AzTrials
AzTrials

Cervical CancerPhase 3NCT07216703

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)

A Phase 3 study testing Pembrolizumab, Sacituzumab Tirumotecan and Bevacizumab in people with Cervical Cancer, run by Merck Sharp & Dohme LLC at 191 sites in 29 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Pembrolizumab, Sacituzumab Tirumotecan and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,023 participants
Where
191 sitesin 29 countries
Study dates
19 Jan 2026to 29 Oct 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

The main inclusion criteria include but are not limited to the following:

  • Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
  • Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics [FIGO]-2018 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
  • If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
  • If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
  • If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
  • Has an Eastern Cooperative Oncology Group performance status of 0 or 1
  • Has tumor programmed cell death ligand 1 expression of combined positive score ≥1

The main exclusion criteria include but are not limited to the following:

  • Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has received prior systemic anticancer therapy other than what is specified in this protocol
  • Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
  • Has a diagnosis of immunodeficiency
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
  • Has a history of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Trial locations and contacts

191 sites in 29 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

191 sites in 29 countries

United States34 sites, 34 recruiting

  • Alaska Womens Cancer Care ( Site 5046)

    Anchorage, Alaska, 99508

    Study Coordinator, 907-562-4673

    Recruiting

  • Winship Cancer Institute of Emory University ( Site 5005)

    Atlanta, Georgia, 30308

    Study Coordinator, 404-778-1900

    Recruiting

  • University of Alabama- Birmingham ( Site 5015)

    Birmingham, Alabama, 35294

    Study Coordinator, 205-934-4011

    Recruiting

  • University of Virginia Cancer Center ( Site 5044)

    Charlottesville, Virginia, 22908

    Study Coordinator, 434-243-8109

    Recruiting

  • University of Virginia Cancer Center ( Site 6014)

    Charlottesville, Virginia, 22908

    Study Coordinator, 434-243-8109

    Recruiting

  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 5020)

    Cincinnati, Ohio, 45219

    Study Coordinator, 855-558-3222

    Recruiting

  • Maryland Oncology Hematology (MOH) ( Site 8001)

    Columbia, Maryland, 21044

    Study Coordinator, 410-964-2212

    Recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002)

    Columbus, Ohio, 43210

    Study Coordinator, 800-293-5066

    Recruiting

  • Minnesota Oncology Hematology, PA ( Site 8003)

    Edina, Minnesota, 55435

    Study Coordinator, 952-928-2944

    Recruiting

  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)

    Eugene, Oregon, 97401

    Study Coordinator, 541-683-5001

    Recruiting

  • Inova Schar Cancer Institute ( Site 5045)

    Fairfax, Virginia, 22031

    Study Coordinator, 571-472-4724

    Recruiting

  • Florida Cancer Specialists - South ( Site 7001)

    Fort Myers, Florida, 33901

    Study Coordinator, 239-274-9930

    Recruiting

  • Texas Oncology - DFW ( Site 8005)

    Fort Worth, Texas, 76104

    Study Coordinator, 817-413-1500

    Recruiting

  • Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010)

    Houston, Texas, 77030

    Study Coordinator, 713-441-6616

    Recruiting

  • CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5037)

    Irvine, California, 92612

    Study Coordinator, 714-456-8000

    Recruiting

  • University of Tennessee Medical Center ( Site 6012)

    Knoxville, Tennessee, 37920

    Study Coordinator, 865-305-4893

    Recruiting

  • Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 5000)

    La Jolla, California, 92093

    Study Coordinator, 858-822-6100

    Recruiting

  • Women's Cancer Center of Nevada ( Site 6011)

    Las Vegas, Nevada, 89106

    Study Coordinator, 702-851-4672

    Recruiting

  • Mount Sinai Braman Comprehensive Cancer Center ( Site 5043)

    Miami Beach, Florida, 33140

    Study Coordinator, 305-674-2625

    Recruiting

  • Mount Sinai Comprehensive Cancer Center ( Site 6000)

    Miami Beach, Florida, 33140

    Study Coordinator, 305-674-2625

    Recruiting

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5039)

    Mineola, New York, 11501

    Study Coordinator, 516-663-3696

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)

    New York, New York, 10016

    Study Coordinator, 212-404-4434

    Recruiting

  • Nebraska Methodist Hospital ( Site 5010)

    Omaha, Nebraska, 68114

    Study Coordinator, 402-354-7939

    Recruiting

  • University of California Irvine Medical Center ( Site 6006)

    Orange, California, 92868

    Study Coordinator, 714-456-8000

    Recruiting

  • Honickman Center ( Site 5033)

    Philadelphia, Pennsylvania, 19107

    Study Coordinator, 215-955-6923

    Recruiting

  • Women & Infants Hospital ( Site 6003)

    Providence, Rhode Island, 02905

    Study Coordinator, 401-430-4818

    Recruiting

  • Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)

    Savannah, Georgia, 31405

    Study Coordinator, 912-819-5789

    Recruiting

  • TRIALS 365 ( Site 6008)

    Shreveport, Louisiana, 71103

    Study Coordinator, 318-408-1198

    Recruiting

  • Moffit Cancer Center ( Site 5026)

    Tampa, Florida, 33612

    Study Coordinator, 888-663-3488

    Recruiting

  • Texas Oncology-The Woodlands ( Site 8000)

    The Woodlands, Texas, 77380

    Study Coordinator, 281-296-0365

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)

    Tulsa, Oklahoma, 74146

    Study Coordinator, 918-505-3200

    Recruiting

  • Texas Oncology - Northeast Texas ( Site 8002)

    Tyler, Texas, 75702

    Study Coordinator, 903-579-9800

    Recruiting

  • Florida Cancer Specialists - East ( Site 7000)

    West Palm Beach, Florida, 33401

    Study Coordinator, 561-366-4100

    Recruiting

  • Asplundh Cancer Pavilion ( Site 5002)

    Willow Grove, Pennsylvania, 19090

    Study Coordinator, 215-481-4000

    Recruiting

Other trials in United States

Japan19 sites, 19 recruiting

  • Hyogo Cancer Center ( Site 2118)

    Akashi, Hyōgo, 673-8558

    Study Coordinator, +81-78-929-1151

    Recruiting

  • National Cancer Center Hospital ( Site 2113)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 2102)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • University of the Ryukyus Hospital ( Site 2117)

    Ginowan, Okinawa, 901-2725

    Study Coordinator, +81-98-894-1301

    Recruiting

  • Saitama Medical University International Medical Center ( Site 2106)

    Hidaka, Saitama, 350-1298

    Study Coordinator, +81-42-984-4111

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 2119)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

  • Kurume University Hospital ( Site 2112)

    Kurume, Fukuoka, 830-0011

    Study Coordinator, +81-942-35-3311

    Recruiting

  • The Jikei University Hospital ( Site 2107)

    Minato, Tokyo, 105-8471

    Study Coordinator, +81-3-3433-1111

    Recruiting

  • Aichi Cancer Center ( Site 2114)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Niigata Cancer Center Hospital ( Site 2110)

    Niigata, 951-8566

    Study Coordinator, +81-25-266-5111

    Recruiting

  • Okayama University Hospital ( Site 2101)

    Okayama, 700-8558

    Study Coordinator, +81-86-223-7151

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2111)

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

  • Gunma Prefectural Cancer Center ( Site 2109)

    Ōta, Gunma, 373-8550

    Study Coordinator, +81-276-38-0771

    Recruiting

  • National Hospital Organization Hokkaido Cancer Center ( Site 2108)

    Sapporo, Hokkaido, 003-0804

    Study Coordinator, +81-11-811-9111

    Recruiting

  • Keio University Hospital ( Site 2103)

    Shinjyuku, Tokyo, 160-8582

    Study Coordinator, +81-3-3353-1211

    Recruiting

  • Iwate Medical University Hospital ( Site 2116)

    Shiwa-gun, Iwate, 028-3695

    Study Coordinator, +81-19-613-7111

    Recruiting

  • Shizuoka Cancer Center ( Site 2104)

    Sunto-gun,, Shizuoka, 411-8777

    Study Coordinator, +81-55-989-5222

    Recruiting

  • Ehime University Hospital ( Site 2105)

    Tōon, Ehime, 791-0295

    Study Coordinator, +81-89-964-5111

    Recruiting

  • Kanagawa Cancer Center ( Site 2121)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

Italy11 sites, 11 recruiting

  • CRO-IRCCS ( Site 2014)

    Aviano, Friuli Venezia Giulia, 33081

    Study Coordinator, +39434659111

    Recruiting

  • ASST Spedali Civili ( Site 2001)

    Brescia, 25123

    Study Coordinator, +393039951

    Recruiting

  • Ospedale Cannizzaro ( Site 2010)

    Catania, 95126

    Study Coordinator, +390957262165

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009)

    Meldola, Forli-Cesena, 47014

    Study Coordinator, +39054331111

    Recruiting

  • Ospedale Humanitas San Pio X ( Site 2013)

    Milan, Lombardy, 20159

    Study Coordinator, +390282243838

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)

    Milan, Milano, 20133

    Study Coordinator, +390223902772

    Recruiting

  • Istituto Europeo di Oncologia ( Site 2003)

    Milan, 20141

    Study Coordinator, +39257489001

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 2005)

    Padova, 35128

    Study Coordinator, +390498215729

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)

    Roma, 00168

    Study Coordinator, +390630155701

    Recruiting

  • Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)

    Torino, 10128

    Study Coordinator, +390115081111

    Recruiting

  • AULSS 2 MARCA TREVIGIANA ( Site 2011)

    Treviso, 95123

    Study Coordinator, +39 0422322922

    Recruiting

Other trials in Italy

Canada10 sites, 10 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0609)

    Calgary, Alberta, T2N 5G2

    Study Coordinator, 18444656330

    Recruiting

  • Cross Cancer Institute ( Site 0614)

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator, 780-432-8771

    Recruiting

  • Nova Scotia Cancer Centre ( Site 0617)

    Halifax, Nova Scotia, B3H 1V7

    Study Coordinator, 902-473-6000

    Recruiting

  • London Health Sciences Centre ( Site 0613)

    London, Ontario, N6A 5W9

    Study Coordinator, 519-685-8500

    Recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0616)

    Montreal, Quebec, H2X 0C1

    Study Coordinator, 514-890-8000

    Recruiting

  • McGill University Health Centre ( Site 0602)

    Montreal, Quebec, H4A 3J1

    Study Coordinator, 514-934-1934x31975

    Recruiting

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)

    Québec, Quebec, G1J 1Z4

    Study Coordinator, 4185254444x0

    Recruiting

  • CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)

    Sherbrooke, Quebec, J1H 5N4

    Study Coordinator, 8193461110x12890

    Recruiting

  • Sunnybrook Research Institute ( Site 0605)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 4164806100

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0601)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 4169464501

    Recruiting

Other trials in Canada

Argentina8 sites, 8 recruiting

  • Fundación Respirar ( Site 0101)

    Belgrano, Buenos Aires F.D., C1118AAT

    Study Coordinator, +5491170781548

    Recruiting

  • Centro de Oncología e Investigación de Buenos Aires ( Site 0107)

    Berazategui, Buenos Aires, B1884BBF

    Study Coordinator, +541142262013

    Recruiting

  • Centro Medico Privado CEMAIC ( Site 0102)

    Córdoba, X5008AAC

    Study Coordinator, +5493513976568

    Recruiting

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)

    La Rioja, F5300COE

    Study Coordinator, +543804436443X108

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +542234963224

    Recruiting

  • Instituto Misionero del Cancer ( Site 0112)

    Posadas, Misiones Province, N3300KAZ

    Study Coordinator, +54376443700ext4304

    Recruiting

  • Instituto de Oncologia de Rosario ( Site 0104)

    Rosario, Santa Fe Province, S2000KZE

    Study Coordinator, +543414484830

    Recruiting

  • Hospital Provincial del Centenario ( Site 0106)

    Rosario, Santa Fe Province, S2002KDS

    Study Coordinator, +5493414307185

    Recruiting

Other trials in Argentina

Brazil8 sites, 8 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)

    Barretos, São Paulo, 14784-400

    Study Coordinator, +55 17 3321-6600

    Recruiting

  • Hospital Araújo Jorge ( Site 0518)

    Goiânia, Goiás, 74605070

    Study Coordinator, +556232437260

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 0513)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0514)

    Porto Alegre, Rio Grande do Sul, 90020-090

    Study Coordinator, 55(51)3214-8143

    Recruiting

  • Hospital São Lucas da PUCRS ( Site 0516)

    Porto Alegre, Rio Grande do Sul, 90610-000

    Study Coordinator, +5551999892554

    Recruiting

  • Instituto Nacional de Câncer - INCA ( Site 0515)

    Rio de Janeiro, 20220-410

    Study Coordinator, +552132072985

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)

    São José do Rio Preto, São Paulo, 15091-000

    Study Coordinator, +55 17 3201-5054

    Recruiting

  • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)

    São Paulo, São Paulo, 04014-002

    Study Coordinator, +551144500360

    Recruiting

Other trials in Brazil

France8 sites, 8 recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1204)

    Bordeaux, Gironde, 33076

    Study Coordinator, +33556333279

    Recruiting

  • CHRU de Brest-Institut de cancérologie et d'Hématologie ( Site 1202)

    Brest, Brittany Region, 29609

    Study Coordinator, +33230338161

    Recruiting

  • Centre François Baclesse ( Site 1201)

    Caen, Calvados, 14076

    Study Coordinator, +33 2 31 45 97 00

    Recruiting

  • Pôle Santé Léonard de Vinci ( Site 1209)

    Chambray-lès-Tours, Centre-Val de Loire, 37170

    Study Coordinator, +33247602060

    Recruiting

  • Hopital Europeen Georges Pompidou ( Site 1210)

    Paris, 75015

    Study Coordinator, +330156092942

    Recruiting

  • Centre Hopitalier Lyon Sud ( Site 1206)

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310

    Study Coordinator, +33478864318

    Recruiting

  • CHU Strasbourg-Hautepierre ( Site 1207)

    Strasbourg, Alsace, 67098

    Study Coordinator, +330368767204

    Recruiting

  • LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1203)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33531155101

    Recruiting

Other trials in France

Spain7 sites, 7 recruiting

  • Hospital Universitari Vall d Hebron ( Site 3003)

    Barcelona, 08035

    Study Coordinator, +34934894350

    Recruiting

  • Hospital Universitario Reina Sofia ( Site 3006)

    Córdoba, 14004

    Study Coordinator, +34957011464

    Recruiting

  • Institut Català d'Oncologia (ICO) - Girona ( Site 3002)

    Girona, Gerona, 17007

    Study Coordinator, +34972225834

    Recruiting

  • Hospital Ramon y Cajal ( Site 3005)

    Madrid, 28034

    Study Coordinator, +34913368263

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 3007)

    Madrid, 28041

    Study Coordinator, +34913908626

    Recruiting

  • Hospital Universitario La Paz ( Site 3004)

    Madrid, 28046

    Study Coordinator, +34679927508

    Recruiting

  • Hosp Clinico Universitario de Valencia ( Site 3001)

    Valencia, Valenciana, Comunitat, 46010

    Study Coordinator, +34961973500

    Recruiting

Other trials in Spain

Belgium6 sites, 6 recruiting

  • Cliniques Universitaires Saint-Luc ( Site 0402)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +3227643513

    Recruiting

  • Grand Hopital de Charleroi ( Site 0404)

    Charleroi, Hainaut, 6060

    Study Coordinator, +32 60 11 25 00

    Recruiting

  • Antwerp University Hospital ( Site 0407)

    Edegem, Antwerpen, 2650

    Study Coordinator, +32 3821 41 60

    Recruiting

  • UZ Gent ( Site 0406)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +3293321591

    Recruiting

  • UZ Leuven ( Site 0401)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +3216347419

    Recruiting

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0403)

    Liège, Liege, 4000

    Study Coordinator, +32 4 323 3552

    Recruiting

Other trials in Belgium

Chile6 sites, 6 recruiting

  • IC La Serena Research ( Site 0710)

    La Serena, Coquimbo Region, 1720430

    Study Coordinator, 562227548702

    Recruiting

  • Fundación Arturo López Pérez ( Site 0701)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224205098

    Recruiting

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0706)

    Santiago, Region M. de Santiago, 8330073

    Study Coordinator, +56934331806

    Recruiting

  • Bradfordhill ( Site 0702)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56998744662

    Recruiting

  • CIDO SpA-Oncology ( Site 0708)

    Temuco, Araucania, 4810148

    Study Coordinator, +56452657374

    Recruiting

  • ONCOCENTRO APYS-ACEREY ( Site 0703)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56323320850

    Recruiting

Other trials in Chile

Israel6 sites, 6 recruiting

  • Hillel Yaffe Medical Center ( Site 1903)

    Hadera, 0038100

    Study Coordinator, +972047744335

    Recruiting

  • Rambam Health Care Campus ( Site 1907)

    Haifa, 3109601

    Study Coordinator, +97247776700

    Recruiting

  • Carmel Hospital ( Site 1901)

    Haifa, 3436212

    Study Coordinator, +97248250211

    Recruiting

  • Shaare Zedek Medical Center ( Site 1905)

    Jerusalem, 9103102

    Study Coordinator, +97226666666

    Recruiting

  • Rabin Medical Center ( Site 1904)

    Petah Tikva, 4941492

    Study Coordinator, 97239377377

    Recruiting

  • Sourasky Medical Center ( Site 1902)

    Tel Aviv, 6423906

    Study Coordinator, +972528844214

    Recruiting

Other trials in Israel

Mexico6 sites, 6 recruiting

  • Grupo Médico ASSET SC ( Site 2203)

    Benito Juárez, Mexico City, 03100

    Study Coordinator, +525551013316

    Recruiting

  • Scientia Investigacion Clinica S.C. ( Site 2201)

    Chihuahua City, 31207

    Study Coordinator, 6146883416

    Recruiting

  • CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 2204)

    Guadalajara, Jalisco, 44260

    Study Coordinator, +523316063096

    Recruiting

  • Higiea Oncologia ( Site 2205)

    Mexico City, Mexico City, 11819

    Study Coordinator, +525514747176

    Recruiting

  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 2202)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528183338111

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 2207)

    Oaxaca City, 68020

    Study Coordinator, +529515473137

    Recruiting

Other trials in Mexico

South Africa6 sites, 6 recruiting

  • Groote Schuur Hospital ( Site 2805)

    Cape Town, Western Cape, 7925

    Study Coordinator, +27 21 404 4261

    Recruiting

  • Hopelands Cancer Centre ( Site 2816)

    Hilton, KwaZulu-Natal, 3245

    Study Coordinator, +27 33 342 0380

    Recruiting

  • Wits Clinical Research ( Site 2803)

    Johannesburg, Gauteng, 2193

    Study Coordinator, +27113390600

    Recruiting

  • Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2804)

    Pretoria, Gauteng, 0002

    Study Coordinator, +27123541771

    Recruiting

  • Curo Oncology. ( Site 2811)

    Pretoria, Gauteng, 0084

    Study Coordinator, +27123356771

    Recruiting

  • Wits Clinical Research ( Site 2813)

    Soweto, Gauteng, 2113

    Study Coordinator, +27119836501

    Recruiting

Other trials in South Africa

Colombia5 sites, 5 recruiting

  • Centro Cancerológico del Caribe (CECAC) ( Site 0906)

    Barranquilla, Atlántico, 080002

    Study Coordinator, +573102316174

    Recruiting

  • Instituto Nacional De Cancerologia ( Site 0909)

    Bogotá, Bogota D.C., 111511

    Study Coordinator, +573154208007

    Recruiting

  • Oncomédica S.A.S ( Site 0905)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +573017057680

    Recruiting

  • Oncólogos del Occidente S.A.S. ( Site 0908)

    Pereira, Risaralda Department, 660001

    Study Coordinator, +573002558656

    Recruiting

  • Clinica Somer ( Site 0903)

    Rionegro, Antioquia, 054040

    Study Coordinator, +576046052626X5387

    Recruiting

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Czechia5 sites, 5 recruiting

  • Fakultní Nemocnice Brno ( Site 1003)

    Brno, Brno-mesto, 602 00

    Study Coordinator, +420532233843

    Recruiting

  • Nemocnice AGEL Novy Jicin a.s. ( Site 1004)

    Nový Jičín, Moravian-Silesian Region, 741 01

    Study Coordinator, +420556416180

    Recruiting

  • Fakultni nemocnice Ostrava ( Site 1005)

    Ostrava, Moravian-Silesian Region, 708 52

    Study Coordinator, +420597371804

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady ( Site 1002)

    Prague, Praha 10, 100 34

    Study Coordinator, +420267162333

    Recruiting

  • Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)

    Prague, 128 08

    Study Coordinator, +420224967425

    Recruiting

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South Korea5 sites, 5 recruiting

  • National Cancer Center ( Site 2905)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82-31-920-1760

    Recruiting

  • Seoul National University Hospital ( Site 2901)

    Jongno-gu, Seoul, 03080

    Study Coordinator, +82220727439

    Recruiting

  • Severance Hospital Yonsei University Health System ( Site 2902)

    Seodaemun-Gu, Seoul, 03722

    Study Coordinator, 82-2-3410-3545

    Recruiting

  • Asan Medical Center ( Site 2904)

    Seoul, 05505

    Study Coordinator, +82230103646

    Recruiting

  • Samsung Medical Center ( Site 2903)

    Seoul, 06351

    Study Coordinator, +82220084085

    Recruiting

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Taiwan5 sites, 5 recruiting

  • Taichung Veterans General Hospital ( Site 3304)

    Taichung, 40705

    Study Coordinator, 886-4-23592525

    Recruiting

  • National Cheng Kung University Hospital ( Site 3308)

    Tainan, 704

    Study Coordinator, +886 6-2353535

    Recruiting

  • Mackay Memorial Hospital ( Site 3303)

    Taipei, 10449

    Study Coordinator, +886-2-25433535

    Recruiting

  • National Taiwan University Hospital ( Site 3301)

    Taiwan, Taipei, 10002

    Study Coordinator, +886-2-23123456

    Recruiting

  • Chang Gung Memorial Hospital ( Site 3302)

    Taoyuan, 333

    Study Coordinator, 886-3-3281200

    Recruiting

Other trials in Taiwan

Austria4 sites, 4 recruiting

  • Medizinische Universitat Graz ( Site 0303)

    Graz, Styria, 8036

    Study Coordinator, +43031638530135

    Recruiting

  • Medizinische Universitaet Innsbruck ( Site 0301)

    Innsbruck, Tyrol, 6020

    Study Coordinator, +43512504-0

    Recruiting

  • Uniklinikum Salzburg Landeskrankenhaus ( Site 0304)

    Salzburg, 5020

    Study Coordinator, +43435725524900

    Recruiting

  • Medizinische Universitaet Wien ( Site 0302)

    Vienna, State of Vienna, 1090

    Study Coordinator, +4314040061091

    Recruiting

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Poland4 sites, 4 recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)

    Gliwice, Silesian Voivodeship, 44-102

    Study Coordinator, +48322788613

    Recruiting

  • Swietokrzyskie Centrum Onkologii. ( Site 2602)

    Kielce, Świętokrzyskie Voivodeship, 25-734

    Study Coordinator, +48885997850

    Recruiting

  • Mazowiecki Szpital Wojewódzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. ( Site 2601)

    Siedlce, Warmian-Masurian Voivodeship, 08-110

    Study Coordinator, +48256403300

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2605)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462295

    Recruiting

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Thailand4 sites, 4 recruiting

  • Chulalongkorn University ( Site 3403)

    Bangkok, Bangkok, 10330

    Study Coordinator, +6622564500

    Recruiting

  • Ramathibodi Hospital ( Site 3404)

    Bangkok, Bangkok, 10400

    Study Coordinator, +6622003611

    Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 3401)

    Bangkok, Bangkok, 10700

    Study Coordinator, +6624141914

    Recruiting

  • Maharaj Nakorn Chiang Mai Hospital ( Site 3402)

    Chiang Mai, 50200

    Study Coordinator, +6653936046

    Recruiting

Other trials in Thailand

United Kingdom4 sites, 4 recruiting

  • Western General Hospital ( Site 3604)

    Edinburgh, Edinburgh, City of, EH4 2XU

    Study Coordinator, +441315371000

    Recruiting

  • University College Hospital London ( Site 3605)

    London, London, City of, NW1 2PG

    Study Coordinator, 0044 203 447 8025

    Recruiting

  • The Royal Cornwall Hospital ( Site 3606)

    Truro, England, TR1 3LJ

    Study Coordinator, 01872 258344

    Recruiting

  • The Christie Hospital NHS Foundation Trust ( Site 3602)

    Withington, Manchester, M20 4BX

    Study Coordinator, +441619187682

    Recruiting

Other trials in United Kingdom

Germany3 sites, 3 recruiting

  • Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 1301)

    Berlin, 13353

    Study Coordinator, +4930450564402

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)

    Hamburg, 20246

    Study Coordinator, +4940741052396

    Recruiting

  • Universitaetsklinikum Jena ( Site 1303)

    Jena, Thuringia, 07747

    Study Coordinator, +4936419300

    Recruiting

Other trials in Germany

Greece3 sites, 3 recruiting

  • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)

    Athens, Attica, 115 28

    Study Coordinator, +302137286444

    Recruiting

  • Aretaieio Hospital Oncology Unit ( Site 1402)

    Athens, Attica, 115 28

    Study Coordinator, +302107286444

    Recruiting

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)

    Chaïdári, Attica, 124 62

    Study Coordinator, +302313301848

    Recruiting

Other trials in Greece

Ireland3 sites, 3 recruiting

  • Cork University Hospital ( Site 1802)

    Cork, T12 E8YV

    Study Coordinator, +353214920500

    Recruiting

  • Mater Misercordiae University Hospital ( Site 1804)

    Dublin, D07 R2WY

    Study Coordinator, 0035318034834

    Recruiting

  • St Jame's Hospital ( Site 1801)

    Dublin, D08 NHY1

    Study Coordinator, +35314103747

    Recruiting

Other trials in Ireland

Philippines3 sites, 3 recruiting

  • Perpetual Succour Hospital ( Site 2502)

    Cebu City, Cebu, 6000

    Study Coordinator, (02) 8731 1631

    Recruiting

  • Makati Medical Center ( Site 2503)

    Makati City, National Capital Region, 1229

    Study Coordinator, (02) 8888 8999

    Recruiting

  • Manila Doctors Hospital ( Site 2501)

    Manila, National Capital Region, 1000

    Study Coordinator, (+632) 8558-0888

    Recruiting

Other trials in Philippines

Sweden3 sites, 3 recruiting

  • Linköping University Hospital ( Site 3101)

    Linköping, Östergötland County, 581 85

    Study Coordinator, +46101030000

    Recruiting

  • Skanes Universitetssjukhus Lund ( Site 3103)

    Lund, Skåne County, 22242

    Study Coordinator, +46171000

    Recruiting

  • Karolinska Universitetssjukhuset-Solna ( Site 3102)

    Stockholm, Stockholm County, 171 64

    Study Coordinator, +46812370000

    Recruiting

Other trials in Sweden

Hungary2 sites, 2 recruiting

  • Országos Onkológiai Intézet ( Site 1603)

    Budapest, 1122

    Study Coordinator, +3612248600

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont ( Site 1601)

    Debrecen, 4032

    Study Coordinator, +36 52 255 705

    Recruiting

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India2 sites, 2 recruiting

  • KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1705)

    Belagavi, Karnataka, 590010

    Study Coordinator, +9108312473777

    Recruiting

  • Mahatma Gandhi Cancer Hospital and Research Institute ( Site 1714)

    Visakhapatnam, Andhra Pradesh, 530017

    Study Coordinator, 0891-2878787

    Recruiting

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Denmark1 site, 1 recruiting

  • Odense Universitetshospital-Department of oncology ( Site 1103)

    Odense C, Region Syddanmark, 5000

    Study Coordinator, +4529649352

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About this study

Official title: A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

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.

Read more

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
Read the detailed description

This is a 2-part study.

In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab.

In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.

Conditions
Cervical Cancer
Being tested
Pembrolizumab, Sacituzumab Tirumotecan, Bevacizumab, Paclitaxel, Cisplatin
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Trophoblast Cell Surface Antigen 2 (TROP2)
Medical subject headings
Uterine Cervical Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called Keytruda®, MK-3475, SCH 900475

    Intravenous (IV) Infusion

  • Sacituzumab TirumotecanBiological

    Also called sac-TMT, MK-2870, SKB264

    IV Infusion

  • BevacizumabBiological

    Also called Avastin®, MVASI®

    IV Infusion

  • PaclitaxelDrug

    Also called Taxol, Onxol

    IV Infusion

  • CisplatinDrug

    Also called Platinol®

    IV Infusion

  • CarboplatinDrug

    Also called Paraplatin®

    IV Infusion

  • Rescue MedicationsDrug

    Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).

Study groups in NCT07216703
Study groupRoleWhat they receive
Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + BevacizumabExperimentalParticipants will receive sac-TMT 4 mg/kg every 2 weeks (q2w) and pembrolizumab 400 mg every 6 weeks (q6w) for up to 14 cycles (up to approximately 20 months). Bevacizumab 15 mg/kg every 3 weeks (q3w) will be administered until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
Receives: Biological: Pembrolizumab; Biological: Sacituzumab Tirumotecan; Biological: Bevacizumab; Drug: Rescue Medications
Part 2: Sac-TMT + Pembrolizumab +/- BevacizumabExperimentalDuring induction treatment, participants will receive pembrolizumab 200 mg q3w for up to 8 cycles, paclitaxel 175 mg/m^2 q3w for up to 6 cycles, and cisplatin 50 mg/m^2 q3w (or carboplatin area under the curve [AUC]5 mg/mL/min q3w) for up to 6 cycles. Participants may also receive bevacizumab 15 mg/kg q3w for up to 8 cycles at the investigator's discretion. Each cycle will be 3 weeks long. During maintenance treatment, participants will receive sac-TMT 4 mg/kg q2w and pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
Receives: Biological: Pembrolizumab; Biological: Sacituzumab Tirumotecan; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Rescue Medications
Part 2: Pembrolizumab +/- BevacizumabActive comparatorDuring induction treatment, participants will receive pembrolizumab 200 mg q3w for up to 8 cycles, paclitaxel 175 mg/m^2 q3w for up to 6 cycles, and cisplatin 50 mg/m^2 q3w (or carboplatin AUC 5 mg/mL/min q3w) for up to 6 cycles. Participants may also receive bevacizumab 15 mg/kg q3w for up to 8 cycles at the investigator's discretion. Each cycle will be 3 weeks long. During maintenance treatment, participants will receive pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
Receives: Biological: Pembrolizumab; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 69 months

  2. Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 66 months

  3. Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by RECIST 1.1 as evaluated by BICR. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 48 months

  4. Part 2 Maintenance Treatment: Overall Survival (OS)

    OS is defined as time from randomization to death due to any cause. OS will be presented.

    Measured: Up to approximately 60 months

Secondary outcomes (7)

  1. Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator

    PFS2 is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first. PFS2 as assessed by the investigator will be presented.

    Measured: Up to approximately 60 months

  2. Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 64 months

  3. Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 61 months

  4. Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1 = Very poor to 7 = Excellent). The combined score of GHS and QoL is computed by averaging the raw scores of the 2 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 GHS and QoL combined score will be presented.

    Measured: Baseline and up to approximately 58 months

  5. Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 5 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 physical functioning combined score will be presented.

    Measured: Baseline and up to approximately 58 months

  6. Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 role functioning combined score will be presented.

    Measured: Baseline and up to approximately 58 months

  7. Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score

    EORTC QLQ-CX24 is a 24-item questionnaire that assesses symptoms common in women with cervical cancer and evaluates the impact of disease and/or its treatments. Items are rated on a 4-point scale (1 = Not at all to 4= Very Much) and are grouped into 3 multi-item scales (symptom experience, body image, and sexual/vaginal functioning) and 6 single-item scales (lymphedema, peripheral neuropathy, menopausal symptom, sexual concerns, sexual activity, and sexual enjoyment). The combined score is computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate more severe symptoms (lower quality of life) for symptoms scales, or better functioning for functional items. The change from baseline in the EORTC QLQ-CX24 combined score will be presented.

    Measured: Baseline and up to approximately 58 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2025
  2. Study start19 Jan 2026
  3. Primary completion29 Oct 2031 (estimated)
  4. Study completion29 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants in Part 1 Safety Run-in are allocated to a single treatment arm. Participants in study Part 2 complete induction treatment and are then randomized to 1 of 2 maintenance treatment arms.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,023 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07216703
Sponsor's protocol ID
2870-036
Other IDs
U1111-1319-9926, 2025-521514-26-00, MK-2870-036, TroFuse-036, GOG-3123, ENGOT-cx22, jRCT2031250604, 2025
Status last verified
Nov 2026
First submitted
10 Oct 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Sacituzumab Tirumotecan and Bevacizumab in people with Cervical Cancer, run by Merck Sharp & Dohme LLC at 191 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Japan, Italy, Canada, Argentina and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) (time frame: Up to approximately 69 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07216703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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