Spots Global Cancer Trial Database for Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
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Trial Identification
Brief Title: Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
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)
Study ID: NCT05116189
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
HonorHealth ( Site 0041), Phoenix, Arizona, United States
Marin Cancer Care ( Site 0055), Greenbrae, California, United States
Pacific Cancer Care ( Site 0028), Monterey, California, United States
Eisenhower Medical Center ( Site 0067), Rancho Mirage, California, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004), New Haven, Connecticut, United States
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054, Gainesville, Florida, United States
Sarasota Memorial Hospital ( Site 0018), Sarasota, Florida, United States
Moffitt Cancer Center ( Site 0033), Tampa, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005), Marietta, Georgia, United States
Advocate Medical Group-Oncology ( Site 0049), Park Ridge, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0027), Fort Wayne, Indiana, United States
St. Vincent Hospital and Health Care Center, Inc ( Site 0032), Indianapolis, Indiana, United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040), Edgewood, Kentucky, United States
WK Physicians Network / Hematology Oncology Associates ( Site 0034), Shreveport, Louisiana, United States
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015), Baltimore, Maryland, United States
University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003), Worcester, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007), Hackensack, New Jersey, United States
Roswell Park Cancer Institute ( Site 0039), Buffalo, New York, United States
Columbia University Medical Center ( Site 0010), New York, New York, United States
Novant Health Presbyterian Medical Center ( Site 0029), Charlotte, North Carolina, United States
Duke Cancer Institute ( Site 0038), Durham, North Carolina, United States
Novant Health Forsyth Medical Center ( Site 0057), Winston-Salem, North Carolina, United States
Aultman Hospital-Oncology Clinical Trials ( Site 0009), Canton, Ohio, United States
MetroHealth Medical Center-Cancer Care Center ( Site 0047), Cleveland, Ohio, United States
Providence Portland Medical Center ( Site 0048), Portland, Oregon, United States
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024), Pittsburgh, Pennsylvania, United States
Sanford Cancer Center ( Site 0064), Sioux Falls, South Dakota, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0058), Germantown, Tennessee, United States
Texas Oncology - Dallas (Presbyterian) ( Site 0065), Dallas, Texas, United States
Texas Oncology - The Woodlands_Lee ( Site 0043), The Woodlands, Texas, United States
Inova Schar Cancer Institute ( Site 0019), Fairfax, Virginia, United States
Westmead Hospital-Department of Gynaecological Oncology ( Site 0201), Westmead, New South Wales, 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
Institut Jules Bordet-Medicine Oncology ( Site 0302), Bruxelles, Bruxelles-Capitale, Region De, Belgium
UZ Gent-Medical oncology ( Site 0301), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0303), Leuven, Vlaams-Brabant, Belgium
AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305), Kortrijk, West-Vlaanderen, Belgium
Hospital Araújo Jorge ( Site 0401), Goiânia, Goias, Brazil
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404), Natal, Rio Grande Do Norte, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0408), Lages, Santa Catarina, 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, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402), Rio de Janeiro, , Brazil
Tom Baker Cancer Center ( Site 0511), Calgary, Alberta, Canada
BC Cancer Abbotsford ( Site 0512), Abbotsford, British Columbia, Canada
BC Cancer Victoria ( Site 0513), Victoria, British Columbia, Canada
Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog, Kingston, Ontario, Canada
Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508), Toronto, 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
Saskatoon Cancer Center ( Site 0510), Saskatoon, Saskatchewan, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Quebec, , Canada
James Lind Centro de Investigación del Cáncer ( Site 0602), Temuco, Araucania, Chile
CIDO SpA-Oncology ( Site 0608), Temuco, Araucania, Chile
Clínica Puerto Montt ( Site 0601), Puerto Montt, Los Lagos, Chile
Oncovida ( Site 0603), Santiago, Region M. De Santiago, Chile
Instituto de Radiomedicina-hemato-oncologia ( Site 0604), Santiago, Region M. De Santiago, Chile
Clínica Vespucio-Hemato - Ocology ( Site 0607), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609), Santiago, Region M. De Santiago, Chile
Bradfordhill ( Site 0605), Santiago, Region M. De Santiago, Chile
Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709), Hefei, Anhui, China
Beijing Cancer hospital ( Site 0711), Beijing, Beijing, China
Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702), Beijing, Beijing, China
Fujian Provincial Cancer Hospital ( Site 0713), Fuzhou, Fujian, China
Lanzhou university second hospital ( Site 0734), Lanzhou, Gansu, China
Zhujiang Hospital ( Site 0739), Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University ( Site 0743), Zhanjiang, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 0717), Nanning, Guangxi, China
Hainan General Hospital ( Site 0736), Haikou, Hainan, China
Henan Cancer Hospital ( Site 0718), Zhengzhou, Henan, China
Wuhan Union Hospital-Medical Oncology ( Site 0735), Wuhan, Hubei, China
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708), Wuhan, Hubei, China
Xiangya Hospital Central South University-Gynecology ( Site 0705), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0704), Changsha, Hunan, 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
Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716), Nanchang, Jiangxi, China
The First Hospital of Jilin University ( Site 0710), Changchun, Jilin, China
Shandong Cancer Hospital-Oncology Department ( Site 0733), Jinan, Shandong, China
LinYi Cancer Hospital ( Site 0731), Linyi, Shandong, China
Obstetrics & Gynecology Hospital of Fudan University ( Site 0715), Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701), Shanghai, Shanghai, China
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744), Shanghai, Shanghai, China
West China Second University Hospital Sichuan University ( Site 0740), Chengdu, Sichuan, China
Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737), Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital ( Site 0720), Tianjin, Tianjin, China
Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714), Kunming, Yunnan, China
The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741), Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706), Wenzhou, Zhejiang, China
Fundación Colombiana de Cancerología Clínica Vida ( Site 0808), Medellin, Antioquia, 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
Oncologos del Occidente ( Site 0807), Pereira, Risaralda, Colombia
Hemato Oncologos SA ( Site 0801), Cali, Valle Del Cauca, Colombia
Aalborg Universitetshospital, Syd ( Site 0901), Aalborg, Nordjylland, Denmark
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001), Turku, Varsinais-Suomi, Finland
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
Institut Curie - site Saint-Cloud ( Site 2909), Saint-Cloud, Hauts-de-Seine, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901), Rennes, Ille-et-Vilaine, 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
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205), Erlangen, Bayern, Germany
Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203), Bonn, Nordrhein-Westfalen, Germany
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204), Düsseldorf, Nordrhein-Westfalen, Germany
Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207), Krefeld, Nordrhein-Westfalen, Germany
CaritasKlinikum Saarbrücken St. Theresia ( Site 1211), Saarbrücken, Saarland, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur, Dresden, Sachsen, Germany
Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213), Leipzig, Sachsen, Germany
Charité Campus Virchow-Klinikum ( Site 1201), Berlin, , Germany
Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214), Hamburg, , Germany
St. James's Hospital-Cancer clinical trials office ( Site 2821), Dublin, , Ireland
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, , Israel
IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501), Bologna, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503), Milan, Lombardia, Italy
Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508), Monza, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 1505), Milan, Milano, Italy
Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507), Torino, Piemonte, Italy
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504), Brescia, , Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502), Milano, , Italy
Aichi Cancer Center Hospital ( Site 1610), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 1609), Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 1603), Matsuyama, Ehime, Japan
Ehime University Hospital ( Site 1606), Toon, Ehime, Japan
Kurume University Hospital ( Site 1607), Kurume, Fukuoka, Japan
Hokkaido University Hospital ( Site 1604), Sapporo, Hokkaido, Japan
Iwate Medical University Hospital ( Site 1613), Shiwa-gun Yahaba-cho, Iwate, Japan
Nippon Medical School Musashi Kosugi Hospital ( Site 1614), Kawasaki, Kanagawa, Japan
Saitama Medical University International Medical Center ( Site 1601), Hidaka-shi, Saitama, Japan
Shizuoka Cancer Center ( Site 1611), Nagaizumi, Shizuoka, Japan
National Cancer Center Hospital ( Site 1612), Chuo-ku, Tokyo, Japan
Japanese Foundation for Cancer Research ( Site 1605), Koto, Tokyo, Japan
Osaka International Cancer Institute ( Site 1602), Osaka, , Japan
Seoul National University Hospital ( Site 2302), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303), Seoul, , 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
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, , Mexico
Radboudumc ( Site 1802), Nijmegen, Gelderland, Netherlands
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801), Leiden, Zuid-Holland, Netherlands
Erasmus Medisch Centrum-Medical Oncology ( Site 1803), Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804), Utrecht, , Netherlands
Auckland City Hospital ( Site 1901), Auckland, , New Zealand
Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001), Tromsø, Troms, Norway
Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103), Warsaw, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit, Warszawa, Mazowieckie, 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, Gdańsk, 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 Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit, Poznan, Wielkopolskie, Poland
Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Ogarev Mordovia State University ( Site 2209), Saransk, Mordoviya, Respublika, 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
SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216), Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
cukurova universty ( Site 2706), Sarçam, Adana, Turkey
Istanbul Universitesi Cerrahpasa ( Site 2709), Fatih, Istanbul, Turkey
Ege University Medicine of Faculty ( Site 2702), Bornova, Izmir, 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
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
Brighton and Sussex University Hospitals NHS Trust ( Site 2803), East Sussex, Brighton And Hove, United Kingdom
Addenbrooke's Hospital ( Site 2808), Cambridge, Cambridgeshire, United Kingdom
The Royal Cornwall Hospital ( Site 2804), Truro, Cornwall, United Kingdom
Westmorland General Hospital ( Site 2815), Kendal, Cumbria, United Kingdom
Ninewells Hospital and Medical School ( Site 2826), Dundee, Dundee City, 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
Velindre Cancer Centre ( Site 2805), Cardiff, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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