RecruitingRecruiting
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
NCT07216703 · Merck Sharp & Dohme LLC
In plain English
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Official title
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
About this study
This is a 2-part study.
In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab.
In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.
Eligibility criteria
The main inclusion criteria include but are not limited to the following:
* Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
* Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \[FIGO\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
* If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
* Has an Eastern Cooperative Oncology Group performance status of 0 or 1
* Has tumor programmed cell death ligand 1 expression of combined positive score ≥1
The main exclusion criteria include but are not limited to the following:
* Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has a 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
* Has received prior systemic anticancer therapy other than what is specified in this protocol
* Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
* Has a diagnosis of immunodeficiency
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system metastases and/or carcinomatous meningitis
* Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
* Has a history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications
Study design
Enrollment target: 1023 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-01-19
Estimated completion: 2031-10-29
Last updated: 2026-06-01
Interventions
Biological: PembrolizumabBiological: Sacituzumab TirumotecanBiological: BevacizumabDrug: PaclitaxelDrug: CisplatinDrug: CarboplatinDrug: Rescue Medications
Primary outcomes
- • Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) (Up to approximately 69 months)
- • Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 66 months)
- • Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (Up to approximately 48 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (115)
Mount Sinai Comprehensive Cancer Center ( Site 6000)Recruiting
Miami Beach, Florida, United States
Florida Cancer Specialists - East ( Site 7000)Recruiting
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University ( Site 5005)Recruiting
Atlanta, Georgia, United States
TRIALS 365 ( Site 6008)Recruiting
Shreveport, Louisiana, United States
Minnesota Oncology Hematology, PA ( Site 8003)Recruiting
Edina, Minnesota, United States
Women's Cancer Center of Nevada ( Site 6011)Recruiting
Las Vegas, Nevada, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)Recruiting
New York, New York, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)Recruiting
Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)Recruiting
Eugene, Oregon, United States
University of Tennessee Medical Center ( Site 6012)Recruiting
Knoxville, Tennessee, United States
Texas Oncology - DFW ( Site 8005)Recruiting
Fort Worth, Texas, United States
Texas Oncology-The Woodlands ( Site 8000)Recruiting
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas ( Site 8002)Recruiting
Tyler, Texas, United States
University of Virginia Cancer Center ( Site 6014)Recruiting
Charlottesville, Virginia, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0107)Recruiting
Berazategui, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)Recruiting
Mar del Plata, Buenos Aires, Argentina
Fundación Respirar ( Site 0101)Recruiting
Belgrano, Buenos Aires F.D., Argentina
Instituto Misionero del Cancer ( Site 0112)Recruiting
Posadas, Misiones Province, Argentina
Instituto de Oncologia de Rosario ( Site 0104)Recruiting
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario ( Site 0106)Recruiting
Rosario, Santa Fe Province, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)Recruiting
La Rioja, Argentina
Medizinische Universitaet Wien ( Site 0302)Recruiting
Vienna, State of Vienna, Austria
Medizinische Universitat Graz ( Site 0303)Recruiting
Graz, Styria, Austria
Medizinische Universitaet Innsbruck ( Site 0301)Recruiting
Innsbruck, Tyrol, Austria
Antwerp University Hospital ( Site 0407)Recruiting
Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc ( Site 0402)Recruiting
Brussels, Bruxelles-Capitale, Region de, Belgium
Grand Hopital de Charleroi ( Site 0404)Recruiting
Charleroi, Hainaut, Belgium
UZ Gent ( Site 0406)Recruiting
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0401)Recruiting
Leuven, Vlaams-Brabant, Belgium
Liga Norte Riograndense Contra o Câncer ( Site 0513)Recruiting
Natal, Rio Grande do Norte, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0514)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS ( Site 0516)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)Recruiting
Barretos, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)Recruiting
São José do Rio Preto, São Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)Recruiting
São Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 0515)Recruiting
Rio de Janeiro, Brazil
Princess Margaret Cancer Centre ( Site 0601)Recruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0616)Recruiting
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0602)Recruiting
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)Recruiting
Québec, Quebec, Canada
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)Recruiting
Sherbrooke, Quebec, Canada
CIDO SpA-Oncology ( Site 0708)Recruiting
Temuco, Araucania, Chile
IC La Serena Research ( Site 0710)Recruiting
La Serena, Coquimbo Region, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0706)Recruiting
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0703)Recruiting
Viña del Mar, Valparaiso, Chile
Clinica Somer ( Site 0903)Recruiting
Rionegro, Antioquia, Colombia
Centro Cancerológico del Caribe (CECAC) ( Site 0906)Recruiting
Barranquilla, Atlántico, Colombia
Instituto Nacional De Cancerologia ( Site 0909)Recruiting
Bogotá, Bogota D.C., Colombia
Oncomédica S.A.S ( Site 0905)Recruiting
Montería, Departamento de Córdoba, Colombia
Oncólogos del Occidente S.A.S. ( Site 0908)Recruiting
Pereira, Risaralda Department, Colombia
Fakultní Nemocnice Brno ( Site 1003)Recruiting
Brno, Brno-mesto, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 1004)Recruiting
Nový Jičín, Moravian-Silesian Region, Czechia
Fakultni nemocnice Ostrava ( Site 1005)Recruiting
Ostrava, Moravian-Silesian Region, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 1002)Recruiting
Prague, Praha 10, Czechia
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)Recruiting
Prague, Czechia
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)Recruiting
Athens, Attica, Greece
Aretaieio Hospital Oncology Unit ( Site 1402)Recruiting
Athens, Attica, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)Recruiting
Chaïdári, Attica, Greece
Országos Onkológiai Intézet ( Site 1603)Recruiting
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1601)Recruiting
Debrecen, Hungary
Hillel Yaffe Medical Center ( Site 1903)Recruiting
Hadera, Israel
Rambam Health Care Campus ( Site 1907)Recruiting
Haifa, Israel
Carmel Hospital ( Site 1901)Recruiting
Haifa, Israel
Shaare Zedek Medical Center ( Site 1905)Recruiting
Jerusalem, Israel
Rabin Medical Center ( Site 1904)Recruiting
Petah Tikva, Israel
Sourasky Medical Center ( Site 1902)Recruiting
Tel Aviv, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009)Recruiting
Meldola, Forli-Cesena, Italy
CRO-IRCCS ( Site 2014)Recruiting
Aviano, Friuli Venezia Giulia, Italy
Ospedale Humanitas San Pio X ( Site 2013)Recruiting
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)Recruiting
Milan, Milano, Italy
Ospedale Cannizzaro ( Site 2010)Recruiting
Catania, Italy
Istituto Europeo di Oncologia ( Site 2003)Recruiting
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)Recruiting
Roma, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)Recruiting
Torino, Italy
National Hospital Organization Hokkaido Cancer Center ( Site 2108)Recruiting
Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 2118)Recruiting
Akashi, Hyōgo, Japan
Iwate Medical University Hospital ( Site 2116)Recruiting
Shiwa-gun, Iwate, Japan
Kanagawa Cancer Center ( Site 2121)Recruiting
Yokohama, Kanagawa, Japan
University of the Ryukyus Hospital ( Site 2117)Recruiting
Ginowan, Okinawa, Japan
Saitama Medical University International Medical Center ( Site 2106)Recruiting
Hidaka, Saitama, Japan
Cancer Institute Hospital of JFCR ( Site 2119)Recruiting
Koto, Tokyo, Japan
The Jikei University Hospital ( Site 2107)Recruiting
Minato, Tokyo, Japan
Niigata Cancer Center Hospital ( Site 2110)Recruiting
Niigata, Japan
Okayama University Hospital ( Site 2101)Recruiting
Okayama, Japan
CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 2204)Recruiting
Guadalajara, Jalisco, Mexico
Grupo Médico ASSET ( Site 2203)Recruiting
Mexico City, Mexico City, Mexico
Higiea Oncologia ( Site 2205)Recruiting
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2202)Recruiting
Monterrey, Nuevo León, Mexico
Scientia Investigacion Clinica S.C. ( Site 2201)Recruiting
Chihuahua City, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 2207)Recruiting
Oaxaca City, Mexico
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)Recruiting
Gliwice, Silesian Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)Recruiting
Siedlce, Warmian-Masurian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii. ( Site 2602)Recruiting
Kielce, Świętokrzyskie Voivodeship, Poland
National Cancer Center ( Site 2905)Recruiting
Goyang-si, Kyonggi-do, South Korea
Seoul National University Hospital ( Site 2901)Recruiting
Jongno-gu, Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 2902)Recruiting
Seodaemun-Gu, Seoul, South Korea
Asan Medical Center ( Site 2904)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 2903)Recruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Girona ( Site 3002)Recruiting
Girona, Gerona, Spain
Hosp Clinico Universitario de Valencia ( Site 3001)Recruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d Hebron ( Site 3003)Recruiting
Barcelona, Spain
Hospital Universitario Reina Sofia ( Site 3006)Recruiting
Córdoba, Spain
Hospital Ramon y Cajal ( Site 3005)Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 3007)Recruiting
Madrid, Spain
Hospital Universitario La Paz ( Site 3004)Recruiting
Madrid, Spain
Skanes Universitetssjukhus Lund ( Site 3103)Recruiting
Lund, Skåne County, Sweden
Karolinska Universitetssjukhuset-Solna ( Site 3102)Recruiting
Stockholm, Stockholm County, Sweden
Linköping University Hospital ( Site 3101)Recruiting
Linköping, Östergötland County, Sweden
National Taiwan University Hospital ( Site 3301)Recruiting
Taiwan, Taipei, Taiwan
Taichung Veterans General Hospital ( Site 3304)Recruiting
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 3308)Recruiting
Tainan, Taiwan
Mackay Memorial Hospital ( Site 3303)Recruiting
Taipei, Taiwan
Chang Gung Memorial Hospital ( Site 3302)Recruiting
Taoyuan, Taiwan
Chulalongkorn University ( Site 3403)Recruiting
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 3401)Recruiting
Bangkok, Bangkok, Thailand