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ACTIVE NOT RECRUITING

NCT03711032

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1397

Start Date

2018-12-24

Completion Date

2034-11-20

Last Updated

2026-10-23

Healthy Volunteers

Conditions

High-risk Non-muscle Invasive Bladder Cancer

Interventions

BIOLOGICAL

Pembrolizumab

Pembrolizumab IV infusion of 200 mg Q3W for BCG Post-Induction Cohort (Cohort A), or IV infusion of 400 mg Q6W for BCG Naïve Cohort (Cohort B), according to randomization

BIOLOGICAL

BCG

BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

Inclusion Criteria: * Have locally and blinded independent central review (BICR)-confirmed histological diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the bladder * Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease * Has provided tissue for biomarker analysis * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Has adequate organ function * During the treatment period and for ≥7 days after the last dose of BCG, male participants are EITHER abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR, must agree to use contraception unless confirmed to be azoospermic * Female participants who are not pregnant, not breastfeeding, and either not a woman of child bearing potential (WOCBP); or are a WOCBP who agrees to use a contraception method that is highly effective or remains abstinent from heterosexual intercourse during the treatment period and for ≥7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever comes last BCG Post-induction Cohort (Cohort A) Only * Has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC * Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC Exclusion Criteria: * Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UC * Has concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UC * Has received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks of start of study treatment * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of start of study treatment * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of start of study treatment * Has a known additional malignancy that is progressing or requires active treatment within the past 3 years * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG * Has an active infection or diagnosis requiring systemic antimicrobial 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 current active tuberculosis * Has had an allogenic-tissue/solid organ transplant * Has any contraindication(s) to IV contrast or is otherwise unable to have screening imaging with IV contrast performed 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

Locations (209)

Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)

Anchorage, Alaska, United States

Mayo Clinic in Arizona - Phoenix ( Site 1094)

Phoenix, Arizona, United States

Del Sol Research Management, LLC ( Site 1096)

Tucson, Arizona, United States

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 1052)

Los Angeles, California, United States

University of California Irvine Medical Center ( Site 1061)

Orange, California, United States

Genesis Research LLC ( Site 1065)

Torrance, California, United States

Colorado Clinical Research ( Site 1100)

Lakewood, Colorado, United States

Urological Research Network ( Site 1106)

Hialeah, Florida, United States

Mayo Clinic in Florida-Urology ( Site 1097)

Jacksonville, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)

Miami, Florida, United States

Woodlands Medical Specialists, PA ( Site 8002)

Pensacola, Florida, United States

Emory School of Medicine ( Site 1076)

Atlanta, Georgia, United States

Advanced Urology ( Site 1092)

Roswell, Georgia, United States

Northwestern Memorial Hospital ( Site 1101)

Chicago, Illinois, United States

Wichita Urology Group ( Site 1086)

Wichita, Kansas, United States

Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)

Shreveport, Louisiana, United States

Henry Ford Hospital ( Site 1062)

Detroit, Michigan, United States

Michigan Institute of Urology ( Site 1077)

Troy, Michigan, United States

Coastal Urology Associates ( Site 1055)

Brick, New Jersey, United States

Morristown Medical Center ( Site 1090)

Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey ( Site 1059)

New Brunswick, New Jersey, United States

St. Peter's Hospital Cancer Care Center ( Site 1087)

Albany, New York, United States

R.J. Zuckerberg Cancer Center ( Site 1080)

Lake Success, New York, United States

Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)

New York, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)

New York, New York, United States

Associated Medical Professionals of NY ( Site 1078)

Syracuse, New York, United States

TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center ( Site 1066)

Cleveland, Ohio, United States

Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 1067)

Columbus, Ohio, United States

OHSU Knight Cancer Institute ( Site 1075)

Portland, Oregon, United States

Oregon Urology Institute ( Site 1098)

Springfield, Oregon, United States

MidLantic Urology ( Site 1071)

Bala-Cynwyd, Pennsylvania, United States

Lancaster Urology ( Site 1079)

Lancaster, Pennsylvania, United States

University of Pennsylvania ( Site 1088)

Philadelphia, Pennsylvania, United States

Carolina Urologic Research Center ( Site 1085)

Myrtle Beach, South Carolina, United States

Urology Associates [Nashville, TN] ( Site 1072)

Nashville, Tennessee, United States

Urology Clinics of North Texas, PLLC ( Site 1064)

Dallas, Texas, United States

University Of Texas Southwestern Medical Center ( Site 1053)

Dallas, Texas, United States

Texas Oncology-Fort Worth Cancer Center ( Site 8003)

Fort Worth, Texas, United States

Houston Metro Urology ( Site 1111)

Houston, Texas, United States

Texas Oncology-Plano West ( Site 8001)

Plano, Texas, United States

Urology San Antonio Research ( Site 1108)

San Antonio, Texas, United States

University of Vermont Medical Center ( Site 1057)

Burlington, Vermont, United States

Urology of Virginia ( Site 1070)

Virginia Beach, Virginia, United States

GenesisCare North Shore ( Site 0010)

St Leonards, New South Wales, Australia

Northern Cancer Institute. ( Site 0003)

St Leonards, New South Wales, Australia

Sydney Adventist Hospital ( Site 0001)

Wahroonga, New South Wales, Australia

Epworth Hospital ( Site 0009)

Richmond, Victoria, Australia

Medizinische Universität Wien ( Site 0054)

Vienna, State of Vienna, Austria

Univ. Klinik f. Urologie Innsbruck ( Site 0051)

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)

Linz, Upper Austria, Austria

Universitaetsklinik Salzburg ( Site 0053)

Salzburg, Austria

UZA University Hospital Antwerp ( Site 0105)

Edegem, Antwerpen, Belgium

CHU UCL Namur Site de Godinne ( Site 0103)

Yvoir, Namur, Belgium

AZORG Campus Aalst-Moorselbaan ( Site 0106)

Aalst, Oost-Vlaanderen, Belgium

AZ Maria Middelares Gent ( Site 0102)

Ghent, Oost-Vlaanderen, Belgium

UZ Gent ( Site 0101)

Ghent, Oost-Vlaanderen, Belgium

Hospital São Carlos-Oncocentro Ce ( Site 1558)

Fortaleza, Ceará, Brazil

Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)

Curitiba, Paraná, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)

Barretos, São Paulo, Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)

São Paulo, Brazil

BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)

São Paulo, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)

São Paulo, Brazil

Exdeo Clinical Research Inc. ( Site 0165)

Abbotsford British Columbia, British Columbia, Canada

Silverado Resarch Inc. ( Site 0155)

Victoria, British Columbia, Canada

Horizon Health Network ( Site 0160)

Moncton, New Brunswick, Canada

Princess Margaret Cancer Centre ( Site 0153)

Toronto, Ontario, Canada

CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)

Chicoutimi, Quebec, Canada

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0151)

Québec, Quebec, Canada

CHUS - Hopital Fleurimont ( Site 0152)

Sherbrooke, Quebec, Canada

Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)

Beijing, Beijing Municipality, China

Peking University First Hospital ( Site 1759)

Beijing, Beijing Municipality, China

Beijing Cancer hospital-Urinary Surgery ( Site 1755)

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital ( Site 1784)

Chongqing, Chongqing Municipality, China

The First Affiliated hospital of Xiamen University-Urology ( Site 1776)

Xiamen, Fujian, China

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University ( Site 1777)

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)

Guangzhou, Guangdong, China

ShenZhen People's Hospital ( Site 1778)

Shenzhen, Guangdong, China

Harbin Medical University Cancer Hospital ( Site 1772)

Harbin, Heilongjiang, China

Henan Cancer Hospital-Urology ( Site 1770)

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)

Wuhan, Hubei, China

Wuhan Union Hospital ( Site 1771)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 1763)

Changsha, Hunan, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1758)

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)

Suzhou, Jiangsu, China

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)

Xi'an, Shaanxi, China

West China Hospital Sichuan University ( Site 1767)

Chengdu, Sichuan, China

The Second Hospital of Tianjin Medical University ( Site 1769)

Tianjin, Tianjin Municipality, China

Zhejiang Provincial People's Hospital-Urology ( Site 1762)

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)

Wenzhou, Zhejiang, China

Instituto de Cancerología-Oncology ( Site 1609)

Medellín, Antioquia, Colombia

Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad ( Site 1606)

Rionegro, Antioquia, Colombia

Administradora Country S.A. - Clinica del Country ( Site 1607)

Bogotá, Bogota D.C., Colombia

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)

Bogotá, Bogota D.C., Colombia

IMAT S.A.S ( Site 1604)

Montería, Departamento de Córdoba, Colombia

Oncologos del Occidente ( Site 1608)

Pereira, Risaralda Department, Colombia

Hemato Oncologos SA-Oncology ( Site 1601)

Cali, Valle del Cauca Department, Colombia

Clínica Imbanaco S.A.S ( Site 1611)

Cali, Valle del Cauca Department, Colombia

And 109 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (209)