Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT07216703

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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