Endometrial Cancer Clinical Trial
Official title:
A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that sacituzumab tirumotecan is superior to TPC with respect to OS.
| Status | Recruiting |
| Enrollment | 710 |
| Est. completion date | January 10, 2028 |
| Est. primary completion date | January 10, 2028 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 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 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting. - Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008) | Buenos Aires | Caba |
| Argentina | Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006) | La Rioja | |
| Australia | Blacktown Hospital ( Site 1101) | Blacktown | New South Wales |
| Australia | Epworth Freemasons ( Site 1104) | East Melbourne | Victoria |
| Australia | Frankston Hospital ( Site 1105) | Frankston | Victoria |
| Australia | GenesisCare North Shore ( Site 1103) | St Leonards | New South Wales |
| Austria | Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201) | Innsbruck | Tirol |
| Belgium | AZ Maria Middelares-IKG ( Site 1305) | Gent | Oost-Vlaanderen |
| Belgium | CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304) | Namur | |
| Canada | Centre Hospitalier de l'Université de Montréal ( Site 1403) | Montréal | Quebec |
| Canada | McGill University Health Centre ( Site 1404) | Montréal | Quebec |
| Chile | Bradfordhill-Clinical Area ( Site 1501) | Santiago | Region M. De Santiago |
| Chile | Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile ( Site 1503) | Santiago | Region M. De Santiago |
| Chile | James Lind Centro de Investigación del Cáncer ( Site 1504) | Temuco | Araucania |
| Czechia | Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1702) | Olomouc | Olomoucky Kraj |
| Czechia | Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 1703) | Ostrava | Moravskoslezsky Kraj |
| Czechia | Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 1701) | Praha | Praha 8 |
| Denmark | Aarhus Universitetshospital, Skejby ( Site 1802) | Aarhus | Midtjylland |
| Finland | Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902) | Helsinki | Uusimaa |
| Finland | Kuopion Yliopistollinen Sairaala ( Site 1904) | Kuopio | Pohjois-Savo |
| Finland | Tampereen yliopistollinen sairaala ( Site 1901) | Tampere | Pirkanmaa |
| France | CHU Besançon ( Site 2009) | Besançon | Doubs |
| France | ROC37 ( Site 2010) | Chambray Les Tours | Centre |
| France | Centre Oscar Lambret ( Site 2007) | Lille | Nord-Pas-de-Calais |
| France | CENTRE LEON BERARD ( Site 2004) | Lyon Cedex08 | Rhone-Alpes |
| France | Hôpital Privé Des Côtes d'Armor ( Site 2001) | Plérin | Cotes-d Armor |
| France | Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2003) | Rennes | Ille-et-Vilaine |
| Greece | Metropolitan Hospital-2nd Oncology Dept ( Site 2202) | Athens | Attiki |
| Israel | Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502) | Haifa | |
| Israel | Edith Wolfson Medical Center ( Site 2501) | Holon | |
| Israel | Shaare Zedek Medical Center ( Site 2503) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 2505) | Petah Tikva | |
| Israel | Sheba Medical Center ( Site 2504) | Ramat Gan | |
| Israel | Sourasky Medical Center ( Site 2506) | Tel Aviv | |
| Korea, Republic of | Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505) | Seongnam | Kyonggi-do |
| Korea, Republic of | Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 3504) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 3502) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503) | Seoul | |
| Malaysia | Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803) | Kuala Lumpur | |
| Netherlands | Leids Universitair Medisch Centrum-Medical Oncology ( Site 3002) | Leiden | Zuid-Holland |
| Norway | Sorlandet Sykehus Kristiansand ( Site 3104) | Kristiansand | Vest-Agder |
| Norway | Sykehusapoteket Oslo, Radiumhospitalet ( Site 3102) | Oslo | |
| Norway | Stavanger Universitetssykehus ( Site 3103) | Stavanger | Rogaland |
| Norway | Universitetssykehuset Nord-Norge HF ( Site 3101) | Tromsø | Troms |
| Poland | Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 3204) | Bialystok | Podlaskie |
| Poland | Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie-Oddzial Radioterapii i Onkologii Ginek | Poznan | Wielkopolskie |
| Poland | Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3201) | Siedlce | Mazowieckie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit | Warszawa | Mazowieckie |
| Puerto Rico | Ad-Vance Medical Research-Research ( Site 3302) | Ponce | |
| Puerto Rico | Pan American Center for Oncology Trials - Ciudadela ( Site 3301) | San Juan | |
| Puerto Rico | UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 3304) | San Juan | |
| Singapore | National Cancer Centre Singapore-Medical Oncology ( Site 3401) | Singapore | Central Singapore |
| Spain | Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 3602) | Barcelona | |
| Spain | Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608) | Hospitalet | Barcelona |
| Spain | Clinica Universidad de Navarra ( Site 3603) | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario La Paz-Oncología Médica ( Site 3604) | Madrid | Madrid, Comunidad De |
| Sweden | Karolinska Universitetssjukhuset Solna ( Site 3701) | Stockholm | Stockholms Lan |
| Switzerland | Ospedale Regionale Bellinzona e Valli ( Site 3802) | Bellinzona | Ticino |
| Switzerland | Kantonsspital Graubünden-Medizin ( Site 3803) | Chur | Grisons |
| United States | Centricity Research Columbus Cancer Center ( Site 4154) | Columbus | Georgia |
| United States | Parkview Research Center at Parkview Regional Medical Center ( Site 4132) | Fort Wayne | Indiana |
| United States | The West Clinic, PLLC dba West Cancer Center ( Site 4102) | Germantown | Tennessee |
| United States | Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130) | Houston | Texas |
| United States | Mount Sinai Cancer Center ( Site 4117) | Miami Beach | Florida |
| United States | Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156) | Mineola | New York |
| United States | USA Mitchell Cancer Institute ( Site 4142) | Mobile | Alabama |
| United States | Laura and Isaac Perlmutter Cancer Center ( Site 4106) | New York | New York |
| United States | The Center of Hope ( Site 4109) | Reno | Nevada |
| United States | TRIALS 365 ( Site 4105) | Shreveport | Louisiana |
| United States | MedStar Washington Hospital Center ( Site 4108) | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC | European Network for Gynaecological Oncological Trial groups(ENGOT), GOG Foundation |
United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, Denmark, Finland, France, Greece, Israel, Korea, Republic of, Malaysia, Netherlands, Norway, Poland, Puerto Rico, Singapore, Spain, Sweden, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. | Up to approximately 4 years | |
| Primary | Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 4 years | |
| Secondary | Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR. | Up to approximately 4 years | |
| Secondary | Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR | For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | Up to approximately 4 years | |
| Secondary | Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. | Up to approximately 4 years | |
| Secondary | Number of Participants Who Discontinue Study Intervention Due to an AE | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. | Up to approximately 4 years | |
| Secondary | Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30]) | The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions, "How would you rate your overall health during the past week (Item 29)?" and "How would you rate your overall quality of life during the past week (Item 30)?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented. | Baseline, up to approximately 4 years |
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