Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)

Ovarian Cancer Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05116189
• Other study ID #: 3475-B96
• Secondary ID: MK-3475-B96KEYNO
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 13, 2021
• Est. completion date: August 31, 2027

Study information

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

Clinical Trial Summary

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 616
• Est. completion date: August 31, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

• Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-PD-1/anti-PD-L1 therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.

• Has provided documented informed consent for the study.

• Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease).

• Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization.

• For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of <1% per year).

• Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the local site investigator.

• Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided.

• Have adequate organ function.

Exclusion Criteria:

• Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.

• Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy.

• Has prior disease progression on weekly paclitaxel alone.

• Has received >2 prior lines of systemic therapy for OC.

• Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization.

• Has received prior radiation therapy within 2 weeks of start of study intervention.

• Has not recovered adequately from surgery and/or any complications from the surgery.

• Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor,[GM-CSF] or recombinant erythropoietin) within 4 weeks before randomization.

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

• Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention.

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.

• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Has severe hypersensitivity (=Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients.

• Has an active autoimmune disease that has required systemic treatment in the 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 a known history of Hepatitis B or known active Hepatitis C virus infection.

• Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.

• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

• Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.

• Has had an allogenic tissue/solid organ transplant.

For bevacizumab treatment

• Has uncontrolled hypertension.

• Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.

• Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• Pembrolizumab
IV infusion

Drug:
• Paclitaxel
IV infusion
• Bevacizumab
IV infusion

Other:
• Placebo for pembrolizumab
IV infusion

Drug:
• Docetaxel
IV infusion

Locations

Country	Name	City	State
Australia	Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)	Brisbane	Queensland
Australia	Epworth Freemasons ( Site 0204)	Melbourne	Victoria
Australia	St. John of God Subiaco Hospital ( Site 0203)	Subiaco	Western Australia
Australia	Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)	Westmead	New South Wales
Belgium	Institut Jules Bordet-Medicine Oncology ( Site 0302)	Bruxelles	Bruxelles-Capitale, Region De
Belgium	UZ Gent-Medical oncology ( Site 0301)	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)	Kortrijk	West-Vlaanderen
Belgium	UZ Leuven ( Site 0303)	Leuven	Vlaams-Brabant
Brazil	Hospital Araújo Jorge ( Site 0401)	Goiânia	Goias
Brazil	ANIMI - Unidade de Tratamento Oncologico ( Site 0408)	Lages	Santa Catarina
Brazil	Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)	Natal	Rio Grande Do Norte
Brazil	Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)	Rio de Janeiro
Brazil	BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)	São Paulo	Sao Paulo
Brazil	Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)	São Paulo	Sao Paulo
Canada	BC Cancer Abbotsford ( Site 0512)	Abbotsford	British Columbia
Canada	Tom Baker Cancer Center ( Site 0511)	Calgary	Alberta
Canada	Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog	Kingston	Ontario
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)	Montreal	Quebec
Canada	Jewish General Hospital ( Site 0505)	Montreal	Quebec
Canada	McGill University Health Centre ( Site 0502)	Montréal	Quebec
Canada	Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0	Quebec
Canada	Saskatoon Cancer Center ( Site 0510)	Saskatoon	Saskatchewan
Canada	Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)	Toronto	Ontario
Canada	BC Cancer Victoria ( Site 0513)	Victoria	British Columbia
Chile	Clínica Puerto Montt ( Site 0601)	Puerto Montt	Los Lagos
Chile	Bradfordhill ( Site 0605)	Santiago	Region M. De Santiago
Chile	Clínica Vespucio-Hemato - Ocology ( Site 0607)	Santiago	Region M. De Santiago
Chile	Instituto de Radiomedicina-hemato-oncologia ( Site 0604)	Santiago	Region M. De Santiago
Chile	Oncovida ( Site 0603)	Santiago	Region M. De Santiago
Chile	Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)	Santiago	Region M. De Santiago
Chile	CIDO SpA-Oncology ( Site 0608)	Temuco	Araucania
Chile	James Lind Centro de Investigación del Cáncer ( Site 0602)	Temuco	Araucania
China	Beijing Cancer hospital ( Site 0711)	Beijing	Beijing
China	Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)	Beijing	Beijing
China	The First Hospital of Jilin University ( Site 0710)	Changchun	Jilin
China	Hunan Cancer Hospital ( Site 0704)	Changsha	Hunan
China	Xiangya Hospital Central South University-Gynecology ( Site 0705)	Changsha	Hunan
China	West China Second University Hospital Sichuan University ( Site 0740)	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital ( Site 0713)	Fuzhou	Fujian
China	Zhujiang Hospital ( Site 0739)	Guangzhou	Guangdong
China	Hainan General Hospital ( Site 0736)	Haikou	Hainan
China	The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)	Hangzhou	Zhejiang
China	Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)	Hefei	Anhui
China	Shandong Cancer Hospital-Oncology Department ( Site 0733)	Jinan	Shandong
China	Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)	Kunming	Yunnan
China	Lanzhou university second hospital ( Site 0734)	Lanzhou	Gansu
China	LinYi Cancer Hospital ( Site 0731)	Linyi	Shandong
China	Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University ( Site 0723)	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)	Shanghai	Shanghai
China	Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)	Shanghai	Shanghai
China	Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)	Shanghai	Shanghai
China	Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital ( Site 0720)	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)	Wenzhou	Zhejiang
China	Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)	Wuhan	Hubei
China	Wuhan Union Hospital-Medical Oncology ( Site 0735)	Wuhan	Hubei
China	Affiliated Hospital of Guangdong Medical University ( Site 0743)	Zhanjiang	Guangdong
China	Henan Cancer Hospital ( Site 0718)	Zhengzhou	Henan
Colombia	Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)	Barranquilla	Atlantico
Colombia	Clínica Universitaria Colombia ( Site 0806)	Bogotá	Distrito Capital De Bogota
Colombia	Hemato Oncologos SA ( Site 0801)	Cali	Valle Del Cauca
Colombia	Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)	Medellin	Antioquia
Colombia	Oncologos del Occidente ( Site 0807)	Pereira	Risaralda
Denmark	Aalborg Universitetshospital, Syd ( Site 0901)	Aalborg	Nordjylland
Finland	Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)	Turku	Varsinais-Suomi
France	Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi	Brest	Bretagne
France	Centre François Baclesse-Recherche clinique ( Site 2904)	Caen	Calvados
France	Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)	Limoges	Haute-Vienne
France	Centre de Cancérologie du Grand Montpellier ( Site 2908)	Montpellier	Languedoc-Roussillon
France	Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)	Nantes	Loire-Atlantique
France	Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)	Rennes	Ille-et-Vilaine
France	Institut Curie - site Saint-Cloud ( Site 2909)	Saint-Cloud	Hauts-de-Seine
Germany	Charité Campus Virchow-Klinikum ( Site 1201)	Berlin
Germany	Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)	Bonn	Nordrhein-Westfalen
Germany	Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur	Dresden	Sachsen
Germany	Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)	Düsseldorf	Nordrhein-Westfalen
Germany	Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)	Erlangen	Bayern
Germany	Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)	Hamburg
Germany	Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)	Krefeld	Nordrhein-Westfalen
Germany	Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)	Leipzig	Sachsen
Germany	CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)	Saarbrücken	Saarland
Ireland	St. James's Hospital-Cancer clinical trials office ( Site 2821)	Dublin
Israel	Emek Medical Center-Gyn-Onc ( Site 1406)	Afula
Israel	Soroka Medical Center ( Site 1404)	Be'er Sheva
Israel	Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)	Haifa
Israel	Shaare Zedek Medical Center ( Site 1405)	Jerusalem
Israel	Rabin Medical Center ( Site 1401)	Petah-Tikva
Israel	Sheba Medical Center ( Site 1407)	Ramat Gan
Israel	Sourasky Medical Center ( Site 1403)	Tel Aviv
Italy	IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)	Brescia
Italy	ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)	Milan	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)	Milan	Lombardia
Italy	Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)	Milano
Italy	Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)	Monza	Lombardia
Italy	Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)	Torino	Piemonte
Japan	National Cancer Center Hospital ( Site 1612)	Chuo-ku	Tokyo
Japan	Saitama Medical University International Medical Center ( Site 1601)	Hidaka-shi	Saitama
Japan	National Cancer Center Hospital East ( Site 1609)	Kashiwa	Chiba
Japan	Nippon Medical School Musashi Kosugi Hospital ( Site 1614)	Kawasaki	Kanagawa
Japan	Japanese Foundation for Cancer Research ( Site 1605)	Koto	Tokyo
Japan	Kurume University Hospital ( Site 1607)	Kurume	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center ( Site 1603)	Matsuyama	Ehime
Japan	Shizuoka Cancer Center ( Site 1611)	Nagaizumi	Shizuoka
Japan	Aichi Cancer Center Hospital ( Site 1610)	Nagoya	Aichi
Japan	Osaka International Cancer Institute ( Site 1602)	Osaka
Japan	Hokkaido University Hospital ( Site 1604)	Sapporo	Hokkaido
Japan	Iwate Medical University Hospital ( Site 1613)	Shiwa-gun Yahaba-cho	Iwate
Japan	Ehime University Hospital ( Site 1606)	Toon	Ehime
Korea, Republic of	Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)	Seoul
Korea, Republic of	Gangnam Severance Hospital ( Site 2301)	Seoul
Korea, Republic of	Seoul National University Hospital ( Site 2302)	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)	Seoul
Mexico	Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)	La Paz	Baja California Sur
Mexico	COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)	Mexico City	Distrito Federal
Mexico	INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)	Mexico City	Distrito Federal
Mexico	iCan Oncology Center Centro Medico AVE ( Site 1704)	Monterrey	Nuevo Leon
Mexico	Centro de Investigacion Clinica de Oaxaca ( Site 1705)	Oaxaca
Netherlands	Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)	Leiden	Zuid-Holland
Netherlands	Radboudumc ( Site 1802)	Nijmegen	Gelderland
Netherlands	Erasmus Medisch Centrum-Medical Oncology ( Site 1803)	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)	Utrecht
New Zealand	Auckland City Hospital ( Site 1901)	Auckland
Norway	Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)	Tromsø	Troms
Poland	Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)	Bialystok	Podlaskie
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)	Bialystok	Podlaskie
Poland	Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi	Gdansk	Pomorskie
Poland	Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21	Gliwice	Slaskie
Poland	Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)	Kielce	Swietokrzyskie
Poland	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit	Poznan	Wielkopolskie
Poland	Szpital Kliniczny im. Ksieznej Anny Mazowieckiej ( Site 2103)	Warsaw	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit	Warszawa	Mazowieckie
Russian Federation	Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary	Chelyabinsk	Chelyabinskaya Oblast
Russian Federation	SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)	Ekaterinburg	Sverdlovskaya Oblast
Russian Federation	Moscow City Oncology Hospital #62 ( Site 2214)	Krasnogorsk D-t	Moskovskaya Oblast
Russian Federation	Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)	Moscow	Moskva
Russian Federation	Ogarev Mordovia State University ( Site 2209)	Saransk	Mordoviya, Respublika
Turkey	Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)	Adana
Turkey	Ankara University Hospital Cebeci ( Site 2701)	Ankara
Turkey	Baskent Universitesi Ankara Hastanesi ( Site 2707)	Ankara
Turkey	Ege University Medicine of Faculty ( Site 2702)	Bornova	Izmir
Turkey	Istanbul Universitesi Cerrahpasa ( Site 2709)	Fatih	Istanbul
Turkey	Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)	Istanbul
Turkey	T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma	Istanbul
Turkey	cukurova universty ( Site 2706)	Sarçam	Adana
United Kingdom	Addenbrooke's Hospital ( Site 2808)	Cambridge	Cambridgeshire
United Kingdom	Velindre Cancer Centre ( Site 2805)	Cardiff
United Kingdom	Ninewells Hospital and Medical School ( Site 2826)	Dundee	Dundee City
United Kingdom	Brighton and Sussex University Hospitals NHS Trust ( Site 2803)	East Sussex	Brighton And Hove
United Kingdom	Westmorland General Hospital ( Site 2815)	Kendal	Cumbria
United Kingdom	Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)	Leicester	England
United Kingdom	Hammersmith Hospital-Medical Oncology ( Site 2818)	London	London, City Of
United Kingdom	The Royal Cornwall Hospital ( Site 2804)	Truro	Cornwall
United States	Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)	Baltimore	Maryland
United States	Roswell Park Cancer Institute ( Site 0039)	Buffalo	New York
United States	Aultman Hospital-Oncology Clinical Trials ( Site 0009)	Canton	Ohio
United States	Novant Health Presbyterian Medical Center ( Site 0029)	Charlotte	North Carolina
United States	MetroHealth Medical Center-Cancer Care Center ( Site 0047)	Cleveland	Ohio
United States	Texas Oncology - Dallas (Presbyterian) ( Site 0065)	Dallas	Texas
United States	Duke Cancer Institute ( Site 0038)	Durham	North Carolina
United States	Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)	Edgewood	Kentucky
United States	Inova Schar Cancer Institute ( Site 0019)	Fairfax	Virginia
United States	Parkview Research Center at Parkview Regional Medical Center ( Site 0027)	Fort Wayne	Indiana
United States	University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054	Gainesville	Florida
United States	The West Clinic, PLLC dba West Cancer Center ( Site 0058)	Germantown	Tennessee
United States	Marin Cancer Care ( Site 0055)	Greenbrae	California
United States	John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)	Hackensack	New Jersey
United States	St. Vincent Hospital and Health Care Center, Inc ( Site 0032)	Indianapolis	Indiana
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)	Marietta	Georgia
United States	Pacific Cancer Care ( Site 0028)	Monterey	California
United States	Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)	New Haven	Connecticut
United States	Columbia University Medical Center ( Site 0010)	New York	New York
United States	Advocate Medical Group-Oncology ( Site 0049)	Park Ridge	Illinois
United States	HonorHealth ( Site 0041)	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Center ( Site 0048)	Portland	Oregon
United States	Eisenhower Medical Center ( Site 0067)	Rancho Mirage	California
United States	Sarasota Memorial Hospital ( Site 0018)	Sarasota	Florida
United States	WK Physicians Network / Hematology Oncology Associates ( Site 0034)	Shreveport	Louisiana
United States	Sanford Cancer Center ( Site 0064)	Sioux Falls	South Dakota
United States	Moffitt Cancer Center ( Site 0033)	Tampa	Florida
United States	Texas Oncology - The Woodlands_Lee ( Site 0043)	The Woodlands	Texas
United States	Novant Health Forsyth Medical Center ( Site 0057)	Winston-Salem	North Carolina
United States	University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Denmark,  Finland,  France,  Germany,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Russian Federation,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator	PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment 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 the Investigator will be presented.	Up to ~38 months
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.	Up to ~64 months
Secondary	PFS per RECIST 1.1 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 blinded independent central review assessment 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 blinded independent central review will be presented.	Up to ~38 months
Secondary	Number of Participants who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.	Up to ~64 months
Secondary	Number of Participants who Discontinue Study Treatment due to an AE	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.	Up to ~64 months
Secondary	Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization 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 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 ~64 months
Secondary	Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30	TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.	Up to ~64 months
Secondary	Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale	The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" 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 abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.	Baseline and up to ~64 months
Secondary	TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale	TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.	Up to ~64 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary