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)
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.
Inclusion Criteria:
Exclusion Criteria:
La Jolla, California 92093, United States
Los Angeles, California 90095, United States
Miami Beach, Florida 33140, United States
Mineola, New York 11501, United States
New York, New York 10016, United States
Tulsa, Oklahoma 74146, United States
Eugene, Oregon 97401, United States
Portland, Oregon 97210, United States
Philadelphia, Pennsylvania 19107, United States
Seattle, Washington 98104, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires C1280AEB, Argentina
Mar del Plata, Buenos Aires B7600FZO, Argentina
CABA, C1431FWO, Argentina
La Rioja, F5300COE, Argentina
Sydney, New South Wales 2560, Australia
Melbourne, Victoria 3000, Australia
Graz, Styria 8036, Austria
Innsbruck, Tyrol 6020, Austria
Linz, Upper Austria 4020, Austria
Belgium, Wallonne, Region 4000, Belgium
Porto Alegre, Rio Grande do Sul 90035-001, Brazil
São Paulo, São Paulo 04014-002, Brazil
Panagyurishte, Pazardzhik 4500, Bulgaria
Québec, Quebec G1J 1Z4, Canada
Beijing, Beijing Municipality 100730, China
Xiamen, Fujian 361003, China
Guangzhou, Guangdong 510000, China
Guangzhou, Guangdong 511400, China
Xinxiang, Henan 453100, China
Shanghai, Shanghai Municipality 200011, China
Chengdu, Sichuan 610000, China
Hangzhou, Zhejiang 310006, China
Wenzhou, Zhejiang 325015, China
Bogotá, Bogota D.C. 110131, Colombia
Valledupar, Cesar Department 200001, Colombia
Bogota, Cundinamarca 111151, Colombia
Odense C, Region Syddanmark 5000, Denmark
Tampere, Pirkanmaa 33520, Finland
Turku, Southwest Finland 20520, Finland
Helsinki, Uusimaa 00029, Finland
Bordeaux, Aquitaine 33076, France
Lyon Cedex08, Auvergne-Rhône-Alpes 69373, France
Clermont-Ferrand, Auvergne 63011, France
Heidelberg, Baden-Wurttemberg 69120, Germany
Schwäbisch Hall, Baden-Wurttemberg 74523, Germany
Munich, Bavaria 81377, Germany
Düsseldorf, North Rhine-Westphalia 40225, Germany
Essen, North Rhine-Westphalia 45136, Germany
Hamburg, 20246, Germany
Patras, Peloponnese 263 35, Greece
Bologna, Emilia-Romagna 40138, Italy
Milan, Lombardy 20133, Italy
Brescia, 25123, Italy
Roma, 00168, Italy
Ohta, Gunma 373-8550, Japan
Shiwa-gun, Iwate 028-3695, Japan
Sunto-gun,, Shizuoka 411-8777, Japan
Koto, Tokyo 135-8550, Japan
Shinjyuku, Tokyo 160-8582, Japan
Osaka, 541-8567, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
San Luis Potosí City, 78200, Mexico
Poznan, Greater Poland Voivodeship 60-569, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Bialystok, Podlaskie Voivodeship 15-027, Poland
San Juan, 00935, Puerto Rico
Seoul, 05505, South Korea
Barcelona, Catalonia 08036, Spain
L'Hospitalet de Llobregat, Catalonia 08908, Spain
Madrid, Madrid, Comunidad de 28034, Spain
Madrid, Madrid, Comunidad de 28041, Spain
Valencia, Valenciana, Comunitat 46009, Spain
Barcelona, 08035, Spain
Lund, Skåne County 221 85, Sweden
Basel, Canton of Basel-City 4031, Switzerland
London, England SW10 9NH, United Kingdom
Sutton, England SM2 5PT, United Kingdom
Glasgow, Glasgow City G12 0YN, United Kingdom