A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.
The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.
Inclusion Criteria:
BCG Post-induction Cohort (Cohort A) Only
Exclusion Criteria:
BCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an induction course of BCG
BCG Naïve Cohort (Cohort B) Only
- Has received any prior treatment with BCG for their NMIBC within the past 2 years prior to study entry
Anchorage, Alaska 99503, United States
Los Angeles, California 90095, United States
Miami, Florida 33136, United States
Shreveport, Louisiana 71106, United States
New York, New York 10010, United States
New York, New York 10016, United States
Cincinnati, Ohio 45212, United States
Columbus, Ohio 43210, United States
Barretos, São Paulo 14784-400, Brazil
Abbotsford British Columbia, British Columbia V2T 1X8, Canada
Montreal, Quebec H1T 2M4, Canada
Québec, Quebec G1J 1Z4, Canada
Beijing, Beijing Municipality 100021, China
Guangzhou, Guangdong 510120, China
Guangzhou, Guangdong 510289, China
Nanjing, Jiangsu 210008, China
Suzhou, Jiangsu 215004, China
Tianjin, Tianjin Municipality 300211, China
Wenzhou, Zhejiang 325000, China
Rionegro, Antioquia 054047, Colombia
Bogotá, Bogota D.C. 111321, Colombia
Dijon, Bourgogne-Franche-Comté 21000, France
Rennes, Brittany Region 35000, France
Munich, Bavaria 81675, Germany
Weiden in Der Oberpfalz, Bavaria 92637, Germany
Trier, Rhineland-Palatinate 54292, Germany
Thessaloniki, Central Macedonia 54007, Greece
Szeged, Csongrád megye 6725, Hungary
Osaka, 541-8567, Japan
Lorenskog, Akershus 1478, Norway
Tarnów, Lesser Poland Voivodeship 33-100, Poland
Wroclaw, Lower Silesian Voivodeship 50-556, Poland
Przemyśl, Podkarpackie Voivodeship 37-700, Poland
Kościerzyna, Pomeranian Voivodeship 83-400, Poland
Słupsk, Pomeranian Voivodeship 76-200, Poland
Coimbra, 3000-075, Portugal
Lisbon, 1649-035, Portugal
Songpagu, Seoul 05505, South Korea
Pozuelo de Alarcón, Madrid, Comunidad de 28223, Spain
Istanbul, 34722, Turkey (Türkiye)
Konya, 42000, Turkey (Türkiye)