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A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-10-20
Completion Date
2036-09-25
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Sac-TMT
IV infusion
Pembrolizumab and Berahyaluronidase alfa
Pembrolizumab coformulated with berahyaluronidase alfa administered as a SC injection
Cisplatin
IV infusion administered at 35 mg/m\^2 weekly for up to 6 doses during RT
5-FU
IV infusion administered at 500 mg/m\^2 on Days 1 to 5 and Days 22 to 26 during RT
MMC
IV infusion administered at 12 mg/m\^2 on Day 1 during RT
Capecitabine
Oral dose administered at 825 mg/m\^2 twice daily during RT
Gemcitabine
IV infusion administered at 27 mg/m\^2 twice weekly for up to 12 doses during RT
Conventional Radiotherapy
External beam radiation administered per global clinical guidelines (64 Gy at 2 Gy/fraction over approximately 6.5 weeks)
Hypofractionated radiotherapy
External beam radiation administered per global clinical guidelines (55 Gy at 2.75 Gy/fraction over approximately 4 weeks)
Rescue Medications
Participants receive rescue medications at the investigator's discretion, per approved product label. Rescue medications include pegfilgrastim (or equivalent), H1 receptor antagonist, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent), steroid mouthwash (dexamethasone or equivalent).