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)
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)
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.
Inclusion Criteria:
Exclusion Criteria:
For bevacizumab treatment
New Haven, Connecticut 06511, United States
Gainesville, Florida 32610, United States
Marietta, Georgia 30060, United States
Fort Wayne, Indiana 46845, United States
Indianapolis, Indiana 46260, United States
Edgewood, Kentucky 41017, United States
Shreveport, Louisiana 71103, United States
Baltimore, Maryland 21202, United States
Worcester, Massachusetts 01605, United States
Hackensack, New Jersey 07601, United States
Charlotte, North Carolina 28204, United States
Pittsburgh, Pennsylvania 15219, United States
Westmead, New South Wales 2145, Australia
Brussels, Bruxelles-Capitale, Region de 1000, Belgium
Natal, Rio Grande do Norte 59075-740, Brazil
Rio de Janeiro, 20220-410, Brazil
Kingston, Ontario K7L 2V7, Canada
Québec, Quebec G1J 1Z4, Canada
Santiago, Region M. de Santiago 7630370, Chile
Santiago, Region M. de Santiago 8330032, Chile
Beijing, Beijing Municipality 100730, China
Nanjing, Jiangsu 210000, China
Nanchang, Jiangxi 330006, China
Shanghai, Shanghai Municipality 200011, China
Shanghai, Shanghai Municipality 200032, China
Shanghai, Shanghai Municipality 201204, China
Tianjin, Tianjin Municipality 300052, China
Tianjin, Tianjin Municipality 300060, China
Hangzhou, Zhejiang 3100000, China
Wenzhou, Zhejiang 325000, China
Barranquilla, Atlántico 080020, Colombia
Turku, Southwest Finland 20521, Finland
Brest, Brittany Region 29200, France
Limoges, Haute-Vienne 87042, France
Rennes, Ille-et-Vilaine 35042, France
Montpellier, Languedoc-Roussillon 34070, France
Nantes, Loire-Atlantique 44277, France
Erlangen, Bavaria 91054, Germany
Bonn, North Rhine-Westphalia 53127, Germany
Düsseldorf, North Rhine-Westphalia 40225, Germany
Krefeld, North Rhine-Westphalia 47805, Germany
Dresden, Saxony 01307, Germany
Leipzig, Saxony 04103, Germany
Bologna, Emilia-Romagna 40138, Italy
Milan, 20141, Italy
Shiwa-gun Yahaba-cho, Iwate 028-3695, Japan
Hidaka-shi, Saitama 350-1200, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto, Tokyo 135-8550, Japan
La Paz, Baja California Sur 23040, Mexico
Mexico City, Mexico City 04700, Mexico
Leiden, South Holland 2333 ZA, Netherlands
Poznan, Greater Poland Voivodeship 61-848, Poland
Warsaw, Masovian Voivodeship 00-315, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Bialystok, Podlaskie Voivodeship 15-027, Poland
Bialystok, Podlaskie Voivodeship 15-276, Poland
Gdansk, Pomeranian Voivodeship 80-214, Poland
Gliwice, Silesian Voivodeship 44-101, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Chelyabinsk, Chelyabinsk Oblast 454087, Russia
Moscow, Moscow 115478, Russia
Krasnogorsk D-t, Moscow Oblast 143423, Russia
Yekaterinburg, Sverdlovsk Oblast 620905, Russia
Seoul, 03722, South Korea
Seoul, 05505, South Korea
Sarçam, Adana 01250, Turkey (Türkiye)
Adana, 01250, Turkey (Türkiye)
Istanbul, 34440, Turkey (Türkiye)
East Sussex, Brighton And Hove BN2 5BE, United Kingdom