Actively Recruiting
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-08
590
Participants Needed
27
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has histologically confirmed locally advanced or metastatic urothelial cancer that cannot be treated curatively with surgery or radiation
- Has measurable disease based on RECIST 1.1 criteria
- Has received prior treatment with anti-PD-[L]1 therapy, platinum-based chemotherapy, and enfortumab vedotin (EV) or disitamab vedotin (DV) in China
- Has received no more than three previous lines of therapy
- Has shown disease progression on or after the last treatment before study entry
- Has an ECOG performance status of 0 or 1 within 7 days before randomization
- Is eligible to receive at least one of the study’s control chemotherapy drugs (paclitaxel, docetaxel, or vinflunine)
- Can provide an archival tumor tissue sample or a new biopsy from a non-irradiated tumor
- If HIV positive, has well-controlled HIV on antiretroviral therapy
- If positive for hepatitis B surface antigen, has received antiviral therapy for at least 4 weeks and has undetectable viral load
- If history of hepatitis C virus infection, has undetectable viral load
- Has adequate organ function
You will not qualify if you...
- Has severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or corneal disease that delays corneal healing
- Has uncontrolled or significant cardiovascular or cerebrovascular disease
- Has a history of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis/interstitial lung disease
- HIV-positive with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Has received systemic anticancer therapy within 4 weeks or 5 half-lives and has not recovered from related adverse events
- Has received prior therapy with TROP2-targeted or topoisomerase 1 inhibitor-containing antibody drug conjugates
- Has had external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks before study start, or has radiation-related toxicities requiring corticosteroids
- Received live or live-attenuated vaccine within 30 days before first study dose
- Has received prior chemotherapy for urothelial cancer with paclitaxel, docetaxel, or vinflunine
- Has used investigational drugs or devices within 4 weeks before study start
- Has immunodeficiency or is on chronic systemic steroids or immunosuppressive therapy within 7 days before first dose
- Has another active malignancy requiring treatment within past 3 years
- Has current or past central nervous system metastases or carcinomatous meningitis
- Has active infections needing systemic therapy not allowed by the protocol
- Has history of stem cell or organ transplant
- Has not recovered from major surgery or has ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
Cincinnati, Ohio, United States, 45220
Actively Recruiting
2
Thompson Cancer Survival Center ( Site 0803)
Knoxville, Tennessee, United States, 37916
Actively Recruiting
3
Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
Actively Recruiting
4
Instituto Alexander Fleming ( Site 0002)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
5
Macquarie University ( Site 0031)
Macquarie, New South Wales, Australia, 2109
Actively Recruiting
6
AZ Maria Middelares ( Site 0063)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
7
Peking University First Hospital ( Site 0184)
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
8
Sun Yat-Sen University Cancer Center ( Site 0183)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
9
Sun Yat-Sen University Cancer Center ( Site 0188)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
10
Zhujiang Hospital of Southern Medical University ( Site 0205)
Guangzhou, Guangdong, China, 510280
Actively Recruiting
11
The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)
Zhuhai, Guangdong, China, 519000
Actively Recruiting
12
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)
Wuhan, Hubei, China, 430022
Actively Recruiting
13
Fudan University Shanghai Cancer Center ( Site 0181)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
14
Zhongshan Hospital Fudan University ( Site 0907)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
15
The First Affiliated Hospital of Ningbo University ( Site 0193)
Ningbo, Zhejiang, China, 315201
Actively Recruiting
16
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)
Wenzhou, Zhejiang, China, 210008
Actively Recruiting
17
The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
18
Rambam Health Care Campus ( Site 0362)
Haifa, Israel, 3109601
Actively Recruiting
19
Shaare Zedek Medical Center ( Site 0366)
Jerusalem, Israel, 9103102
Actively Recruiting
20
Rabin Medical Center ( Site 0364)
Petah Tikva, Israel, 4941492
Actively Recruiting
21
Osaka Rosai Hospital ( Site 0428)
Sakai, Osaka, Japan, 591-8025
Actively Recruiting
22
Isala, locatie Zwolle ( Site 0486)
Zwolle, Overijssel, Netherlands, 8025 AB
Actively Recruiting
23
Hospital Universitario Marques de Valdecilla ( Site 0605)
Santander, Cantabria, Spain, 39008
Actively Recruiting
24
Hospital Universitario Insular de Gran Canaria ( Site 0604)
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Actively Recruiting
25
Hospital Universitario Ramon y Cajal ( Site 0606)
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
26
Hospital Clinico San Carlos ( Site 0608)
Madrid, Spain, 28040
Actively Recruiting
27
Karolinska Universitetssjukhuset Solna ( Site 0631)
Stockholm, Stockholm County, Sweden, 171 76
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here