Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
Launched by MERCK SHARP & DOHME LLC · Nov 10, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called MK-2870, also known as sacituzumab tirumotecan, for women with endometrial cancer who have already received certain types of treatments. These women have often undergone platinum-based chemotherapy and immunotherapy, which helps the body's immune system fight cancer. The trial aims to find out if MK-2870 can help patients live longer and keep their cancer from worsening compared to standard chemotherapy.
To be eligible for this study, participants must have a confirmed diagnosis of endometrial cancer or a related type called carcinosarcoma and have evaluable disease. They should have previously been treated with platinum chemotherapy and immunotherapy. If you join the trial, you will receive either the new treatment or standard chemotherapy, and the researchers will monitor your health over time to see how well the treatments work. It's important to note that there are certain conditions that might exclude someone from participating, such as specific types of tumors or previous treatments that could interfere with the study.
Gender
FEMALE
Eligibility criteria
- The main inclusion and exclusion criteria include but are not limited to the following:
- Inclusion Criteria:
- • Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- • Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
- • Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
- Exclusion Criteria:
- • Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
- • 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
- • Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \>12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
- • Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
- • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- • Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
- • Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
- • Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
- • Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
- • Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
Warszawa, Mazowieckie, Poland
Montréal, Quebec, Canada
East Melbourne, Victoria, Australia
Frankston, Victoria, Australia
Haifa, , Israel
Petah Tikva, , Israel
Holon, , Israel
Jerusalem, , Israel
Tel Aviv, , Israel
St Leonards, New South Wales, Australia
Ramat Gan, , Israel
Tel Aviv, , Israel
Seoul, , Korea, Republic Of
Miami Beach, Florida, United States
Madrid, Madrid, Comunidad De, Spain
Washington, District Of Columbia, United States
Shreveport, Louisiana, United States
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Seongnam, Kyonggi Do, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Hospitalet, Barcelona, Spain
Temuco, Araucania, Chile
Rennes, Ille Et Vilaine, France
Seoul, , Korea, Republic Of
Bialystok, Podlaskie, Poland
Ponce, , Puerto Rico
Fort Wayne, Indiana, United States
Mineola, New York, United States
New York, New York, United States
Montréal, Quebec, Canada
Chambray Les Tours, Centre, France
Plérin, Cotes D Armor, France
Athens, Attiki, Greece
Leiden, Zuid Holland, Netherlands
Stavanger, Rogaland, Norway
Kristiansand, Vest Agder, Norway
Oslo, , Norway
Siedlce, Mazowieckie, Poland
Singapore, Central Singapore, Singapore
Madrid, Madrid, Comunidad De, Spain
Barcelona, , Spain
Chur, Grisons, Switzerland
Mobile, Alabama, United States
Columbus, Georgia, United States
Reno, Nevada, United States
Germantown, Tennessee, United States
Houston, Texas, United States
Buenos Aires, Caba, Argentina
La Rioja, , Argentina
Blacktown, New South Wales, Australia
Innsbruck, Tirol, Austria
Gent, Oost Vlaanderen, Belgium
Namur, , Belgium
Ostrava, Moravskoslezsky Kraj, Czechia
Olomouc, Olomoucky Kraj, Czechia
Praha, Praha 8, Czechia
Aarhus, Midtjylland, Denmark
Tampere, Pirkanmaa, Finland
Kuopio, Pohjois Savo, Finland
Helsinki, Uusimaa, Finland
Besançon, Doubs, France
Lille, Nord Pas De Calais, France
Lyon Cedex08, Rhone Alpes, France
Petah Tikva, , Israel
Kuala Lumpur, , Malaysia
Tromsø, Troms, Norway
Oslo, , Norway
Poznan, Wielkopolskie, Poland
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Stockholm, Stockholms Lan, Sweden
Bellinzona, Ticino, Switzerland
Durham, North Carolina, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Caba, Argentina
Ciudad Autónoma De Buenos Aires, Caba, Argentina
Brisbane, Queensland, Australia
Copenhagen, Hovedstaden, Denmark
Turku, Varsinais Suomi, Finland
Roma, Lazio, Italy
Rozzano, Milano, Italy
Brescia, , Italy
Napoli, , Italy
Torino, , Italy
Cordoba, Andalucia, Spain
Madrid, Madrid, Comunidad De, Spain
Berne, , Switzerland
Truro, England, United Kingdom
London, London, City Of, United Kingdom
Manchester, , United Kingdom
New Haven, Connecticut, United States
Evanston, Illinois, United States
Saint Louis, Missouri, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, , Argentina
Leuven, Vlaams Brabant, Belgium
Nový Jiín, Novy Jicin, Czechia
Montpellier, Herault, France
Paris, , France
Milano, , Italy
Valencia, Valenciana, Comunitat, Spain
London, England, United Kingdom
London, Sutton, United Kingdom
Roeselare, West Vlaanderen, Belgium
Joinville, Santa Catarina, Brazil
Chicoutimi, Quebec, Canada
Hidaka, Saitama, Japan
Lund, Skane Lan, Sweden
London, Sutton, United Kingdom
Anchorage, Alaska, United States
Los Angeles, California, United States
San Francisco, California, United States
Orlando, Florida, United States
Hackensack, New Jersey, United States
New York, New York, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Sydney, New South Wales, Australia
Wien, , Austria
Gent, Oost Vlaanderen, Belgium
Sao Luis, Maranhao, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sorocaba, Sao Paulo, Brazil
Sao Paulo, , Brazil
Vancouver, British Columbia, Canada
Temuco, Araucania, Chile
Santiago, Region M. De Santiago, Chile
Guangzhou, Guangdong, China
Shantou, Guangdong, China
Zhanjiang, Guangdong, China
Nanning, Guangxi, China
Zhengzhou Shi, Henan, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Shanghai, Shanghai, China
Chengdu, Sichuan, China
Urumqi, Xinjiang, China
Hangzhou, Zhejiang, China
Linhai, Zhejiang, China
Wenzhou, Zhejiang, China
Copenhagen, Hovedstaden, Denmark
Bordeaux, Aquitaine, France
Toulouse, Haute Garonne, France
Montpellier, Herault, France
Rennes, Ille Et Vilaine, France
Heilbronn, Baden Wurttemberg, Germany
Patras, Achaia, Greece
Cork, , Ireland
Dublin, , Ireland
Bologna, Emilia Romagna, Italy
Aviano, Friuli Venezia Giulia, Italy
Roma, Lazio, Italy
Milano, Lombardia, Italy
Milan, Lombardia, Italy
Candiolo, Torino, Italy
Reggio Emilia, , Italy
Matsuyama, Ehime, Japan
Kurume, Fukuoka, Japan
Otashi, Gunma, Japan
Tokyo, , Japan
Lembah Pantai, Kuala Lumpur, Malaysia
Oslo, , Norway
Girona, Gerona, Spain
Valencia, Valenciana, Comunitat, Spain
Basel, Basel Stadt, Switzerland
East Sussex, Brighton And Hove, United Kingdom
West Islip, New York, United States
Zhengzhou, Henan, China
Shiwa Gun, Iwate, Japan
Koto, Tokyo, Japan
London, London, City Of, United Kingdom
Worcester, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Rio De Janeiro, , Brazil
Chengdu, Sichuan, China
Urumqi, Xinjiang, China
Kunming, Yunnan, China
Brno, Brno Mesto, Czechia
Marousi, Attiki, Greece
Fukuoka, , Japan
L Hospitalet, Barcelona, Spain
Morristown, New Jersey, United States
Santiago, Region M. De Santiago, Chile
Plerin, Cotes D Armor, France
Dublin, , Ireland
Sapporo, Hokkaido, Japan
Tsukuba, Ibaraki, Japan
Niigata Shi, Niigata, Japan
New Orleans, Louisiana, United States
Providence, Rhode Island, United States
Uberlândia, Minas Gerais, Brazil
Zhengzhou, Henan, China
Wuhan, Hubei, China
Ravensburg, Baden Wurttemberg, Germany
Chuo Ku, Tokyo, Japan
Kagoshima, , Japan
Atlanta, Georgia, United States
Augusta, Georgia, United States
Edgewood, Kentucky, United States
Sao Paulo, , Brazil
Edmonton, Alberta, Canada
Hefei, Anhui, China
Fuzhou, Fujian, China
Haikou, Hainan, China
Linyi, Shandong, China
Tübingen, Baden Wurttemberg, Germany
Osaka, , Japan
Nijmegen, Gelderland, Netherlands
Derby, Derbyshire, United Kingdom
Teaneck, New Jersey, United States
Brooklyn, New York, United States
Montreal, Quebec, Canada
Guangzhou, Guangdong, China
Shanghai, Shanghai, China
Hangzhou, Zhejiang, China
Coyoacan, Distrito Federal, Mexico
London, London, City Of, United Kingdom
Changsha, Hunan, China
Augusta, Georgia, United States
Sao Paulo, , Brazil
Mississauga, Ontario, Canada
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Changsha, Hunan, China
Milano, , Italy
Nagoya, Aichi, Japan
Toon, Ehime, Japan
Sunto Gun,, Shizuoka, Japan
Glasgow, Scotland, United Kingdom
West Palm Beach, Florida, United States
Ravensburg, Baden Wurttemberg, Germany
Athens, Attiki, Greece
Tucson, Arizona, United States
Santiago, Region M. De Santiago, Chile
Praha, Praha 2, Czechia
Phoenix, Arizona, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Ciudad Autónoma De Buenos Aires, Caba, Argentina
Calgary, Alberta, Canada
Beijing, Beijing, China
Nanchang, Jiangxi, China
Chengdu, Sichuan, China
Wenzhou, Zhejiang, China
Bari, , Italy
Roma, , Italy
Amsterdam, Noord Holland, Netherlands
Stockholm, Stockholms Lan, Sweden
Harbin, Heilongjiang, China
Ravensburg, Baden Wurttemberg, Germany
Wuhan, Hubei, China
Mannheim, Baden Wurttemberg, Germany
Tsukuba, Ibaraki, Japan
Koto, Tokyo, Japan
Shinjuku, Tokyo, Japan
San Pedro Garza Garcia, Nuevo Leon, Mexico
San Pedro Garza García, Nuevo Leon, Mexico
Oaxaca De Juarez, Oaxaca, Mexico
Cordoba, , Spain
Kuala Lumpur, , Malaysia
Mexico City, Distrito Federal, Mexico
Berlin, , Germany
Xiamen, Fujian, China
Munich, Bayern, Germany
Koto, Tokyo, Japan
Shinagawa, Tokyo, Japan
Praha, , Czechia
Nagoya, Aichi, Japan
Los Angeles, California, United States
New York, New York, United States
Columbus, Ohio, United States
Munich, Bayern, Germany
Dresden, Sachsen, Germany
Bologna, Emilia Romagna, Italy
Milan, Lombardia, Italy
Candiolo, Torino, Italy
Napoli, , Italy
Warszawa, Mazowieckie, Poland
Poznan, Wielkopolskie, Poland
Porto Alegre, Rio Grande Do Sul, Brazil
Santiago., Region M. De Santiago, Chile
Kunming, Yunnan, China
Cork, , Ireland
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Essen, Nordrhein Westfalen, Germany
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Valencia, , Spain
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported