A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)

NCT07419295 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 2870-031U1111-1316-43902024-520014-22-00MK-2870-031jRCT2051260020
• Study Type: interventional
• Target: 590
• Locations: 13 countries
• Sites: 50

Brief Summary

Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy. Researchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as time from randomization to death due to any cause.

  Up to approximately 40 months

Secondary Outcomes (11)

• Progression-Free Survival (PFS)

  Up to approximately 32 months

• Objective Response Rate (ORR)

  Up to approximately 32 months

• Duration of Response (DOR)

  Up to approximately 49 months

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 49 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 48 months

Study Arms (2)

Sacituzumab tirumotecan

EXPERIMENTAL

Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity.

Biological: Sacituzumab tirumotecan; Drug: Rescue medications for sacituzumab tirumotecan

Chemotherapy

ACTIVE COMPARATOR

Participants receive paclitaxel 175 mg/m\^2, docetaxel 75 mg/m\^2, or vinflunine 320 mg/m\^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity.

Drug: Vinflunine; Drug: Docetaxel; Drug: Paclitaxel; Drug: Rescue medications for chemotherapy

Interventions

Rescue medications for sacituzumab tirumotecan DRUG

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

Sacituzumab tirumotecan

Sacituzumab tirumotecan BIOLOGICAL

IV infusion

Also known as: MK-2870, SKB264, sac-TMT

Sacituzumab tirumotecan

Vinflunine DRUG

IV infusion

Chemotherapy

Docetaxel DRUG

IV infusion

Chemotherapy

Rescue medications for chemotherapy DRUG

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative.

Chemotherapy

Paclitaxel DRUG

IV infusion

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment
• Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator
• Has received treatment with anti-programmed cell death \[ligand\] 1 (anti-PD-\[L\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)
• Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry
• Has received a maximum of 3 prior lines of therapy
• Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
• Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)
• Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated
• If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)
• If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load
• If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
• Has adequate organ function

You may not qualify if:

• 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 uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy
• Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC)
• Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC
• Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
• Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine)
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active infection requiring systemic therapy other than those permitted per protocol

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (50)

Munson Medical Center ( Site 0812)

Traverse City, Michigan, 49684, United States

RECRUITING

TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)

Cincinnati, Ohio, 45220, United States

RECRUITING

Thompson Cancer Survival Center ( Site 0803)

Knoxville, Tennessee, 37916, United States

RECRUITING

Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN, Argentina

RECRUITING

Instituto Alexander Fleming ( Site 0002)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Macquarie University ( Site 0031)

Macquarie, New South Wales, 2109, Australia

RECRUITING

AZ Maria Middelares ( Site 0063)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UZ Gent ( Site 0064)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Hospital Moinhos de Vento ( Site 0102)

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Peking University First Hospital ( Site 0184)

Beijing, Beijing Municipality, 100034, China

RECRUITING

Sun Yat-Sen University Cancer Center ( Site 0183)

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-Sen University Cancer Center ( Site 0188)

Guangzhou, Guangdong, 510060, China

RECRUITING

Zhujiang Hospital of Southern Medical University ( Site 0205)

Guangzhou, Guangdong, 510280, China

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)

Zhuhai, Guangdong, 519000, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)

Wuhan, Hubei, 430022, China

RECRUITING

Fudan University Shanghai Cancer Center ( Site 0181)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan Hospital Fudan University ( Site 0907)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

The First Affiliated Hospital of Ningbo University ( Site 0193)

Ningbo, Zhejiang, 315201, China

RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)

Wenzhou, Zhejiang, 210008, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)

Wenzhou, Zhejiang, 325000, China

RECRUITING

General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)

Athens, Attica, 145 64, Greece

RECRUITING

Athens Medical Center ( Site 0336)

Marousi, Attica, 151 25, Greece

RECRUITING

Rambam Health Care Campus ( Site 0362)

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 0366)

Jerusalem, 9103102, Israel

RECRUITING

Rabin Medical Center ( Site 0364)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 0361)

Ramat Gan, 5265601, Israel

RECRUITING

Yitzhak Shamir Medical Center. ( Site 0367)

Ẕerifin, 7033001, Israel

RECRUITING

Centro Ricerche Cliniche di Verona ( Site 0393)

Verona, Veneto, 37134, Italy

RECRUITING

Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)

Arezzo, 52100, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)

Milan, 20133, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)

Roma, 00168, Italy

RECRUITING

Hokkaido University Hospital ( Site 0436)

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kagawa University Hospital ( Site 0424)

Kita-gun, Kagawa-ken, 761-0793, Japan

RECRUITING

St. Marianna University Hospital ( Site 0422)

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Nara Medical University Hospital ( Site 0423)

Kashihara, Nara, 634-8522, Japan

RECRUITING

Osaka Rosai Hospital ( Site 0428)

Sakai, Osaka, 591-8025, Japan

RECRUITING

Institute of Science Tokyo Hospital ( Site 0421)

Bunkyo, Tokyo, 113-8519, Japan

RECRUITING

Isala, locatie Zwolle ( Site 0486)

Zwolle, Overijssel, 8025 AB, Netherlands

RECRUITING

St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)

Utrecht, 3543 AZ, Netherlands

RECRUITING

H. de Badalona Germans Trias I Pujol ( Site 0603)

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla ( Site 0605)

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario Insular de Gran Canaria ( Site 0604)

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

Hospital Universitario Ramon y Cajal ( Site 0606)

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 0607)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinico San Carlos ( Site 0608)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 0602)

Madrid, 28041, Spain

RECRUITING

Hospital Virgen del Rocio ( Site 0601)

Seville, 41013, Spain

RECRUITING

Laenssjukhuset Ryhov ( Site 0632)

Jönköping, Jönköping County, 551 85, Sweden

RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 0631)

Stockholm, Stockholm County, 171 76, Sweden

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

vinflunine; Docetaxel; Paclitaxel; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 19, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): July 27, 2029
• Study Completion (Estimated): April 23, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

GR (2); NL (2); CN (11); AR (2); IT (4); BE (2); IL (5); SE (2); BR (2); JP (6); ES (8); AU (1); US (3)