Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Conventional Radiotherapy | Radiation | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| MMC | Drug | — | UNRESOLVED |
| Pembrolizumab and Berahyaluronidase alfa | Biological | — | UNRESOLVED |
| Rescue Medications |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy
- description
- Participants will receive sac-TMT 4 mg/kg by intravenous (IV) infusion every 2 weeks (q2w) for up to 6 doses plus pembrolizumab and berahyaluronidase alfa 790 mg SC every 6 weeks (q6w) for up to 2 doses. CRT (radiotherapy \[RT\] and concurrent chemotherapy) will then be administered to all participants as standard of care per treatment regimens chosen by the investigator. RT will include conventional radiation or hypofractionated radiation to the bladder for up to approximately 6.5 weeks. Concurrent chemotherapy will be administered with RT and will include cisplatin, or 5-fluorouracil (5-FU) + mitomycin C, or capecitabine + mitomycin C, or gemcitabine. Pembrolizumab and berahyaluronidase alfa 790 mg SC will be administered q6w for up to additional 7 cycles as consolidation therapy. Each cycle is 42 days (up to approximately 42 weeks).
- interventionNames
- Biological: Sac-TMT
- Biological: Pembrolizumab and Berahyaluronidase alfa
- Drug: Cisplatin
- Drug: 5-FU
- Drug: MMC
- Drug: Capecitabine
- Drug: Gemcitabine
- Radiation: Conventional Radiotherapy
- Radiation: Hypofractionated radiotherapy
- Drug: Rescue Medications
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available