A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
Launched by MERCK SHARP & DOHME LLC · Jun 10, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called sacituzumab tirumotecan for women with recurrent or metastatic cervical cancer, which means the cancer has come back or spread after initial treatment. The goal is to see if this new treatment works better than the current options that doctors might choose for patients in a similar situation. The trial has two parts: the first part looks at the safety of the treatment, and the second part directly compares its effectiveness to other options selected by doctors.
To be eligible for this trial, participants need to be adult women (at least 18 years old) with a specific type of cervical cancer that has worsened after at least one round of chemotherapy. They should also have measurable disease and meet certain health criteria, such as having good organ function. Participants will undergo tests to monitor their health throughout the study and will receive either the new treatment or the physician's choice of therapy. It’s important for potential participants to discuss this opportunity with their doctors to understand how it might fit into their overall treatment plan.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- • Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
- • Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
- • Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
- • Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
- • Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
- • HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
- • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
- • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- • Has adequate organ function
- Exclusion Criteria:
- • Has Grade ≥2 peripheral neuropathy
- • Has 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.
- • Received prior systemic anticancer therapy
- • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- • Has histological subtypes of cervical cancer other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma) or nonepithelial cancer (eg, sarcoma, neuroendocrine tumors)
- • Known additional malignancy that is progressing or has required active treatment within the past 3 years
- • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- • Active infection requiring systemic therapy
- • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- • Concurrent active Hepatitis B and active Hepatitis C virus infection
- • Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
- • Participants who have not adequately recovered from major surgery or have ongoing surgical complications
- • Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD
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
Barcelona, Cataluna, Spain
Warszawa, Mazowieckie, Poland
Ramat Gan, , Israel
Durham, North Carolina, United States
Los Angeles, California, United States
Reno, Nevada, United States
Haifa, , Israel
Holon, , Israel
Shreveport, Louisiana, United States
Jerusalem, , Israel
San Juan, , Puerto Rico
Sydney, New South Wales, Australia
Seoul, , Korea, Republic Of
Basel, Basel Stadt, Switzerland
Seoul, , Korea, Republic Of
Berne, , Switzerland
Tulsa, Oklahoma, United States
La Rioja, , Argentina
Herston, Queensland, Australia
Clayton, Victoria, Australia
Melbourne, Victoria, Australia
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Mar Del Plata, Buenos Aires, Argentina
Nedlands, Western Australia, Australia
Namur, , Belgium
Tampere, Pirkanmaa, Finland
Rozzano, Milano, Italy
Amsterdam, Noord Holland, Netherlands
Oslo, , Norway
Charlottesville, Virginia, United States
Caba, , Argentina
Sydney, New South Wales, Australia
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Viña Del Mar, Valparaiso, Chile
Aarhus, Midtjylland, Denmark
Odense C, Syddanmark, Denmark
Roma, Lazio, Italy
Nijmegen, Gelderland, Netherlands
Rotterdam, Zuid Holland, Netherlands
Madrid, Madrid, Comunidad De, Spain
Madrid, , Spain
Uppsala, Uppsala Lan, Sweden
New Orleans, Louisiana, United States
Teaneck, New Jersey, United States
Houston, Texas, United States
Buenos Aires, , Argentina
Caba, , Argentina
Wien, , Austria
Leuven, Vlaams Brabant, Belgium
São Paulo, Sao Paulo, Brazil
Quebec City, Quebec, Canada
Valledupar, Cesar, Colombia
Montería, Cordoba, Colombia
Bogota, Distrito Capital De Bogota, Colombia
Pereira, Risaralda, Colombia
Cali, Valle Del Cauca, Colombia
Patras, Peloponnisos, Greece
Dublin, , Ireland
Bologna, Emilia Romagna, Italy
Milano, Lombardia, Italy
Milano, , Italy
Matsuyama, Ehime, Japan
Sapporo, Hokkaido, Japan
Hidaka, Saitama, Japan
Koto, Tokyo, Japan
Kuala Lumpur, , Malaysia
Eindhoven, Noord Brabant, Netherlands
Bialystok, Podlaskie, Poland
Singapore, Central Singapore, Singapore
Girona, Gerona, Spain
Madrid, Madrid, Comunidad De, Spain
Valencia, Valenciana, Comunitat, Spain
Barcelona, , Spain
Cordoba, , Spain
Lund, Skane Lan, Sweden
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Aalst, Oost Vlaanderen, Belgium
Helsinki, Uusimaa, Finland
Monza, Lombardia, Italy
Lund, Skane Lan, Sweden
Plovdiv, , Bulgaria
Montreal, Quebec, Canada
Montréal, Quebec, Canada
Clermont Ferrand, Auvergne, France
Villejuif, Ile De France, France
Napoli, , Italy
Kurume, Fukuoka, Japan
Ohta, Gunma, Japan
Chuo, Tokyo, Japan
Groningen, , Netherlands
Stockholm, Stockholms Lan, Sweden
Córdoba, Cordoba, Argentina
Joinville, Santa Catarina, Brazil
Rio De Janeiro, , Brazil
Besancon, Doubs, France
Montpellier, Herault, France
Nantes, Loire Atlantique, France
Dublin, , Ireland
Brescia, , Italy
Fukuoka, , Japan
Osaka, , Japan
Madrid, Madrid, Comunidad De, Spain
Valencia, Valenciana, Comunitat, Spain
Mobile, Alabama, United States
Tucson, Arizona, United States
La Jolla, California, United States
Newport Beach, California, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Savannah, Georgia, United States
Albuquerque, New Mexico, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Buenos Aires, Caba, Argentina
Linz, Oberosterreich, Austria
Graz, Steiermark, Austria
Innsbruck, Tirol, Austria
Gent, Oost Vlaanderen, Belgium
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, , Brazil
Santiago, Region M. De Santiago, Chile
Kobenhavn, Hovedstaden, Denmark
Turku, Varsinais Suomi, Finland
Strasbourg, Alsace, France
Bordeaux, Aquitaine, France
Marseille, Bouches Du Rhone, France
Toulouse, Haute Garonne, France
Lyon Cedex08, Rhone Alpes, France
Paris, , France
Athens, Attiki, Greece
Athens, Attiki, Greece
Chaidari, Attiki, Greece
Torino, Piemonte, Italy
Catania, , Italy
Roma, , Italy
Nagoya, Aichi, Japan
Shiwa Gun, Iwate, Japan
Shinjyuku, Tokyo, Japan
Niigata, , Japan
Lembah Pantai, Kuala Lumpur, Malaysia
Pulau Pinang, , Malaysia
L Hospitalet De Llobregat, Cataluna, Spain
Linköping, Ostergotlands Lan, Sweden
London, England, United Kingdom
Sutton, England, United Kingdom
Manchester, , United Kingdom
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Hilliard, Ohio, United States
San Antonio, Texas, United States
Chongqing, Chongqing, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Zhanjiang, Guangdong, China
Nanning, Guangxi, China
Xinxiang, Henan, China
Wuhan, Hubei, China
Nanchang, Jiangxi, China
Wenzhou, Zhejiang, China
Plérin, Cotes D Armor, France
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Augusta, Georgia, United States
Fort Worth, Texas, United States
Seattle, Washington, United States
Aalst, Oost Vlaanderen, Belgium
Pleven, , Bulgaria
Kelowna, British Columbia, Canada
Surrey, British Columbia, Canada
Victoria, British Columbia, Canada
Santiago, Region M. De Santiago, Chile
Wuhan, Hubei, China
Jinan, Shandong, China
Linyi, Shandong, China
Shanghai, Shanghai, China
Hangzhou, Zhejiang, China
Bogota., Distrito Capital De Bogota, Colombia
Villejuif, Ile De France, France
Milan, Lombardia, Italy
Milan, Lombardia, Italy
Tsukuba, Ibaraki, Japan
Sunto Gun,, Shizuoka, Japan
Kagoshima, , Japan
Petaling Jaya, Selangor, Malaysia
Singapore, Central Singapore, Singapore
London, London, City Of, United Kingdom
Belgium, Wallonne, Region, Belgium
Hefei, Anhui, China
Zhengzhou, Henan, China
Xi'an, Shaanxi, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Bogota., Distrito Capital De Bogota, Colombia
Toon, Ehime, Japan
Haikou, Hainan, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Pereira., Risaralda, Colombia
Milano, , Italy
Glasgow, Glasgow City, United Kingdom
Panagyurishte, Pazardzhik, Bulgaria
Hefei, Anhui, China
Xiamen, Fujian, China
Changchun, Jilin, China
Padova, , Italy
Beijing, Beijing, China
Changsha, Hunan, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Pereira., Risaralda, Colombia
Koto, Tokyo, Japan
Taiyuan, Shanxi, China
Montería, Cordoba, Colombia
Eugene, Oregon, United States
Fairfax, Virginia, United States
Cork, , Ireland
Santiago, Region M. De Santiago, Chile
Nagoya, Aichi, Japan
Los Angeles, California, United States
Belgium, Wallonne, Region, Belgium
Quebec City, Quebec, Canada
Bogota., Distrito Capital De Bogota, Colombia
Bologna, Emilia Romagna, Italy
Milan, Lombardia, Italy
Amsterdam, Noord Holland, Netherlands
Warszawa, Mazowieckie, Poland
Barcelona, Cataluna, Spain
Leeds, , United Kingdom
Cincinnati, Ohio, United States
Guangzhou, Guangdong, China
Kunming, Yunnan, China
Besancon, Franche Comte, France
Poznan, Wielkopolskie, Poland
Changsha, Hunan, China
Buenos Aires, Caba, Argentina
Belgium, , Belgium
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Valencia, , Spain
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