwan Recruiting
• MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 3004)
  Cherkasy, Cherkasy Oblast, Ukraine Recruiting
• Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 3000)
  Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine Recruiting
• Limited Liability Company Ukrainian Center of Tomotherapy ( Site 3008)
  Kropyvnytskyi, Kirovohrad Oblast, Ukraine Recruiting
• University Hospital of the State Nonprofit Company "Danylo Halytsky Lviv National Medical University ( Site 3002)
  Lviv, Lviv Oblast, Ukraine Recruiting
• MNPE Lviv Oncology Regional Treatment and Diagnostic Center of Lviv Regional Council ( Site 3005)
  Lviv, Lviv Oblast, Ukraine Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@merck.com
• Phone: 1-888-577-8839

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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.