A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)
Status: Recruiting
Location: See all (198) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
• Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
• Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment
Locations
United States
Alaska
Alaska Women's Cancer Care ( Site 6036)
RECRUITING
Anchorage
Alabama
University of South Alabama, Mitchell Cancer Institute ( Site 6033)
RECRUITING
Mobile
California
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)
RECRUITING
Orange
Washington, D.c.
MedStar Washington Hospital Center ( Site 5005)
RECRUITING
Washington D.c.
Florida
Florida Cancer Specialists - South ( Site 7003)
RECRUITING
Fort Myers
UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)
RECRUITING
Gainesville
Mount Sinai Cancer Center ( Site 6031)
RECRUITING
Miami Beach
Florida Cancer Specialists - North ( Site 7002)
RECRUITING
St. Petersburg
Florida Cancer Specialists East ( Site 7001)
RECRUITING
West Palm Beach
Georgia
St. Joseph's/Candler Health System ( Site 6021)
RECRUITING
Savannah
Indiana
Parkview Research Center ( Site 6008)
RECRUITING
Fort Wayne
Louisiana
Women's Cancer Care ( Site 6010)
RECRUITING
Covington
TRIALS 365 ( Site 6005)
RECRUITING
Shreveport
Maine
Maine Medical Center - Scarborough Campus ( Site 6042)
RECRUITING
Scarborough
Minnesota
Minnesota Oncology Hematology, PA ( Site 8003)
RECRUITING
Minneapolis
Mississippi
St. Dominic's Hospital ( Site 5004)
RECRUITING
Jackson
North Carolina
Duke Cancer Institute ( Site 6049)
RECRUITING
Durham
FirstHealth of the Carolinas ( Site 6037)
RECRUITING
Pinehurst
New Jersey
Holy Name Medical Center ( Site 6011)
RECRUITING
Teaneck
New Mexico
University of New Mexico Comprehensive Cancer Center ( Site 6046)
RECRUITING
Albuquerque
New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)
RECRUITING
New York
Ohio
Miami Valley Hospital South ( Site 6014)
RECRUITING
Centerville
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)
RECRUITING
Tulsa
Pennsylvania
St. Luke's University Health Network ( Site 6041)
RECRUITING
Bethlehem
Hospital of the University of Pennsylvania ( Site 5007)
RECRUITING
Philadelphia
Hospital of the University of Pennsylvania ( Site 6023)
RECRUITING
Philadelphia
AHN West Penn Hospital ( Site 6006)
RECRUITING
Pittsburgh
Rhode Island
Women & Infants Hospital ( Site 5003)
RECRUITING
Providence
Texas
Texas Oncology - DFW ( Site 8004)
RECRUITING
Fort Worth
Texas Oncology-San Antonio Medical Center ( Site 8001)
RECRUITING
San Antonio
Texas Oncology - Northeast Texas ( Site 8002)
RECRUITING
Tyler
Virginia
Inova Schar Cancer Institute ( Site 6003)
RECRUITING
Fairfax
VCU Health Adult Outpatient Pavillion ( Site 5000)
RECRUITING
Richmond
Other Locations
Argentina
Fundación Respirar ( Site 0101)
RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires ( Site 0103)
RECRUITING
Caba
Instituto Alexander Fleming ( Site 0105)
RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0108)
RECRUITING
Mar Del Plata
Instituto San Marcos ( Site 0106)
RECRUITING
San Juan
Australia
Blacktown Hospital ( Site 0201)
RECRUITING
Blacktown
Royal Brisbane and Women's Hospital ( Site 0206)
RECRUITING
Brisbane
Epworth Freemasons ( Site 0207)
RECRUITING
Melbourne
Austria
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 0303)
RECRUITING
Graz
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0301)
RECRUITING
Innsbruck
Medizinische Universität Wien - Allg. Gynaekologie & Gyn. Onkologie ( Site 0302)
RECRUITING
Vienna
Belgium
CHU Saint-Pierre ( Site 0405)
RECRUITING
Brussels
Grand Hôpital de Charleroi ( Site 0403)
RECRUITING
Charleroi
AZ Maria Middelares ( Site 0402)
RECRUITING
Ghent
UZ Leuven ( Site 0401)
RECRUITING
Leuven
CHU de Liege ( Site 0404)
RECRUITING
Liège
Brazil
Hospital Araújo Jorge ( Site 0521)
RECRUITING
Goiânia
Hospital São Lucas da PUCRS ( Site 0522)
RECRUITING
Porto Alegre
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0525)
RECRUITING
São Paulo
Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0605)
RECRUITING
Montreal
Jewish General Hospital ( Site 0606)
RECRUITING
Montreal
McGill University Health Centre ( Site 0604)
RECRUITING
Montreal
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0608)
RECRUITING
Sherbrooke
Princess Margaret Cancer Center ( Site 0609)
RECRUITING
Toronto
Sunnybrook Research Institute ( Site 0610)
RECRUITING
Toronto
Chile
Bradfordhill ( Site 0703)
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA ( Site 0708)
RECRUITING
Santiago
FALP ( Site 0702)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 0705)
RECRUITING
Santiago
ONCOCENTRO APYS ( Site 0704)
RECRUITING
Viña Del Mar
China
Peking University Peoples Hospital ( Site 0845)
RECRUITING
Beijing
The First Hospital Of Jilin University ( Site 0815)
RECRUITING
Changchun
Xiangya Hospital Central South University ( Site 0821)
RECRUITING
Changsha
Chongqing University Cancer Hospital ( Site 0838)
RECRUITING
Chongqing
Fujian Province Cancer Hospital ( Site 0802)
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center ( Site 0846)
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University ( Site 0829)
RECRUITING
Guangzhou
The Affiliated Women's Hospital of Zhejiang University ( Site 0834)
RECRUITING
Hangzhou
Shandong Cancer Hospital ( Site 0803)
RECRUITING
Jinan
Yunnan Province Cancer Hospital ( Site 0811)
RECRUITING
Kunming
Taizhou Hospital of Zhejiang Province ( Site 0809)
RECRUITING
Linhai
Liuzhou People's Hospital ( Site 0831)
RECRUITING
Liuchow
Jiangxi Maternal and Child Health Hospital ( Site 0807)
RECRUITING
Nanchang
Nanjing First Hospital ( Site 0828)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital. ( Site 0825)
RECRUITING
Nanning
Obstetrics & Gynecology Hospital of Fudan University ( Site 0818)
RECRUITING
Shanghai
Shanghai Tenth People's Hospital ( Site 0847)
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College ( Site 0827)
RECRUITING
Shantou
Shanxi Provincial Cancer Hospital ( Site 0843)
RECRUITING
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University ( Site 0805)
RECRUITING
Wenzhou
Wuhan Union Hospital Cancer Center ( Site 0824)
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0816)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University ( Site 0822)
RECRUITING
Xiamen
The Second People's Hospital of Yibin ( Site 0840)
RECRUITING
Yibin
Affiliated Hospital of Guangdong Medical University ( Site 0823)
RECRUITING
Zhanjiang
Henan Cancer Hospital ( Site 0806)
RECRUITING
Zhengzhou
The Second Affiliated Hospital of Zhengzhou University ( Site 0833)
RECRUITING
Zhengzhou
Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0902)
RECRUITING
Bogotá
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0905)
RECRUITING
Medellín
Instituto de Cancerología S.A.S ( Site 0904)
RECRUITING
Medellín
Oncologos Del Occidente ( Site 0907)
RECRUITING
Pereira
Denmark
Aalborg Universitetshospital, Syd ( Site 1203)
RECRUITING
Aalborg
Aarhus Universitetshospital, Skejby ( Site 1205)
RECRUITING
Aarhus
Roskilde Sygehus ( Site 1204)
RECRUITING
Roskilde
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1301)
RECRUITING
Helsinki
Kuopion Yliopistollinen Sairaala ( Site 1304)
RECRUITING
Kuopio
Tampereen yliopistollinen sairaala ( Site 1303)
RECRUITING
Tampere
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1302)
RECRUITING
Turku
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1405)
RECRUITING
Bordeaux
Centre Francois Baclesse ( Site 1412)
RECRUITING
Caen
CENTRE LEON BERARD ( Site 1401)
RECRUITING
Lyon
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1409)
RECRUITING
Paris
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1411)
RECRUITING
Paris
Hôpital Privé Des Côtes d'Armor ( Site 1404)
RECRUITING
Plérin
Institut Curie - site Saint-Cloud ( Site 1408)
RECRUITING
Saint-cloud
Oncopole Claudius Regaud ( Site 1407)
RECRUITING
Toulouse
Germany
Universitaetsklinikum Jena ( Site 1503)
RECRUITING
Jena
CaritasKlinikum Saarbrücken St. Theresia ( Site 1508)
RECRUITING
Saarbrücken
Greece
Alexandra General Hospital of Athens ( Site 1604)
RECRUITING
Athens
Aretaieio Hospital ( Site 1602)
RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1603)
RECRUITING
Chaïdári
Agios Loukas Clinic-DEPARTMENT OF ONCOLOGY ( Site 1601)
RECRUITING
Thessaloniki
Hungary
Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 1701)
RECRUITING
Debrecen
Ireland
Mater Misericordiae University Hospital ( Site 1904)
RECRUITING
Dublin
Israel
Carmel Hospital ( Site 2023)
RECRUITING
Haifa
Rambam Health Care Campus ( Site 2025)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 2020)
RECRUITING
Jerusalem
Meir Medical Center. ( Site 2021)
RECRUITING
Kfar Saba
Sourasky Medical Center ( Site 2022)
RECRUITING
Tel Aviv
Italy
Ospedale Cannizzaro ( Site 2103)
RECRUITING
Catania
Azienda Ospedaliera Universitaria Careggi ( Site 2109)
RECRUITING
Florence
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 2107)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2114)
RECRUITING
Milan
Istituto Europeo di Oncologia ( Site 2110)
RECRUITING
Milan
Ospedale Humanitas San Pio X ( Site 2106)
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2104)
RECRUITING
Napoli
Fondazione Policlinico Universitario Agostino Gemelli ( Site 2105)
RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena ( Site 2102)
RECRUITING
Roma
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 2111)
RECRUITING
Torino
Ospedale Santa Maria di Ca' Foncello ( Site 2112)
RECRUITING
Treviso
Japan
Hyogo Cancer Center ( Site 2216)
RECRUITING
Akashi
National Cancer Center Hospital ( Site 2211)
RECRUITING
Chūō
National Hospital Organization Kyushu Cancer Center ( Site 2203)
RECRUITING
Fukuoka
Saitama Medical University International Medical Center ( Site 2201)
RECRUITING
Hidaka
Cancer Institute Hospital of JFCR ( Site 2208)
RECRUITING
Koto
Kurume University Hospital ( Site 2204)
RECRUITING
Kurume
National Hospital Organization Shikoku Cancer Center ( Site 2206)
RECRUITING
Matsuyama
Niigata Cancer Center Hospital ( Site 2210)
RECRUITING
Niigata
Okayama University Hospital ( Site 2215)
RECRUITING
Okayama
Gunma Prefectural Cancer Center ( Site 2202)
RECRUITING
Ōta
National Hospital Organization Hokkaido Cancer Center ( Site 2212)
RECRUITING
Sapporo
Keio University Hospital ( Site 2209)
RECRUITING
Shinjuku
Iwate Medical University Hospital ( Site 2207)
RECRUITING
Shiwa-gun
Ehime University Hospital ( Site 2213)
RECRUITING
Tōon
Netherlands
Maastricht UMC+ ( Site 2501)
RECRUITING
Maastricht
Norway
Stavanger Universitetssykehus ( Site 2703)
RECRUITING
Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 2701)
RECRUITING
Oslo
Universitetssykehuset Nord-Norge HF ( Site 2702)
RECRUITING
Tromsø
Peru
Clínica San Felipe ( Site 2804)
RECRUITING
Jesus Maria
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2805)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2803)
RECRUITING
San Isidro
Poland
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi ( Site 3001)
RECRUITING
Gdansk
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 3006)
RECRUITING
Gliwice
Swietokrzyskie Centrum Onkologii. ( Site 3008)
RECRUITING
Kielce
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3011)
RECRUITING
Poznan
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 3003)
RECRUITING
Poznan
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3004)
RECRUITING
Siedlce
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3002)
RECRUITING
Warsaw
Puerto Rico
Puerto Rico Cancer Specialists Clinical Trials ( Site 4201)
RECRUITING
San Juan
Republic of Korea
Keimyung University Dongsan Hospital ( Site 3105)
RECRUITING
Daegu
National Cancer Center ( Site 3106)
RECRUITING
Gyeonggi-do
Asan Medical Center ( Site 3103)
RECRUITING
Seoul
Samsung Medical Center ( Site 3104)
RECRUITING
Seoul
Seoul National University Hospital ( Site 3102)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 3101)
RECRUITING
Seoul
Singapore
National Cancer Centre Singapore ( Site 3201)
RECRUITING
Singapore
National University Hospital ( Site 3202)
RECRUITING
Singapore
Spain
Hospital Universitari Vall d''Hebron ( Site 3401)
RECRUITING
Barcelona
Hospital Universitario Reina Sofia ( Site 3402)
RECRUITING
Córdoba
Institut Català d'Oncologia (ICO) - Girona ( Site 3407)
RECRUITING
Girona
Institut Català d'Oncologia - L'Hospitalet ( Site 3408)
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario 12 de Octubre ( Site 3404)
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal ( Site 3403)
RECRUITING
Madrid
Fundación Instituto Valenciano de Oncología ( Site 3405)
RECRUITING
Valencia
Sweden
Skånes Universitetssjukhus Lund ( Site 3502)
RECRUITING
Lund
Akademiska Sjukhuset ( Site 3501)
RECRUITING
Uppsala
Taiwan
Taichung Veterans General Hospital ( Site 3703)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 3702)
RECRUITING
Tainan
Mackay Memorial Hospital ( Site 3704)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 3701)
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital ( Site 3705)
RECRUITING
Taoyuan District
Thailand
Faculty of Medicine Siriraj Hospital ( Site 3801)
RECRUITING
Bangkok
Ramathibodi Hospital. ( Site 3802)
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital ( Site 3804)
RECRUITING
Chiang Mai
Faculty of Medicine - Khon Kaen University ( Site 3803)
RECRUITING
Khon Kaen
United Kingdom
Addenbrookes Hospital ( Site 4002)
RECRUITING
Cambridge
University Hospitals Sussex NHS Foundation Trust ( Site 4011)
RECRUITING
East Sussex
Western General Hospital ( Site 4012)
RECRUITING
Edinburgh
Hammersmith Hospital ( Site 4010)
RECRUITING
London
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 4006)
RECRUITING
London
Royal Marsden Hospital (Sutton) ( Site 4005)
RECRUITING
London
University College London Hospital ( Site 4001)
RECRUITING
London
Maidstone Hospital ( Site 4007)
RECRUITING
Maidstone
The Christie NHS Foundation Trust ( Site 4003)
RECRUITING
Manchester
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2032-05-24
Participants
Target number of participants: 1123
Treatments
Experimental: Maintenance Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin area under the curve (AUC) 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).~During the Maintenance Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Active_comparator: Maintenance Treatment Arm B: Pembrolizumab Monotherapy
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).~During the Maintenance Treatment Phase, participants receive pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Experimental: Subsequent Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).~During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Active_comparator: Subsequent Treatment Arm B: Sacituzumab Tirumotecan Monotherapy
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).~During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC