NCT07829783Not yet recruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 15 Sept 2026
- Start date
- 20 Oct 2026
- Primary completion date
- 17 Nov 2031
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Bladder cancer
- NCT number
- NCT07829783
- EU CT number
- 2026-526407-30-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 20 Oct 2026 to the primary completion date, 17 Nov 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- The main exclusion criteria include but are not limited to the following:
- Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.