Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
研究单位：[1]Merck Sharp & Dohme LLC[2]( Site 1072),Nashville,Tennessee,United States,37209[3]Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083),Anchorage,Alaska,United States,99503[4]Mayo Clinic in Arizona - Phoenix ( Site 1094),Phoenix,Arizona,United States,85054[5]Arizona Urology Specialists (AUS)-Professional Park ( Site 1096),Tucson,Arizona,United States,85704[6]UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro,Los Angeles,California,United States,90095[7]University of California Irvine Medical Center ( Site 1061),Orange,California,United States,92868[8]Genesis Research LLC ( Site 1065),Torrance,California,United States,90505[9]Colorado Clinical Research ( Site 1100),Lakewood,Colorado,United States,80228[10]Urological Research Network ( Site 1106),Hialeah,Florida,United States,33016[11]Mayo Clinic in Florida-Urology ( Site 1097),Jacksonville,Florida,United States,32224[12]University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056),Miami,Florida,United States,33136[13]Woodlands Medical Specialists, PA ( Site 8002),Pensacola,Florida,United States,32503[14]Emory School of Medicine ( Site 1076),Atlanta,Georgia,United States,30322[15]Advanced Urology ( Site 1092),Roswell,Georgia,United States,30076[16]Northwestern Memorial Hospital ( Site 1101),Chicago,Illinois,United States,60611[17]Wichita Urology Group ( Site 1086),Wichita,Kansas,United States,67226[18]Ochsner LSU Health Shreveport - Regional Urology ( Site 1099),Shreveport,Louisiana,United States,71106[19]Henry Ford Health System ( Site 1062),Detroit,Michigan,United States,48202[20]Michigan Institute of Urology ( Site 1077),Troy,Michigan,United States,48084[21]Coastal Urology Associates ( Site 1055),Brick,New Jersey,United States,08724[22]Morristown Medical Center ( Site 1090),Morristown,New Jersey,United States,07960[23]Rutgers Cancer Institute of New Jersey ( Site 1059),New Brunswick,New Jersey,United States,08903[24]St. Peter's Hospital Cancer Care Center ( Site 1087),Albany,New York,United States,12208[25]Monter Cancer Center ( Site 1080),Lake Success,New York,United States,11042[26]Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112),New York,New York,United States,10010[27]Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074),New York,New York,United States,10016[28]Associated Medical Professionals of NY ( Site 1078),Syracuse,New York,United States,13210[29]TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091),Cincinnati,Ohio,United States,45212[30]University Hospitals Cleveland Medical Center ( Site 1066),Cleveland,Ohio,United States,44106[31]Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10,Columbus,Ohio,United States,43210[32]OHSU Knight Cancer Institute ( Site 1075),Portland,Oregon,United States,97210[33]Oregon Urology Institute ( Site 1098),Springfield,Oregon,United States,97477[34]MidLantic Urology ( Site 1071),Bala-Cynwyd,Pennsylvania,United States,19004[35]Lancaster Urology ( Site 1079),Lancaster,Pennsylvania,United States,17604[36]University of Pennsylvania ( Site 1088),Philadelphia,Pennsylvania,United States,19104[37]Carolina Urologic Research Center ( Site 1085),Myrtle Beach,South Carolina,United States,29572[38]Urology Clinics of North Texas, PLLC ( Site 1064),Dallas,Texas,United States,75231[39]University Of Texas Southwestern Medical Center ( Site 1053),Dallas,Texas,United States,75390[40]Texas Oncology-Fort Worth Cancer Center ( Site 8003),Fort Worth,Texas,United States,76104[41]Houston Metro Urology ( Site 1111),Houston,Texas,United States,77027[42]Texas Oncology-Plano West ( Site 8001),Plano,Texas,United States,75093[43]Urology San Antonio Research ( Site 1108),San Antonio,Texas,United States,78229[44]University of Vermont Medi
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.
