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)

April 19, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

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.

Study Overview

Status

Recruiting

Conditions

Urinary Bladder Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

636

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Toll Free Number
Phone Number: 1-888-577-8839
Email: Trialsites@merck.com

Study Locations

Australia
- New South Wales
  - Liverpool, New South Wales, Australia, 2170
    - Completed
    - Liverpool Hospital ( Site 0220)
  - St Leonards, New South Wales, Australia, 2065
    - Recruiting
    - GenesisCare North Shore ( Site 0217)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 61294631172
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Completed
    - Monash Medical Centre ( Site 0216)
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Austin Health ( Site 0218)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 610420381848
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Completed
    - Sir Charles Gairdner Hospital ( Site 0223)
Chile
- - Antofagasta, Chile, 1240000
    - Recruiting
    - Bradford Hill Norte ( Site 7052)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 56994198125
- Los Rios
  - Valdivia, Los Rios, Chile, 5112129
    - Recruiting
    - Oncocentro Valdivia ( Site 7055)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56992195434
- Region M. De Santiago
  - Santiago, Region M. De Santiago, Chile, 8420383
    - Recruiting
    - Bradfordhill-Clinical Area ( Site 7051)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56998744662
  - Santiago, Region M. De Santiago, Chile, 7500921
    - Recruiting
    - FALP ( Site 7056)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56956075934
- Valparaiso
  - Viña del Mar, Valparaiso, Chile, 2520598
    - Recruiting
    - ONCOCENTRO APYS-ACEREY ( Site 7054)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56992369820
Czechia
- - Olomouc, Czechia, 77900
    - Recruiting
    - Fakultni nemocnice Olomouc ( Site 0559)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420588444295
  - Praha 5, Czechia, 150 06
    - Recruiting
    - 2. LF UK a FN Motol ( Site 0555)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420266084516
  - Praha 8, Czechia, 180 81
    - Completed
    - Nemocnice Na Bulovce ( Site 0556)
Denmark
- Hovedstaden
  - Herlev, Hovedstaden, Denmark, 2730
    - Completed
    - Herlev og Gentofte Hospital. ( Site 0401)
- Syddanmark
  - Odense, Syddanmark, Denmark, 5000
    - Completed
    - Odense Universitetshospital ( Site 0403)
Estonia
- Harjumaa
  - Tallin, Harjumaa, Estonia, 13419
    - Recruiting
    - North Estonia Medical Centre Foundation ( Site 0081)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3726172323
- Tartumaa
  - Tartu, Tartumaa, Estonia, 51014
    - Recruiting
    - Tartu University Hospital ( Site 0079)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3727318815
France
- - Paris, France, 75005
    - Recruiting
    - Institut Curie ( Site 0112)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33172389445
  - Paris, France, 75018
    - Recruiting
    - A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33140258935
- Provence-Alpes-Cote-d Azur
  - Avignon, Provence-Alpes-Cote-d Azur, France, 84918
    - Recruiting
    - Institut Sainte Catherine ( Site 0121)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33490276090
- Somme
  - Amiens, Somme, France, 80000
    - Recruiting
    - CHU Amiens Picardie Site Sud Amiens ( Site 0123)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3332022087996
Guatemala
- - Guatemala, Guatemala, 01010
    - Recruiting
    - Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +502 42142081
  - Guatemala, Guatemala, 01010
    - Recruiting
    - Oncomedica ( Site 0145)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 50222781268
  - Guatemala, Guatemala, 01015
    - Recruiting
    - Grupo Medico Angeles ( Site 0143)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +50223857572
  - Guatemala, Guatemala, 01016
    - Recruiting
    - Medi-K Cayala ( Site 0142)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +50223752222
  - Quetzaltenango, Guatemala, 09002
    - Recruiting
    - Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +50259458053
Hungary
- - Debrecen, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem Klinikai Kozpont ( Site 0097)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3652255585
  - Kaposvar, Hungary, 7400
    - Recruiting
    - Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +36306554043
- Bacs-Kiskun
  - Kecskemét, Bacs-Kiskun, Hungary, 6000
    - Recruiting
    - Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3676516719
- Borsod-Abauj-Zemplen
  - Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
    - Recruiting
    - BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3646515200
- Gyor-Moson-Sopron
  - Gyor, Gyor-Moson-Sopron, Hungary, 9024
    - Recruiting
    - Petz Aladar Megyei Oktato Korhaz ( Site 0099)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3696507900
Israel
- - Be'er Sheva, Israel, 8400000
    - Recruiting
    - Soroka Medical Center-Oncology ( Site 7031)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +972508946244
  - Haifa, Israel, 3109601
    - Recruiting
    - Rambam Health Care Campus-Oncology Division ( Site 0088)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +97247773811
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Hadassah Medical Center. Ein Kerem ( Site 0086)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +97226776760
  - Petah Tikva, Israel, 4941492
    - Recruiting
    - Rabin Medical Center ( Site 7032)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +97239378101
  - Ramat Gan, Israel, 5262000
    - Recruiting
    - Chaim Sheba Medical Center ( Site 0087)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +97235302542
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Sourasky Medical Center ( Site 0089)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +97236973413
Italy
- - Firenze, Italy, 50134
    - Recruiting
    - AOU Careggi ( Site 0191)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390557947019
  - Macerata, Italy, 62100
    - Recruiting
    - Ospedale Civile di Macerata ( Site 0190)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3907332572881
  - Milano, Italy, 20133
    - Recruiting
    - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390223903818
  - Modena, Italy, 41124
    - Completed
    - Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)
  - Napoli, Italy, 80131
    - Recruiting
    - Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390815903637
- Lazio
  - Roma, Lazio, Italy, 00128
    - Completed
    - Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041)
- Lombardia
  - Milano, Lombardia, Italy, 20132
    - Recruiting
    - Ospedale San Raffaele ( Site 0194)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390226435668
- Puglia
  - Bari, Puglia, Italy, 70124
    - Recruiting
    - IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390805555355
Japan
- - Nagasaki, Japan, 852-8501
    - Active, not recruiting
    - Nagasaki University Hospital ( Site 0600)
  - Tokyo, Japan, 113-8677
    - Recruiting
    - Tokyo Metropolitan Komagome Hospital ( Site 0606)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-3-3823-2101
  - Tokyo, Japan, 113-8519
    - Recruiting
    - Tokyo Medical and Dental University Hospital ( Site 0601)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81338136111
- Aomori
  - Hirosaki, Aomori, Japan, 036-8563
    - Recruiting
    - Hirosaki University Hospital ( Site 0602)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81172335111
- Ibaraki
  - Tsukuba, Ibaraki, Japan, 305-8576
    - Recruiting
    - University of Tsukuba Hospital ( Site 0605)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81298533900
- Osaka
  - Takatsuki, Osaka, Japan, 5698686
    - Recruiting
    - Osaka Medical and Pharmaceutical University Hospital ( Site 0604)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81726831221
Korea, Republic of
- - Seoul, Korea, Republic of, 02841
    - Completed
    - Korea University Anam Hospital ( Site 0205)
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Severance Hospital Yonsei University Health System ( Site 0201)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82222288138
- Kyonggi-do
  - Gyeonggi-do, Kyonggi-do, Korea, Republic of, 10408
    - Recruiting
    - National Cancer Center ( Site 0202)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82319203679
  - Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
    - Recruiting
    - Seoul National University Bundang Hospital ( Site 0204)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82317877071
- Seoul
  - Songpagu, Seoul, Korea, Republic of, 05505
    - Recruiting
    - Asan Medical Center ( Site 0200)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82230105614
- Taejon-Kwangyokshi
  - Daejeon, Taejon-Kwangyokshi, Korea, Republic of, 35015
    - Recruiting
    - Chungnam National University Hospital ( Site 0203)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82422808369
Latvia
- - Riga, Latvia, LV1002
    - Recruiting
    - Pauls Stradins Clinical University Hospital ( Site 0073)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +37129262596
Malaysia
- - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - University Malaya Medical Centre ( Site 0236)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +60379492120
  - Kuala Lumpur, Malaysia, 50586
    - Completed
    - Hospital Kuala Lumpur ( Site 0238)
- Kelantan
  - Kubang Kerian, Kelantan, Malaysia, 16150
    - Recruiting
    - Hospital Universiti Sains Malaysia ( Site 0237)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +6097676684
- Pulau Pinang
  - Penang, Pulau Pinang, Malaysia, 10990
    - Recruiting
    - Hospital Pulau Pinang ( Site 0239)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +6042225768
Netherlands
- Noord-Holland
  - Amsterdam, Noord-Holland, Netherlands, 1066 CX
    - Recruiting
    - Netherlands Cancer Institute (NKI) ( Site 0183)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +31205122569
- Zuid-Holland
  - Rotterdam, Zuid-Holland, Netherlands, 3015 GD
    - Recruiting
    - Erasmus MC ( Site 0182)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +31107041505
Poland
- Malopolskie
  - Krakow, Malopolskie, Poland, 31-826
    - Recruiting
    - Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 48606751459
- Mazowieckie
  - Siedlce, Mazowieckie, Poland, 08-110
    - Recruiting
    - Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48603936331
- Zachodniopomorskie
  - Koszalin, Zachodniopomorskie, Poland, 75-581
    - Recruiting
    - Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48943488931
Portugal
- - Coimbra, Portugal, 3000-075
    - Recruiting
    - Centro Hospitalar e Universitario de Coimbra ( Site 0306)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +351239400457
  - Lisboa, Portugal, 1449-005
    - Recruiting
    - CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +351210431703
  - Lisboa, Portugal, 1649-035
    - Recruiting
    - Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +351217805000
- Lisboa
  - Loures, Lisboa, Portugal, 2674-514
    - Recruiting
    - Hospital Beatriz Angelo ( Site 0303)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +351219847200
Puerto Rico
- - Ponce, Puerto Rico, 00716
    - Recruiting
    - Advance Urology and Laparoscopic Center ( Site 0281)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 7872843333
  - San Juan, Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - PAN American Center Oncologic ( Site 0280)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 7874073333
Romania
- - Bucuresti, Romania, 022548
    - Recruiting
    - S.C.Focus Lab Plus S.R.L ( Site 0253)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +40721298677
  - Cluj, Romania, 400015
    - Recruiting
    - Institutul Oncologic-Oncologie Medicala ( Site 0256)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 40745646368
  - Iasi, Romania, 700483
    - Completed
    - Institutul Regional de Oncologie Iasi ( Site 0255)
- Cluj
  - Cluj Napoca, Cluj, Romania, 400015
    - Recruiting
    - Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +40745976913
  - Cluj-Napoca, Cluj, Romania, 407280
    - Recruiting
    - S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +40742206212
- Dolj
  - Craiova, Dolj, Romania, 200542
    - Recruiting
    - S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +40727774974
- Timis
  - Timisoara, Timis, Romania, 300239
    - Recruiting
    - Policlinica Oncomed SRL ( Site 0254)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +40745100495
Spain
- - Sevilla, Spain, 41013
    - Recruiting
    - HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34955013068
- Barcelona
  - L Hospitalet De Llobregat, Barcelona, Spain, 08908
    - Recruiting
    - Instituto Catalan de Oncologia - ICO ( Site 0103)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34932607744
- Valenciana, Comunitat
  - Valencia, Valenciana, Comunitat, Spain, 46026
    - Recruiting
    - Hospital La Fe de Valencia ( Site 0105)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34961244188
Taiwan
- - Kaohsiung, Taiwan, 83301
    - Recruiting
    - Kaohsiung Chang Gung Memorial Hospital ( Site 0209)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 88677317123
  - Taichung, Taiwan, 407
    - Recruiting
    - Taichung Veterans General Hospital ( Site 0213)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +8886423592525
  - Tainan, Taiwan, 70403
    - Completed
    - National Cheng Kung University Hospital ( Site 0208)
  - Taipei, Taiwan, 10002
    - Recruiting
    - National Taiwan University Hospital ( Site 0210)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +886223123456
  - Taipei, Taiwan, 112
    - Recruiting
    - Taipei Veterans General Hospital ( Site 0211)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +886228757519304
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Chang Gung Medical Foundation.Linkou Branch ( Site 0212)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +886 3-3281200 ext8825
- Tainan
  - Tainan City, Tainan, Taiwan, 71004
    - Recruiting
    - Chi Mei Medical Center ( Site 0215)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +88662812811
Turkey
- - Ankara, Turkey, 06010
    - Recruiting
    - University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 905366401020
  - Ankara, Turkey, 06100
    - Recruiting
    - Ankara Universitesi Tip Fakultesi. ( Site 0502)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905337483275
  - Istanbul, Turkey, 34098
    - Recruiting
    - Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905333682319
  - Istanbul, Turkey, 34147
    - Recruiting
    - T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905326761078
  - Istanbul, Turkey, 34722
    - Recruiting
    - Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905063509061
  - Izmir, Turkey, 35100
    - Recruiting
    - Ege University Medical Faculty ( Site 0508)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905337360674
  - Trabzon, Turkey, 61080
    - Recruiting
    - Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905052180361
Ukraine
- - Kyiv, Ukraine, 03115
    - Suspended
    - Kyiv City Clinical Oncology Center ( Site 0135)
- Dnipropetrovska Oblast
  - Dnipro, Dnipropetrovska Oblast, Ukraine, 49055
    - Suspended
    - Clinical oncology dispensary of Dnipro ( Site 0133)
- Kharkivska Oblast
  - Kharkiv, Kharkivska Oblast, Ukraine, 61024
    - Suspended
    - Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)
  - Kharkiv, Kharkivska Oblast, Ukraine, 61070
    - Suspended
    - MNPE Regional Center of Oncology ( Site 0134)
- Kirovohradska Oblast
  - Kropyvnytskiy, Kirovohradska Oblast, Ukraine, 25011
    - Suspended
    - Ukranian Center of TomoTherapy ( Site 0140)
- Kyivska Oblast
  - Kyiv, Kyivska Oblast, Ukraine, 03022
    - Suspended
    - SNPE National Cancer Institute ( Site 0136)
United Kingdom
- - Darlington, United Kingdom, DL3 6HX
    - Recruiting
    - Darlington Memorial Hospital NHS Trust ( Site 0446)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +441325743654
- Denbighshire
  - Rhyl, Denbighshire, United Kingdom, LL18 5UJ
    - Completed
    - Betsi Cadwaladr University Health Board ( Site 0447)
- Devon
  - Torquay, Devon, United Kingdom, TQ2 7AA
    - Recruiting
    - South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +441803614567
- Lancashire
  - Preston, Lancashire, United Kingdom, PR2 9HT
    - Recruiting
    - Royal Preston Hospital ( Site 0449)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 441772523191
- London, City Of
  - London, London, City Of, United Kingdom, NW1 2PG
    - Recruiting
    - University College London Hospitals NHS Foundation Trust ( Site 0445)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +4420 3456 7014
  - London, London, City Of, United Kingdom, SW3 6JJ
    - Recruiting
    - The Royal Marsden NHS Foundation Trust. ( Site 0442)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +442078082788
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    - Completed
    - Nottingham University Hospital NHS Trust ( Site 0250)
United States
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Recruiting
    - Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 202-877-9386
- Florida
  - Bay Pines, Florida, United States, 33744
    - Active, not recruiting
    - Bay Pines VA Medical Center ( Site 0055)
  - Orlando, Florida, United States, 32804
    - Completed
    - AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0004)
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Completed
    - Norton Cancer Institute ( Site 0044)
  - Pikeville, Kentucky, United States, 41501
    - Completed
    - Pikeville Medical Center ( Site 0009)
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Completed
    - Baltimore VA Medical Center ( Site 0054)
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Active, not recruiting
    - Washington University ( Site 0003)
- New Jersey
  - Florham Park, New Jersey, United States, 07932
    - Recruiting
    - Summit Medical Group Cancer Center ( Site 6008)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 855-413-2220
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 551-996-1379
- New York
  - Albany, New York, United States, 12206
    - Recruiting
    - New York Oncology Hematology P.C ( Site 0024)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 518-489-3612
  - Buffalo, New York, United States, 14203
    - Recruiting
    - Roswell Park Cancer Institute ( Site 6009)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 716-845-4922
  - Mineola, New York, United States, 11501
    - Recruiting
    - Winthrop University Hospital ( Site 0069)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 516-289-3772
  - New York, New York, United States, 10016
    - Recruiting
    - New York University Perlmutter Cancer Center ( Site 0001)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 212-731-6455
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic ( Site 0062)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 866-223-8100
- Pennsylvania
  - Bala-Cynwyd, Pennsylvania, United States, 19004
    - Recruiting
    - MidLantic urology ( Site 0070)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 610-667-0458
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Completed
    - Saint Francis Cancer Center ( Site 0026)
  - Myrtle Beach, South Carolina, United States, 29572
    - Recruiting
    - Carolina Urologic Research Center ( Site 0002)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 843-449-1010 ext. 257
- Texas
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Urology San Antonio Research ( Site 6010)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 832-472-5482
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Completed
    - Inova Schar Cancer Institute ( Site 6006)
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Recruiting
    - West Virginia University - Charleston Area Medical Center ( Site 6003)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 304-388-5432
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Froedtert and Medical College of Wisconsin ( Site 0022)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 414-805-8900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
Has clinically nonmetastatic 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Chemotherapy + Radiotherapy Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.	Drug: Pembrolizumab 400 mg of IV (intravenous) pembrolizumab once every 6 weeks. Other Names: MK-3475 KEYTRUDA® Radiation: Conventional Radiotherapy (Bladder only) 64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks. Radiation: Conventional Radiotherapy (Bladder and pelvic nodes) 64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks. Radiation: Hypofractionated Radiotherapy (Bladder only) 55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks. Drug: Cisplatin 35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion. Drug: Fluorouracil (5-FU) 5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26. Drug: Mitomycin C (MMC) MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1. Drug: Gemcitabine Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
Placebo Comparator: Placebo + Chemotherapy + Radiotherapy Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.	Radiation: Conventional Radiotherapy (Bladder only) 64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks. Radiation: Conventional Radiotherapy (Bladder and pelvic nodes) 64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks. Radiation: Hypofractionated Radiotherapy (Bladder only) 55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks. Drug: Cisplatin 35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion. Drug: Fluorouracil (5-FU) 5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26. Drug: Mitomycin C (MMC) MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1. Drug: Gemcitabine Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly. Drug: Placebo to Pembrolizumab Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.

Participant Group / Arm

Intervention / Treatment

Experimental: Pembrolizumab + Chemotherapy + Radiotherapy

Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.

Drug: Pembrolizumab

400 mg of IV (intravenous) pembrolizumab once every 6 weeks.

Other Names:

MK-3475
KEYTRUDA®

Radiation: Conventional Radiotherapy (Bladder only)

64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.

Radiation: Conventional Radiotherapy (Bladder and pelvic nodes)

64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks.

Radiation: Hypofractionated Radiotherapy (Bladder only)

55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.

Drug: Cisplatin

35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.

Drug: Fluorouracil (5-FU)

5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26.

Drug: Mitomycin C (MMC)

MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.

Drug: Gemcitabine

Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.

Placebo Comparator: Placebo + Chemotherapy + Radiotherapy

Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.

Radiation: Conventional Radiotherapy (Bladder only)

64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.

Radiation: Conventional Radiotherapy (Bladder and pelvic nodes)

64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks.

Radiation: Hypofractionated Radiotherapy (Bladder only)

55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.

Drug: Cisplatin

35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.

Drug: Fluorouracil (5-FU)

5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26.

Drug: Mitomycin C (MMC)

MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.

Drug: Gemcitabine

Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.

Drug: Placebo to Pembrolizumab

Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Intact Event-Free Survival (BI-EFS) Time Frame: Up to approximately 71 months	BI-EFS is defined as the time from randomization to any of the following events: residual/recurrent MIBC post-chemoradiotherapy (CRT), nodal or distant metastases as assessed by computerized tomography (CT) and CT urography (CTU) or magnetic resonance urography (MRU) per blinded independent central review (BICR) and/or biopsy results assessed by central pathology review, radical cystectomy, or death due to any cause. If biopsy is not feasible due to participant safety, the imaging alone will be sufficient. The BI-EFS for all participants will be presented.	Up to approximately 71 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to approximately 83 months	Time from randomization to death due to any cause.	Up to approximately 83 months
Metastasis-Free Survival (MFS) Time Frame: Up to approximately 83 months	MFS is defined as the time from randomization to the first documented occurrence of nodal or distant metastases as assessed by CT and CTU or MRU per BICR and/or biopsy results assessed by central pathology review If biopsy is not feasible due to participant safety, the imaging alone will be sufficient.	Up to approximately 83 months
Time to Occurrence of Non-Muscle-Invasive Bladder Cancer (NMIBC) Time Frame: Up to approximately 83 months	Time to occurrence of low-grade disease, defined as the time from randomization until the development of NMIBC, will be presented.	Up to approximately 83 months
Number of Participants Who Experienced an Adverse Event (AE) Time Frame: Up to approximately 83 months	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.	Up to approximately 83 months
Number of Participants Who Discontinued Study Intervention Due to an AE Time Frame: Up to approximately 1 year	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.	Up to approximately 1 year
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Time Frame: Baseline and up to approximately 83 months	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.	Baseline and up to approximately 83 months
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 Time Frame: Baseline and up to approximately 83 months	EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.	Baseline and up to approximately 83 months
Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI) Time Frame: Baseline and up to approximately 83 months	The BCI is a validated, condition-specific health questionnaire assessing quality of life among participants with bladder cancer. The BCI contains 36 items which assess 3 domains (urinary, bowel, and sexual) with function and bother subdomains. Scores range from 0 to 100 with higher scores corresponding to better functioning and health-related quality of life. The change from baseline in the combined scores of the urinary, bowel, and sexual domains of the BCI will be presented.	Baseline and up to approximately 83 months
Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Time Frame: Baseline and up to approximately 83 months	The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.	Baseline and up to approximately 83 months
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 Time Frame: Up to approximately 83 months	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.	Up to approximately 83 months
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 Time Frame: Up to approximately 83 months	EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. TTD in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores.	Up to approximately 83 months
TTD in Urinary, Bowel, and Sexual Domains of the BCI Time Frame: Up to approximately 83 months	The BCI is a validated, condition-specific health questionnaire assessing quality of life among participants with bladder cancer. The BCI contains 36 items which assess 3 domains (urinary, bowel, and sexual) with function and bother subdomains. Scores range from 0 to 100 with higher scores corresponding to better functioning and health-related quality of life. TTD in BCI is defined as a 6, 7, and 7 points or greater worsening from baseline for urinary, bowel, and sexual domains, respectively, with or without subsequent confirmation, under a right-censoring rule.	Up to approximately 83 months
TTD in the VAS of the EQ-5D-5L Time Frame: Up to approximately 83 months	The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.	Up to approximately 83 months
Time to Cystectomy Time Frame: Up to approximately 83 months	Time to cystectomy is defined as time from a participant's randomization to date of cystectomy.	Up to approximately 83 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2020

Primary Completion (Estimated)

June 10, 2029

Study Completion (Estimated)

June 10, 2031

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

3475-992
MK-3475-992 (Other Identifier: Merck Protocol Number)
205383 (Registry Identifier: JAPIC-CTI)
2019-004023-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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