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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Pemetrexed; Drug: Irinotecan; Biological: Sacituzumab Tirumotecan; Biological: Tisotumab Vedotin; Drug: Topotecan; Drug: Vinorelbine

• Study Type: Interventional
• Enrollment (Estimated): 686
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman-Oncology ( Site 0100)
  • CABA, Argentina, C1431FWO
    • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)
  • La Rioja, Argentina, F5300COE
    • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
      • Hospital Británico de Buenos Aires-Oncology ( Site 0102)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1417
      • Instituto de Oncología Angel H. Roffo ( Site 0103)
    • Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
      • Instituto Alexander Fleming ( Site 0108)
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, 5000
      • Sanatorio Allende - Cerro-Oncology ( Site 0106)
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2148
      • Blacktown Hospital ( Site 3006)
    • Sydney, New South Wales, Australia, 2560
      • Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital ( Site 3001)
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health-Oncology Research ( Site 3002)
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital ( Site 3003)
• Austria
  • Vienna, Austria, 1090
    • Medizinische Universität Wien ( Site 1001)
  • Styria
    • Graz, Styria, Austria, 8036
      • Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)
• Belgium
  • Namur, Belgium, 5000
    • CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • AZORG Campus Aalst-Moorselbaan ( Site 2905)
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent-Medical oncology ( Site 2901)
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven-Gynecologic Oncology ( Site 2900)
  • Wallonne, Region
    • Belgium, Wallonne, Region, Belgium, 4000
      • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)
• Brazil
  • Rio de Janeiro, Brazil, 22775-001
    • Americas Centro de Oncologia Integrado ( Site 0202)
  • São Paulo, Brazil, 01321-001
    • Hospital Paulistano ( Site 0209)
  • Paraná
    • Curitiba, Paraná, Brazil, 80510130
      • Instituto do Câncer e Transplante de Curitiba ( Site 0205)
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
      • Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
      • Hospital do Câncer Mãe de Deus ( Site 0201)
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89202-050
      • Centro de Hematologia e Oncologia ( Site 0203)
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04014-002
      • IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)
• Bulgaria
  • Pleven, Bulgaria, 5804
    • MHAT - Heart and Brain ( Site 1100)
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center - Plovdiv EOOD ( Site 1102)
  • Pazardzhik
    • Panagyurishte, Pazardzhik, Bulgaria, 4500
      • MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • BC Cancer Kelowna ( Site 4007)
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer Surrey ( Site 4006)
    • Victoria, British Columbia, Canada, V8R 6V5
      • BC Cancer Victoria ( Site 4008)
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre ( Site 4009)
    • Hamilton, Ontario, Canada, L8V 5C2
      • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 4003)
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Université de Montréal ( Site 4001)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 4000)
    • Québec, Quebec, Canada, G1J 1Z4
      • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)
• Chile
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7500921
      • FALP-UIDO ( Site 0300)
    • Santiago, Region M. de Santiago, Chile, 832000
      • Pontificia Universidad Catolica de Chile ( Site 0302)
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • ONCOCENTRO APYS-ACEREY ( Site 0303)
• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)
    • Hefei, Anhui, China, 230071
      • Anhui Provincial Hospital ( Site 5011)
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Peking Union Medical College Hospital ( Site 5045)
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing University Cancer Hospital ( Site 5003)
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospial ( Site 5012)
    • Xiamen, Fujian, China, 361003
      • The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)
    • Guangzhou, Guangdong, China, 511400
      • Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)
    • Zhanjiang, Guangdong, China, 524004
      • Affiliated Hospital of Guangdong Medical University ( Site 5004)
  • Guangxi
    • Nanning, Guangxi, China, 530200
      • Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital ( Site 5032)
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hospital ( Site 5010)
  • Henan
    • Xinxiang, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital ( Site 5026)
  • Hubei
    • Wuhan, Hubei, China, 430048
      • Wuhan Union Hospital ( Site 5020)
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital ( Site 5021)
    • Changsha, Hunan, China, 410028
      • Xiangya Hospital Central South University ( Site 5009)
  • Jiangsu
    • Nanjing, Jiangsu, China, 210036
      • Jiangsu Province Hospital-Oncology Department ( Site 5018)
  • Jiangxi
    • Nanchang, Jiangxi, China, 330077
      • Jiangxi Maternal and Child Health Hospital ( Site 5031)
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Province Tumor Hospital ( Site 5036)
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 5007)
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital ( Site 5014)
    • Linyi, Shandong, China, 276000
      • LinYi Cancer Hospital-Gastrology department ( Site 5039)
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Obstetrics & Gynecology Hospital of Fudan University ( Site 5015)
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Cancer Hospital ( Site 5043)
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Second University Hospital, Sichuan University ( Site 5017)
    • Chengdu, Sichuan, China, 610042
      • Sichuan Cancer hospital-Oncology ( Site 5030)
  • Yunnan
    • Kunming, Yunnan, China, 650107
      • Yunnan Province Cancer Hospital-Gynecology Department ( Site 5005)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women s Hospital School of Medicine Zhejiang University ( Site 5022)
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital ( Site 5008)
    • Wenzhou, Zhejiang, China, 325015
      • The First Affiliated Hospital of Wenzhou Medical University ( Site 5033)
• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110131
      • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0403)
  • Cesar Department
    • Valledupar, Cesar Department, Colombia, 200001
      • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 111151
      • Instituto Nacional De Cancerologia-Oncología Clínica ( Site 0404)
  • Departamento de Córdoba
    • Montería, Departamento de Córdoba, Colombia, 230002
      • IMAT S.A.S ( Site 0402)
  • Risaralda Department
    • Pereira, Risaralda Department, Colombia, 660001
      • Oncologos del Occidente ( Site 0405)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760032
      • Fundación Valle del Lili ( Site 0406)
• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Rigshospitalet-Dept. of Oncology ( Site 1300)
  • Central Jutland
    • Aarhus, Central Jutland, Denmark, 8200
      • Aarhus Universitetshospital, Skejby ( Site 1301)
  • Region Syddanmark
    • Odense C, Region Syddanmark, Denmark, 5000
      • Odense Universitetshospital-Department of oncology ( Site 1302)
• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1401)
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1400)
• France
  • Paris, France, 75020
    • Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1506)
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33076
      • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1503)
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63011
      • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1508)
  • Auvergne-Rhône-Alpes
    • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
      • CENTRE LEON BERARD ( Site 1505)
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67200
      • Hopitaux Universitaires de Strasbourg ( Site 1501)
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13009
      • Institut Paoli-Calmettes ( Site 1504)
  • Cotes-d Armor
    • Plérin, Cotes-d Armor, France, 22190
      • Hôpital Privé Des Côtes d'Armor ( Site 1510)
  • Franche-Comte
    • Besançon, Franche-Comte, France, 25030
      • CHU Besançon ( Site 1507)
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Oncopole Claudius Regaud ( Site 1502)
  • Herault
    • Montpellier, Herault, France, 34298
      • Institut Regional du Cancer Montpellier ( Site 1511)
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44277
      • Hôpital privé du Confluent SAS ( Site 1509)
  • Île-de-France Region
    • Villejuif, Île-de-France Region, France, 94805
      • Gustave Roussy ( Site 1512)
• Germany
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf-Department of Gynecology ( Site 1611)
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen ( Site 1612)
    • Heilbronn, Baden-Wurttemberg, Germany, 74078
      • SLK-Kliniken Heilbronn ( Site 1617)
    • Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523
      • Diakonie-Klinikum Schwaebisch-Hall gGmbH Frauenklinik ( Site 1614)
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 1605)
  • Hesse
    • Marburg, Hesse, Germany, 35043
      • Universitätsklinikum Marburg ( Site 1604)
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1607)
    • Essen, North Rhine-Westphalia, Germany, 45136
      • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Gynäkologie und Gynäkologische Onko ( Site 1600)
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Universitaetsklinikum Essen ( Site 1613)
  • Rhineland-Palatinate
    • Worms, Rhineland-Palatinate, Germany, 67550
      • Klinikum Worms ( Site 1619)
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Universitaetsklinikum des Saarlandes ( Site 1618)
• Greece
  • Attica
    • Athens, Attica, Greece, 115 28
      • Aretaieio Hospital ( Site 1700)
    • Athens, Attica, Greece, 151 23
      • Mitera Hospital ( Site 1702)
    • Chaïdári, Attica, Greece, 124 62
      • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1703)
  • Peloponnese
    • Patras, Peloponnese, Greece, 263 35
      • Agios Andreas Hospital Patras ( Site 1701)
• Ireland
  • Cork, Ireland, T12 E8YV
    • Cork University Hospital ( Site 1900)
  • Dublin, Ireland, D07 R2WY
    • Mater Misericordiae University Hospital ( Site 1901)
  • Dublin, Ireland, D08 E9P6
    • St. James's Hospital-Cancer clinical trials office ( Site 1902)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 2002)
  • Holon, Israel, 5810001
    • Edith Wolfson Medical Center ( Site 2003)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center ( Site 2000)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 2001)
• Italy
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2110)
  • Catania, Italy, 95126
    • Ospedale Cannizzaro ( Site 2104)
  • Milan, Italy, 20132
    • Ospedale San Raffaele. ( Site 2106)
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS ( Site 2108)
  • Naples, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2103)
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS ( Site 2109)
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC ( Site 2105)
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2107)
    • Milan, Lombardy, Italy, 20159
      • Ospedale Humanitas San Pio X ( Site 2113)
    • Monza, Lombardy, Italy, 20900
      • Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2111)
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Humanitas University ( Site 2112)
  • Piedmont
    • Turin, Piedmont, Italy, 10128
      • Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 2100)
• Japan
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center ( Site 5104)
  • Kagoshima, Japan, 890-8760
    • Kagoshima City Hospital ( Site 5115)
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital ( Site 5100)
  • Osaka, Japan, 541-8567
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5103)
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center ( Site 5110)
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East ( Site 5113)
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center ( Site 5109)
    • Tōon, Ehime, Japan, 791-0295
      • Ehime University Hospital ( Site 5102)
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital ( Site 5105)
  • Gunma
    • Ohta, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center ( Site 5116)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital ( Site 5106)
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital ( Site 5114)
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital ( Site 5112)
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center ( Site 5117)
  • Shizuoka
    • Sunto-gun,, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center ( Site 5107)
  • Tokyo
    • Chūō, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital ( Site 5108)
    • Koto, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of JFCR ( Site 5111)
    • Minato, Tokyo, Japan, 105-8471
      • The Jikei University Hospital ( Site 5118)
    • Shinjyuku, Tokyo, Japan, 160-8582
      • Keio University Hospital ( Site 5101)
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Pantai Hospital Kuala Lumpur ( Site 3100)
  • Pulau Pinang, Malaysia, 10350
    • Penang Adventist Hospital ( Site 3101)
  • Kuala Lumpur
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre ( Site 3102)
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 47500
      • Sunway Medical Centre ( Site 3105)
• Mexico
  • Aguascalientes, Mexico, 20124
    • Centro de Investigación Oncológica Galerías SC ( Site 0508)
  • San Luis Potosí City, Mexico, 78200
    • Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0506)
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03100
      • CENEIT Oncologicos ( Site 0507)
  • Nuevo León
    • San Pedro Garza García, Nuevo León, Mexico, 66220
      • Oncare - Unidad Valle ( Site 0509)
  • Oaxaca
    • Oaxaca City, Oaxaca, Mexico, 68020
      • Centro de Investigacion Clinica de Oaxaca ( Site 0505)
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen ( Site 2204)
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc-Medical Oncology ( Site 2202)
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Catharina Ziekenhuis-Oncology ( Site 2203)
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1081 HV
      • Amsterdam UMC, locatie VUmc ( Site 2201)
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum-Medical Oncology ( Site 2200)
• Norway
  • Oslo, Norway, 0379
    • Oslo universitetssykehus, Radiumhospitalet ( Site 2300)
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-569
      • Uniwersytecki Szpital Kliniczny w Poznaniu-Klinika Ginekologii Onkologicznej ( Site 2404)
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2400)
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-027
      • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 119228
      • National University Hospital ( Site 3301)
    • Singapore, Central Singapore, Singapore, 168583
      • National Cancer Centre Singapore ( Site 3300)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 3403)
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System ( Site 3402)
  • Seoul, South Korea, 05505
    • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)
  • Seoul, South Korea, 06351
    • Samsung Medical Center ( Site 3400)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz-Oncología Médica ( Site 2504)
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2509)
    • L'Hospitalet de Llobregat, Catalonia, Spain, 08908
      • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2508)
  • Gerona
    • Girona, Gerona, Spain, 17007
      • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28027
      • Clinica Universidad de Navarra ( Site 2510)
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2506)
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46009
      • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • HOSPITAL CLINICO DE VALENCIA ( Site 2505)
• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden, 221 85
      • Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2602)
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 171 64
      • Karolinska Universitetssjukhuset Solna ( Site 2601)
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 751 85
      • Akademiska sjukhuset ( Site 2603)
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 581 85
      • Universitetssjukhuset i Linköping ( Site 2600)
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern-Oncology ( Site 2700)
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4031
      • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital ( Site 2804)
  • Manchester, United Kingdom, m20 4bx
    • The Christie NHS Foundation Trust-Research and Development ( Site 2802)
  • England
    • London, England, United Kingdom, SW10 9NH
      • ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 2807)
    • Sutton, England, United Kingdom, SM2 5PT
      • Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 2801)
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G12 0YN
      • Gartnavel General Hospital-Clinical Trials Unit ( Site 2800)
  • London, City of
    • London, London, City of, United Kingdom, NW1 2PG
      • University College London Hospital ( Site 2805)
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Alaska Medical Center ( Site 4137)
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • HonorHealth (HH) ( Site 8002)
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates - HOPE ( Site 8001)
  • California
    • La Jolla, California, United States, 92093
      • Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian ( Site 4104)
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Braman Comprehensive Cancer Center ( Site 4143)
    • Orlando, Florida, United States, 32804
      • Advent Health ( Site 4140)
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists East ( Site 7001)
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital ( Site 4127)
    • Augusta, Georgia, United States, 30912
      • Georgia Cancer Center at Augusta University ( Site 4112)
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer and Research Pavilion ( Site 4114)
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans ( Site 4132)
    • Shreveport, Louisiana, United States, 71103
      • Willis Knighton Medical Center ( Site 4101)
  • Nevada
    • Reno, Nevada, United States, 89511
      • The Center of Hope ( Site 4106)
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center ( Site 4117)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Optimum Clinical Research Group ( Site 4138)
  • New York
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145)
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121)
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute ( Site 4120)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center ( Site 4128)
    • Hilliard, Ohio, United States, 43026
      • The Ohio State University ( Site 4103)
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)
    • Willow Grove, Pennsylvania, United States, 19090
      • Asplundh Cancer Pavilion ( Site 4113)
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, PLLC dba West Cancer Center ( Site 4108)
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Central/South Texas ( Site 8010)
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - DFW ( Site 8003)
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital OB/GYN ( Site 4102)
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio ( Site 8006)
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Northeast Texas ( Site 8009)
    • Webster, Texas, United States, 77598
      • Texas Oncology - Gulf Coast ( Site 8008)
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center ( Site 4123)
    • Fairfax, Virginia, United States, 22031-4867
      • Inova Schar Cancer Institute ( Site 4139)
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center-Swedish Cancer Institute ( Site 4134)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Tirumotecan; Participants will receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.	Biological: Sacituzumab Tirumotecan; IV infusion; Other Names: SKB264; MK-2870; sac-TMT
Active Comparator: Treatment of Physician's Choice (TPC); At 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.	Drug: Gemcitabine; IV infusion; Drug: Pemetrexed; IV infusion; Drug: Irinotecan; IV infusion; Biological: Tisotumab Vedotin; IV infusion; Drug: Topotecan; IV infusion; Drug: Vinorelbine; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 46 months
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.	Up to approximately 46 months
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.	Up to approximately 46 months
Overall Survival (OS) in Phase 3 Portion	OS is defined as the time from randomization to death due to any cause.	Up to approximately 35 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 35 months
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.	Up to approximately 35 months
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.	Up to approximately 35 months
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.	Up to approximately 46 months
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.	Up to approximately 46 months
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.	Baseline and up to approximately 46 months
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.	Baseline and up to approximately 46 months
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.	Baseline and up to approximately 46 months
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.	Baseline and up to approximately 46 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT)
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Indoles; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Irinotecan; Vinorelbine; Pemetrexed; Gemcitabine; Topotecan; tisotumab vedotin
• Other Study ID Numbers: 2870-020; MK-2870-020 (Other Identifier: MSD); TroFuse-020 (Other Identifier: MSD); U1111-1298-0563 (Registry Identifier: UTN); GOG-3101 (Other Identifier: Gynecologic Oncology Group); ENGOT-cx20 (Other Identifier: European Network of Gynaecological Oncological Trial Groups (ENGOT)); jRCT2031240201 (Registry Identifier: Japan Registry of Clinical Trials (jRCT)); 2023-508323-12-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No