Actively Recruiting
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-08
1023
Participants Needed
91
Research Sites
301 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
E
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment
CONDITIONS
Official Title
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- Has persistent, recurrent, or newly diagnosed metastatic cervical cancer (FIGO-2028 Stage IVB) not treatable by surgery or radiation
- If infected with HIV, has well-controlled infection on antiretroviral therapy
- If positive for hepatitis B surface antigen, has received antiviral therapy and has undetectable viral load
- If has a history of hepatitis C infection, has undetectable viral load
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1
- Has tumor programmed cell death ligand 1 expression with combined positive score of 1 or higher
You will not qualify if you...
- Has HIV infection with a history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Has severe dry eye syndrome, severe Meibomian gland disease, severe blepharitis, or severe corneal disease preventing or delaying corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or history of inflammatory bowel disease
- Has uncontrolled significant cardiovascular or cerebrovascular disease
- Has received prior systemic anticancer therapy not specified in the protocol
- Is currently receiving a strong inducer or inhibitor of cytochrome P450 3A4 that cannot be stopped during sac-TMT treatment
- Has a diagnosis of immunodeficiency
- Has another progressing malignancy or one requiring active treatment within the past 3 years
- Has active central nervous system metastases or carcinomatous meningitis
- Has active autoimmune disease requiring systemic treatment in the past 2 years
- Has a history of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/ILD
- Has a history of stem cell or solid organ transplant
- Has not fully 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: 91 locations
1
Mount Sinai Comprehensive Cancer Center ( Site 6000)
Miami Beach, Florida, United States, 33140
Actively Recruiting
2
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, United States, 33401
Actively Recruiting
3
TRIALS 365 ( Site 6008)
Shreveport, Louisiana, United States, 71103
Actively Recruiting
4
Minnesota Oncology Hematology, PA ( Site 8003)
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
5
Women's Cancer Center of Nevada ( Site 6011)
Las Vegas, Nevada, United States, 89106
Actively Recruiting
6
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York, New York, United States, 10016
Actively Recruiting
7
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon, United States, 97401
Actively Recruiting
8
University of Tennessee Medical Center ( Site 6012)
Knoxville, Tennessee, United States, 37920
Actively Recruiting
9
Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas, United States, 76104
Actively Recruiting
10
Texas Oncology-The Woodlands ( Site 8000)
The Woodlands, Texas, United States, 77380
Actively Recruiting
11
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, United States, 75702
Actively Recruiting
12
University of Virginia Cancer Center ( Site 6014)
Charlottesville, Virginia, United States, 22908
Actively Recruiting
13
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
14
Fundación Respirar ( Site 0101)
Belgrano, Buenos Aires F.D., Argentina, C1118AAT
Actively Recruiting
15
Instituto de Oncologia de Rosario ( Site 0104)
Rosario, Santa Fe Province, Argentina, S2000KZE
Actively Recruiting
16
Hospital Provincial del Centenario ( Site 0106)
Rosario, Santa Fe Province, Argentina, S2002KDS
Actively Recruiting
17
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)
La Rioja, Argentina, F5300COE
Actively Recruiting
18
Antwerp University Hospital ( Site 0407)
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
19
Cliniques Universitaires Saint-Luc ( Site 0402)
Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
Actively Recruiting
20
Grand Hopital de Charleroi ( Site 0404)
Charleroi, Hainaut, Belgium, 6060
Actively Recruiting
21
UZ Gent ( Site 0406)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
22
UZ Leuven ( Site 0401)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
23
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0514)
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
24
Hospital São Lucas da PUCRS ( Site 0516)
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
25
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
26
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)
São José do Rio Preto, São Paulo, Brazil, 15091-000
Actively Recruiting
27
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)
São Paulo, São Paulo, Brazil, 04014-002
Actively Recruiting
28
Princess Margaret Cancer Centre ( Site 0601)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
29
Centre Hospitalier de l'Université de Montréal ( Site 0616)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
30
McGill University Health Centre ( Site 0602)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
31
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
32
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
33
Clinica Somer ( Site 0903)
Rionegro, Antioquia, Colombia, 054040
Actively Recruiting
34
Centro Cancerológico del Caribe (CECAC) ( Site 0906)
Barranquilla, Atlántico, Colombia, 080002
Actively Recruiting
35
Instituto Nacional De Cancerologia ( Site 0909)
Bogotá, Bogota D.C., Colombia, 111511
Actively Recruiting
36
Oncomédica S.A.S ( Site 0905)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
37
Oncólogos del Occidente S.A.S. ( Site 0908)
Pereira, Risaralda Department, Colombia, 660001
Actively Recruiting
38
Nemocnice AGEL Novy Jicin a.s. ( Site 1004)
Nový Jičín, Moravian-Silesian Region, Czechia, 741 01
Actively Recruiting
39
Fakultni nemocnice Ostrava ( Site 1005)
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Actively Recruiting
40
Fakultni nemocnice Kralovske Vinohrady ( Site 1002)
Prague, Praha 10, Czechia, 100 34
Actively Recruiting
41
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)
Prague, Czechia, 128 08
Actively Recruiting
42
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)
Athens, Attica, Greece, 115 28
Actively Recruiting
43
Aretaieio Hospital Oncology Unit ( Site 1402)
Athens, Attica, Greece, 115 28
Actively Recruiting
44
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)
Chaïdári, Attica, Greece, 124 62
Actively Recruiting
45
Országos Onkológiai Intézet ( Site 1603)
Budapest, Hungary, 1122
Actively Recruiting
46
Debreceni Egyetem Klinikai Kozpont ( Site 1601)
Debrecen, Hungary, 4032
Actively Recruiting
47
Hillel Yaffe Medical Center ( Site 1903)
Hadera, Israel, 0038100
Actively Recruiting
48
Rambam Health Care Campus ( Site 1907)
Haifa, Israel, 3109601
Actively Recruiting
49
Carmel Hospital ( Site 1901)
Haifa, Israel, 3436212
Actively Recruiting
50
Shaare Zedek Medical Center ( Site 1905)
Jerusalem, Israel, 9103102
Actively Recruiting
51
Rabin Medical Center ( Site 1904)
Petah Tikva, Israel, 4941492
Actively Recruiting
52
Sourasky Medical Center ( Site 1902)
Tel Aviv, Israel, 6423906
Actively Recruiting
53
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009)
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
54
Ospedale Humanitas San Pio X ( Site 2013)
Milan, Lombardy, Italy, 20159
Actively Recruiting
55
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)
Milan, Milano, Italy, 20133
Actively Recruiting
56
Ospedale Cannizzaro ( Site 2010)
Catania, Italy, 95126
Actively Recruiting
57
Istituto Europeo di Oncologia ( Site 2003)
Milan, Italy, 20141
Actively Recruiting
58
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)
Roma, Italy, 00168
Actively Recruiting
59
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)
Torino, Italy, 10128
Actively Recruiting
60
National Hospital Organization Hokkaido Cancer Center ( Site 2108)
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
61
Hyogo Cancer Center ( Site 2118)
Akashi, Hyōgo, Japan, 673-8558
Actively Recruiting
62
Iwate Medical University Hospital ( Site 2116)
Shiwa-gun, Iwate, Japan, 028-3695
Actively Recruiting
63
University of the Ryukyus Hospital ( Site 2117)
Ginowan, Okinawa, Japan, 901-2725
Actively Recruiting
64
Saitama Medical University International Medical Center ( Site 2106)
Hidaka, Saitama, Japan, 350-1298
Actively Recruiting
65
Cancer Institute Hospital of JFCR ( Site 2119)
Koto, Tokyo, Japan, 135-8550
Actively Recruiting
66
The Jikei University Hospital ( Site 2107)
Minato, Tokyo, Japan, 105-8471
Actively Recruiting
67
Niigata Cancer Center Hospital ( Site 2110)
Niigata, Japan, 951-8566
Actively Recruiting
68
Okayama University Hospital ( Site 2101)
Okayama, Japan, 700-8558
Actively Recruiting
69
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)
Gliwice, Silesian Voivodeship, Poland, 44-102
Actively Recruiting
70
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)
Siedlce, Warmian-Masurian Voivodeship, Poland, 08-110
Actively Recruiting
71
Swietokrzyskie Centrum Onkologii. ( Site 2602)
Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
Actively Recruiting
72
National Cancer Center ( Site 2905)
Goyang-si, Kyonggi-do, South Korea, 10408
Actively Recruiting
73
Seoul National University Hospital ( Site 2901)
Jongno-gu, Seoul, South Korea, 03080
Actively Recruiting
74
Severance Hospital Yonsei University Health System ( Site 2902)
Seodaemun-Gu, Seoul, South Korea, 03722
Actively Recruiting
75
Asan Medical Center ( Site 2904)
Seoul, South Korea, 05505
Actively Recruiting
76
Samsung Medical Center ( Site 2903)
Seoul, South Korea, 06351
Actively Recruiting
77
Institut Català d'Oncologia (ICO) - Girona ( Site 3002)
Girona, Gerona, Spain, 17007
Actively Recruiting
78
Hosp Clinico Universitario de Valencia ( Site 3001)
Valencia, Valenciana, Comunitat, Spain, 46010
Actively Recruiting
79
Hospital Universitari Vall d Hebron ( Site 3003)
Barcelona, Spain, 08035
Actively Recruiting
80
Hospital Universitario Reina Sofia ( Site 3006)
Córdoba, Spain, 14004
Actively Recruiting
81
Hospital Ramon y Cajal ( Site 3005)
Madrid, Spain, 28034
Actively Recruiting
82
Hospital Universitario 12 de Octubre ( Site 3007)
Madrid, Spain, 28041
Actively Recruiting
83
Hospital Universitario La Paz ( Site 3004)
Madrid, Spain, 28046
Actively Recruiting
84
Skanes Universitetssjukhus Lund ( Site 3103)
Lund, Skåne County, Sweden, 22242
Actively Recruiting
85
Karolinska Universitetssjukhuset-Solna ( Site 3102)
Stockholm, Stockholm County, Sweden, 171 64
Actively Recruiting
86
Linköping University Hospital ( Site 3101)
Linköping, Östergötland County, Sweden, 581 85
Actively Recruiting
87
National Taiwan University Hospital ( Site 3301)
Taiwan, Taipei, Taiwan, 10002
Actively Recruiting
88
Taichung Veterans General Hospital ( Site 3304)
Taichung, Taiwan, 40705
Actively Recruiting
89
National Cheng Kung University Hospital ( Site 3308)
Tainan, Taiwan, 704
Actively Recruiting
90
Mackay Memorial Hospital ( Site 3303)
Taipei, Taiwan, 10449
Actively Recruiting
91
Chang Gung Memorial Hospital ( Site 3302)
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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