AzTrials
AzTrials

Cervical CancerPhase 3NCT06459180

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

A Phase 3 study testing Sacituzumab Tirumotecan, Pemetrexed and Tisotumab Vedotin in people with Cervical Cancer, run by Merck Sharp & Dohme LLC at 240 sites in 32 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. 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?
Sacituzumab Tirumotecan, Pemetrexed and Tisotumab Vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
686 participants
Where
240 sitesin 32 countries
Study dates
24 Jul 2024to 15 Jun 2028
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

Who may be able to join

  • Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  • Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
  • Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
  • Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
  • Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
  • Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
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  • HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Has adequate organ function

Who cannot join

  • Has Grade ≥2 peripheral neuropathy
  • Has 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.
  • Received prior systemic anticancer therapy
  • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
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  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
  • Has other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Concurrent active Hepatitis B and active Hepatitis C virus infection
  • Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications
  • Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD

Trial locations and contacts

240 sites in 32 countries.

240 sites in 32 countries

United States38 sites

  • Optimum Clinical Research Group ( Site 4138)

    Albuquerque, New Mexico, 87109

  • Providence Alaska Medical Center ( Site 4137)

    Anchorage, Alaska, 99508

  • Northside Hospital ( Site 4127)

    Atlanta, Georgia, 30342

  • Georgia Cancer Center at Augusta University ( Site 4112)

    Augusta, Georgia, 30912

  • Texas Oncology - Central/South Texas ( Site 8010)

    Austin, Texas, 78731

  • University of Virginia Cancer Center ( Site 4123)

    Charlottesville, Virginia, 22908

  • University of Cincinnati Medical Center ( Site 4128)

    Cincinnati, Ohio, 45219

  • Duke Cancer Institute ( Site 4120)

    Durham, North Carolina, 27710

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

    Eugene, Oregon, 97401

  • Inova Schar Cancer Institute ( Site 4139)

    Fairfax, Virginia, 22031-4867

  • Texas Oncology - DFW ( Site 8003)

    Fort Worth, Texas, 76104

  • The West Clinic, PLLC dba West Cancer Center ( Site 4108)

    Germantown, Tennessee, 38138

  • The Ohio State University ( Site 4103)

    Hilliard, Ohio, 43026

  • Houston Methodist Hospital OB/GYN ( Site 4102)

    Houston, Texas, 77030

  • Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)

    La Jolla, California, 92093

  • UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)

    Los Angeles, California, 90095

  • Mount Sinai Comprehensive Cancer Center ( Site 4143)

    Miami Beach, Florida, 33140

  • Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145)

    Mineola, New York, 11501

  • USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)

    Mobile, Alabama, 36604

  • University Medical Center New Orleans ( Site 4132)

    New Orleans, Louisiana, 70112

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121)

    New York, New York, 10016

  • Hoag Memorial Hospital Presbyterian ( Site 4104)

    Newport Beach, California, 92663

  • Advent Health ( Site 4140)

    Orlando, Florida, 32804

  • Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)

    Philadelphia, Pennsylvania, 19107

  • HonorHealth (HH) ( Site 8002)

    Phoenix, Arizona, 85016

  • Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)

    Portland, Oregon, 97210

  • The Center of Hope ( Site 4106)

    Reno, Nevada, 89511

  • Texas Oncology - San Antonio ( Site 8006)

    San Antonio, Texas, 78240

  • Lewis Cancer and Research Pavilion ( Site 4114)

    Savannah, Georgia, 31405

  • Swedish Medical Center-Swedish Cancer Institute ( Site 4134)

    Seattle, Washington, 98104

  • Willis Knighton Medical Center ( Site 4101)

    Shreveport, Louisiana, 71103

  • Holy Name Medical Center ( Site 4117)

    Teaneck, New Jersey, 07666

  • Arizona Oncology Associates - HOPE ( Site 8001)

    Tucson, Arizona, 85711

  • Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)

    Tulsa, Oklahoma, 74146

  • Texas Oncology - Northeast Texas ( Site 8009)

    Tyler, Texas, 75702

  • Texas Oncology - Gulf Coast ( Site 8008)

    Webster, Texas, 77598

  • Florida Cancer Specialists East ( Site 7001)

    West Palm Beach, Florida, 33401

  • Asplundh Cancer Pavilion ( Site 4113)

    Willow Grove, Pennsylvania, 19090

Other trials in United States

China32 sites

  • Beijing Peking Union Medical College Hospital ( Site 5045)

    Beijing, Beijing Municipality, 100730

  • Jilin Province Tumor Hospital ( Site 5036)

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital ( Site 5021)

    Changsha, Hunan, 410013

  • Xiangya Hospital Central South University ( Site 5009)

    Changsha, Hunan, 410028

  • West China Second University Hospital, Sichuan University ( Site 5017)

    Chengdu, Sichuan, 610000

  • Sichuan Cancer hospital-Oncology ( Site 5030)

    Chengdu, Sichuan, 610042

  • Chongqing University Cancer Hospital ( Site 5003)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Provincial Cancer Hospial ( Site 5012)

    Fuzhou, Fujian, 350014

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)

    Guangzhou, Guangdong, 510000

  • Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)

    Guangzhou, Guangdong, 511400

  • Hainan General Hospital ( Site 5032)

    Haikou, Hainan, 570311

  • Women s Hospital School of Medicine Zhejiang University ( Site 5022)

    Hangzhou, Zhejiang, 310006

  • Zhejiang Cancer Hospital ( Site 5008)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 5010)

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)

    Hefei, Anhui, 230000

  • Anhui Provincial Hospital ( Site 5011)

    Hefei, Anhui, 230071

  • Shandong Cancer Hospital ( Site 5014)

    Jinan, Shandong, 250117

  • Yunnan Province Cancer Hospital-Gynecology Department ( Site 5005)

    Kunming, Yunnan, 650107

  • LinYi Cancer Hospital-Gastrology department ( Site 5039)

    Linyi, Shandong, 276000

  • Jiangxi Maternal and Child Health Hospital ( Site 5031)

    Nanchang, Jiangxi, 330077

  • Jiangsu Province Hospital-Oncology Department ( Site 5018)

    Nanjing, Jiangsu, 210036

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)

    Nanning, Guangxi, 530200

  • Obstetrics & Gynecology Hospital of Fudan University ( Site 5015)

    Shanghai, Shanghai Municipality, 200011

  • Shanxi Cancer Hospital ( Site 5043)

    Taiyuan, Shanxi, 030000

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 5033)

    Wenzhou, Zhejiang, 325015

  • Wuhan Union Hospital ( Site 5020)

    Wuhan, Hubei, 430048

  • Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 5007)

    Xi'an, Shaanxi, 710061

  • The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)

    Xiamen, Fujian, 361003

  • The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)

    Xinxiang, Henan, 453100

  • Affiliated Hospital of Guangdong Medical University ( Site 5004)

    Zhanjiang, Guangdong, 524004

  • Henan Cancer Hospital ( Site 5026)

    Zhengzhou, Henan, 450008

Other trials in China

Japan19 sites

  • National Cancer Center Hospital ( Site 5108)

    Chūō, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center ( Site 5104)

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center ( Site 5117)

    Hidaka, Saitama, 350-1298

  • Kagoshima City Hospital ( Site 5115)

    Kagoshima, 890-8760

  • National Cancer Center Hospital East ( Site 5113)

    Kashiwa, Chiba, 277-8577

  • Cancer Institute Hospital of JFCR ( Site 5111)

    Koto, Tokyo, 135-8550

  • Kurume University Hospital ( Site 5105)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 5109)

    Matsuyama, Ehime, 791-0280

  • The Jikei University Hospital ( Site 5118)

    Minato, Tokyo, 105-8471

  • Aichi Cancer Center ( Site 5110)

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital ( Site 5100)

    Niigata, 951-8566

  • Gunma Prefectural Cancer Center ( Site 5116)

    Ohta, Gunma, 373-8550

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5103)

    Osaka, 541-8567

  • Hokkaido University Hospital ( Site 5106)

    Sapporo, Hokkaido, 060-8648

  • Keio University Hospital ( Site 5101)

    Shinjyuku, Tokyo, 160-8582

  • Iwate Medical University Hospital ( Site 5112)

    Shiwa-gun, Iwate, 028-3695

  • Shizuoka Cancer Center ( Site 5107)

    Sunto-gun,, Shizuoka, 411-8777

  • Ehime University Hospital ( Site 5102)

    Tōon, Ehime, 791-0295

  • University of Tsukuba Hospital ( Site 5114)

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Italy13 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC ( Site 2105)

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2110)

    Brescia, 25123

  • Ospedale Cannizzaro ( Site 2104)

    Catania, 95126

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2107)

    Milan, Lombardy, 20133

  • Istituto Europeo di Oncologia IRCCS ( Site 2108)

    Milan, Lombardy, 20141

  • Ospedale Humanitas San Pio X ( Site 2113)

    Milan, Lombardy, 20159

  • Ospedale San Raffaele. ( Site 2106)

    Milan, 20132

  • Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2111)

    Monza, Lombardy, 20900

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2103)

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS ( Site 2109)

    Padova, 35128

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)

    Roma, 00168

  • Humanitas University ( Site 2112)

    Rozzano, Milano, 20089

  • Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 2100)

    Turin, Piedmont, 10128

Other trials in Italy

France12 sites

  • CHU Besançon ( Site 1507)

    Besançon, Franche-Comte, 25030

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1503)

    Bordeaux, Aquitaine, 33076

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1508)

    Clermont-Ferrand, Auvergne, 63011

  • CENTRE LEON BERARD ( Site 1505)

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

  • Institut Paoli-Calmettes ( Site 1504)

    Marseille, Bouches-du-Rhone, 13009

  • Institut Regional du Cancer Montpellier ( Site 1511)

    Montpellier, Herault, 34298

  • Hôpital privé du Confluent SAS ( Site 1509)

    Nantes, Loire-Atlantique, 44277

  • Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1506)

    Paris, 75020

  • Hôpital Privé Des Côtes d'Armor ( Site 1510)

    Plérin, Cotes-d Armor, 22190

  • Hopitaux Universitaires de Strasbourg ( Site 1501)

    Strasbourg, Bas-Rhin, 67098

  • Oncopole Claudius Regaud ( Site 1502)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 1512)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Germany11 sites

  • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1607)

    Düsseldorf, North Rhine-Westphalia, 40225

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Gynäkologie und Gynäkologische Onko ( Site 1600)

    Essen, North Rhine-Westphalia, 45136

  • Universitaetsklinikum Essen ( Site 1613)

    Essen, North Rhine-Westphalia, 45147

  • Universitaetsklinikum Hamburg-Eppendorf-Department of Gynecology ( Site 1611)

    Hamburg, 20246

  • Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen ( Site 1612)

    Heidelberg, Baden-Wurttemberg, 69120

  • SLK-Kliniken Heilbronn ( Site 1617)

    Heilbronn, Baden-Wurttemberg, 74078

  • Universitaetsklinikum des Saarlandes ( Site 1618)

    Homburg, Saarland, 66421

  • Universitätsklinikum Marburg ( Site 1604)

    Marburg, Hesse, 35043

  • Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 1605)

    Munich, Bavaria, 81377

  • Diakonie-Klinikum Schwaebisch-Hall gGmbH Frauenklinik ( Site 1614)

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • Klinikum Worms ( Site 1619)

    Worms, Rhineland-Palatinate, 67550

Other trials in Germany

Spain11 sites

  • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2509)

    Barcelona, Catalonia, 08036

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)

    Barcelona, 08035

  • Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)

    Córdoba, 14004

  • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)

    Girona, Gerona, 17007

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2508)

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Clinica Universidad de Navarra ( Site 2510)

    Madrid, Madrid, Comunidad de, 28027

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2506)

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario La Paz-Oncología Médica ( Site 2504)

    Madrid, 28046

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)

    Valencia, Valenciana, Comunitat, 46009

  • HOSPITAL CLINICO DE VALENCIA ( Site 2505)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Argentina8 sites

  • Instituto de Oncología Angel H. Roffo ( Site 0103)

    Buenos Aires, Buenos Aires F.D., C1417

  • Instituto Alexander Fleming ( Site 0108)

    Buenos Aires, Buenos Aires F.D., C1426ANZ

  • Hospital Aleman-Oncology ( Site 0100)

    Buenos Aires, C1118AAT

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)

    CABA, C1431FWO

  • Hospital Británico de Buenos Aires-Oncology ( Site 0102)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

  • Sanatorio Allende - Cerro-Oncology ( Site 0106)

    Córdoba, Córdoba Province, 5000

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)

    La Rioja, F5300COE

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)

    Mar del Plata, Buenos Aires, B7600FZO

Other trials in Argentina

Canada8 sites

  • Royal Victoria Regional Health Centre ( Site 4009)

    Barrie, Ontario, L4M 6M2

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 4003)

    Hamilton, Ontario, L8V 5C2

  • BC Cancer Kelowna ( Site 4007)

    Kelowna, British Columbia, V1Y 5L3

  • Centre Hospitalier de l'Université de Montréal ( Site 4001)

    Montreal, Quebec, H2X 0C1

  • McGill University Health Centre ( Site 4000)

    Montreal, Quebec, H4A 3J1

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)

    Québec, Quebec, G1J 1Z4

  • BC Cancer Surrey ( Site 4006)

    Surrey, British Columbia, V3V 1Z2

  • BC Cancer Victoria ( Site 4008)

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Brazil7 sites

  • Instituto do Câncer e Transplante de Curitiba ( Site 0205)

    Curitiba, Paraná, 80510130

  • Centro de Hematologia e Oncologia ( Site 0203)

    Joinville, Santa Catarina, 89202-050

  • Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital do Câncer Mãe de Deus ( Site 0201)

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Americas Centro de Oncologia Integrado ( Site 0202)

    Rio de Janeiro, 22775-001

  • IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)

    São Paulo, São Paulo, 04014-002

  • Hospital Paulistano ( Site 0209)

    São Paulo, 01321-001

Other trials in Brazil

Australia6 sites

  • Monash Health-Oncology Research ( Site 3002)

    Clayton, Victoria, 3168

  • Royal Brisbane and Women's Hospital ( Site 3001)

    Herston, Queensland, 4029

  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)

    Melbourne, Victoria, 3000

  • Sir Charles Gairdner Hospital ( Site 3003)

    Nedlands, Western Australia, 6009

  • Blacktown Hospital ( Site 3006)

    Sydney, New South Wales, 2148

  • Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)

    Sydney, New South Wales, 2560

Other trials in Australia

Colombia6 sites

  • Instituto Nacional De Cancerologia-Oncología Clínica ( Site 0404)

    Bogota, Cundinamarca, 111151

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0403)

    Bogotá, Bogota D.C., 110131

  • Fundación Valle del Lili ( Site 0406)

    Cali, Valle del Cauca Department, 760032

  • IMAT S.A.S ( Site 0402)

    Montería, Departamento de Córdoba, 230002

  • Oncologos del Occidente ( Site 0405)

    Pereira, Risaralda Department, 660001

  • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

United Kingdom6 sites

  • Gartnavel General Hospital-Clinical Trials Unit ( Site 2800)

    Glasgow, Glasgow City, G12 0YN

  • St James's University Hospital ( Site 2804)

    Leeds, LS9 7TF

  • ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 2807)

    London, England, SW10 9NH

  • University College London Hospital ( Site 2805)

    London, London, City of, NW1 2PG

  • The Christie NHS Foundation Trust-Research and Development ( Site 2802)

    Manchester, m20 4bx

  • Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 2801)

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Belgium5 sites

  • AZORG Campus Aalst-Moorselbaan ( Site 2905)

    Aalst, Oost-Vlaanderen, 9300

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)

    Belgium, Wallonne, Region, 4000

  • UZ Gent-Medical oncology ( Site 2901)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven-Gynecologic Oncology ( Site 2900)

    Leuven, Vlaams-Brabant, 3000

  • CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)

    Namur, 5000

Other trials in Belgium

Mexico5 sites

  • Centro de Investigación Oncológica Galerías SC ( Site 0508)

    Aguascalientes, 20124

  • CENEIT Oncologicos ( Site 0507)

    Mexico City, Mexico City, 03100

  • Centro de Investigacion Clinica de Oaxaca ( Site 0505)

    Oaxaca City, Oaxaca, 68020

  • Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0506)

    San Luis Potosí City, 78200

  • Oncare - Unidad Valle ( Site 0509)

    San Pedro Garza García, Nuevo León, 66220

Other trials in Mexico

Netherlands5 sites

  • Amsterdam UMC, locatie VUmc ( Site 2201)

    Amsterdam, North Holland, 1081 HV

  • Catharina Ziekenhuis-Oncology ( Site 2203)

    Eindhoven, North Brabant, 5623 EJ

  • University Medical Center Groningen ( Site 2204)

    Groningen, 9713 GZ

  • Radboudumc-Medical Oncology ( Site 2202)

    Nijmegen, Gelderland, 6525 GA

  • Erasmus Medisch Centrum-Medical Oncology ( Site 2200)

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

Austria4 sites

  • Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)

    Innsbruck, Tyrol, 6020

  • Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)

    Linz, Upper Austria, 4020

  • Medizinische Universität Wien ( Site 1001)

    Vienna, 1090

Other trials in Austria

Greece4 sites

  • Aretaieio Hospital ( Site 1700)

    Athens, Attica, 115 28

  • Mitera Hospital ( Site 1702)

    Athens, Attica, 151 23

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1703)

    Chaïdári, Attica, 124 62

  • Agios Andreas Hospital Patras ( Site 1701)

    Patras, Peloponnese, 263 35

Other trials in Greece

Israel4 sites

  • Rambam Health Care Campus ( Site 2002)

    Haifa, 3109601

  • Edith Wolfson Medical Center ( Site 2003)

    Holon, 5810001

  • Hadassah Medical Center ( Site 2000)

    Jerusalem, 9112001

  • Sheba Medical Center ( Site 2001)

    Ramat Gan, 5265601

Other trials in Israel

Malaysia4 sites

  • Pantai Hospital Kuala Lumpur ( Site 3100)

    Kuala Lumpur, 59100

  • University Malaya Medical Centre ( Site 3102)

    Lembah Pantai, Kuala Lumpur, 59100

  • Sunway Medical Centre ( Site 3105)

    Petaling Jaya, Selangor, 47500

  • Penang Adventist Hospital ( Site 3101)

    Pulau Pinang, 10350

Other trials in Malaysia

South Korea4 sites

  • Seoul National University Hospital ( Site 3403)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System ( Site 3402)

    Seoul, 03722

  • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)

    Seoul, 05505

  • Samsung Medical Center ( Site 3400)

    Seoul, 06351

Other trials in South Korea

Sweden4 sites

  • Universitetssjukhuset i Linköping ( Site 2600)

    Linköping, Östergötland County, 581 85

  • Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2602)

    Lund, Skåne County, 221 85

  • Karolinska Universitetssjukhuset Solna ( Site 2601)

    Stockholm, Stockholm County, 171 64

  • Akademiska sjukhuset ( Site 2603)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Bulgaria3 sites

  • MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)

    Panagyurishte, Pazardzhik, 4500

  • MHAT - Heart and Brain ( Site 1100)

    Pleven, 5804

  • Complex Oncology Center - Plovdiv EOOD ( Site 1102)

    Plovdiv, 4004

Other trials in Bulgaria

Chile3 sites

  • FALP-UIDO ( Site 0300)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 0302)

    Santiago, Region M. de Santiago, 832000

  • ONCOCENTRO APYS-ACEREY ( Site 0303)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Denmark3 sites

  • Aarhus Universitetshospital, Skejby ( Site 1301)

    Aarhus, Central Jutland, 8200

  • Rigshospitalet-Dept. of Oncology ( Site 1300)

    Copenhagen, Capital Region, 2100

  • Odense Universitetshospital-Department of oncology ( Site 1302)

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Finland3 sites

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1400)

    Helsinki, Uusimaa, 00029

  • Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1401)

    Turku, Southwest Finland, 20520

Other trials in Finland

Ireland3 sites

  • Cork University Hospital ( Site 1900)

    Cork, T12 E8YV

  • Mater Misericordiae University Hospital ( Site 1901)

    Dublin, D07 R2WY

  • St. James's Hospital-Cancer clinical trials office ( Site 1902)

    Dublin, D08 E9P6

Other trials in Ireland

Poland3 sites

  • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Uniwersytecki Szpital Kliniczny w Poznaniu-Klinika Ginekologii Onkologicznej ( Site 2404)

    Poznan, Greater Poland Voivodeship, 60-569

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2400)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Singapore2 sites

  • National University Hospital ( Site 3301)

    Singapore, Central Singapore, 119228

  • National Cancer Centre Singapore ( Site 3300)

    Singapore, Central Singapore, 168583

Other trials in Singapore

Switzerland2 sites

  • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)

    Basel, Canton of Basel-City, 4031

  • Inselspital Bern-Oncology ( Site 2700)

    Bern, 3010

Other trials in Switzerland

Norway1 site

  • Oslo universitetssykehus, Radiumhospitalet ( Site 2300)

    Oslo, 0379

Other trials in Norway

Puerto Rico1 site

  • UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.

The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.

Conditions
Cervical Cancer
Being tested
Sacituzumab Tirumotecan, Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

Study groups in NCT06459180
Study groupRoleWhat they receive
Sacituzumab TirumotecanExperimentalParticipants will receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Receives: Biological: Sacituzumab Tirumotecan
Treatment of Physician's Choice (TPC)Active comparatorAt the physician's discretion, participants will receive 500 mg/m^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m^2 (or 1.25 mg/m^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m^2 (or 125 mg/m^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation.
Receives: Drug: Pemetrexed; Biological: Tisotumab Vedotin; Drug: Topotecan; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Irinotecan

What is being measured

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

  1. Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 46 months

  2. Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in

    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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 46 months

  3. Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in

    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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 46 months

  4. Overall Survival (OS) in Phase 3 Portion

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 35 months

Secondary outcomes (9)

  1. Progression-free Survival (PFS) in Phase 3 Portion

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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 at least 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 35 months

  2. ORR in Phase 3 Portion

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by BICR in the Phase 3 portion will be presented.

    Measured: Up to approximately 35 months

  3. Duration of Response (DOR) in Phase 3 Portion

    For participants who demonstrate CR (CR: disappearance of all target lesions) or PR (PR: at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR will be presented as assessed by BICR and analyzed by the Kaplan-Meier method for censored data.

    Measured: Up to approximately 35 months

  4. Number of Participants Experiencing One or More AEs in Phase 3 Portion

    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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 46 months

  5. Number of Participants Discontinuing Study Treatment Due to an AE in Phase 3 Portion

    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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 46 months

  6. Time to First Deterioration (TTD) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function. TTD in Global Health Status (GHS)/Quality of Life (QoL) is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in combined GHS/QoL score. The TTD in GHS/QoL (Items 29 and 30) combined score will be reported.

    Measured: Baseline and up to approximately 46 months

  7. Change from Baseline in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be reported.

    Measured: Baseline and up to approximately 46 months

  8. Change from Baseline in EORTC QLQ-C30 Physical Functioning Score in Phase 3 Portion

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.

    Measured: Baseline and up to approximately 46 months

  9. Change from Baseline in EORTC QLQ-C30 Role Functioning Score in Phase 3 Portion

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning score will be presented.

    Measured: Baseline and up to approximately 46 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 Jun 2024
  2. Study start24 Jul 2024
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion15 Jun 2028 (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
Masking
None (open label)
Enrolment
686 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459180
Sponsor's protocol ID
2870-020
Other IDs
MK-2870-020, TroFuse-020, 2023-508323-12-00, U1111-1298-0563, GOG-3101, ENGOT-cx20, jRCT2031240201, 2023
Status last verified
Aug 2026
First submitted
10 Jun 2024
Last updated
28 Aug 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 Sacituzumab Tirumotecan, Pemetrexed and Tisotumab Vedotin in people with Cervical Cancer, run by Merck Sharp & Dohme LLC at 240 sites in 32 countries.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 240 sites in United States, China, Japan, Italy, France and 27 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in (time frame: Up to approximately 46 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 NCT06459180.

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 28 Aug 2026.

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Clinical Trial NCT06459180 | AzTrials