Actively Recruiting
Study of Sacituzumab Tirumotecan With Pembrolizumab With or Without Bevacizumab Compared to Standard Care as Maintenance Treatment for Metastatic Cervical Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
1023
Participants Needed
125
Research Sites
N/A
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 investigating new treatment options for metastatic cervical cancer, a type of cancer that starts in the cervix and has spread to other parts of the body. This study focuses on evaluating sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate designed to target cancer cells, in combination with pembrolizumab and bevacizumab. The main goals are to assess the safety and tolerability of these drugs given together and to see if they help patients live longer or delay cancer progression compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab to assess safety. In Part 2, all participants first receive standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, with optional bevacizumab. Those whose cancer does not worsen then start maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may also be added during maintenance at the doctor's discretion. Treatments are given through intravenous infusions on schedules that range from every 2 to 6 weeks, lasting up to approximately 20 months. During the study, participants will have regular evaluations to monitor safety and how well the treatments work. Assessments include tracking side effects, cancer progression using imaging criteria, overall survival, and quality of life questionnaires focused on health status and physical function. The research team will observe participants for several years to collect data on treatment outcomes and tolerability, with some follow-up lasting up to about 69 months.
CONDITIONS
Brief 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 metastatic cervical cancer that cannot be cured with surgery or radiation (FIGO Stage IVB)
- If infected with HIV, has well-controlled HIV on antiretroviral therapy
- If positive for hepatitis B, has received antiviral therapy and has undetectable viral load
- If has history of hepatitis C, has undetectable viral load
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1
- Has tumor PD-L1 expression with a combined positive score of 1 or higher
You will not qualify if you...
- Has HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Has severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease delaying corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or past history of such diseases
- Has uncontrolled or significant cardiovascular or cerebrovascular disease
- Has received prior systemic anticancer therapy not specified in this study
- Is currently using 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 cancer or one that required active treatment within the past 3 years
- Has active brain metastases or carcinomatous meningitis
- Has active autoimmune disease requiring systemic treatment in the past 2 years (replacement therapies allowed)
- Has history or current pneumonitis or interstitial lung disease requiring steroids
- Has 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 20 months
Participants receive sacituzumab tirumotecan every 2 weeks, pembrolizumab every 6 weeks, and bevacizumab every 3 weeks for up to approximately 20 months.
Regular infusions every 2 to 6 weeks according to each medication's schedule
Duration - Up to approximately 4 months
Participants receive pembrolizumab, paclitaxel, and cisplatin or carboplatin every 3 weeks for up to 6 cycles (approximately 4 months). Bevacizumab may also be given at the investigator's discretion.
Infusions every 3 weeks for up to 6 cycles
Duration - Up to approximately 20 months
Participants whose cancer does not progress after induction receive maintenance treatment with sacituzumab tirumotecan every 2 weeks and pembrolizumab every 6 weeks for up to approximately 20 months. Bevacizumab may also be given at the investigator's discretion during maintenance.
Infusions every 2 to 6 weeks according to each medication's schedule
Trial Site Locations
Total: 125 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
Winship Cancer Institute of Emory University ( Site 5005)
Atlanta, Georgia, United States, 30308
Actively Recruiting
4
Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)
Savannah, Georgia, United States, 31405
Actively Recruiting
5
TRIALS 365 ( Site 6008)
Shreveport, Louisiana, United States, 71103
Actively Recruiting
6
Minnesota Oncology Hematology, PA ( Site 8003)
Edina, Minnesota, United States, 55435
Actively Recruiting
7
Women's Cancer Center of Nevada ( Site 6011)
Las Vegas, Nevada, United States, 89106
Actively Recruiting
8
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York, New York, United States, 10016
Actively Recruiting
9
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
10
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon, United States, 97401
Actively Recruiting
11
Women & Infants Hospital ( Site 6003)
Providence, Rhode Island, United States, 02905
Actively Recruiting
12
University of Tennessee Medical Center ( Site 6012)
Knoxville, Tennessee, United States, 37920
Actively Recruiting
13
Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas, United States, 76104
Actively Recruiting
14
Texas Oncology-The Woodlands ( Site 8000)
The Woodlands, Texas, United States, 77380
Actively Recruiting
15
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, United States, 75702
Actively Recruiting
16
University of Virginia Cancer Center ( Site 6014)
Charlottesville, Virginia, United States, 22908
Actively Recruiting
17
Centro de Oncología e Investigación de Buenos Aires ( Site 0107)
Berazategui, Buenos Aires, Argentina, B1884BBF
Actively Recruiting
18
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
19
Fundación Respirar ( Site 0101)
Belgrano, Buenos Aires F.D., Argentina, C1118AAT
Actively Recruiting
20
Instituto Misionero del Cancer ( Site 0112)
Posadas, Misiones Province, Argentina, N3300KAZ
Actively Recruiting
21
Instituto de Oncologia de Rosario ( Site 0104)
Rosario, Santa Fe Province, Argentina, S2000KZE
Actively Recruiting
22
Hospital Provincial del Centenario ( Site 0106)
Rosario, Santa Fe Province, Argentina, S2002KDS
Actively Recruiting
23
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)
La Rioja, Argentina, F5300COE
Actively Recruiting
24
Medizinische Universitaet Wien ( Site 0302)
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
25
Medizinische Universitat Graz ( Site 0303)
Graz, Styria, Austria, 8036
Actively Recruiting
26
Medizinische Universitaet Innsbruck ( Site 0301)
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
27
Uniklinikum Salzburg Landeskrankenhaus ( Site 0304)
Salzburg, Austria, 5020
Actively Recruiting
28
Antwerp University Hospital ( Site 0407)
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
29
Cliniques Universitaires Saint-Luc ( Site 0402)
Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
Actively Recruiting
30
Grand Hopital de Charleroi ( Site 0404)
Charleroi, Hainaut, Belgium, 6060
Actively Recruiting
31
UZ Gent ( Site 0406)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
32
UZ Leuven ( Site 0401)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
33
Liga Norte Riograndense Contra o Câncer ( Site 0513)
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
34
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0514)
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
35
Hospital São Lucas da PUCRS ( Site 0516)
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
36
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
37
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
38
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)
São Paulo, São Paulo, Brazil, 04014-002
Actively Recruiting
39
Instituto Nacional de Câncer - INCA ( Site 0515)
Rio de Janeiro, Brazil, 20220-410
Actively Recruiting
40
Princess Margaret Cancer Centre ( Site 0601)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
41
Centre Hospitalier de l'Université de Montréal ( Site 0616)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
42
McGill University Health Centre ( Site 0602)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
43
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
44
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
45
CIDO SpA-Oncology ( Site 0708)
Temuco, Araucania, Chile, 4810148
Actively Recruiting
46
IC La Serena Research ( Site 0710)
La Serena, Coquimbo Region, Chile, 1720430
Actively Recruiting
47
Pontificia Universidad Catolica de Chile-CICUC ( Site 0706)
Santiago, Region M. de Santiago, Chile, 8330073
Actively Recruiting
48
ONCOCENTRO APYS-ACEREY ( Site 0703)
Viña del Mar, Valparaiso, Chile, 2520598
Actively Recruiting
49
Clinica Somer ( Site 0903)
Rionegro, Antioquia, Colombia, 054040
Actively Recruiting
50
Centro Cancerológico del Caribe (CECAC) ( Site 0906)
Barranquilla, Atlántico, Colombia, 080002
Actively Recruiting
51
Instituto Nacional De Cancerologia ( Site 0909)
Bogotá, Bogota D.C., Colombia, 111511
Actively Recruiting
52
Oncomédica S.A.S ( Site 0905)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
53
Oncólogos del Occidente S.A.S. ( Site 0908)
Pereira, Risaralda Department, Colombia, 660001
Actively Recruiting
54
Fakultní Nemocnice Brno ( Site 1003)
Brno, Brno-mesto, Czechia, 602 00
Actively Recruiting
55
Nemocnice AGEL Novy Jicin a.s. ( Site 1004)
Nový Jičín, Moravian-Silesian Region, Czechia, 741 01
Actively Recruiting
56
Fakultni nemocnice Ostrava ( Site 1005)
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Actively Recruiting
57
Fakultni nemocnice Kralovske Vinohrady ( Site 1002)
Prague, Praha 10, Czechia, 100 34
Actively Recruiting
58
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)
Prague, Czechia, 128 08
Actively Recruiting
59
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)
Athens, Attica, Greece, 115 28
Actively Recruiting
60
Aretaieio Hospital Oncology Unit ( Site 1402)
Athens, Attica, Greece, 115 28
Actively Recruiting
61
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)
Chaïdári, Attica, Greece, 124 62
Actively Recruiting
62
Országos Onkológiai Intézet ( Site 1603)
Budapest, Hungary, 1122
Actively Recruiting
63
Debreceni Egyetem Klinikai Kozpont ( Site 1601)
Debrecen, Hungary, 4032
Actively Recruiting
64
Mater Misercordiae University Hospital ( Site 1804)
Dublin, Ireland, D07 R2WY
Actively Recruiting
65
Hillel Yaffe Medical Center ( Site 1903)
Hadera, Israel, 0038100
Actively Recruiting
66
Rambam Health Care Campus ( Site 1907)
Haifa, Israel, 3109601
Actively Recruiting
67
Carmel Hospital ( Site 1901)
Haifa, Israel, 3436212
Actively Recruiting
68
Shaare Zedek Medical Center ( Site 1905)
Jerusalem, Israel, 9103102
Actively Recruiting
69
Rabin Medical Center ( Site 1904)
Petah Tikva, Israel, 4941492
Actively Recruiting
70
Sourasky Medical Center ( Site 1902)
Tel Aviv, Israel, 6423906
Actively Recruiting
71
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009)
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
72
CRO-IRCCS ( Site 2014)
Aviano, Friuli Venezia Giulia, Italy, 33081
Actively Recruiting
73
Ospedale Humanitas San Pio X ( Site 2013)
Milan, Lombardy, Italy, 20159
Actively Recruiting
74
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)
Milan, Milano, Italy, 20133
Actively Recruiting
75
Ospedale Cannizzaro ( Site 2010)
Catania, Italy, 95126
Actively Recruiting
76
Istituto Europeo di Oncologia ( Site 2003)
Milan, Italy, 20141
Actively Recruiting
77
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)
Roma, Italy, 00168
Actively Recruiting
78
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)
Torino, Italy, 10128
Actively Recruiting
79
Kurume University Hospital ( Site 2112)
Kurume, Fukuoka, Japan, 830-0011
Actively Recruiting
80
Gunma Prefectural Cancer Center ( Site 2109)
Ōta, Gunma, Japan, 373-8550
Actively Recruiting
81
National Hospital Organization Hokkaido Cancer Center ( Site 2108)
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
82
Hyogo Cancer Center ( Site 2118)
Akashi, Hyōgo, Japan, 673-8558
Actively Recruiting
83
Iwate Medical University Hospital ( Site 2116)
Shiwa-gun, Iwate, Japan, 028-3695
Actively Recruiting
84
Kanagawa Cancer Center ( Site 2121)
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
85
University of the Ryukyus Hospital ( Site 2117)
Ginowan, Okinawa, Japan, 901-2725
Actively Recruiting
86
Saitama Medical University International Medical Center ( Site 2106)
Hidaka, Saitama, Japan, 350-1298
Actively Recruiting
87
Shizuoka Cancer Center ( Site 2104)
Sunto-gun,, Shizuoka, Japan, 411-8777
Actively Recruiting
88
Cancer Institute Hospital of JFCR ( Site 2119)
Koto, Tokyo, Japan, 135-8550
Actively Recruiting
89
The Jikei University Hospital ( Site 2107)
Minato, Tokyo, Japan, 105-8471
Actively Recruiting
90
Niigata Cancer Center Hospital ( Site 2110)
Niigata, Japan, 951-8566
Actively Recruiting
91
Okayama University Hospital ( Site 2101)
Okayama, Japan, 700-8558
Actively Recruiting
92
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2111)
Osaka, Japan, 541-8567
Actively Recruiting
93
CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 2204)
Guadalajara, Jalisco, Mexico, 44260
Actively Recruiting
94
Grupo Médico ASSET ( Site 2203)
Mexico City, Mexico City, Mexico, 03100
Actively Recruiting
95
Higiea Oncologia ( Site 2205)
Mexico City, Mexico City, Mexico, 11819
Actively Recruiting
96
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2202)
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
97
Scientia Investigacion Clinica S.C. ( Site 2201)
Chihuahua City, Mexico, 31207
Actively Recruiting
98
Centro de Investigacion Clinica de Oaxaca ( Site 2207)
Oaxaca City, Mexico, 68020
Actively Recruiting
99
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)
Gliwice, Silesian Voivodeship, Poland, 44-102
Actively Recruiting
100
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)
Siedlce, Warmian-Masurian Voivodeship, Poland, 08-110
Actively Recruiting
101
Swietokrzyskie Centrum Onkologii. ( Site 2602)
Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
Actively Recruiting
102
National Cancer Center ( Site 2905)
Goyang-si, Kyonggi-do, South Korea, 10408
Actively Recruiting
103
Seoul National University Hospital ( Site 2901)
Jongno-gu, Seoul, South Korea, 03080
Actively Recruiting
104
Severance Hospital Yonsei University Health System ( Site 2902)
Seodaemun-Gu, Seoul, South Korea, 03722
Actively Recruiting
105
Asan Medical Center ( Site 2904)
Seoul, South Korea, 05505
Actively Recruiting
106
Samsung Medical Center ( Site 2903)
Seoul, South Korea, 06351
Actively Recruiting
107
Institut Català d'Oncologia (ICO) - Girona ( Site 3002)
Girona, Gerona, Spain, 17007
Actively Recruiting
108
Hosp Clinico Universitario de Valencia ( Site 3001)
Valencia, Valenciana, Comunitat, Spain, 46010
Actively Recruiting
109
Hospital Universitari Vall d Hebron ( Site 3003)
Barcelona, Spain, 08035
Actively Recruiting
110
Hospital Universitario Reina Sofia ( Site 3006)
Córdoba, Spain, 14004
Actively Recruiting
111
Hospital Ramon y Cajal ( Site 3005)
Madrid, Spain, 28034
Actively Recruiting
112
Hospital Universitario 12 de Octubre ( Site 3007)
Madrid, Spain, 28041
Actively Recruiting
113
Hospital Universitario La Paz ( Site 3004)
Madrid, Spain, 28046
Actively Recruiting
114
Skanes Universitetssjukhus Lund ( Site 3103)
Lund, Skåne County, Sweden, 22242
Actively Recruiting
115
Karolinska Universitetssjukhuset-Solna ( Site 3102)
Stockholm, Stockholm County, Sweden, 171 64
Actively Recruiting
116
Linköping University Hospital ( Site 3101)
Linköping, Östergötland County, Sweden, 581 85
Actively Recruiting
117
National Taiwan University Hospital ( Site 3301)
Taiwan, Taipei, Taiwan, 10002
Actively Recruiting
118
Taichung Veterans General Hospital ( Site 3304)
Taichung, Taiwan, 40705
Actively Recruiting
119
National Cheng Kung University Hospital ( Site 3308)
Tainan, Taiwan, 704
Actively Recruiting
120
Mackay Memorial Hospital ( Site 3303)
Taipei, Taiwan, 10449
Actively Recruiting
121
Chang Gung Memorial Hospital ( Site 3302)
Taoyuan, Taiwan, 333
Actively Recruiting
122
Chulalongkorn University ( Site 3403)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
123
Faculty of Medicine Siriraj Hospital ( Site 3401)
Bangkok, Bangkok, Thailand, 10700
Actively Recruiting
124
Maharaj Nakorn Chiang Mai Hospital ( Site 3402)
Chiang Mai, Thailand, 50200
Actively Recruiting
125
The Christie Hospital NHS Foundation Trust ( Site 3602)
Withington, Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
T
Toll Free Number
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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