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)
NCT ID: NCT04241185
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
520 participants
INTERVENTIONAL
2020-05-19
2031-11-01
Brief Summary
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MIBC is treated by having surgery to remove the bladder (cystectomy). Not all people choose to have surgery and want to keep their bladder using other treatments.
Chemoradiotherapy (CRT)- is a type of non-surgical treatment for MIBC which combines Chemotherapy (a treatment with medicine to destroy cancer cells or stop them growing) and Radiation therapy (a treatment that uses beams of intense energy \[like X-rays\] to shrink or get rid of tumors).
Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer.
A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand if the study medicine works.
The goal of this study is to learn: 1. If a study medicine pembrolizumab given with Chemoradiotherapy (CRT) can help people live longer without their cancer growing, spreading, or coming back compared to placebo given with CRT. 2.About the safety and how well people tolerate CRT alone or in combination with pembrolizumab.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pembrolizumab + Chemotherapy + Radiotherapy
Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab
400 mg of IV (intravenous) pembrolizumab once every 6 weeks.
Conventional Radiotherapy (Bladder only)
64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
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.
Hypofractionated Radiotherapy (Bladder only)
55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
Cisplatin
35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
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.
Mitomycin C (MMC)
MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
Gemcitabine
Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
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.
Conventional Radiotherapy (Bladder only)
64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
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.
Hypofractionated Radiotherapy (Bladder only)
55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
Cisplatin
35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
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.
Mitomycin C (MMC)
MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
Gemcitabine
Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
Placebo to Pembrolizumab
Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.
Interventions
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Pembrolizumab
400 mg of IV (intravenous) pembrolizumab once every 6 weeks.
Conventional Radiotherapy (Bladder only)
64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
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.
Hypofractionated Radiotherapy (Bladder only)
55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
Cisplatin
35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
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.
Mitomycin C (MMC)
MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
Gemcitabine
Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
Placebo to Pembrolizumab
Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 for any reason 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)
Washington D.C., District of Columbia, United States
Bay Pines VA Medical Center ( Site 0055)
Bay Pines, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0004)
Orlando, Florida, United States
Norton Cancer Institute ( Site 0044)
Louisville, Kentucky, United States
Pikeville Medical Center ( Site 0009)
Pikeville, Kentucky, United States
Baltimore VA Medical Center ( Site 0054)
Baltimore, Maryland, United States
Washington University ( Site 0003)
St Louis, Missouri, United States
Summit Medical Group Cancer Center ( Site 6008)
Florham Park, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)
Hackensack, New Jersey, United States
New York Oncology Hematology P.C ( Site 0024)
Albany, New York, United States
Roswell Park Cancer Institute ( Site 6009)
Buffalo, New York, United States
Winthrop University Hospital ( Site 0069)
Mineola, New York, United States
New York University Perlmutter Cancer Center ( Site 0001)
New York, New York, United States
Fairview Hospital-Moll Cancer Center ( Site 6013)
Cleveland, Ohio, United States
Cleveland Clinic Main ( Site 0062)
Cleveland, Ohio, United States
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012)
Mayfield Heights, Ohio, United States
MidLantic urology ( Site 0070)
Bala-Cynwyd, Pennsylvania, United States
Saint Francis Cancer Center ( Site 0026)
Greenville, South Carolina, United States
Carolina Urologic Research Center ( Site 0002)
Myrtle Beach, South Carolina, United States
Urology San Antonio Research ( Site 6010)
San Antonio, Texas, United States
Inova Schar Cancer Institute ( Site 6006)
Fairfax, Virginia, United States
West Virginia University - Charleston Area Medical Center ( Site 6003)
Charleston, West Virginia, United States
Froedtert and Medical College of Wisconsin ( Site 0022)
Milwaukee, Wisconsin, United States
Liverpool Hospital ( Site 0220)
Liverpool, New South Wales, Australia
GenesisCare North Shore ( Site 0217)
St Leonards, New South Wales, Australia
Monash Medical Centre ( Site 0216)
Clayton, Victoria, Australia
Austin Health ( Site 0218)
Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 0223)
Nedlands, Western Australia, Australia
Oncocentro Valdivia ( Site 7055)
Valdivia, Los Ríos Region, Chile
FALP ( Site 7056)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 7051)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 7054)
Viña del Mar, Región de Valparaíso, Chile
Bradford Hill Norte ( Site 7052)
Antofagasta, , Chile
Fakultni nemocnice Olomouc ( Site 0559)
Olomouc, , Czechia
2. LF UK a FN Motol ( Site 0555)
Prague, , Czechia
Nemocnice Na Bulovce ( Site 0556)
Prague, , Czechia
Herlev og Gentofte Hospital. ( Site 0401)
Herlev, Capital Region, Denmark
Odense Universitetshospital ( Site 0403)
Odense, Region Syddanmark, Denmark
North Estonia Medical Centre Foundation ( Site 0081)
Tallinn, Harju, Estonia
Tartu University Hospital ( Site 0079)
Tartu, Tartu, Estonia
Institut Sainte Catherine ( Site 0121)
Avignon, Provence-Alpes-Côte d'Azur Region, France
CHU Amiens Picardie Site Sud Amiens ( Site 0123)
Amiens, Somme, France
Institut Curie ( Site 0112)
Paris, , France
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)
Paris, , France
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)
Guatemala City, , Guatemala
Oncomedica ( Site 0145)
Guatemala City, , Guatemala
Grupo Medico Angeles ( Site 0143)
Guatemala City, , Guatemala
Medi-K Cayala ( Site 0142)
Guatemala City, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)
Quetzaltenango, , Guatemala
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0099)
Győr, Győr-Moson-Sopron, Hungary
Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga ( Site 0095)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0097)
Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)
Kaposvár, , Hungary
Soroka Medical Center-Oncology ( Site 7031)
Beersheba, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0088)
Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0086)
Jerusalem, , Israel
Rabin Medical Center ( Site 7032)
Petah Tikva, , Israel
Chaim Sheba Medical Center ( Site 0087)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0089)
Tel Aviv, , Israel
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)
Bari, Apulia, Italy
Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)
Milan, Lombardy, Italy
AOU Careggi ( Site 0191)
Florence, , Italy
Ospedale Civile di Macerata ( Site 0190)
Macerata, , Italy
Ospedale San Raffaele ( Site 0194)
Milan, , Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)
Modena, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)
Napoli, , Italy
Hirosaki University Hospital ( Site 0602)
Hirosaki, Aomori, Japan
University of Tsukuba Hospital ( Site 0605)
Tsukuba, Ibaraki, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 0604)
Takatsuki, Osaka, Japan
Nagasaki University Hospital ( Site 0600)
Nagasaki, , Japan
Institute of Science Tokyo Hospital ( Site 0601)
Tokyo, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 0606)
Tokyo, , Japan
Pauls Stradins Clinical University Hospital ( Site 0073)
Riga, , Latvia
Hospital Universiti Sains Malaysia ( Site 0237)
Kubang Kerian, Kelantan, Malaysia
Hospital Pulau Pinang ( Site 0239)
George Town, Pulau Pinang, Malaysia
Hospital Kuala Lumpur ( Site 0238)
Kuala Lumpur, , Malaysia
University Malaya Medical Centre ( Site 0236)
Kuala Lumpur, , Malaysia
Netherlands Cancer Institute (NKI) ( Site 0183)
Amsterdam, North Holland, Netherlands
Erasmus MC ( Site 0182)
Rotterdam, South Holland, Netherlands
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)
Krakow, Lesser Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154)
Siedlce, Masovian Voivodeship, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland
Unidade Local de Saude Loures-Odivelas - Hospital Beatriz Angelo ( Site 0303)
Loures, Lisbon District, Portugal
Centro Hospitalar e Universitario de Coimbra ( Site 0306)
Coimbra, , Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 0302)
Lisbon, , Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0305)
Lisbon, , Portugal
Advance Urology and Laparoscopic Center ( Site 0281)
Ponce, , Puerto Rico
PAN American Center Oncologic ( Site 0280)
San Juan, Rio Piedras, , Puerto Rico
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)
Cluj-Napoca, Cluj, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)
Cluj-Napoca, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)
Craiova, Dolj, Romania
Policlinica Oncomed SRL ( Site 0254)
Timișoara, Timiș County, Romania
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 0253)
Bucharest, , Romania
Institutul Oncologic-Oncologie Medicala ( Site 0256)
Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi ( Site 0255)
Iași, , Romania
National Cancer Center ( Site 0202)
Gyeonggi-do, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0204)
Seongnam-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 0200)
Songpagu, Seoul, South Korea
Chungnam National University Hospital ( Site 0203)
Daejeon, Taejon-Kwangyokshi, South Korea
Korea University Anam Hospital ( Site 0205)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 0201)
Seoul, , South Korea
Instituto Catalan de Oncologia - ICO ( Site 0103)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital La Fe de Valencia ( Site 0105)
Valencia, Valenciana, Comunitat, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106)
Seville, , Spain
University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)
Ankara, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi. ( Site 0502)
Ankara, , Turkey (Türkiye)
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)
Istanbul, , Turkey (Türkiye)
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
Istanbul, , Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty ( Site 0508)
Izmir, , Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)
Trabzon, , Turkey (Türkiye)
Clinical oncology dispensary of Dnipro ( Site 0133)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
MNPE Regional Center of Oncology ( Site 0134)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Ukranian Center of TomoTherapy ( Site 0140)
Kropyvnytskiy, Kirovohrad Oblast, Ukraine
SNPE National Cancer Institute ( Site 0136)
Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0135)
Kyiv, , Ukraine
Betsi Cadwaladr University Health Board ( Site 0447)
Rhyl, Denbighshire, United Kingdom
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)
Torquay, Devon, United Kingdom
Royal Preston Hospital ( Site 0449)
Preston, Lancashire, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 0445)
London, London, City of, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0442)
London, London, City of, United Kingdom
Nottingham University Hospital NHS Trust ( Site 0250)
Nottingham, Nottinghamshire, United Kingdom
Darlington Memorial Hospital NHS Trust ( Site 0446)
Darlington, , United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-992
Identifier Type: OTHER
Identifier Source: secondary_id
205383
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1287-4190
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503500-87
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2080225287
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-004023-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-992
Identifier Type: -
Identifier Source: org_study_id
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