A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) (TroFuse-027)

A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.

Study Overview

• Status: Recruiting
• Conditions: Non-Muscle Invasive Bladder Cancer
• Intervention / Treatment: Drug: Rescue medication; Drug: Sacituzumab tirumotecan; Drug: Supportive care measures

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@msd.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre ( Site 0003)
      • Contact: Study Coordinator; Phone Number: 4169462246
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • CIUSSS de l'Estrie-CHUS ( Site 0002)
      • Contact: Study Coordinator; Phone Number: 8193461110 x13446
• France
  • Nord
    • Lille, Nord, France, 59037
      • Recruiting
      • Hôpital Claude Huriez ( Site 0012)
      • Contact: Study Coordinator; Phone Number: 0320444398
  • Val-de-Marne
    • Créteil, Val-de-Marne, France, 94010
      • Recruiting
      • HENRI MONDOR HOSPITAL ( Site 0011)
      • Contact: Study Coordinator; Phone Number: 01 48 99 13 49
    • Villejuif, Val-de-Marne, France, 94805
      • Recruiting
      • Gustave Roussy ( Site 0013)
      • Contact: Study Coordinator; Phone Number: +33142114211
• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Recruiting
      • Erasmus Medisch Centrum ( Site 0032)
      • Contact: Study Coordinator; Phone Number: +31107041566
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre ( Site 0042)
    • Contact: Study Coordinator; Phone Number: +34913908121
  • Andalusia
    • Málaga, Andalusia, Spain, 29010
      • Recruiting
      • Hospital Universitario Virgen de la Victoria ( Site 0043)
      • Contact: Study Coordinator; Phone Number: +34951032095
• United Kingdom
  • London, City of
    • London, London, City of, United Kingdom, EC1A 7BE
      • Recruiting
      • St Bartholomew s Hospital ( Site 0061)
      • Contact: Study Coordinator; Phone Number: +4407535510363
• United States
  • California
    • Bakersfield, California, United States, 93301
      • Recruiting
      • Michael G Oefelein Clinical Trials ( Site 0053)
      • Contact: Study Coordinator; Phone Number: 661-310-1063
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center ( Site 0057)
      • Contact: Study Coordinator; Phone Number: 888-663-3488
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University ( Site 0051)
      • Contact: Study Coordinator; Phone Number: 312-695-1102
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University ( Site 0055)
      • Contact: Study Coordinator; Phone Number: 410-614-0009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

• Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder
• Must have visible tumor by cystoscopy within 12 weeks prior to first dose

• Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:

  • Multiple tumors
  • >1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
  • Early recurrence (<1 year) of the initial diagnosis of low-grade disease
  • Solitary tumor >3 cm
  • Failure of prior intravesical treatment
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

• Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder
• Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
• Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sacituzumab tirumotecan; Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks

Drug: Rescue medication; Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.; Drug: Sacituzumab tirumotecan; Intravesical administration; Other Names: SKB264; MK-2870; sac-TMT; Drug: Supportive care measures; Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Dose Limiting Toxicity (DLT)	DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (7 weeks). All toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0.	Up to approximately 7 weeks
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)	An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.	Up to approximately 6 weeks
Number of Participants Experiencing an Adverse Event (AE)	An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported.	Up to approximately 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CRR)	CRR is defined as the percentage of participants who will be absent of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable.	Up to approximately 6 months
Duration of Complete Response (DCR)	Duration of CR for participants who demonstrate CR is defined as the time from the first documented evidence of CR (absence of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable) until the occurrence of histologically confirmed nonmuscle invasive urothelial carcinoma (UC) by local pathology review or locally advanced or metastatic UC, or death due to any cause, whichever occurs first.	Up to approximately 24 months
Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC)	Blood samples will be collected to determine the AUC of sac-TIMT ADC	Up to approximately 6 weeks
Maximum Serum Concentration (Cmax) of sac-TMT ADC	Blood samples will be collected to determine the Cmax of sac-TMT ADC	Up to approximately 6 weeks
Minimum Serum Concentration (Cmin) of sac-TMT ADC	Blood samples will be collected to determine the Cmin of sac-TMT ADC	Up to approximately 6 weeks
Serum Apparent terminal half-life (t½) of sac-TMT ADC	Blood samples will be collected to determine the t1/2 of sac-TMT ADC	Up to approximately 6 weeks
Serum AUC of sac-TMT Total Antibody (TAb)	Blood samples will be collected to determine the AUC of sac-TMT Tab	Up to approximately 6 weeks
Serum Cmax of sac-TMT Tab	Blood samples will be collected to determine the Cmax of sac-TMT Tab	Up to approximately 6 weeks
Serum Cmin of sac-TMT Tab	Blood samples will be collected to determine the Cmin of sac-TMT Tab	Up to approximately 6 weeks
Serum t½ of sac-TMT Tab	Blood samples will be collected to determine the t1/2 of sac-TMT Tab	Up to approximately 6 weeks
Plasma AUC of sac-TMT payload	Blood samples will be collected to determine the AUC of sac-TMT payload	Up to approximately 6 weeks
Plasma Cmax of sac-TMT payload	Blood samples will be collected to determine the Cmax of sac-TMT payload	Up to approximately 6 weeks
Plasma Cmin of sac-TMT payload	Blood samples will be collected to determine the Cmin of sac-TMT payload	Up to approximately 6 weeks
Plasma t½ of sac-TMT payload	Blood samples will be collected to determine the t1/2 of sac-TMT payload	Up to approximately 6 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Low Grade; Intermediate Risk; Non-Muscle Invasive Bladder Cancer; Recurrent Low-Grade
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: 2870-027; U1111-1308-6998 (Registry Identifier: UTN); MK-2870-027 (Other Identifier: MSD); 2024-514983-23-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No