Actively Recruiting
A Phase 3 Randomized Study of Sacituzumab Tirumotecan Versus Non-platinum Chemotherapy for Pretreated Locally Advanced or Metastatic Urothelial Carcinoma
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
590
Participants Needed
50
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for locally advanced or metastatic urothelial cancer (UC), focusing on whether sacituzumab tirumotecan (sac-TMT) can help people live longer after their cancer has worsened following certain prior treatments. This Phase 3 trial compares sac-TMT with non-platinum chemotherapy options to see which may be more effective for patients whose disease has progressed despite standard therapies. Participants are randomly assigned to receive either sacituzumab tirumotecan at a dose of 4 mg/kg every two weeks via intravenous infusion or one of three chemotherapy drugs—paclitaxel, docetaxel, or vinflunine—administered every three weeks. Treatment continues until the cancer progresses or side effects become unacceptable. Rescue medications may be given as needed following approved guidelines to help manage side effects. During the study, participants will undergo regular assessments to monitor overall survival up to about 40 months, along with measurements of progression-free survival, response rates, and quality of life scores using the EORTC QLQ-C30 questionnaire. Safety is closely tracked by recording adverse events and reasons for stopping treatment. Participants remain in the study for extended follow-up to evaluate the duration of response and other health outcomes.
CONDITIONS
Brief 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...
- Histologically confirmed locally advanced or metastatic urothelial cancer not suitable for curative surgery or radiation
- Measurable disease by RECIST 1.1 criteria
- Prior treatment with anti-PD-[L]1 therapy, platinum-based chemotherapy, and enfortumab vedotin (disitamab vedotin allowed in China instead of enfortumab vedotin)
- No more than 3 prior therapy lines
- Radiographic disease progression after the most recent prior therapy
- ECOG performance status of 0 or 1 within 7 days before randomization
- Eligible to receive at least one of the control chemotherapy drugs (paclitaxel, docetaxel, vinflunine)
- Able to provide archival tumor tissue or new biopsy from tumor lesion not previously irradiated
- Well-controlled HIV on antiretroviral therapy if HIV positive
- If hepatitis B surface antigen positive, received antiviral therapy for at least 4 weeks with undetectable viral load
- Undetectable hepatitis C viral load if history of hepatitis C
- Adequate organ function
You will not qualify if you...
- History of severe dry eye syndrome, severe Meibomian gland disease, severe blepharitis, or severe corneal disease delaying healing
- Uncontrolled significant cardiovascular or cerebrovascular disease
- History or current pneumonitis/interstitial lung disease requiring steroids
- HIV-positive with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Received systemic anticancer therapy within 4 weeks or 5 half-lives and not recovered to grade 1 or baseline from related adverse events
- Prior therapy with TROP2-targeted antibody drug conjugate or topoisomerase 1 inhibitor-containing ADC
- Completed external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks before study start or with radiation toxicities needing corticosteroids
- Received live or live-attenuated vaccine within 30 days before study drug; killed vaccines allowed
- Prior chemotherapy for urothelial cancer with paclitaxel, docetaxel, or vinflunine
- Received investigational agents or devices within 4 weeks before study drug
- Immunodeficiency diagnosis or receiving systemic steroid or other immunosuppressive therapy within 7 days before study drug
- Additional progressing malignancy requiring active treatment within past 3 years
- Current or past CNS metastases or carcinomatous meningitis
- Active infection requiring systemic therapy not allowed by protocol
- History of stem cell or solid organ transplant
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Until disease progression or unacceptable toxicity
Participants receive sacituzumab tirumotecan every 2 weeks or chemotherapy (paclitaxel, docetaxel, or vinflunine) every 3 weeks via intravenous infusion until disease progression or unacceptable toxicity.
Infusions every 2 or 3 weeks depending on assigned treatment
Duration - Up to approximately 40 months
Participants are monitored for overall survival and other health outcomes after treatment ends.
Follow-up visits as scheduled for survival and health assessments
Trial Site Locations
Total: 50 locations
1
Munson Medical Center ( Site 0812)
Traverse City, Michigan, United States, 49684
Actively Recruiting
2
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
Cincinnati, Ohio, United States, 45220
Actively Recruiting
3
Thompson Cancer Survival Center ( Site 0803)
Knoxville, Tennessee, United States, 37916
Actively Recruiting
4
Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
Actively Recruiting
5
Instituto Alexander Fleming ( Site 0002)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
6
Macquarie University ( Site 0031)
Macquarie, New South Wales, Australia, 2109
Actively Recruiting
7
AZ Maria Middelares ( Site 0063)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
8
UZ Gent ( Site 0064)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
9
Hospital Moinhos de Vento ( Site 0102)
Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
Actively Recruiting
10
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
11
Peking University First Hospital ( Site 0184)
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
12
Sun Yat-Sen University Cancer Center ( Site 0183)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
13
Sun Yat-Sen University Cancer Center ( Site 0188)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
14
Zhujiang Hospital of Southern Medical University ( Site 0205)
Guangzhou, Guangdong, China, 510280
Actively Recruiting
15
The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)
Zhuhai, Guangdong, China, 519000
Actively Recruiting
16
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)
Wuhan, Hubei, China, 430022
Actively Recruiting
17
Fudan University Shanghai Cancer Center ( Site 0181)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
18
Zhongshan Hospital Fudan University ( Site 0907)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
19
The First Affiliated Hospital of Ningbo University ( Site 0193)
Ningbo, Zhejiang, China, 315201
Actively Recruiting
20
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)
Wenzhou, Zhejiang, China, 210008
Actively Recruiting
21
The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
22
General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)
Athens, Attica, Greece, 145 64
Actively Recruiting
23
Athens Medical Center ( Site 0336)
Marousi, Attica, Greece, 151 25
Actively Recruiting
24
Rambam Health Care Campus ( Site 0362)
Haifa, Israel, 3109601
Actively Recruiting
25
Shaare Zedek Medical Center ( Site 0366)
Jerusalem, Israel, 9103102
Actively Recruiting
26
Rabin Medical Center ( Site 0364)
Petah Tikva, Israel, 4941492
Actively Recruiting
27
Sheba Medical Center ( Site 0361)
Ramat Gan, Israel, 5265601
Actively Recruiting
28
Yitzhak Shamir Medical Center. ( Site 0367)
Ẕerifin, Israel, 7033001
Actively Recruiting
29
Centro Ricerche Cliniche di Verona ( Site 0393)
Verona, Veneto, Italy, 37134
Actively Recruiting
30
Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)
Arezzo, Italy, 52100
Actively Recruiting
31
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)
Milan, Italy, 20133
Actively Recruiting
32
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)
Roma, Italy, 00168
Actively Recruiting
33
Hokkaido University Hospital ( Site 0436)
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
34
Kagawa University Hospital ( Site 0424)
Kita-gun, Kagawa-ken, Japan, 761-0793
Actively Recruiting
35
St. Marianna University Hospital ( Site 0422)
Kawasaki, Kanagawa, Japan, 216-8511
Actively Recruiting
36
Nara Medical University Hospital ( Site 0423)
Kashihara, Nara, Japan, 634-8522
Actively Recruiting
37
Osaka Rosai Hospital ( Site 0428)
Sakai, Osaka, Japan, 591-8025
Actively Recruiting
38
Institute of Science Tokyo Hospital ( Site 0421)
Bunkyo, Tokyo, Japan, 113-8519
Actively Recruiting
39
Isala, locatie Zwolle ( Site 0486)
Zwolle, Overijssel, Netherlands, 8025 AB
Actively Recruiting
40
St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)
Utrecht, Netherlands, 3543 AZ
Actively Recruiting
41
H. de Badalona Germans Trias I Pujol ( Site 0603)
Badalona, Barcelona, Spain, 08916
Actively Recruiting
42
Hospital Universitario Marques de Valdecilla ( Site 0605)
Santander, Cantabria, Spain, 39008
Actively Recruiting
43
Hospital Universitario Insular de Gran Canaria ( Site 0604)
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Actively Recruiting
44
Hospital Universitario Ramon y Cajal ( Site 0606)
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
45
Hospital Universitari Vall d'Hebron ( Site 0607)
Barcelona, Spain, 08035
Actively Recruiting
46
Hospital Clinico San Carlos ( Site 0608)
Madrid, Spain, 28040
Actively Recruiting
47
Hospital Universitario 12 de Octubre ( Site 0602)
Madrid, Spain, 28041
Actively Recruiting
48
Hospital Virgen del Rocio ( Site 0601)
Seville, Spain, 41013
Actively Recruiting
49
Laenssjukhuset Ryhov ( Site 0632)
Jönköping, Jönköping County, Sweden, 551 85
Actively Recruiting
50
Karolinska Universitetssjukhuset Solna ( Site 0631)
Stockholm, Stockholm County, Sweden, 171 76
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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