Back to resultsEfficacy 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)
Primary Purpose
Urinary Bladder Neoplasms
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Conventional Radiotherapy (Bladder only)
Conventional Radiotherapy (Bladder and pelvic nodes)
Hypofractionated Radiotherapy (Bladder only)
Cisplatin
Fluorouracil (5-FU)
Mitomycin C (MMC)
Gemcitabine
Placebo to Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
- Has clinically non-metastatic bladder cancer (N0M0)
- Has planned and is eligible to receive chemoradiotherapy (CRT) and one of the protocol-specified radiosensitizing chemotherapy regimens
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Demonstrates adequate organ function
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of CRT treatment:
- Refrain from donating sperm
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days the time needed to eliminate each study intervention after the last dose of study intervention; and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: MK-3475 - 120 days and CRT - 180 days
Exclusion Criteria:
- Has the presence of diffuse carcinoma in situ (CIS) (multiple foci of CIS) throughout the bladder
- Has the presence of urothelial carcinoma (UC) at any site outside of the urinary bladder in the previous 2 years except for Ta stage/T1 stage/CIS of the upper tract if the participant has undergone a complete nephroureterectomy
- Has a known additional malignancy that is progressing or has required active therapy within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or other carcinoma in situ that has undergone potentially curative therapy
- Has the presence of bilateral hydronephrosis
- Has limited bladder function with frequency of small amounts of urine (< 30 mL), urinary incontinence, or requires self-catheterization or a permanent indwelling catheter
- Has received prior pelvic/local radiation therapy or any antineoplastic treatment for muscle-invasive bladder cancer (MIBC). Treatment for non-muscle invasive bladder cancer (NMIBC) with intravesical instillation therapy that was completed ≥28 days prior to randomization is allowed. Prior systemic treatment of NMIBC is not permitted.
- Received prior therapy with an anti-PD-1 (programmed cell death protein 1), anti-PD-L1 (programmed death-ligand 1), or anti-PD-L2 (programmed cell death 1 ligand 2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4 [cytotoxic T-lymphocyte-associated protein 4], OX 40, or CD137 [cluster of differentiation 137])
- Has received a live vaccine within 30 days before the first dose of study medication
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study medication
- Has known severe hypersensitivity (≥Grade 3) to the selected chemotherapy regimen, and/or any of their excipients and excipients of pembrolizumab
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B or known active Hepatitis C virus infection
- Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)Recruiting
- Bay Pines VA Medical Center ( Site 0055)
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0004)
- Norton Cancer Institute ( Site 0044)
- Pikeville Medical Center ( Site 0009)Recruiting
- Baltimore VA Medical Center ( Site 0054)
- Washington University ( Site 0003)Recruiting
- Summit Medical Group Cancer Center ( Site 6008)Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)Recruiting
- New York Oncology Hematology P.C ( Site 0024)Recruiting
- Winthrop University Hospital ( Site 0069)Recruiting
- New York University Perlmutter Cancer Center ( Site 0001)Recruiting
- Cleveland Clinic ( Site 0062)Recruiting
- MidLantic urology ( Site 0070)Recruiting
- Saint Francis Cancer Center ( Site 0026)
- Carolina Urologic Research Center ( Site 0002)Recruiting
- Urology San Antonio Research ( Site 6010)Recruiting
- Inova Schar Cancer Institute ( Site 6006)Recruiting
- West Virginia University - Charleston Area Medical Center ( Site 6003)Recruiting
- Froedtert and Medical College of Wisconsin ( Site 0022)Recruiting
- Liverpool Hospital ( Site 0220)
- GenesisCare North Shore ( Site 0217)Recruiting
- Monash Medical Centre ( Site 0216)
- Austin Health ( Site 0218)Recruiting
- Sir Charles Gairdner Hospital ( Site 0223)
- Oncocentro Valdivia ( Site 7055)Recruiting
- FALP ( Site 7056)Recruiting
- Bradfordhill-Clinical Area ( Site 7051)Recruiting
- ONCOCENTRO APYS-ACEREY ( Site 7054)Recruiting
- Centro de Investigación Oncológica del Norte ( Site 7052)Recruiting
- Fakultni nemocnice Olomouc ( Site 0559)Recruiting
- 2. LF UK a FN Motol ( Site 0555)Recruiting
- Nemocnice Na Bulovce ( Site 0556)
- Herlev og Gentofte Hospital. ( Site 0401)
- Odense Universitetshospital ( Site 0403)
- North Estonia Medical Centre Foundation ( Site 0081)Recruiting
- Tartu University Hospital ( Site 0079)Recruiting
- Institut Sainte Catherine ( Site 0121)Recruiting
- CHU Amiens Picardie Site Sud Amiens ( Site 0123)Recruiting
- Institut Curie ( Site 0112)
- A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)Recruiting
- Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)Recruiting
- Oncomedica ( Site 0145)Recruiting
- Grupo Medico Angeles ( Site 0143)Recruiting
- Medi-K Cayala ( Site 0142)Recruiting
- Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)Recruiting
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095)Recruiting
- BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)Recruiting
- Petz Aladar Megyei Oktato Korhaz ( Site 0099)Recruiting
- Debreceni Egyetem Klinikai Kozpont ( Site 0097)Recruiting
- Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)Recruiting
- Soroka Medical Center-Oncology ( Site 7031)Recruiting
- Rambam Health Care Campus-Oncology Division ( Site 0088)Recruiting
- Hadassah Medical Center. Ein Kerem ( Site 0086)Recruiting
- Rabin Medical Center ( Site 7032)Recruiting
- Chaim Sheba Medical Center ( Site 0087)Recruiting
- Sourasky Medical Center ( Site 0089)Recruiting
- Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041)Recruiting
- Ospedale San Raffaele ( Site 0194)Recruiting
- IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)Recruiting
- AOU Careggi ( Site 0191)Recruiting
- Ospedale Civile di Macerata ( Site 0190)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)Recruiting
- Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)Recruiting
- Hirosaki University Hospital ( Site 0602)Recruiting
- University of Tsukuba Hospital ( Site 0605)Recruiting
- Osaka Medical and Pharmaceutical University Hospital ( Site 0604)Recruiting
- Nagasaki University Hospital ( Site 0600)Recruiting
- Tokyo Medical and Dental University Hospital ( Site 0601)Recruiting
- Tokyo Metropolitan Komagome Hospital ( Site 0606)Recruiting
- National Cancer Center ( Site 0202)Recruiting
- Seoul National University Bundang Hospital ( Site 0204)Recruiting
- Asan Medical Center ( Site 0200)Recruiting
- Chungnam National University Hospital ( Site 0203)Recruiting
- Korea University Anam Hospital ( Site 0205)
- Severance Hospital Yonsei University Health System ( Site 0201)Recruiting
- Pauls Stradins Clinical University Hospital ( Site 0073)Recruiting
- Hospital Universiti Sains Malaysia ( Site 0237)Recruiting
- Hospital Pulau Pinang ( Site 0239)Recruiting
- Hospital Kuala Lumpur ( Site 0238)
- University Malaya Medical Centre ( Site 0236)Recruiting
- Netherlands Cancer Institute (NKI) ( Site 0183)Recruiting
- Erasmus MC ( Site 0182)Recruiting
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)Recruiting
- Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154)Recruiting
- Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)Recruiting
- Hospital Beatriz Angelo ( Site 0303)Recruiting
- Centro Hospitalar e Universitario de Coimbra ( Site 0306)Recruiting
- CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302)Recruiting
- Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305)Recruiting
- Advance Urology and Laparoscopic Center ( Site 0281)Recruiting
- PAN American Center Oncologic ( Site 0280)Recruiting
- Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)Recruiting
- S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)Recruiting
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)Recruiting
- Policlinica Oncomed SRL ( Site 0254)Recruiting
- S.C.Focus Lab Plus S.R.L ( Site 0253)Recruiting
- Institutul Oncologic-Oncologie Medicala ( Site 0256)Recruiting
- Institutul Regional de Oncologie Iasi ( Site 0255)
- Instituto Catalan de Oncologia - ICO ( Site 0103)Recruiting
- Hospital La Fe de Valencia ( Site 0105)Recruiting
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106)Recruiting
- Chi Mei Medical Center ( Site 0215)Recruiting
- Kaohsiung Chang Gung Memorial Hospital ( Site 0209)Recruiting
- Taichung Veterans General Hospital ( Site 0213)Recruiting
- National Cheng Kung University Hospital ( Site 0208)
- National Taiwan University Hospital ( Site 0210)Recruiting
- Taipei Veterans General Hospital ( Site 0211)Recruiting
- Chang Gung Medical Foundation.Linkou Branch ( Site 0212)Recruiting
- University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)Recruiting
- Ankara Universitesi Tip Fakultesi. ( Site 0502)Recruiting
- Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)Recruiting
- T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (Recruiting
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)Recruiting
- Ege University Medical Faculty ( Site 0508)Recruiting
- Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)Recruiting
- Clinical oncology dispensary of Dnipro ( Site 0133)
- Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)
- CNPE "Regional Center of Oncology" ( Site 0134)
- Ukranian Center of TomoTherapy ( Site 0140)
- National Cancer Institute of the MoH of Ukraine ( Site 0136)
- Kyiv City Clinical Oncology Center ( Site 0135)
- Betsi Cadwaladr University Health Board ( Site 0447)
- South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)Recruiting
- University College London Hospitals NHS Foundation Trust ( Site 0445)Recruiting
- The Royal Marsden NHS Foundation Trust. ( Site 0442)Recruiting
- Nottingham University Hospital NHS Trust ( Site 0250)
- Darlington Memorial Hospital NHS Trust ( Site 0446)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pembrolizumab + Chemotherapy + Radiotherapy
Placebo + Chemotherapy + Radiotherapy
Arm Description
Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Outcomes
Primary Outcome Measures
Bladder Intact Event-Free Survival (BI-EFS)
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
Overall Survival (OS)
Time from randomization to death due to any cause.
Metastasis-Free Survival (MFS)
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)
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)
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
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)
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
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 Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI)
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.
Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)
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.
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
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
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
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
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
Time to cystectomy is defined as time from a participant's randomization to date of cystectomy.
Full Information
NCT ID
NCT04241185
First Posted
January 22, 2020
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04241185
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
June 10, 2029 (Anticipated)
Study Completion Date
June 10, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All Sponsor personnel will be blinded to treatment assignments, with the exception of designated unblinded team members. Chemoradiotherapy will be administered to all participants and will be open-label.
Allocation
Randomized
Enrollment
636 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Chemotherapy + Radiotherapy
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Arm Title
Placebo + Chemotherapy + Radiotherapy
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
400 mg of IV (intravenous) pembrolizumab once every 6 weeks.
Intervention Type
Radiation
Intervention Name(s)
Conventional Radiotherapy (Bladder only)
Intervention Description
64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
Intervention Type
Radiation
Intervention Name(s)
Conventional Radiotherapy (Bladder and pelvic nodes)
Intervention Description
64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiotherapy (Bladder only)
Intervention Description
55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil (5-FU)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C (MMC)
Intervention Description
MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
Intervention Type
Drug
Intervention Name(s)
Placebo to Pembrolizumab
Intervention Description
Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.
Primary Outcome Measure Information:
Title
Bladder Intact Event-Free Survival (BI-EFS)
Description
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.
Time Frame
Up to approximately 71 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Time from randomization to death due to any cause.
Time Frame
Up to approximately 83 months
Title
Metastasis-Free Survival (MFS)
Description
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 Frame
Up to approximately 83 months
Title
Time to Occurrence of Non-Muscle-Invasive Bladder Cancer (NMIBC)
Description
Time to occurrence of low-grade disease, defined as the time from randomization until the development of NMIBC, will be presented.
Time Frame
Up to approximately 83 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 83 months
Title
Number of Participants Who Discontinued Study Intervention Due to an AE
Description
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.
Time Frame
Up to approximately 1 year
Title
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)
Description
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.
Time Frame
Baseline and up to approximately 83 months
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Description
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.
Time Frame
Baseline and up to approximately 83 months
Title
Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI)
Description
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 Frame
Baseline and up to approximately 83 months
Title
Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)
Description
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.
Time Frame
Baseline and up to approximately 83 months
Title
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
Description
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.
Time Frame
Up to approximately 83 months
Title
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Description
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.
Time Frame
Up to approximately 83 months
Title
TTD in Urinary, Bowel, and Sexual Domains of the BCI
Description
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.
Time Frame
Up to approximately 83 months
Title
TTD in the VAS of the EQ-5D-5L
Description
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 Frame
Up to approximately 83 months
Title
Time to Cystectomy
Description
Time to cystectomy is defined as time from a participant's randomization to date of cystectomy.
Time Frame
Up to approximately 83 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
202-877-9386
Facility Name
Bay Pines VA Medical Center ( Site 0055)
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0004)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Completed
Facility Name
Norton Cancer Institute ( Site 0044)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Completed
Facility Name
Pikeville Medical Center ( Site 0009)
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
606-218-2212
Facility Name
Baltimore VA Medical Center ( Site 0054)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Completed
Facility Name
Washington University ( Site 0003)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-747-4328
Facility Name
Summit Medical Group Cancer Center ( Site 6008)
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
855-413-2220
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
551-996-1379
Facility Name
New York Oncology Hematology P.C ( Site 0024)
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
518-489-3612
Facility Name
Winthrop University Hospital ( Site 0069)
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
516-289-3772
Facility Name
New York University Perlmutter Cancer Center ( Site 0001)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-731-6455
Facility Name
Cleveland Clinic ( Site 0062)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
866-223-8100
Facility Name
MidLantic urology ( Site 0070)
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
610-667-0458
Facility Name
Saint Francis Cancer Center ( Site 0026)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Completed
Facility Name
Carolina Urologic Research Center ( Site 0002)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
843-449-1010 ext. 257
Facility Name
Urology San Antonio Research ( Site 6010)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
832-472-5482
Facility Name
Inova Schar Cancer Institute ( Site 6006)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
571-472-1390
Facility Name
West Virginia University - Charleston Area Medical Center ( Site 6003)
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
304-388-5432
Facility Name
Froedtert and Medical College of Wisconsin ( Site 0022)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
414-805-8900
Facility Name
Liverpool Hospital ( Site 0220)
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Completed
Facility Name
GenesisCare North Shore ( Site 0217)
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61294631172
Facility Name
Monash Medical Centre ( Site 0216)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Completed
Facility Name
Austin Health ( Site 0218)
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
610420381848
Facility Name
Sir Charles Gairdner Hospital ( Site 0223)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Completed
Facility Name
Oncocentro Valdivia ( Site 7055)
City
Valdivia
State/Province
Los Rios
ZIP/Postal Code
5112129
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56992195434
Facility Name
FALP ( Site 7056)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56956075934
Facility Name
Bradfordhill-Clinical Area ( Site 7051)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56998744662
Facility Name
ONCOCENTRO APYS-ACEREY ( Site 7054)
City
Viña del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56992369820
Facility Name
Centro de Investigación Oncológica del Norte ( Site 7052)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56994198125
Facility Name
Fakultni nemocnice Olomouc ( Site 0559)
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420588444295
Facility Name
2. LF UK a FN Motol ( Site 0555)
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420266084516
Facility Name
Nemocnice Na Bulovce ( Site 0556)
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Completed
Facility Name
Herlev og Gentofte Hospital. ( Site 0401)
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Completed
Facility Name
Odense Universitetshospital ( Site 0403)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Completed
Facility Name
North Estonia Medical Centre Foundation ( Site 0081)
City
Tallin
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3726172323
Facility Name
Tartu University Hospital ( Site 0079)
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
51014
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3727318815
Facility Name
Institut Sainte Catherine ( Site 0121)
City
Avignon
State/Province
Provence-Alpes-Cote-d Azur
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33490276090
Facility Name
CHU Amiens Picardie Site Sud Amiens ( Site 0123)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3332022087996
Facility Name
Institut Curie ( Site 0112)
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Active, not recruiting
Facility Name
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33140258935
Facility Name
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+502 42142081
Facility Name
Oncomedica ( Site 0145)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50222781268
Facility Name
Grupo Medico Angeles ( Site 0143)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50223857572
Facility Name
Medi-K Cayala ( Site 0142)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50223752222
Facility Name
Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)
City
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50259458053
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3676516719
Facility Name
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3646515200
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 0099)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3696507900
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 0097)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3652255585
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36306554043
Facility Name
Soroka Medical Center-Oncology ( Site 7031)
City
Be'er Sheva
ZIP/Postal Code
8400000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972508946244
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 0088)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97247773811
Facility Name
Hadassah Medical Center. Ein Kerem ( Site 0086)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97226776760
Facility Name
Rabin Medical Center ( Site 7032)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97239378101
Facility Name
Chaim Sheba Medical Center ( Site 0087)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97235302542
Facility Name
Sourasky Medical Center ( Site 0089)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97236973413
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3470112401
Facility Name
Ospedale San Raffaele ( Site 0194)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390226435668
Facility Name
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390805555355
Facility Name
AOU Careggi ( Site 0191)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390557947019
Facility Name
Ospedale Civile di Macerata ( Site 0190)
City
Macerata
ZIP/Postal Code
62100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3907332572881
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223903818
Facility Name
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Completed
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390815903637
Facility Name
Hirosaki University Hospital ( Site 0602)
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81172335111
Facility Name
University of Tsukuba Hospital ( Site 0605)
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81298533900
Facility Name
Osaka Medical and Pharmaceutical University Hospital ( Site 0604)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81726831221
Facility Name
Nagasaki University Hospital ( Site 0600)
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81958197200
Facility Name
Tokyo Medical and Dental University Hospital ( Site 0601)
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81338136111
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 0606)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3823-2101
Facility Name
National Cancer Center ( Site 0202)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82319203679
Facility Name
Seoul National University Bundang Hospital ( Site 0204)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82317877071
Facility Name
Asan Medical Center ( Site 0200)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82230105614
Facility Name
Chungnam National University Hospital ( Site 0203)
City
Daejeon
State/Province
Taejon-Kwangyokshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82422808369
Facility Name
Korea University Anam Hospital ( Site 0205)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Severance Hospital Yonsei University Health System ( Site 0201)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82222288138
Facility Name
Pauls Stradins Clinical University Hospital ( Site 0073)
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37129262596
Facility Name
Hospital Universiti Sains Malaysia ( Site 0237)
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6097676684
Facility Name
Hospital Pulau Pinang ( Site 0239)
City
Penang
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6042225768
Facility Name
Hospital Kuala Lumpur ( Site 0238)
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Completed
Facility Name
University Malaya Medical Centre ( Site 0236)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60379492120
Facility Name
Netherlands Cancer Institute (NKI) ( Site 0183)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31205122569
Facility Name
Erasmus MC ( Site 0182)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31107041505
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48606751459
Facility Name
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154)
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48603936331
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48943488931
Facility Name
Hospital Beatriz Angelo ( Site 0303)
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351219847200
Facility Name
Centro Hospitalar e Universitario de Coimbra ( Site 0306)
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351239400457
Facility Name
CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302)
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351210431703
Facility Name
Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217805000
Facility Name
Advance Urology and Laparoscopic Center ( Site 0281)
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7872843333
Facility Name
PAN American Center Oncologic ( Site 0280)
City
San Juan, Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7874073333
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40745976913
Facility Name
S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40742206212
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40727774974
Facility Name
Policlinica Oncomed SRL ( Site 0254)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40745100495
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 0253)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721298677
Facility Name
Institutul Oncologic-Oncologie Medicala ( Site 0256)
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40745646368
Facility Name
Institutul Regional de Oncologie Iasi ( Site 0255)
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Completed
Facility Name
Instituto Catalan de Oncologia - ICO ( Site 0103)
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932607744
Facility Name
Hospital La Fe de Valencia ( Site 0105)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34961244188
Facility Name
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34955013068
Facility Name
Chi Mei Medical Center ( Site 0215)
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88662812811
Facility Name
Kaohsiung Chang Gung Memorial Hospital ( Site 0209)
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88677317123
Facility Name
Taichung Veterans General Hospital ( Site 0213)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8886423592525
Facility Name
National Cheng Kung University Hospital ( Site 0208)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Completed
Facility Name
National Taiwan University Hospital ( Site 0210)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886223123456
Facility Name
Taipei Veterans General Hospital ( Site 0211)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886228757519304
Facility Name
Chang Gung Medical Foundation.Linkou Branch ( Site 0212)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886 3-3281200 ext8825
Facility Name
University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905366401020
Facility Name
Ankara Universitesi Tip Fakultesi. ( Site 0502)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905337483275
Facility Name
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905333682319
Facility Name
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905326761078
Facility Name
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905063509061
Facility Name
Ege University Medical Faculty ( Site 0508)
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905337360674
Facility Name
Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905052180361
Facility Name
Clinical oncology dispensary of Dnipro ( Site 0133)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61024
Country
Ukraine
Individual Site Status
Suspended
Facility Name
CNPE "Regional Center of Oncology" ( Site 0134)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Ukranian Center of TomoTherapy ( Site 0140)
City
Kropyvnytskiy
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25011
Country
Ukraine
Individual Site Status
Suspended
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 0136)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kyiv City Clinical Oncology Center ( Site 0135)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Betsi Cadwaladr University Health Board ( Site 0447)
City
Rhyl
State/Province
Denbighshire
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441803614567
Facility Name
University College London Hospitals NHS Foundation Trust ( Site 0445)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4420 3456 7014
Facility Name
The Royal Marsden NHS Foundation Trust. ( Site 0442)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442078082788
Facility Name
Nottingham University Hospital NHS Trust ( Site 0250)
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Darlington Memorial Hospital NHS Trust ( Site 0446)
City
Darlington
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441325743654
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://merckclinicaltrials.com
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-992&&kw=3475-992
Description
Plain Language Summary
Learn more about this trial
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
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