A Phase 3 interventional study of Sac-TMT and Pembrolizumab and Berahyaluronidase alfa in Bladder Cancer, sponsored by Merck Sharp & Dohme LLC. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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
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.
Drug: Cisplatin · Drug: 5-FU · Drug: MMC · Drug: Capecitabine · Drug: Gemcitabine · Radiation: Conventional Radiotherapy · Radiation: Hypofractionated radiotherapy
IV infusion
Also known as: MK-2870, SKB264, Sacituzumab tirumotecan
Pembrolizumab coformulated with berahyaluronidase alfa administered as a SC injection
Also known as: MK-3475A
IV infusion administered at 35 mg/m\^2 weekly for up to 6 doses during RT
IV infusion administered at 500 mg/m\^2 on Days 1 to 5 and Days 22 to 26 during RT
IV infusion administered at 12 mg/m\^2 on Day 1 during RT
Oral dose administered at 825 mg/m\^2 twice daily during RT
IV infusion administered at 27 mg/m\^2 twice weekly for up to 12 doses during RT
External beam radiation administered per global clinical guidelines (64 Gy at 2 Gy/fraction over approximately 6.5 weeks)
External beam radiation administered per global clinical guidelines (55 Gy at 2.75 Gy/fraction over approximately 4 weeks)
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).
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the first occurrence of any of the following events, as assessed by blinded independent central review (BICR): residual/recurrent MIBC, or locoregional disease, or distant metastases as assessed by imaging and/or biopsy results, or death from any cause. The EFS for all participants will be presented.
Time frame: Up to approximately 60 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. The OS for all participants will be presented.
Time frame: Up to approximately 90 months
Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from randomization to the first occurrence of any of the following events, as assessed by BICR: distant metastatic disease as assessed by imaging and/or biopsy results, or death due to any cause. DMFS for all participants will be presented.
Time frame: Up to approximately 90 months
Bladder Intact (BI)-EFS
BI-EFS is defined as the time from randomization to the first occurrence of any of the following events: residual/recurrent MIBC, or locoregional disease, or distant metastases as assessed by imaging and/or biopsy results, or radical cystectomy, or death from any cause. The BI-EFS for all participants will be presented.
Time frame: Up to approximately 90 months
Time to Occurrence of Non-Muscle-Invasive Bladder Cancer (NMIBC)
Time to occurrence of NMIBC, defined as the time from randomization to the first occurrence of NMIBC (\<T2 disease in bladder) after CRT as assessed by biopsy results, will be presented for all participants.
Time frame: Up to approximately 90 months
Disease-Specific Survival
DSS is defined as the time from randomization to death due to bladder cancer. The DSS for all participants will be presented.
Time frame: Up to approximately 90 months
Rate of Radical Cystectomy
Rate of radical cystectomy is defined as the percentage of participants who undergo radical cystectomy at any time after randomization, for any reason. Rate of radical cystectomy for all participants will be presented.
Time frame: Up to approximately 90 months
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 90 months
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately 90 months
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Oct 2026 (actual). Primary completion is estimated for Nov 2031, 60 months after the start.
Of 39 industry-sponsored phase 3 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 74. This study's planned 60 months is above that.
Counting every sponsor, half of 73 studies reached it within 65 months; a quarter within 40 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Sacituzumab tirumotecan