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)

Status: Recruiting
Location: See all (219) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Providence Alaska Medical Center ( Site 4137)
RECRUITING
Anchorage
Alabama
USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
RECRUITING
Mobile
Arizona
HonorHealth (HH) ( Site 8002)
RECRUITING
Phoenix
Arizona Oncology Associates - HOPE ( Site 8001)
RECRUITING
Tucson
California
Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
RECRUITING
La Jolla
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian ( Site 4104)
RECRUITING
Newport Beach
Florida
Mount Sinai Comprehensive Cancer Center ( Site 4143)
RECRUITING
Miami Beach
Advent Health ( Site 4140)
RECRUITING
Orlando
Florida Cancer Specialists East ( Site 7001)
RECRUITING
West Palm Beach
Georgia
Northside Hospital ( Site 4127)
RECRUITING
Atlanta
Georgia Cancer Center at Augusta University ( Site 4112)
RECRUITING
Augusta
Lewis Cancer and Research Pavilion ( Site 4114)
RECRUITING
Savannah
Louisiana
University Medical Center New Orleans ( Site 4132)
RECRUITING
New Orleans
Willis Knighton Medical Center ( Site 4101)
RECRUITING
Shreveport
North Carolina
Duke Cancer Institute ( Site 4120)
RECRUITING
Durham
New Jersey
Holy Name Medical Center ( Site 4117)
RECRUITING
Teaneck
New Mexico
Optimum Clinical Research Group ( Site 4138)
RECRUITING
Albuquerque
Nevada
The Center of Hope ( Site 4106)
RECRUITING
Reno
Ohio
University of Cincinnati Medical Center ( Site 4128)
RECRUITING
Cincinnati
The Ohio State University ( Site 4103)
RECRUITING
Hilliard
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)
RECRUITING
Tulsa
Oregon
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
RECRUITING
Eugene
Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)
RECRUITING
Portland
Pennsylvania
Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)
RECRUITING
Philadelphia
Asplundh Cancer Pavilion ( Site 4113)
RECRUITING
Willow Grove
Texas
Texas Oncology - DFW ( Site 8003)
RECRUITING
Fort Worth
Houston Methodist Hospital OB/GYN ( Site 4102)
RECRUITING
Houston
Texas Oncology - San Antonio ( Site 8006)
RECRUITING
San Antonio
Virginia
University of Virginia Cancer Center ( Site 4123)
RECRUITING
Charlottesville
Inova Schar Cancer Institute ( Site 4139)
RECRUITING
Fairfax
Washington
Swedish Medical Center-Swedish Cancer Institute ( Site 4134)
RECRUITING
Seattle
Other Locations
Argentina
Hospital Aleman-Oncology ( Site 0100)
RECRUITING
Buenos Aires
Instituto Alexander Fleming ( Site 0108)
RECRUITING
Buenos Aires
Instituto de Oncología Angel H. Roffo ( Site 0103)
RECRUITING
Buenos Aires
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)
RECRUITING
Caba
Hospital Británico de Buenos Aires-Oncology ( Site 0102)
RECRUITING
Ciudad Autónoma De Buenos Aires
Sanatorio Allende - Cerro-Oncology ( Site 0106)
RECRUITING
Córdoba
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)
RECRUITING
La Rioja
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)
RECRUITING
Mar Del Plata
Australia
Monash Health-Oncology Research ( Site 3002)
RECRUITING
Clayton
Royal Brisbane and Women's Hospital ( Site 3001)
RECRUITING
Herston
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)
COMPLETED
Melbourne
Sir Charles Gairdner Hospital ( Site 3003)
RECRUITING
Nedlands
Blacktown Hospital ( Site 3006)
RECRUITING
Sydney
Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)
RECRUITING
Sydney
Austria
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)
RECRUITING
Graz
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)
RECRUITING
Innsbruck
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)
RECRUITING
Linz
Medizinische Universität Wien ( Site 1001)
RECRUITING
Vienna
Belgium
AZORG Campus Aalst-Moorselbaan ( Site 2905)
RECRUITING
Aalst
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)
RECRUITING
Belgium
UZ Gent-Medical oncology ( Site 2901)
RECRUITING
Ghent
UZ Leuven-Gynecologic Oncology ( Site 2900)
RECRUITING
Leuven
CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)
RECRUITING
Namur
Brazil
Instituto do Câncer e Transplante de Curitiba ( Site 0205)
RECRUITING
Curitiba
Centro de Hematologia e Oncologia ( Site 0203)
RECRUITING
Joinville
Hospital do Câncer Mãe de Deus ( Site 0201)
RECRUITING
Porto Alegre
Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)
RECRUITING
Porto Alegre
Americas Centro de Oncologia Integrado ( Site 0202)
RECRUITING
Rio De Janeiro
Hospital Paulistano ( Site 0209)
RECRUITING
São Paulo
IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)
RECRUITING
São Paulo
Bulgaria
MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)
RECRUITING
Panagyurishte
MHAT - Heart and Brain ( Site 1100)
RECRUITING
Pleven
Complex Oncology Center - Plovdiv EOOD ( Site 1102)
RECRUITING
Plovdiv
Canada
Royal Victoria Regional Health Centre ( Site 4009)
RECRUITING
Barrie
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 4003)
RECRUITING
Hamilton
BC Cancer Kelowna ( Site 4007)
RECRUITING
Kelowna
Centre Hospitalier de l'Université de Montréal ( Site 4001)
RECRUITING
Montreal
McGill University Health Centre ( Site 4000)
RECRUITING
Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)
RECRUITING
Québec
BC Cancer Surrey ( Site 4006)
RECRUITING
Surrey
BC Cancer Victoria ( Site 4008)
RECRUITING
Victoria
Chile
FALP-UIDO ( Site 0300)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 0302)
RECRUITING
Santiago
ONCOCENTRO APYS-ACEREY ( Site 0303)
RECRUITING
Viña Del Mar
China
Beijing Peking Union Medical College Hospital ( Site 5045)
RECRUITING
Beijing
Jilin Province Tumor Hospital ( Site 5036)
RECRUITING
Changchun
Hunan Cancer Hospital ( Site 5021)
RECRUITING
Changsha
Xiangya Hospital Central South University ( Site 5009)
RECRUITING
Changsha
Sichuan Cancer hospital-Oncology ( Site 5030)
RECRUITING
Chengdu
West China Second University Hospital, Sichuan University ( Site 5017)
RECRUITING
Chengdu
Chongqing University Cancer Hospital ( Site 5003)
RECRUITING
Chongqing
Fujian Provincial Cancer Hospial ( Site 5012)
RECRUITING
Fuzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)
RECRUITING
Guangzhou
Hainan General Hospital ( Site 5032)
RECRUITING
Haikou
Women s Hospital School of Medicine Zhejiang University ( Site 5022)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 5008)
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital ( Site 5010)
RECRUITING
Harbin
Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)
RECRUITING
Hefei
Anhui Provincial Hospital ( Site 5011)
RECRUITING
Hefei
Shandong Cancer Hospital ( Site 5014)
RECRUITING
Jinan
Yunnan Province Cancer Hospital-Gynecology Department ( Site 5005)
RECRUITING
Kunming
LinYi Cancer Hospital-Gastrology department ( Site 5039)
RECRUITING
Linyi
Jiangxi Maternal and Child Health Hospital ( Site 5031)
RECRUITING
Nanchang
Jiangsu Province Hospital-Oncology Department ( Site 5018)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)
RECRUITING
Nanning
Obstetrics & Gynecology Hospital of Fudan University ( Site 5015)
RECRUITING
Shanghai
Shanxi Cancer Hospital ( Site 5043)
RECRUITING
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University ( Site 5033)
RECRUITING
Wenzhou
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)
RECRUITING
Wuhan
Wuhan Union Hospital ( Site 5020)
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 5007)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)
RECRUITING
Xiamen
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)
RECRUITING
Xinxiang
Affiliated Hospital of Guangdong Medical University ( Site 5004)
RECRUITING
Zhanjiang
Henan Cancer Hospital ( Site 5026)
RECRUITING
Zhengzhou
Colombia
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 0404)
RECRUITING
Bogota
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0403)
RECRUITING
Bogotá
IMAT S.A.S ( Site 0402)
COMPLETED
Montería
Oncologos del Occidente ( Site 0405)
RECRUITING
Pereira
Fundación Valle del Lili ( Site 0406)
RECRUITING
Santiago De Cali
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)
RECRUITING
Valledupar
Denmark
Aarhus Universitetshospital, Skejby ( Site 1301)
RECRUITING
Aarhus
Rigshospitalet-Dept. of Oncology ( Site 1300)
RECRUITING
Copenhagen
Odense Universitetshospital-Department of oncology ( Site 1302)
RECRUITING
Odense C
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1400)
RECRUITING
Helsinki
Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)
RECRUITING
Tampere
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1401)
RECRUITING
Turku
France
CHU Besançon ( Site 1507)
RECRUITING
Besançon
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1503)
RECRUITING
Bordeaux
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1508)
RECRUITING
Clermont-ferrand
CENTRE LEON BERARD ( Site 1505)
RECRUITING
Lyon Cedex08
Institut Paoli-Calmettes ( Site 1504)
RECRUITING
Marseille
Institut Regional du Cancer Montpellier ( Site 1511)
RECRUITING
Montpellier
Hôpital privé du Confluent SAS ( Site 1509)
RECRUITING
Nantes
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1506)
RECRUITING
Paris
Hôpital Privé Des Côtes d'Armor ( Site 1510)
RECRUITING
Plérin
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1501)
RECRUITING
Strasbourg
Oncopole Claudius Regaud ( Site 1502)
RECRUITING
Toulouse
Gustave Roussy ( Site 1512)
RECRUITING
Villejuif
Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Gynäkologie und Gynäkologische Onko ( Site 1600)
RECRUITING
Essen
Universitaetsklinikum des Saarlandes ( Site 1618)
RECRUITING
Homburg
Greece
Aretaieio Hospital ( Site 1700)
RECRUITING
Athens
Mitera Hospital ( Site 1702)
RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1703)
RECRUITING
Chaïdári
Agios Andreas Hospital Patras ( Site 1701)
RECRUITING
Patras
Ireland
Cork University Hospital ( Site 1900)
RECRUITING
Cork
Mater Misericordiae University Hospital ( Site 1901)
RECRUITING
Dublin
St. James's Hospital-Cancer clinical trials office ( Site 1902)
RECRUITING
Dublin
Israel
Rambam Health Care Campus ( Site 2002)
RECRUITING
Haifa
Edith Wolfson Medical Center ( Site 2003)
RECRUITING
Holon
Hadassah Medical Center ( Site 2000)
RECRUITING
Jerusalem
Sheba Medical Center ( Site 2001)
RECRUITING
Ramat Gan
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC ( Site 2105)
RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2110)
RECRUITING
Brescia
Ospedale Cannizzaro ( Site 2104)
RECRUITING
Catania
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2107)
RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS ( Site 2108)
RECRUITING
Milan
Ospedale Humanitas San Pio X ( Site 2113)
RECRUITING
Milan
Ospedale San Raffaele. ( Site 2106)
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2111)
RECRUITING
Monza
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2103)
RECRUITING
Napoli
Istituto Oncologico Veneto IRCCS ( Site 2109)
RECRUITING
Padua
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)
RECRUITING
Roma
Humanitas University ( Site 2112)
RECRUITING
Rozzano
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 2100)
RECRUITING
Turin
Japan
National Cancer Center Hospital ( Site 5108)
RECRUITING
Chūō
National Hospital Organization Kyushu Cancer Center ( Site 5104)
RECRUITING
Fukuoka
Saitama Medical University International Medical Center ( Site 5117)
RECRUITING
Hidaka
Kagoshima City Hospital ( Site 5115)
RECRUITING
Kagoshima
National Cancer Center Hospital East ( Site 5113)
RECRUITING
Kashiwa
Cancer Institute Hospital of JFCR ( Site 5111)
RECRUITING
Koto
Kurume University Hospital ( Site 5105)
RECRUITING
Kurume
National Hospital Organization Shikoku Cancer Center ( Site 5109)
RECRUITING
Matsuyama
Aichi Cancer Center ( Site 5110)
RECRUITING
Nagoya
Niigata Cancer Center Hospital ( Site 5100)
RECRUITING
Niigata
Gunma Prefectural Cancer Center ( Site 5116)
RECRUITING
Ohta
Osaka International Cancer Institute ( Site 5103)
RECRUITING
Osaka
Hokkaido University Hospital ( Site 5106)
RECRUITING
Sapporo
Keio University Hospital ( Site 5101)
RECRUITING
Shinjyuku
Iwate Medical University Hospital ( Site 5112)
RECRUITING
Shiwa-gun
Shizuoka Cancer Center ( Site 5107)
RECRUITING
Sunto-gun,
Ehime University Hospital ( Site 5102)
RECRUITING
Tōon
University of Tsukuba Hospital ( Site 5114)
RECRUITING
Tsukuba
Malaysia
Pantai Hospital Kuala Lumpur ( Site 3100)
RECRUITING
Kuala Lumpur
University Malaya Medical Centre ( Site 3102)
RECRUITING
Lembah Pantai
Sunway Medical Centre ( Site 3105)
RECRUITING
Petaling Jaya
Penang Adventist Hospital ( Site 3101)
RECRUITING
Pulau Pinang
Netherlands
Amsterdam UMC, locatie VUmc ( Site 2201)
RECRUITING
Amsterdam
Catharina Ziekenhuis-Oncology ( Site 2203)
RECRUITING
Eindhoven
University Medical Center Groningen ( Site 2204)
RECRUITING
Groningen
Radboudumc-Medical Oncology ( Site 2202)
RECRUITING
Nijmegen
Erasmus Medisch Centrum-Medical Oncology ( Site 2200)
RECRUITING
Rotterdam
Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 2300)
RECRUITING
Oslo
Poland
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)
RECRUITING
Bialystok
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2404)
RECRUITING
Poznan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2400)
RECRUITING
Warsaw
Puerto Rico
UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)
RECRUITING
San Juan
Republic of Korea
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)
RECRUITING
Seoul
Samsung Medical Center ( Site 3400)
RECRUITING
Seoul
Seoul National University Hospital ( Site 3403)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 3402)
RECRUITING
Seoul
Singapore
National Cancer Centre Singapore ( Site 3300)
RECRUITING
Singapore
National University Hospital ( Site 3301)
RECRUITING
Singapore
Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2509)
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)
RECRUITING
Barcelona
Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)
RECRUITING
Córdoba
Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)
RECRUITING
Girona
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2508)
RECRUITING
L'hospitalet De Llobregat
Clinica Universidad de Navarra ( Site 2510)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2506)
RECRUITING
Madrid
Hospital Universitario La Paz-Oncología Médica ( Site 2504)
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)
RECRUITING
Madrid
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)
RECRUITING
Valencia
HOSPITAL CLINICO DE VALENCIA ( Site 2505)
RECRUITING
Valencia
Sweden
Universitetssjukhuset i Linköping ( Site 2600)
RECRUITING
Linköping
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2602)
RECRUITING
Lund
Karolinska Universitetssjukhuset Solna ( Site 2601)
RECRUITING
Stockholm
Akademiska sjukhuset ( Site 2603)
RECRUITING
Uppsala
Switzerland
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)
RECRUITING
Basel
Inselspital Bern-Oncology ( Site 2700)
RECRUITING
Bern
United Kingdom
Gartnavel General Hospital-Clinical Trials Unit ( Site 2800)
RECRUITING
Glasgow
St James's University Hospital ( Site 2804)
RECRUITING
Leeds
ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 2807)
RECRUITING
London
University College London Hospital ( Site 2805)
RECRUITING
London
The Christie NHS Foundation Trust-Research and Development ( Site 2802)
RECRUITING
Manchester
Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 2801)
RECRUITING
Sutton
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2028-10-23
Participants
Target number of participants: 686
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

This content was sourced from clinicaltrials.gov