Tests sacituzumab tirumotecan and pembrolizumab with chemoradiation to keep the bladder in bladder cancer
Tests two treatments with chemoradiation in muscle-invasive bladder cancer, keeping the bladder.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Key facts
- Where
- Kaohsiung City, TaiwanSee the site
- Phase
- Phase 3
Where in Taiwan
- Chang Gung Memorial Hospital at Kaohsiung (Site 2702)Kaohsiung City, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07829783EU 2026-526407-30-00
- Record updated
- 6 November 2026
- Original description
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body.Read full original descriptionShow less
A Phase 3 Study Evaluating Sacituzumab Tirumotecan Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) as Induction Therapy, Followed by Local Therapy With Chemoradiation and MK-3475A Consolidation Versus Local Therapy With Chemoradiation in Participants With MIBC Who Elect Bladder Preservation
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body.
The usual treatment for MIBC is surgery to remove the bladder but some people choose to have other treatments, such as chemoradiotherapy (CRT), instead of surgery so they can keep their bladder.
Researchers want to know if giving 2 trial treatments with CRT can treat MIBC. One trial treatment is called sacituzumab tirumotecan (sac-TMT) and the other trial treatment is called subcutaneous (SC) pembrolizumab (or pembrolizumab and berahyaluronidase alfa). The main goal of this trial is to learn if participants who receive sac-TMT, SC pembrolizumab, and CRT live longer without their cancer growing, spreading, or coming back compared to those who receive CRT alone.
Inclusion: 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: Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing; Has uncontrolled, significant cardiovascular disease or cerebrovascular disease; 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; The main exclusion criteria include but are not limited to the following:; Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder.