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)
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)
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:
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.
The main inclusion criteria include but are not limited to the following:
The main exclusion criteria include but are not limited to the following:
Trialsites@msd.com1-888-577-8839
Fort Myers, Florida 33901, United States
239-274-9930
Miami Beach, Florida 33140, United States
Miami Beach, Florida 33140, United States
West Palm Beach, Florida 33401, United States
Atlanta, Georgia 30308, United States
Savannah, Georgia 31405, United States
New York, New York 10016, United States
Tulsa, Oklahoma 74146, United States
Eugene, Oregon 97401, United States
Knoxville, Tennessee 37920, United States
Charlottesville, Virginia 22908, United States
Charlottesville, Virginia 22908, United States
Berazategui, Buenos Aires B1884BBF, Argentina
Mar del Plata, Buenos Aires B7600FZO, Argentina
Rosario, Santa Fe Province S2000KZE, Argentina
Rosario, Santa Fe Province S2002KDS, Argentina
La Rioja, F5300COE, Argentina
Brussels, Bruxelles-Capitale, Region de 1200, Belgium
Natal, Rio Grande do Norte 59062-000, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Barretos, São Paulo 14784-400, Brazil
São José do Rio Preto, São Paulo 15091-000, Brazil
São Paulo, São Paulo 04014-002, Brazil
Montreal, Quebec H2X 0C1, Canada
Québec, Quebec G1J 1Z4, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Santiago, Region M. de Santiago 8330073, Chile
Barranquilla, Atlántico 080002, Colombia
Nový Jičín, Moravian-Silesian Region 741 01, Czechia
Prague, 128 08, Czechia
Brest, Brittany Region 29609, France
Chambray-lès-Tours, Centre-Val de Loire 37170, France
Bordeaux, Gironde 33076, France
Athens, Attica 115 28, Greece
Visakhapatnam, Andhra Pradesh 530017, India
Belagavi, Karnataka 590010, India
Meldola, Forli-Cesena 47014, Italy
Roma, 00168, Italy
Sapporo, Hokkaido 003-0804, Japan
Shiwa-gun, Iwate 028-3695, Japan
+81-19-613-7111
Hidaka, Saitama 350-1298, Japan
Sunto-gun,, Shizuoka 411-8777, Japan
+81-55-989-5222
Koto, Tokyo 135-8550, Japan
+81-3-3520-0111
Shinjyuku, Tokyo 160-8582, Japan
+81-3-3353-1211
Osaka, 541-8567, Japan
Guadalajara, Jalisco 44260, Mexico
Monterrey, Nuevo León 64460, Mexico
Warsaw, Masovian Voivodeship 02-781, Poland
Gliwice, Silesian Voivodeship 44-102, Poland
Siedlce, Warmian-Masurian Voivodeship 08-110, Poland
+48256403300
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Pretoria, Gauteng 0002, South Africa
Jongno-gu, Seoul 03080, South Korea
+82220727439
Seodaemun-Gu, Seoul 03722, South Korea
82-2-3410-3545
Valencia, Valenciana, Comunitat 46010, Spain
Stockholm, Stockholm County 171 64, Sweden
Taiwan, Taipei 10002, Taiwan
+886-2-23123456
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