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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03884101
Other study ID # 7902-001
Secondary ID MK-7902-001ENGOT
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 11, 2019
Est. completion date January 15, 2025

Study information

Verified date June 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 842
Est. completion date January 15, 2025
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or nonmeasurable but radiographically apparent, per RECIST 1.1 as assessed by BICR (note: may have received prior chemotherapy only if administered concurrently with radiation; may have received prior radiation without concurrent chemotherapy; may have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued =1 week prior to randomization; and may have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy) - Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determination of mismatch repair (MMR) status - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study intervention - Is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to use contraception during the study and for =120 days after pembrolizumab, =30 days after lenvatinib, or =180 days after (chemotherapy) [if a WOCBP, a pregnancy test will be required within 24 hours of first dose of study drug] - Has adequately controlled blood pressure within 7 days prior to randomization - Has adequate organ function based on assessment within 7 days prior to the first dose of study intervention Exclusion Criteria: - Has carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma or other high grade sarcomas, or endometrial stromal sarcomas - Has a central nervous system (CNS) metastasis, unless local therapy (e.g., whole brain radiation therapy, surgery, or radiosurgery) has been completed and have discontinued use of corticosteroids for this indication for =4 weeks prior to starting study medication (major surgery within 3 weeks of the first dose of study drug will be exclusionary) - Has a known additional malignancy (other than endometrial carcinoma) that is progressing or has required active treatment in the last 3 years - Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib - Has a pre-existing Grade =3 gastrointestinal or nongastrointestinal fistula - Has radiographic evidence of major blood vessel invasion/infiltration - Has active hemoptysis (bright red blood at =0.5 teaspoon) within 3 weeks prior to the first dose of study intervention or tumor bleeding within 2 weeks prior to randomization - Has clinically significant cardiovascular disease within 12 months from first dose of study intervention including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction or cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability - Has any infection requiring systemic treatment - Has not recovered adequately from any toxicity and/or complications from major surgery prior to randomization - Has a known history of human immunodeficiency virus (HIV) infection (HIV test is required at screening) - Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) [defined as HCV ribonucleic acid (RNA) is detected] (hepatitis B and C testing is required at screening only when mandated by local health authority) - Has a history of (noninfectious) pneumonitis that required treatment with steroids, or has current pneumonitis - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator - Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization - Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) - Has received prior systemic chemotherapy in any setting for the treatment of endometrial carcinoma (note: prior chemotherapy administered concurrently with radiation is permitted) - Has received prior radiotherapy within 4 weeks prior to randomization (participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - a 2-week washout is permitted for palliative radiation to non-CNS disease and vaginal brachytherapy) - Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1 week of randomization - Has received prior therapy with any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis, an anti-programmed cell death (PD)-1, anti-PD ligand (L)1, or anti-PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) - Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention - Has known intolerance to study intervention (or any of the excipients) - Has had an allogenic tissue/solid organ transplant - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenvatinib
Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.
Biological:
Pembrolizumab
Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.
Drug:
Paclitaxel
Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle.
Carboplatin
Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle.

Locations

Country Name City State
Argentina Hospital Aleman ( Site 2600) Buenos Aires
Argentina Hospital Italiano de Buenos Aires ( Site 2603) Buenos Aires
Argentina IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607) Caba Buenos Aires
Argentina Hospital Italiano de La Plata ( Site 2601) La Plata Buenos Aires
Argentina Centro Oncologico Riojano Integral ( Site 2605) La Rioja
Argentina Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606) Mar del Plata Buenos Aires
Australia Chris OBrien Lifehouse ( Site 1605) Camperdown New South Wales
Australia Monash Health ( Site 1606) Clayton Victoria
Australia Epworth Freemasons Hospital ( Site 1609) Melbourne Victoria
Australia Sir Charles Gairdner Hospital ( Site 1604) Nedlands Western Australia
Australia Prince of Wales Hospital [Australia] ( Site 1603) Randwick New South Wales
Australia Mater Misericordiae Ltd ( Site 1608) South Brisbane Queensland
Australia Royal North Shore Hospital ( Site 1600) St Leonards New South Wales
Australia The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602) Westmead New South Wales
Austria Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301) Graz Steiermark
Austria Medizinische Universitat Innsbruck ( Site 3302) Innsbruck Tirol
Austria Medizinische Universitat Wien ( Site 3300) Vienna Wien
Belgium Cliniques Universitaires Saint-Luc ( Site 3203) Brussels Bruxelles-Capitale, Region De
Belgium UZA University Hospital Antwerp ( Site 3204) Edegem Antwerpen
Belgium AZ Maria Middelares Gent ( Site 3202) Gent Oost-Vlaanderen
Belgium UZ Leuven ( Site 3200) Leuven Antwerpen
Belgium AZ Delta ( Site 3206) Roeselare West-Vlaanderen
Brazil Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708) Belo Horizonte Minas Gerais
Brazil Instituto do Cancer do Ceara ( Site 2703) Fortaleza Ceara
Brazil Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702) Goiania Goias
Brazil Hospital de Caridade de Ijui ( Site 2712) Ijui Rio Grande Do Sul
Brazil Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701) Porto Alegre Rio Grande Do Sul
Brazil Instituto Nacional do Cancer II ( Site 2707) Rio de Janeiro
Brazil Hospital de Base de Sao Jose de Rio Preto ( Site 2704) Sao Jose do Rio Preto Sao Paulo
Brazil A.C. Camargo Cancer Center ( Site 2705) Sao Paulo
Brazil Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706) Sao Paulo
Brazil Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713) Sao Paulo
Canada Cross Cancer Institute ( Site 0408) Edmonton Alberta
Canada Juravinski Cancer Centre ( Site 0406) Hamilton Ontario
Canada BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402) Kelowna British Columbia
Canada Kingston Health Sciences Centre ( Site 0401) Kingston Ontario
Canada The Credit Valley Hospital ( Site 0403) Mississauga Ontario
Canada Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411) Montreal Quebec
Canada CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414) Montreal Quebec
Canada McGill University Health Centre ( Site 0404) Montreal Quebec
Canada CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417) Sherbrooke Quebec
Canada Princess Margaret Cancer Centre ( Site 0409) Toronto Ontario
Canada Sunnybrook Research Institute ( Site 0410) Toronto Ontario
Canada BC Cancer-Vancouver Center ( Site 0412) Vancouver British Columbia
China Beijing Cancer Hospital ( Site 2504) Beijing Beijing
China Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505) Beijing Beijing
China Peking Union Medical College Hospital ( Site 2501) Beijing Beijing
China Xiangya Hospital Central-South University ( Site 2512) Changsha Hunan
China Chongqing Cancer Hospital ( Site 2513) Chongqing Chongqing
China The First Affiliated Hospital.Sun Yat-sen University ( Site 2507) Guangzhou Guangdong
China Women s Hospital School of Medicine Zhejiang University ( Site 2511) Hangzhou Zhejiang
China Zhejiang Cancer Hospital ( Site 2506) Hangzhou Zhejiang
China Anhui Provincial Cancer Hospital ( Site 2509) Hefei Anhui
China Nanjing Maternity and Child Health Care Hospital ( Site 2508) Nanjing Jiangsu
China Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517) Nanning Guangxi
China Fudan University Shanghai Cancer Center ( Site 2500) Shanghai Shanghai
China Obstetrics and Gynecology Hosp. Fudan University ( Site 2503) Shanghai Shanghai
China The First Affiliated Hospital of Xinjiang Medical University ( Site 2515) Urumqi Xinjiang
China Hubei Cancer Hospital ( Site 2510) Wuhan Hubei
China The first affiliated Hospital of Xi an Jiaotong University ( Site 2502) XI An Shaanxi
Germany Charite Universitaetsmedizin Berlin ( Site 0609) Berlin
Germany Universitaetsklinikum Essen ( Site 0616) Essen Nordrhein-Westfalen
Germany Universitaetsklinikum Jena ( Site 0612) Jena Thuringen
Germany Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622) Mannheim Baden-Wurttemberg
Germany Universitaetsklinikum Muenster ( Site 0615) Muenster Baden-Wurttemberg
Germany Caritas-Krankenhaus St. Josef Regensburg ( Site 0613) Regensburg Bayern
Germany HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623) Wiesbaden Hessen
Ireland Cork University Hospital ( Site 1400) Cork
Ireland St James Hospital ( Site 1401) Dublin
Israel Rambam Medical Center ( Site 0700) Haifa
Israel Edith Wolfson Medical Center ( Site 0703) Holon Tell Abib
Israel Meir Medical Center ( Site 0702) Kfar-Saba Central
Israel Chaim Sheba Medical Center ( Site 0707) Ramat Gan
Italy Medical Oncology Ospedale San Donato ( Site 0812) Arezzo
Italy IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801) Bari
Italy Ospedale Policlinico S. Orsola-Malpighi ( Site 0803) Bologna
Italy Ospedale Antonio Perrino ( Site 0806) Brindisi
Italy Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807) Catania
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800) Meldola Emilia-Romagna
Italy Ospedale dell Angelo ( Site 0810) Mestre Venezia
Italy Istituto Nazionale Tumori Fondazione Pascale ( Site 0808) Napoli
Italy Policlinico Universitario Agostino Gemelli ( Site 0805) Rome Roma
Japan Hyogo Cancer Center ( Site 2414) Akashi Hyogo
Japan National Hospital Organization Kyushu Cancer Center ( Site 2405) Fukuoka
Japan Saitama Medical University International Medical Center ( Site 2410) Hidaka Saitama
Japan Nippon Medical School Musashi Kosugi Hospital ( Site 2417) Kawasaki Kanagawa
Japan St. Marianna University School of Medicine Hospital ( Site 2416) Kawasaki Kanagawa
Japan Saitama Cancer Center ( Site 2406) Kitaadachi-gun Saitama
Japan Kurume University Hospital ( Site 2403) Kurume Fukuoka
Japan Kyorin University Hospital ( Site 2402) Mitaka Tokyo
Japan University of the Ryukyus Hospital ( Site 2412) Nakagami-gun Okinawa
Japan Niigata Cancer Center Hospital ( Site 2415) Niigata
Japan Osaka International Cancer Institute ( Site 2409) Osaka
Japan Gunma Prefectural Cancer Center ( Site 2404) Ota Gunma
Japan National Hospital Organization Hokkaido Cancer Center ( Site 2408) Sapporo Hokkaido
Japan National Defense Medical College Hospital ( Site 2418) Tokorozawa Saitama
Japan Keio University Hospital ( Site 2411) Tokyo
Japan Showa University Hospital ( Site 2419) Tokyo
Japan The Cancer Institute Hospital of JFCR ( Site 2401) Tokyo
Japan Ehime University Hospital ( Site 2413) Toon Ehime
Korea, Republic of Seoul National University Bundang Hospital ( Site 1802) Seongnam-si Kyonggi-do
Korea, Republic of Asan Medical Center ( Site 1800) Seoul
Korea, Republic of Samsung Medical Center ( Site 1803) Seoul
Korea, Republic of Seoul National University Hospital ( Site 1801) Seoul
Korea, Republic of Severance Hospital Yonsei University Health System ( Site 1804) Seoul
Mexico Centro Estatal de Cancerologia de Chihuahua ( Site 3101) Chihuahua
Mexico Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108) Ciudad de Mexico
Mexico Centro de Investigacion Clinica Gramel ( Site 3107) Mexico City
Mexico Centro Oncologico Internacional. SEDNA ( Site 3106) Mexico City
Mexico I CAN Oncology SA de SV ( Site 3102) Monterrey Nuevo Leon
Mexico Hospital San Lucas Cardiologica del Sureste ( Site 3103) Tuxtla Gutierrez Chiapas
Poland Bialostockie Centrum Onkologii ( Site 1005) Bialystok Podlaskie
Poland Centrum Onkologii Instytut im. MSC Oddzial w Gliwicach ( Site 1017) Gliwice Slaskie
Poland Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019) Krakow Malopolskie
Poland Instytut Centrum Zdrowia Matki Polki ( Site 1020) Lodz Lodzkie
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008) Lublin Dolnoslaskie
Poland Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004) Poznan Wielkopolskie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009) Warsaw Mazowieckie
Poland Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011) Warszawa Mazowieckie
Russian Federation Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108) Kazan Tatarstan, Respublika
Russian Federation Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118) Krasnoyarsk Krasnoyarskiy Kray
Russian Federation FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102) Moscow Moskva
Russian Federation Medical Rehabilitation Center ( Site 1101) Moscow Moskva
Russian Federation Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100) Moscow Moskva
Russian Federation SPb SBHI City Clinical Oncological Dispensary ( Site 1104) Saint Petersburg Sankt-Peterburg
Russian Federation St.Petersburg Clinical Hospital RAS ( Site 1124) Saint Petersburg Sankt-Peterburg
Russian Federation National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103) Saint-Petersburg Sankt-Peterburg
Russian Federation Railway Hospital of OJSC ( Site 1122) Saint-Petersburg Sankt-Peterburg
Russian Federation Samara Regional Clinical Oncology Center ( Site 1117) Samara Samarskaya Oblast
Russian Federation Siberian State Medical University ( Site 1121) Tomsk Tomskaya Oblast
Spain Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202) A Coruna La Coruna
Spain Institut Catala d Oncologia Badalona ( Site 1201) Badalona Barcelona
Spain Parc de Salut Mar ( Site 1200) Barcelona
Spain Hospital Universitario Reina Sofia ( Site 1207) Cordoba
Spain Hospital Clinico San Carlos ( Site 1209) Madrid
Spain Hospital Materno Infantil [Malaga, Spain] ( Site 1208) Malaga
Spain Hospital General Universitario de Valencia ( Site 1203) Valencia Valenciana, Comunitat
Spain Instituto Valenciano de Oncologia - IVO ( Site 1205) Valencia Valenciana, Comunitat
Taiwan China Medical University Hospital ( Site 1903) Taichung
Taiwan Taichung Veterans General Hospital ( Site 1902) Taichung
Taiwan National Taiwan University Hospital ( Site 1904) Taipei
Taiwan Taipei Veterans General Hospital ( Site 1900) Taipei
Taiwan Linkou Chang Gung Memorial Hospital ( Site 1901) Taoyuan
Turkey Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303) Adana
Turkey Cukurova Uni. Tip Fakultesi ( Site 1302) Adana
Turkey Baskent Universitesi Ankara Hastanesi ( Site 1300) Ankara
Turkey Gazi Universitesi Tip Fakultesi ( Site 1308) Ankara
Turkey Akdeniz Universitesi Tip Fakultesi ( Site 1301) Antalya
Turkey Uludag Universitesi Tip Fakultesi ( Site 1307) Bursa
Ukraine City Clinical Hosp.4 of DCC ( Site 1501) Dnipro Dnipropetrovska Oblast
Ukraine Clinical oncology dispensary of Dnipro ( Site 1512) Dnipro Dnipropetrovska Oblast
Ukraine MI Precarpathian Clinical Oncology Center ( Site 1503) Ivano-Frankivsk Ivano-Frankivska Oblast
Ukraine Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509) Kharkiv Kharkivska Oblast
Ukraine Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511) Kharkiv Kharkivska Oblast
Ukraine Khmelnitskiy Regional Onkology Dispensary ( Site 1513) Khmelnitskiy Khmelnytska Oblast
Ukraine Medical Center Asklepion LLC ( Site 1514) Khodosivka Kyivska Oblast
Ukraine Kyiv City Clinical Oncology Centre ( Site 1505) Kyiv
Ukraine Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507) Kyiv Kyivska Oblast
Ukraine National Cancer Institute of the MoH of Ukraine ( Site 1510) Kyiv Kyivska Oblast
Ukraine MI Odessa Regional Oncological Centre ( Site 1504) Odesa Odeska Oblast
United Kingdom Western General Hospital ( Site 1411) Edinburgh Edinburgh, City Of
United Kingdom UCLH NHS Foundation Trust ( Site 1405) London London, City Of
United Kingdom The James Cook University Hospital ( Site 1403) Middlesbrough
United Kingdom Northern Centre for Cancer Care ( Site 1408) Newcastle Upon Tyne
United Kingdom Mount Vernon Cancer Centre ( Site 1409) Northwood London, City Of
United Kingdom Churchill Hospital ( Site 1406) Oxford Oxfordshire
United States Georgia Cancer Center at Augusta University ( Site 0222) Augusta Georgia
United States University of Colorado Cancer Center ( Site 0204) Aurora Colorado
United States Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268) Basking Ridge New Jersey
United States University of North Carolina- Chapel Hill ( Site 0254) Chapel Hill North Carolina
United States Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267) Commack New York
United States Women's Cancer Care ( Site 0208) Covington Louisiana
United States Parkland Health & Hospital System ( Site 0272) Dallas Texas
United States University of Texas Southwestern Medical Center ( Site 0264) Dallas Texas
United States Willamette Valley Cancer Institute and Research Center ( Site 8004) Eugene Oregon
United States Roger Maris Cancer Center ( Site 0277) Fargo North Dakota
United States John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226) Hackensack New Jersey
United States Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274) Harrison New York
United States UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233) Los Angeles California
United States University of Miami Health System ( Site 0249) Miami Florida
United States Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273) Middletown New Jersey
United States Minnesota Oncology Hematology, PA ( Site 8003) Minneapolis Minnesota
United States University of South Alabama, Mitchell Cancer Institute ( Site 0245) Mobile Alabama
United States MSKCC-Bergen ( Site 0276) Montvale New Jersey
United States Smilow Cancer Hospital at Yale New Haven ( Site 0202) New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center ( Site 0246) New York New York
United States The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206) New York New York
United States University of Rochester ( Site 0238) Rochester New York
United States Maine Medical Partners ( Site 0217) Scarborough Maine
United States Sanford Cancer Center Oncology Clinic ( Site 0205) Sioux Falls South Dakota
United States Holy Name Medical Center ( Site 0235) Teaneck New Jersey
United States Texas Oncology-The Woodlands ( Site 8000) The Woodlands Texas
United States Arizona Oncology Associates PC- HOPE ( Site 8005) Tucson Arizona
United States Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275) Uniondale New York
United States Legacy Salmon Creek Medical Center ( Site 0253) Vancouver Washington

Sponsors (2)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC Eisai Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Germany,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) Progression-free survival based on RECIST 1.1 as assessed by BICR. Progression-free survival is measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first. Up to approximately 31 months
Primary Overall Survival (OS) Overall survival is measured from the time of randomization up to death due to any cause. Up to approximately 45 months
Secondary Objective response rate (ORR ) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR) The ORR (either confirmed complete response [CR] or partial response [PR]) based on RECIST 1.1 and assessed by BICR will be determined in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry. Up to approximately 31 months
Secondary Mean change from baseline in the global health status/quality of life score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR and in all-comer participants The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms. Baseline and designated time points up to 27 months
Secondary Percentage of participants experiencing an adverse event (AE) An AE is 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 27 months (through 90 days after the last dose of study treatment)
Secondary Percentage of participants experiencing a serious adverse event (SAE) An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event. Up to approximately 28 months (through 120 days after the last dose of study treatment)
Secondary Percentage of participants experiencing an immune-related AE (irAE) Immune-related AEs will be monitored in both arms. Up to approximately 27 months (through 90 days after the last dose of study treatment)
Secondary Percentage of participants discontinuing from study treatment due to an AE(s) Discontinuations related to AEs will be monitored in both arms. Up to approximately 24 months (through the last dose of study treatment)
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