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NCT Number: NCT07829783

A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sac-TMT

Biological

IV infusion

Other names: MK-2870, SKB264, Sacituzumab tirumotecan

Pembrolizumab and Berahyaluronidase alfa

Biological

Pembrolizumab coformulated with berahyaluronidase alfa administered as a SC injection

Other names: MK-3475A

Cisplatin

Drug

IV infusion administered at 35 mg/m^2 weekly for up to 6 doses during RT

5-FU

Drug

IV infusion administered at 500 mg/m^2 on Days 1 to 5 and Days 22 to 26 during RT

MMC

Drug

IV infusion administered at 12 mg/m^2 on Day 1 during RT

Capecitabine

Drug

Oral dose administered at 825 mg/m^2 twice daily during RT

Gemcitabine

Drug

IV infusion administered at 27 mg/m^2 twice weekly for up to 12 doses during RT

Conventional radiotherapy

Radiation

External beam radiation administered per global clinical guidelines (64 Gy at 2 Gy/fraction over approximately 6.5 weeks)

Hypofractionated radiotherapy

Radiation

External beam radiation administered per global clinical guidelines (55 Gy at 2.75 Gy/fraction over approximately 4 weeks)

Rescue medications

Drug

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).

Primary outcomes

  1. Event-Free Survival (EFS)

    Time frame: Up to approximately 60 months

    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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 90 months

    OS is defined as the time from randomization to death due to any cause. The OS for all participants will be presented.

  2. Distant Metastasis-Free Survival (DMFS)

    Time frame: Up to approximately 90 months

    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.

  3. Bladder Intact (BI)-EFS

    Time frame: Up to approximately 90 months

    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.

  4. Time to Occurrence of Non-Muscle-Invasive Bladder Cancer (NMIBC)

    Time frame: Up to approximately 90 months

    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.

  5. Disease-Specific Survival

    Time frame: Up to approximately 90 months

    DSS is defined as the time from randomization to death due to bladder cancer. The DSS for all participants will be presented.

  6. Rate of Radical Cystectomy

    Time frame: Up to approximately 90 months

    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.

  7. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 90 months

    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.

  8. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 90 months

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Acronym: TroFuse-055

Important dates

Study start
2026
Primary completion
2031
Study completion
2036
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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