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)

Phase 3

Active, not recruiting

Conditions: Urinary Bladder Neoplasms

Interventions: Drug: Pembrolizumab
Radiation: Conventional Radiotherapy (Bladder only)
Radiation: Conventional Radiotherapy (Bladder and pelvic nodes)
Radiation: Hypofractionated Radiotherapy (Bladder only)
Drug: Cisplatin
Drug: Mitomycin C (MMC)
Drug: Fluorouracil (5-FU)
Drug: Placebo to Pembrolizumab
Drug: Gemcitabine

Registration Number: NCT04241185

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 520

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 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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Chemotherapy + Radiotherapy	Mitomycin C (MMC)	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Fluorouracil (5-FU)	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Placebo + Chemotherapy + Radiotherapy	Placebo to Pembrolizumab	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Conventional Radiotherapy (Bladder only)	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Placebo + Chemotherapy + Radiotherapy	Conventional Radiotherapy (Bladder and pelvic nodes)	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Mitomycin C (MMC)	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Pembrolizumab	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Placebo + Chemotherapy + Radiotherapy	Hypofractionated Radiotherapy (Bladder only)	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Conventional Radiotherapy (Bladder and pelvic nodes)	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Hypofractionated Radiotherapy (Bladder only)	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Placebo + Chemotherapy + Radiotherapy	Conventional Radiotherapy (Bladder only)	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Placebo + Chemotherapy + Radiotherapy	Fluorouracil (5-FU)	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Cisplatin	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Pembrolizumab + Chemotherapy + Radiotherapy	Gemcitabine	Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Placebo + Chemotherapy + Radiotherapy	Cisplatin	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Placebo + Chemotherapy + Radiotherapy	Gemcitabine	Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.

Primary Outcome Measures

Name	Time	Method
Bladder Intact Event-Free Survival (BI-EFS)	Up to approximately 76 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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 95 months	Time from randomization to death due to any cause.
Metastasis-Free Survival (MFS)	Up to approximately 95 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.
Time to Occurrence of Non-Muscle-Invasive Bladder Cancer (NMIBC)	Up to approximately 95 months	Time to occurrence of low-grade disease, defined as the time from randomization until the development of NMIBC, will be presented.
Number of Participants Who Experienced an Adverse Event (AE)	Up to approximately 95 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.
Number of Participants Who Discontinued Study Intervention Due to an AE	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.
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)	Baseline and up to approximately 24 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.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	Baseline and up to approximately 24 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.
Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)	Baseline and up to approximately 24 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.
Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI)	Baseline and up to approximately 24 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.
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30	Up to approximately 24 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.
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	Up to approximately 24 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.
TTD in Urinary, Bowel, and Sexual Domains of the BCI	Up to approximately 24 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.
TTD in the VAS of the EQ-5D-5L	Up to approximately 24 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.
Time to Cystectomy	Up to approximately 95 months	Time to cystectomy is defined as time from a participant's randomization to date of cystectomy.

Trial Locations

Locations (126): Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga ( Site 0095)
🇭🇺
Budapest, Hungary
Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)
🇺🇸
Washington, District of Columbia, United States
Bay Pines VA Medical Center ( Site 0055)
🇺🇸
Bay Pines, Florida, United States
Institute of Science Tokyo Hospital ( Site 0601)
🇯🇵
Tokyo, Japan
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)
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Pikeville, Kentucky, United States
Baltimore VA Medical Center ( Site 0054)
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Baltimore, Maryland, United States
Washington University ( Site 0003)
🇺🇸
Saint Louis, Missouri, United States
Summit Medical Group Cancer Center ( Site 6008)
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Florham Park, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)
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Hackensack, New Jersey, United States
Roswell Park Cancer Institute ( Site 6009)
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Buffalo, New York, United States
New York Oncology Hematology P.C ( Site 0024)
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Albany, New York, United States
Winthrop University Hospital ( Site 0069)
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Mineola, New York, United States
New York University Perlmutter Cancer Center ( Site 0001)
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New York, New York, United States
Fairview Hospital-Moll Cancer Center ( Site 6013)
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Cleveland, Ohio, United States
Cleveland Clinic Main ( Site 0062)
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Cleveland, Ohio, United States
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012)
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Mayfield Heights, Ohio, United States
MidLantic urology ( Site 0070)
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Bala-Cynwyd, Pennsylvania, United States
Saint Francis Cancer Center ( Site 0026)
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Greenville, South Carolina, United States
Carolina Urologic Research Center ( Site 0002)
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Myrtle Beach, South Carolina, United States
Urology San Antonio Research ( Site 6010)
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San Antonio, Texas, United States
Inova Schar Cancer Institute ( Site 6006)
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Fairfax, Virginia, United States
West Virginia University - Charleston Area Medical Center ( Site 6003)
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Charleston, West Virginia, United States
Froedtert and Medical College of Wisconsin ( Site 0022)
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Milwaukee, Wisconsin, United States
Liverpool Hospital ( Site 0220)
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Liverpool, New South Wales, Australia
GenesisCare North Shore ( Site 0217)
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St Leonards, New South Wales, Australia
Monash Medical Centre ( Site 0216)
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Clayton, Victoria, Australia
Austin Health ( Site 0218)
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Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 0223)
🇦🇺
Nedlands, Western Australia, Australia
Oncocentro Valdivia ( Site 7055)
🇨🇱
Valdivia, Los Rios, 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)
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Viña del Mar, Valparaiso, Chile
Bradford Hill Norte ( Site 7052)
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Antofagasta, Chile
Fakultni nemocnice Olomouc ( Site 0559)
🇨🇿
Olomouc, Czechia
2. LF UK a FN Motol ( Site 0555)
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Praha 5, Czechia
Nemocnice Na Bulovce ( Site 0556)
🇨🇿
Praha 8, Czechia
Herlev og Gentofte Hospital. ( Site 0401)
🇩🇰
Herlev, Hovedstaden, Denmark
Odense Universitetshospital ( Site 0403)
🇩🇰
Odense, Syddanmark, Denmark
North Estonia Medical Centre Foundation ( Site 0081)
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Tallin, Harjumaa, Estonia
Tartu University Hospital ( Site 0079)
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Tartu, Tartumaa, Estonia
Institut Sainte Catherine ( Site 0121)
🇫🇷
Avignon, Provence-Alpes-Cote-d Azur, France
CHU Amiens Picardie Site Sud Amiens ( Site 0123)
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Amiens, Somme, France
Institut Curie ( Site 0112)
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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, Guatemala
Oncomedica ( Site 0145)
🇬🇹
Guatemala, Guatemala
Grupo Medico Angeles ( Site 0143)
🇬🇹
Guatemala, Guatemala
Medi-K Cayala ( Site 0142)
🇬🇹
Guatemala, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)
🇬🇹
Quetzaltenango, Guatemala
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)
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Miskolc, Borsod-Abauj-Zemplen, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0099)
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Gyor, Gyor-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0097)
🇭🇺
Debrecen, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)
🇭🇺
Kaposvar, Hungary
Soroka Medical Center-Oncology ( Site 7031)
🇮🇱
Be'er Sheva, Israel
Rambam Health Care Campus-Oncology Division ( Site 0088)
🇮🇱
Haifa, Israel
Hadassah Medical Center. Ein Kerem ( Site 0086)
🇮🇱
Jerusalem, Israel
Chaim Sheba Medical Center ( Site 0087)
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Ramat Gan, Israel
Rabin Medical Center ( Site 7032)
🇮🇱
Petah Tikva, Israel
Sourasky Medical Center ( Site 0089)
🇮🇱
Tel Aviv, Israel
Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041)
🇮🇹
Roma, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)
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Milano, Lombardia, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)
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Bari, Puglia, Italy
AOU Careggi ( Site 0191)
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Firenze, Italy
Ospedale Civile di Macerata ( Site 0190)
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Macerata, Italy
Ospedale San Raffaele ( Site 0194)
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Milano, Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)
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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
Tokyo Metropolitan Komagome Hospital ( Site 0606)
🇯🇵
Tokyo, Japan
National Cancer Center ( Site 0202)
🇰🇷
Gyeonggi-do, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0204)
🇰🇷
Seongnam-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 0200)
🇰🇷
Songpagu, Seoul, Korea, Republic of
Chungnam National University Hospital ( Site 0203)
🇰🇷
Daejeon, Taejon-Kwangyokshi, Korea, Republic of
Korea University Anam Hospital ( Site 0205)
🇰🇷
Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0201)
🇰🇷
Seoul, Korea, Republic of
Pauls Stradins Clinical University Hospital ( Site 0073)
🇱🇻
Riga, Latvia
Hospital Universiti Sains Malaysia ( Site 0237)
🇲🇾
Kubang Kerian, Kelantan, Malaysia
Hospital Pulau Pinang ( Site 0239)
🇲🇾
Penang, 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, Noord-Holland, Netherlands
Erasmus MC ( Site 0182)
🇳🇱
Rotterdam, Zuid-Holland, Netherlands
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)
🇵🇱
Krakow, Malopolskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154)
🇵🇱
Siedlce, Mazowieckie, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)
🇵🇱
Koszalin, Zachodniopomorskie, Poland
Unidade Local de Saude Loures-Odivelas - Hospital Beatriz Angelo ( Site 0303)
🇵🇹
Loures, Lisboa, Portugal
Centro Hospitalar e Universitario de Coimbra ( Site 0306)
🇵🇹
Coimbra, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 0302)
🇵🇹
Lisboa, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0305)
🇵🇹
Lisboa, 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)
🇷🇴
Timisoara, Timis, Romania
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 0253)
🇷🇴
Bucuresti, Romania
Institutul Oncologic-Oncologie Medicala ( Site 0256)
🇷🇴
Cluj, Romania
Institutul Regional de Oncologie Iasi ( Site 0255)
🇷🇴
Iasi, Romania
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)
🇪🇸
Sevilla, Spain
University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)
🇹🇷
Ankara, Turkey
Ankara Universitesi Tip Fakultesi. ( Site 0502)
🇹🇷
Ankara, Turkey
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)
🇹🇷
Istanbul, Turkey
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
🇹🇷
Istanbul, Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)
🇹🇷
Istanbul, Turkey
Ege University Medical Faculty ( Site 0508)
🇹🇷
Izmir, Turkey
Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)
🇹🇷
Trabzon, Turkey
Clinical oncology dispensary of Dnipro ( Site 0133)
🇺🇦
Dnipro, Dnipropetrovska Oblast, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)
🇺🇦
Kharkiv, Kharkivska Oblast, Ukraine
MNPE Regional Center of Oncology ( Site 0134)
🇺🇦
Kharkiv, Kharkivska Oblast, Ukraine
Ukranian Center of TomoTherapy ( Site 0140)
🇺🇦
Kropyvnytskiy, Kirovohradska 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

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)

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts