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)
Status: Recruiting
Location: See all (77) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Mount Sinai Comprehensive Cancer Center ( Site 6000)
RECRUITING
Miami Beach
Louisiana
TRIALS 365 ( Site 6008)
RECRUITING
Shreveport
Nevada
Women's Cancer Center of Nevada ( Site 6011)
RECRUITING
Las Vegas
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
RECRUITING
New York
Oregon
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
RECRUITING
Eugene
Tennessee
University of Tennessee Medical Center ( Site 6012)
RECRUITING
Knoxville
Texas
Texas Oncology - DFW ( Site 8005)
RECRUITING
Fort Worth
Texas Oncology - Northeast Texas ( Site 8002)
RECRUITING
Tyler
Other Locations
Argentina
Fundación Respirar ( Site 0101)
RECRUITING
Belgrano
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)
RECRUITING
La Rioja
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
RECRUITING
Mar Del Plata
Hospital Provincial del Centenario ( Site 0106)
RECRUITING
Rosario
Instituto de Oncologia de Rosario ( Site 0104)
RECRUITING
Rosario
Belgium
Cliniques Universitaires Saint-Luc ( Site 0402)
RECRUITING
Brussels
Grand Hopital de Charleroi ( Site 0404)
RECRUITING
Charleroi
Antwerp University Hospital ( Site 0407)
RECRUITING
Edegem
UZ Gent ( Site 0406)
RECRUITING
Ghent
UZ Leuven ( Site 0401)
RECRUITING
Leuven
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)
RECRUITING
Barretos
Hospital São Lucas da PUCRS ( Site 0516)
RECRUITING
Porto Alegre
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)
RECRUITING
São José Do Rio Preto
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)
RECRUITING
São Paulo
Canada
Centre Hospitalier de l'Université de Montréal ( Site 0616)
RECRUITING
Montreal
McGill University Health Centre ( Site 0602)
RECRUITING
Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)
RECRUITING
Québec
Princess Margaret Cancer Centre ( Site 0601)
RECRUITING
Toronto
Colombia
Centro Cancerológico del Caribe (CECAC) ( Site 0906)
RECRUITING
Barranquilla
Instituto Nacional De Cancerologia ( Site 0909)
RECRUITING
Bogotá
Oncomédica S.A.S ( Site 0905)
RECRUITING
Montería
Oncólogos del Occidente S.A.S. ( Site 0908)
RECRUITING
Pereira
Clinica Somer ( Site 0903)
RECRUITING
Rionegro
Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)
RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)
RECRUITING
Chaïdári
Hungary
Országos Onkológiai Intézet ( Site 1603)
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont ( Site 1601)
RECRUITING
Debrecen
Israel
Hillel Yaffe Medical Center ( Site 1903)
RECRUITING
Hadera
Carmel Hospital ( Site 1901)
RECRUITING
Haifa
Rambam Health Care Campus ( Site 1907)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 1905)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1904)
RECRUITING
Petah Tikva
Sourasky Medical Center ( Site 1902)
RECRUITING
Tel Aviv
Italy
Ospedale Cannizzaro ( Site 2010)
RECRUITING
Catania
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 2009)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)
RECRUITING
Milan
Istituto Europeo di Oncologia ( Site 2003)
RECRUITING
Milan
Ospedale Humanitas San Pio X ( Site 2013)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)
RECRUITING
Roma
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)
RECRUITING
Torino
Japan
Hyogo Cancer Center ( Site 2118)
RECRUITING
Akashi
University of the Ryukyus Hospital ( Site 2117)
RECRUITING
Ginowan
Saitama Medical University International Medical Center ( Site 2106)
RECRUITING
Hidaka
Cancer Institute Hospital of JFCR ( Site 2119)
RECRUITING
Koto
Niigata Cancer Center Hospital ( Site 2110)
RECRUITING
Niigata
National Hospital Organization Hokkaido Cancer Center ( Site 2108)
RECRUITING
Sapporo
Iwate Medical University Hospital ( Site 2116)
RECRUITING
Shiwa-gun
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)
RECRUITING
Gliwice
Swietokrzyskie Centrum Onkologii. ( Site 2602)
RECRUITING
Kielce
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)
RECRUITING
Siedlce
Republic of Korea
National Cancer Center ( Site 2905)
RECRUITING
Goyang-si
Seoul National University Hospital ( Site 2901)
RECRUITING
Jongno-gu
Severance Hospital Yonsei University Health System ( Site 2902)
RECRUITING
Seodaemun-gu
Asan Medical Center ( Site 2904)
RECRUITING
Seoul
Samsung Medical Center ( Site 2903)
RECRUITING
Seoul
Spain
Hospital Universitari Vall d Hebron ( Site 3003)
RECRUITING
Barcelona
Hospital Universitario Reina Sofia ( Site 3006)
RECRUITING
Córdoba
Institut Català d'Oncologia (ICO) - Girona ( Site 3002)
RECRUITING
Girona
Hospital Ramon y Cajal ( Site 3005)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 3007)
RECRUITING
Madrid
Hospital Universitario La Paz ( Site 3004)
RECRUITING
Madrid
Sweden
Linköping University Hospital ( Site 3101)
RECRUITING
Linköping
Skanes Universitetssjukhus Lund ( Site 3103)
RECRUITING
Lund
Karolinska Universitetssjukhuset-Solna ( Site 3102)
RECRUITING
Stockholm
Taiwan
Taichung Veterans General Hospital ( Site 3304)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 3308)
RECRUITING
Tainan
Mackay Memorial Hospital ( Site 3303)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 3301)
RECRUITING
Taiwan
Chang Gung Memorial Hospital ( Site 3302)
RECRUITING
Taoyuan District
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-01-19
Estimated Completion Date: 2031-10-29
Participants
Target number of participants: 1023
Treatments
Experimental: Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab
Participants will receive sac-TMT 4 mg/kg every 2 weeks (q2w) and pembrolizumab 400 mg every 6 weeks (q6w) for up to 14 cycles (up to approximately 20 months). Bevacizumab 15 mg/kg every 3 weeks (q3w) will be administered until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
Experimental: Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab
During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m\^2 q3w, and cisplatin 50 mg/m\^2 q3w (or carboplatin area under the curve \[AUC\]5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months).~During maintenance treatment, participants will receive sac-TMT 4 mg/kg q2w and pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
Active_comparator: Part 2: Pembrolizumab +/- Bevacizumab
During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m\^2 q3w, and cisplatin 50 mg/m\^2 q3w (or carboplatin AUC5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months).~During maintenance treatment, participants will receive pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation