Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

Endometrial Neoplasms Clinical Trial

Official title:

A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05173987
• Other study ID #: 3475-C93
• Secondary ID: MK-3475-C93KEYNO
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 3, 2022
• Est. completion date: May 27, 2027

Study information

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

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.

The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: May 27, 2027
• Est. primary completion date: May 27, 2027
• 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 inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.

• Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.

• Has received no prior systemic therapy for EC except for the following:

1. May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurrence occurred =6 months after the last dose of chemotherapy.

2. May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system (CNS) disease.

3. May have received prior hormonal therapy for treatment of EC, provided that it was discontinued =1 week prior to randomization.

• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.

• Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).

• Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.

• Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.

• If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.

• If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.

Exclusion Criteria:

• Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.

• Has EC of any histology that is proficient mismatch repair (pMMR).

• Is a candidate for curative-intent surgery or curative-intent radiotherapy.

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]).

• Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.

• Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.

• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.

• Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.

• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.

• Has known active CNS metastases and/or carcinomatous meningitis.

• Has a known intolerance to any study intervention and/or any of its excipients.

• Has an active autoimmune disease that has required systemic treatment in past 2 years.

• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

• Has an active infection, requiring systemic therapy.

• Has a known history of human immunodeficiency virus (HIV) infection.

• Has had an allogenic tissue/solid organ transplant.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Biological:
• pembrolizumab
Intravenous (IV) infusion

Drug:
• carboplatin
IV infusion
• paclitaxel
IV infusion
• docetaxel
IV infusion
• cisplatin
IV infusion

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si	Brisbane	Queensland
Australia	Monash Health ( Site 0202)	Clayton	Victoria
Australia	Epworth Freemasons ( Site 0203)	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207)	Melbourne	Victoria
Australia	Northern Cancer Institute ( Site 0206)	St Leonards	New South Wales
Australia	St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204)	Subiaco	Western Australia
Australia	Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)	Westmead	New South Wales
Belgium	Institut Jules Bordet-Medicine Oncology ( Site 0321)	Bruxelles	Bruxelles-Capitale, Region De
Belgium	Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0323)	Charleroi	Hainaut
Belgium	Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0320)	Liège	Liege
Brazil	Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 3005)	Natal	Rio Grande Do Norte
Brazil	A. C. Camargo Cancer Center-CAPEC ( Site 3003)	Sao Paulo
Brazil	ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3001)	São Paulo	Sao Paulo
Canada	Cross Cancer Institute ( Site 0513)	Edmonton	Alberta
Canada	BC Cancer Kelowna ( Site 0517)	Kelowna	British Columbia
Canada	Jewish General Hospital ( Site 0504)	Montreal	Quebec
Canada	Centre Hospitalier de l'Université de Montréal ( Site 0519)	Montréal	Quebec
Canada	McGill University Health Centre ( Site 0505)	Montréal	Quebec
Canada	Saskatoon Cancer Center-Clinical Research Department ( Site 0520)	Saskatoon	Saskatchewan
Canada	Princess Margaret Cancer Centre ( Site 0510)	Toronto	Ontario
Canada	Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0509)	Toronto	Ontario
Canada	BC Cancer Vancouver-Clinical Trials Unit ( Site 0518)	Vancouver	British Columbia
Chile	Bradfordhill-Clinical Area ( Site 0603)	Santiago	Region M. De Santiago
Chile	FALP-UIDO ( Site 0602)	Santiago	Region M. De Santiago
Chile	Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0604)	Santiago	Region M. De Santiago
China	Beijing Cancer hospital ( Site 0715)	Beijing	Beijing
China	Beijing Obstetric and Gynecology Hospital ( Site 0740)	Beijing	Beijing
China	Peking University First Hospital ( Site 0723)	Beijing	Beijing
China	Binzhou Medical University Hospital-Oncology department ( Site 0735)	Binzhou	Shandong
China	The First Hospital of Jilin University ( Site 0705)	Changchun	Jilin
China	Hunan Cancer Hospital ( Site 0709)	Changsha	Hunan
China	Xiangya Hospital Central South University-Gynecology ( Site 0708)	Changsha	Hunan
China	West China Second University Hospital Sichuan University ( Site 0701)	Chengdu	Sichuan
China	2nd Affiliated Hospital Chongqing Medical Universi ( Site 0745)	Chongqing	Chongqing
China	Southwest Hospital of Third Military Medical University ( Site 0719)	Chongqing	Chongqing
China	Fuling Central Hospital ( Site 0733)	Fulingqu	Chongqing
China	Fujian Provincial Cancer Hospital ( Site 0720)	Fuzhou	Fujian
China	SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0710)	Guangzhou	Guangdong
China	Hainan General Hospital ( Site 0703)	Haikou	Hainan
China	The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0726)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital-Oncology ( Site 0700)	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital ( Site 0711)	Harbin	Heilongjiang
China	Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0730)	Hefei	Anhui
China	Yunnan Province Cancer Hospital-Gynecology Department ( Site 0721)	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University ( Site 0729)	Nanchang	Jiangxi
China	Jiangsu Province Hospital-Oncology Department ( Site 0707)	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 0704)	Nanning	Guangxi
China	Obstetrics & Gynecology Hospital of Fudan University ( Site 0702)	Shanghai	Shanghai
China	Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0717)	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College ( Site 0732)	Shantou	Guangdong
China	Tianjin Medical University Cancer Institute and Hospital ( Site 0706)	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0725)	Wenzhou	Zhejiang
China	Wuhan Union Hospital-Medical Oncology ( Site 0716)	Wuhan	Hubei
China	Shaanxi Provincial Cancer Hospital ( Site 0714)	XI An	Shaanxi
China	Affiliated Hospital of Guangdong Medical College ( Site 0731)	Zhanjiang	Guangdong
China	Henan Cancer Hospital ( Site 0713)	Zhengzhou	Henan
Czechia	Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 0404)	Brno	Brno-mesto
Czechia	Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 0406)	Nový Jiín	Novy Jicin
Czechia	Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0402)	Olomouc	Olomoucky Kraj
Czechia	Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 0403)	Ostrava	Moravskoslezsky Kraj
Czechia	Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 0401)	Praha	Praha 8
Czechia	Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 0405)	Praha	Praha 2
Czechia	Fakultni nemocnice Kralovske Vinohrady-Gynekologicko-porodnická klinika ( Site 0408)	Praha 10
Czechia	Nemocnice Tomase Bati ve Zline-Onkologické oddelení ( Site 0407)	Zlín	Zlinsky Kraj
Denmark	Aalborg Universitetshospital, Syd ( Site 0905)	Aalborg	Nordjylland
Denmark	Herlev and Gentofte Hospital ( Site 0902)	Copenhagen	Hovedstaden
Denmark	Rigshospitalet ( Site 0903)	Copenhagen	Hovedstaden
Denmark	Roskilde Sygehus-Oncology department ( Site 0904)	Roskilde	Sjaelland
Finland	Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1003)	Helsinki	Uusimaa
Finland	Kuopion Yliopistollinen Sairaala ( Site 1002)	Kuopio	Pohjois-Savo
Finland	Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1001)	Tampere	Pirkanmaa
Germany	Charité Campus Virchow-Klinikum ( Site 1103)	Berlin
Germany	Universitätsklinikum Bonn-Gynaecological oncology ( Site 1105)	Bonn	Nordrhein-Westfalen
Germany	Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur	Dresden	Sachsen
Germany	Universitaetsklinikum Ulm ( Site 1106)	Ulm	Baden-Wurttemberg
Hungary	Országos Onkológiai Intézet-Ngyógyászat ( Site 1201)	Budapest
Ireland	Bon Secours Cork Hospital ( Site 1305)	Cork
Ireland	St. James's Hospital-Cancer clinical trials office ( Site 1301)	Dublin
Israel	Soroka Medical Center ( Site 1403)	Be'er Sheva
Israel	Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)	Haifa
Israel	Edith Wolfson Medical Center-Obstetrics & Gynecology ( Site 1405)	Holon
Israel	Shaare Zedek Medical Center ( Site 1404)	Jerusalem
Israel	Sheba Medical Center ( Site 1401)	Ramat Gan
Italy	IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1503)	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1509)	Firenze	Toscana
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1513)	Meldola	Emilia-Romagna
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 150	Milan	Lombardia
Italy	Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1506)	Milano
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 1	Napoli	Campania
Italy	Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 1502)	Roma	Lazio
Italy	Istituto Nazionale Tumori Regina Elena-Oncologia Medica 1 ( Site 1504)	Rome	Roma
Italy	Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 1514)	Torino	Piemonte
Italy	AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 1510)	Vicenza	Veneto
Japan	National Cancer Center Hospital ( Site 1607)	Chuo-ku	Tokyo
Japan	Niigata University Medical & Dental Hospital ( Site 1613)	Chuo-ku, Niigata	Niigata
Japan	National Hospital Organization Kyushu Cancer Center ( Site 1608)	Fukuoka
Japan	Saitama Medical University International Medical Center ( Site 1605)	Hidaka-shi	Saitama
Japan	National Cancer Center Hospital East ( Site 1604)	Kashiwa	Chiba
Japan	Japanese Foundation for Cancer Research ( Site 1616)	Koto	Tokyo
Japan	Kurume University Hospital ( Site 1612)	Kurume	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center ( Site 1611)	Matsuyama	Ehime
Japan	The Jikei University Hospital ( Site 1615)	Minato-ku	Tokyo
Japan	Shizuoka Cancer Center ( Site 1609)	Nagaizumi-cho,Sunto-gun	Shizuoka
Japan	Osaka International Cancer Institute ( Site 1617)	Osaka
Japan	Gunma Prefectural Cancer Center-Gynecology ( Site 1603)	Ota	Gunma
Japan	Hokkaido University Hospital ( Site 1601)	Sapporo	Hokkaido
Japan	Keio university hospital ( Site 1606)	Shinjyuku-ku	Tokyo
Japan	Iwate Medical University Hospital ( Site 1602)	Shiwa-gun Yahaba-cho	Iwate
Japan	Ehime University Hospital ( Site 1614)	Toon	Ehime
Japan	Tsukuba University Hospital ( Site 1618)	Tsukuba	Ibaraki
Korea, Republic of	Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2303)	Seoul
Korea, Republic of	Gangnam Severance Hospital ( Site 2304)	Seoul
Korea, Republic of	Seoul National University Hospital ( Site 2302)	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2301)	Seoul
Netherlands	Amsterdam UMC, locatie AMC ( Site 1706)	Amsterdam	Noord-Holland
Netherlands	Catharina Ziekenhuis-Oncology ( Site 1704)	Eindhoven	Noord-Brabant
Netherlands	University Medical Center Groningen ( Site 1707)	Groningen
Netherlands	Leids Universitair Medisch Centrum-Medical Oncology ( Site 1702)	Leiden	Zuid-Holland
Netherlands	Maastricht UMC+ ( Site 1709)	Maastricht	Limburg
Netherlands	Radboudumc-Medical Oncology ( Site 1703)	Nijmegen	Gelderland
Netherlands	Erasmus Medisch Centrum-Medical Oncology ( Site 1701)	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1705)	Utrecht
New Zealand	Auckland City Hospital-Cancer & Blood Research ( Site 1801)	Auckland
Norway	Oslo universitetssykehus, Radiumhospitalet ( Site 1901)	Oslo
Poland	Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2003)	Bialystok	Podlaskie
Poland	Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 20	Gliwice	Slaskie
Poland	Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2010)	Kielce	Swietokrzyskie
Poland	Centrum Onkologii Ziemi Lubelskiej ( Site 2006)	Lublin	Lubelskie
Poland	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit	Poznan	Wielkopolskie
Poland	Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2007)	Siedlce	Mazowieckie
Poland	Szpital Kliniczny im. Ksieznej Anny Mazowieckiej ( Site 2009)	Warsaw	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit	Warszawa	Mazowieckie
Russian Federation	Moscow City Oncology Hospital #62 ( Site 2204)	Krasnogorsk	Moskovskaya Oblast
Russian Federation	Yaroslavl Regional Cancer Hospital-Oncology ( Site 2202)	Yaroslavl	Yaroslavskaya Oblast
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2405)	A Coruña	La Coruna
Spain	Hospital Universitari Vall d'Hebron ( Site 2403)	Barcelona
Spain	Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2406)	Hospitalet	Barcelona
Spain	Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2402)	Madrid	Madrid, Comunidad De
Spain	COMPLEJO HOSPITALARIO DE NAVARRA ( Site 2407)	Pamplona	Navarra
Spain	HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2401)	Sevilla
Spain	Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2404)	Valencia	Valenciana, Comunitat
Sweden	Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2504)	Lund	Skane Lan
Sweden	Karolinska Universitetssjukhuset Solna ( Site 2502)	Solna	Stockholms Lan
Sweden	Norrlands universitetssjukhus-Cancercentrum ( Site 2503)	Umeå	Vasterbottens Lan
Taiwan	Taichung Veterans General Hospital ( Site 2602)	Taichung
Taiwan	NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2604)	Tainan
Taiwan	Mackay Memorial Hospital ( Site 2601)	Taipei
Taiwan	National Taiwan University Hospital ( Site 2603)	Taipei
Taiwan	Taipei Veterans General Hospital ( Site 2605)	Taipei
Turkey	Ankara Bilkent Sehir Hastanesi-Medical Oncology ( Site 2706)	Ankara
Turkey	Hacettepe Universite Hastaneleri-oncology hospital ( Site 2704)	Ankara
Turkey	Akdeniz Universitesi Hastanesi ( Site 2701)	Antalya
Turkey	Istanbul Universitesi Cerrahpasa ( Site 2702)	Fatih	Istanbul
Turkey	Istanbul University Capa Campus-department of obstetrics and gynaecology ( Site 2705)	Istanbul
Turkey	T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma	Istanbul
United Kingdom	The Beatson West of Scotland Cancer Centre ( Site 2805)	Glasgow	Glasgow City
United Kingdom	Hammersmith Hospital-Medical Oncology ( Site 2808)	London	London, City Of
United Kingdom	ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2806)	London	London, City Of
United Kingdom	St Bartholomew's Hospital ( Site 2804)	London	England
United Kingdom	The Christie ( Site 2807)	Manchester	England
United States	Northside Hospital ( Site 0017)	Atlanta	Georgia
United States	Texas Oncology - Austin-USOR Texas Oncology - Austin ( Site 8003)	Austin	Texas
United States	Sanford Medical Center ( Site 0054)	Bismarck	North Dakota
United States	University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039)	Cincinnati	Ohio
United States	The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C	Columbus	Ohio
United States	Texas Oncology - Dallas-USOR Texas Oncology - Dallas (Sammons) ( Site 8005)	Dallas	Texas
United States	Karmanos Cancer Institute ( Site 0029)	Detroit	Michigan
United States	Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055)	Fargo	North Dakota
United States	John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026)	Hackensack	New Jersey
United States	St. Vincent Hospital and Health Care Center, Inc ( Site 0006)	Indianapolis	Indiana
United States	St. Dominic's Hospital ( Site 0024)	Jackson	Mississippi
United States	Moores Cancer Center ( Site 0037)	La Jolla	California
United States	Baptist Health Lexington ( Site 0042)	Lexington	Kentucky
United States	Mount Sinai Cancer Center ( Site 0018)	Miami Beach	Florida
United States	Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai ( Site 0052)	New York	New York
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016)	New York	New York
United States	Memorial Sloan Kettering Cancer Center ( Site 0009)	New York	New York
United States	The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023)	New York	New York
United States	Southeastern Regional Medical Center ( Site 0046)	Newnan	Georgia
United States	Sidney Kimmel Cancer Center - Jefferson Health ( Site 0053)	Philadelphia	Pennsylvania
United States	HonorHealth-USOR HonorHealth ( Site 8000)	Phoenix	Arizona
United States	FirstHealth Clinical Trials ( Site 0050)	Pinehurst	North Carolina
United States	AHN West Penn Hospital ( Site 0011)	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034)	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Center ( Site 0031)	Portland	Oregon
United States	VCU Health Adult Outpatient Pavillion ( Site 0022)	Richmond	Virginia
United States	Kaiser Permanente Riverside Medical Center ( Site 0045)	Riverside	California
United States	Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)	Rockville	Maryland
United States	Sarasota Memorial Hospital ( Site 0005)	Sarasota	Florida
United States	Sanford Cancer Center-Gynecologic Oncology ( Site 0002)	Sioux Falls	South Dakota
United States	Texas Oncology - Tyler-USOR Texas Oncology - Northeast Texas ( Site 8004)	Tyler	Texas
United States	Asplundh Cancer Pavilion ( Site 0014)	Willow Grove	Pennsylvania
United States	University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008)	Worcester	Massachusetts
United States	Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)	Zion	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC	European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  Denmark,  Finland,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (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 (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by BICR will be reported for participants.	Up to approximately 45 months
Primary	Overall Survival	OS is defined as the time from randomization to death due to any cause. The OS will be reported for all participants.	Up to approximately 59 months
Secondary	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.	Up to approximately 45 months
Secondary	Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	DCR is defined, per RECIST 1.1, as the percentage of participants who have achieved Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or demonstrated Stable Disease (SD) for at least 24 weeks. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.) The DCR as assessed by BICR will be presented.	Up to approximately 45 months
Secondary	Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	DOR is defined as the time from first documented evidence of CR or PR until the first documented date of disease progression (PD) or death due to any cause, whichever occurs first, for participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.	Up to approximately 45 months
Secondary	Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator	PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by investigator will be reported for participants.	Up to approximately 45 months
Secondary	Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator	PFS2 is defined as the time from randomization to subsequent disease progression (PD) per RECIST 1.1 after initiation of a new anticancer therapy, or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by investigator will be reported for participants.	Up to approximately 45 months
Secondary	Number of Participants Who Experience at Least One 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.	Up to approximately 27 months
Secondary	Number of Participants Who Discontinue Study Treatment Due to 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.	Up to approximately 24 months
Secondary	Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" 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. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.	Baseline and up to approximately 25 months
Secondary	Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.	Baseline and up to approximately 25 months

External Links

•   Merck Clinical Trial Information
•   Plain Language Summary