Bladder Cancer Clinical Trial

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

Summary

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
Has clinically non-metastatic bladder cancer (N0M0)
Has planned and is eligible to receive chemoradiotherapy (CRT) and one of the protocol-specified radiosensitizing chemotherapy regimens
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Demonstrates adequate organ function

Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of CRT treatment:

Refrain from donating sperm
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic

A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

Is not a woman of childbearing potential (WOCBP)
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days the time needed to eliminate each study intervention after the last dose of study intervention; and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: MK-3475 - 120 days and CRT - 180 days

Exclusion Criteria:

Has the presence of diffuse carcinoma in situ (CIS) (multiple foci of CIS) throughout the bladder
Has the presence of urothelial carcinoma (UC) at any site outside of the urinary bladder in the previous 2 years except for Ta stage/T1 stage/CIS of the upper tract if the participant has undergone a complete nephroureterectomy
Has a known additional malignancy that is progressing or has required active therapy within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or other carcinoma in situ that has undergone potentially curative therapy
Has the presence of bilateral hydronephrosis
Has limited bladder function with frequency of small amounts of urine (< 30 mL), urinary incontinence, or requires self-catheterization or a permanent indwelling catheter
Has received prior pelvic/local radiation therapy or any antineoplastic treatment for muscle-invasive bladder cancer (MIBC). Treatment for non-muscle invasive bladder cancer (NMIBC) with intravesical instillation therapy that was completed ≥28 days prior to randomization is allowed. Prior systemic treatment of NMIBC is not permitted.
Received prior therapy with an anti-PD-1 (programmed cell death protein 1), anti-PD-L1 (programmed death-ligand 1), or anti-PD-L2 (programmed cell death 1 ligand 2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4 [cytotoxic T-lymphocyte-associated protein 4], OX 40, or CD137 [cluster of differentiation 137])
Has received a live vaccine within 30 days before the first dose of study medication
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study medication
Has known severe hypersensitivity (≥Grade 3) to the selected chemotherapy regimen, and/or any of their excipients and excipients of pembrolizumab
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic 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 a known history of active tuberculosis (TB; Bacillus tuberculosis)
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has had an allogenic tissue/solid organ transplant

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

636

Study ID:

NCT04241185

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 115 Locations for this study

See Locations Near You

Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)
Washington District of Columbia, 20010, United States More Info
Study Coordinator
Contact
202-877-9386
Bay Pines VA Medical Center ( Site 0055)
Bay Pines Florida, 33744, United States More Info
Study Coordinator
Contact
727-398-6661
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0004)
Orlando Florida, 32804, United States
Norton Cancer Institute ( Site 0044)
Louisville Kentucky, 40207, United States
Pikeville Medical Center ( Site 0009)
Pikeville Kentucky, 41501, United States More Info
Study Coordinator
Contact
606-218-2212
Baltimore VA Medical Center ( Site 0054)
Baltimore Maryland, 21201, United States
Washington University ( Site 0003)
Saint Louis Missouri, 63110, United States More Info
Study Coordinator
Contact
314-747-4328
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)
Hackensack New Jersey, 07601, United States More Info
Study Coordinator
Contact
551-996-1379
New York Oncology Hematology P.C ( Site 0024)
Albany New York, 12206, United States More Info
Study Coordinator
Contact
518-489-3612
Winthrop University Hospital ( Site 0069)
Mineola New York, 11501, United States More Info
Study Coordinator
Contact
516-289-3772
New York University Perlmutter Cancer Center ( Site 0001)
New York New York, 10016, United States More Info
Study Coordinator
Contact
212-731-6455
Cleveland Clinic ( Site 0062)
Cleveland Ohio, 44195, United States More Info
Study Coordinator
Contact
866-223-8100
MidLantic urology ( Site 0070)
Bala-Cynwyd Pennsylvania, 19004, United States More Info
Study Coordinator
Contact
610-667-0458
Saint Francis Cancer Center ( Site 0026)
Greenville South Carolina, 29607, United States
Carolina Urologic Research Center ( Site 0002)
Myrtle Beach South Carolina, 29572, United States More Info
Study Coordinator
Contact
843-449-1010 ext. 257
Inova Schar Cancer Institute ( Site 6006)
Fairfax Virginia, 22031, United States More Info
Study Coordinator
Contact
571-472-1390
West Virginia University - Charleston Area Medical Center ( Site 6003)
Charleston West Virginia, 25304, United States More Info
Study Coordinator
Contact
304-388-5432
Froedtert and Medical College of Wisconsin ( Site 0022)
Milwaukee Wisconsin, 53226, United States More Info
Study Coordinator
Contact
414-805-8900
Liverpool Hospital ( Site 0220)
Liverpool New South Wales, 2170, Australia More Info
Study Coordinator
Contact
61287389181
Northern Cancer Institute ( Site 0217)
St Leonards New South Wales, 2065, Australia More Info
Study Coordinator
Contact
61294631172
Monash Health-Monash Medical Centre ( Site 0216)
Clayton Victoria, 3168, Australia
Austin Health ( Site 0218)
Heidelberg Victoria, 3084, Australia More Info
Study Coordinator
Contact
610420381848
Sir Charles Gairdner Hospital ( Site 0223)
Nedlands Western Australia, 6009, Australia More Info
Study Coordinator
Contact
61893891437
Fakultni nemocnice Olomouc ( Site 0559)
Olomouc , 775 2, Czechia More Info
Study Coordinator
Contact
+420588444295
2. LF UK a FN Motol ( Site 0555)
Praha 5 , 150 0, Czechia More Info
Study Coordinator
Contact
+420266084516
Nemocnice Na Bulovce ( Site 0556)
Praha 8 , 180 8, Czechia
Herlev og Gentofte Hospital. ( Site 0401)
Herlev Hovedstaden, 2730, Denmark More Info
Study Coordinator
Contact
4538683868
Odense Universitetshospital ( Site 0403)
Odense Syddanmark, 5000, Denmark More Info
Study Coordinator
Contact
4566113333
North Estonia Medical Centre Foundation ( Site 0081)
Tallin Harjumaa, 13419, Estonia More Info
Study Coordinator
Contact
+3726172323
Tartu University Hospital ( Site 0079)
Tartu Tartumaa, 51014, Estonia More Info
Study Coordinator
Contact
+3727318815
Institut Sainte Catherine ( Site 0121)
Avignon Provence-Alpes-Cote-d Azur, 84918, France More Info
Study Coordinator
Contact
+33490276090
CHU Amiens Picardie Site Sud Amiens ( Site 0123)
Amiens Somme, 80000, France More Info
Study Coordinator
Contact
+3332022087996
Institut Curie ( Site 0112)
Paris , 75005, France More Info
Study Coordinator
Contact
+33172389445
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)
Paris , 75018, France More Info
Study Coordinator
Contact
+33140258935
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
+502 42142081
Oncomedica ( Site 0145)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
50222781268
Grupo Medico Angeles ( Site 0143)
Guatemala , 01015, Guatemala More Info
Study Coordinator
Contact
+50223857572
Medi-K Cayala ( Site 0142)
Guatemala , 01016, Guatemala More Info
Study Coordinator
Contact
+50223752222
Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)
Quetzaltenango , 09002, Guatemala More Info
Study Coordinator
Contact
+50259458053
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095)
Kecskemét Bacs-Kiskun, 6000, Hungary More Info
Study Coordinator
Contact
+3676516719
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)
Miskolc Borsod-Abauj-Zemplen, 3526, Hungary More Info
Study Coordinator
Contact
+3646515200
Petz Aladar Megyei Oktato Korhaz ( Site 0099)
Gyor Gyor-Moson-Sopron, 9024, Hungary More Info
Study Coordinator
Contact
+3696507900
Debreceni Egyetem Klinikai Kozpont ( Site 0097)
Debrecen , 4032, Hungary More Info
Study Coordinator
Contact
+3652255585
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)
Kaposvar , 7400, Hungary More Info
Study Coordinator
Contact
+36306554043
Soroka Medical Center-Oncology ( Site 7031)
Be'er Sheva , 84000, Israel More Info
Study Coordinator
Contact
+972508946244
Rambam Health Care Campus-Oncology Division ( Site 0088)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247773811
Hadassah Medical Center. Ein Kerem ( Site 0086)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+97226776760
Chaim Sheba Medical Center ( Site 0087)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+97235302542
Sourasky Medical Center ( Site 0089)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
+97236973413
Ospedale San Raffaele ( Site 0194)
Milano Lombardia, 20132, Italy More Info
Study Coordinator
Contact
+390226435668
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)
Bari Puglia, 70124, Italy More Info
Study Coordinator
Contact
+390805555355
AOU Careggi ( Site 0191)
Firenze , 50134, Italy More Info
Study Coordinator
Contact
+390557947019
Ospedale Civile di Macerata ( Site 0190)
Macerata , 62100, Italy More Info
Study Coordinator
Contact
+3907332572881
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)
Milano , 20133, Italy More Info
Study Coordinator
Contact
+390223903818
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)
Modena , 41124, Italy More Info
Study Coordinator
Contact
+390594224767
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)
Napoli , 80131, Italy More Info
Study Coordinator
Contact
+390815903637
Hirosaki University Hospital ( Site 0602)
Hirosaki Aomori, 036-8, Japan More Info
Study Coordinator
Contact
+81172335111
University of Tsukuba Hospital ( Site 0605)
Tsukuba Ibaraki, 305-8, Japan More Info
Study Coordinator
Contact
+81298533900
Osaka Medical and Pharmaceutical University Hospital ( Site 0604)
Takatsuki Osaka, 569-8, Japan More Info
Study Coordinator
Contact
+81726831221
Nagasaki University Hospital ( Site 0600)
Nagasaki , 852-8, Japan More Info
Study Coordinator
Contact
+81958197200
Tokyo Metropolitan Komagome Hospital ( Site 0606)
Tokyo , 113-8, Japan More Info
Study Coordinator
Contact
+81-3-3823-2101
Tokyo Medical and Dental University Hospital ( Site 0601)
Tokyo , , Japan More Info
Study Coordinator
Contact
+81338136111
National Cancer Center ( Site 0202)
Gyeonggi-do Kyonggi-do, 10408, Korea, Republic of More Info
Study Coordinator
Contact
+82319203679
Seoul National University Bundang Hospital ( Site 0204)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of More Info
Study Coordinator
Contact
+82317877071
Asan Medical Center ( Site 0200)
Songpagu Seoul, 05505, Korea, Republic of More Info
Study Coordinator
Contact
+82230105614
Chungnam National University Hospital ( Site 0203)
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of More Info
Study Coordinator
Contact
+82422808369
Korea University Anam Hospital ( Site 0205)
Seoul , 02841, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0201)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
+82222288138
Pauls Stradins Clinical University Hospital ( Site 0073)
Riga , LV-10, Latvia More Info
Study Coordinator
Contact
+37129262596
Hospital Universiti Sains Malaysia ( Site 0237)
Kubang Kerian Kelantan, 16150, Malaysia More Info
Study Coordinator
Contact
+6097676684
Hospital Pulau Pinang ( Site 0239)
Penang Pulau Pinang, 10990, Malaysia More Info
Study Coordinator
Contact
+6042225768
Hospital Kuala Lumpur ( Site 0238)
Kuala Lumpur , 50586, Malaysia More Info
Study Coordinator
Contact
+60326155810
University Malaya Medical Centre ( Site 0236)
Kuala Lumpur , 59100, Malaysia More Info
Study Coordinator
Contact
+60379492120
Netherlands Cancer Institute (NKI) ( Site 0183)
Amsterdam Noord-Holland, 1066 , Netherlands More Info
Study Coordinator
Contact
+31205122569
Erasmus MC ( Site 0182)
Rotterdam Zuid-Holland, 3015 , Netherlands More Info
Study Coordinator
Contact
+31107041505
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)
Krakow Malopolskie, 31-82, Poland More Info
Study Coordinator
Contact
48606751459
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)
Koszalin Zachodniopomorskie, 75-58, Poland More Info
Study Coordinator
Contact
+48943488931
Centro Hospitalar e Universitario de Coimbra ( Site 0306)
Coimbra , 3000-, Portugal More Info
Study Coordinator
Contact
+351239400457
CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302)
Lisboa , 1449-, Portugal More Info
Study Coordinator
Contact
+351210431703
Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305)
Lisboa , 1649-, Portugal More Info
Study Coordinator
Contact
+351217805000
Advance Urology and Laparoscopic Center ( Site 0281)
Ponce , 00716, Puerto Rico More Info
Study Coordinator
Contact
7872843333
PAN American Center Oncologic ( Site 0280)
San Juan, Rio Piedras , 00935, Puerto Rico More Info
Study Coordinator
Contact
7874073333
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)
Cluj Napoca Cluj, 40001, Romania More Info
Study Coordinator
Contact
+40745976913
S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)
Cluj-Napoca Cluj, 40728, Romania More Info
Study Coordinator
Contact
+40742206212
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)
Craiova Dolj, 20034, Romania More Info
Study Coordinator
Contact
+40727774974
Policlinica Oncomed SRL ( Site 0254)
Timisoara Timis, 30023, Romania More Info
Study Coordinator
Contact
+40745100495
S.C.Focus Lab Plus S.R.L ( Site 0253)
Bucuresti , 02254, Romania More Info
Study Coordinator
Contact
+40721298677
Institutul Regional de Oncologie Iasi ( Site 0255)
Iasi , 70048, Romania
Instituto Catalan de Oncologia - ICO ( Site 0103)
L Hospitalet De Llobregat Barcelona, 08908, Spain More Info
Study Coordinator
Contact
+34932607744
Hospital La Fe de Valencia ( Site 0105)
Valencia Valenciana, Comunitat, 46026, Spain More Info
Study Coordinator
Contact
+34961244188
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106)
Sevilla , 41013, Spain More Info
Study Coordinator
Contact
+34955013068
Chi Mei Medical Center ( Site 0215)
Tainan City Tainan, 71004, Taiwan More Info
Study Coordinator
Contact
+88662812811
Kaohsiung Chang Gung Memorial Hospital ( Site 0209)
Kaohsiung , 83301, Taiwan More Info
Study Coordinator
Contact
88677317123
Taichung Veterans General Hospital ( Site 0213)
Taichung , 407, Taiwan More Info
Study Coordinator
Contact
+8886423592525
National Cheng Kung University Hospital ( Site 0208)
Tainan , 704, Taiwan
National Taiwan University Hospital ( Site 0210)
Taipei , 10002, Taiwan More Info
Study Coordinator
Contact
+886223123456
Taipei Veterans General Hospital ( Site 0211)
Taipei , 11217, Taiwan More Info
Study Coordinator
Contact
+886228757519304
Chang Gung Medical Foundation.Linkou Branch ( Site 0212)
Taoyuan , 333, Taiwan More Info
Study Coordinator
Contact
+886 3-3281200 ext8825
University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)
Ankara , 06010, Turkey More Info
Study Coordinator
Contact
905366401020
Ankara Universitesi Tip Fakultesi. ( Site 0502)
Ankara , 06100, Turkey More Info
Study Coordinator
Contact
+905337483275
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)
Istanbul , 34098, Turkey More Info
Study Coordinator
Contact
+905333682319
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
Istanbul , 34147, Turkey More Info
Study Coordinator
Contact
+905326761078
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)
Istanbul , 34722, Turkey More Info
Study Coordinator
Contact
+905063509061
Ege University Medical Faculty ( Site 0508)
Izmir , 35100, Turkey More Info
Study Coordinator
Contact
+905337360674
Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)
Trabzon , 61080, Turkey More Info
Study Coordinator
Contact
+905052180361
Clinical oncology dispensary of Dnipro ( Site 0133)
Dnipro Dnipropetrovska Oblast, 49055, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)
Kharkiv Kharkivska Oblast, 61024, Ukraine
CNPE "Regional Center of Oncology" ( Site 0134)
Kharkiv Kharkivska Oblast, 61070, Ukraine
Ukranian Center of TomoTherapy ( Site 0140)
Kropyvnytskiy Kirovohradska Oblast, 25011, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0136)
Kyiv Kyivska Oblast, 03022, Ukraine
Kyiv City Clinical Oncology Center ( Site 0135)
Kyiv , 03115, Ukraine
Betsi Cadwaladr University Health Board ( Site 0447)
Rhyl Denbighshire, LL18 , United Kingdom
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)
Torquay Devon, TQ2 7, United Kingdom More Info
Study Coordinator
Contact
+441803614567
University College London Hospitals NHS Foundation Trust ( Site 0445)
London London, City Of, NW1 2, United Kingdom More Info
Study Coordinator
Contact
+4420 3456 7014
The Royal Marsden NHS Foundation Trust. ( Site 0442)
London London, City Of, SW3 6, United Kingdom More Info
Study Coordinator
Contact
+442078082788
Nottingham University Hospital NHS Trust ( Site 0250)
Nottingham Nottinghamshire, NG5 1, United Kingdom More Info
Study Coordinator
Contact
+441159691169 x71985
Darlington Memorial Hospital NHS Trust ( Site 0446)
Darlington , DL3 6, United Kingdom More Info
Study Coordinator
Contact
+441325743654

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

636

Study ID:

NCT04241185

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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