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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)

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)

INTRODUCTION

  • Org Study ID: 3475-992
  • Secondary ID: MK-3475-992, 205383, 2019-004023-20
  • NTC ID: NCT04241185
  • Sponsor: Merck Sharp & Dohme LLC

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.

  • Overall Status
    Recruiting
  • Start Date
    May 19, 2020
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Bladder Intact Event-Free Survival (BI-EFS)

Primary Outcome 1 - Timeframe: Up to approximately 71 months

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)
Washington, District of Columbia 20010
United States
Status: Recruiting Contact: Contact
Study Coordinator
202-877-9386
Facility: Bay Pines VA Medical Center ( Site 0055)
Bay Pines, Florida 33744
United States
Status: Recruiting Contact: Contact
Study Coordinator
727-398-6661
Facility: Pikeville Medical Center ( Site 0009)
Pikeville, Kentucky 41501
United States
Status: Recruiting Contact: Contact
Study Coordinator
551-996-1379
Facility: Washington University ( Site 0003)
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Study Coordinator
516-289-3772
Facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-731-6455
Facility: New York Oncology Hematology P.C ( Site 0024)
Albany, New York 12206
United States
Status: Recruiting Contact: Contact
Study Coordinator
866-223-8100
Facility: Winthrop University Hospital ( Site 0069)
Mineola, New York 11501
United States
Status: Recruiting Contact: Contact
Study Coordinator
610-667-0458
Facility: New York University Perlmutter Cancer Center ( Site 0001)
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Study Coordinator
843-449-1010 ext. 257
Facility: Cleveland Clinic ( Site 0062)
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Contact
Study Coordinator
304-388-5432
Facility: MidLantic urology ( Site 0070)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Study Coordinator
414-805-8900
Facility: Carolina Urologic Research Center ( Site 0002)
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Study Coordinator
61294631172
Facility: West Virginia University - Charleston Area Medical Center ( Site 6003)
Charleston, West Virginia 25304
United States
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Study Coordinator
61436387664
Facility: Froedtert and Medical College of Wisconsin ( Site 0022)
Milwaukee, Wisconsin 53226
United States
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Study Coordinator
610420381848
Facility: Liverpool Hospital ( Site 0220)
Liverpool, New South Wales 2170
Australia
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Study Coordinator
61893891437
Facility: Northern Cancer Institute ( Site 0217)
St Leonards, New South Wales 2065
Australia
Status: Recruiting Contact: Contact
Study Coordinator
+420588444295
Facility: Monash Health-Monash Medical Centre ( Site 0216)
Clayton, Victoria 3168
Australia
Status: Recruiting Contact: Contact
Study Coordinator
+420266084516
Facility: Austin Health ( Site 0218)
Heidelberg, Victoria 3084
Australia
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Study Coordinator
4538683868
Facility: Sir Charles Gairdner Hospital ( Site 0223)
Nedlands, Western Australia 6009
Australia
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Study Coordinator
4566113333
Facility: Fakultni nemocnice Olomouc ( Site 0559)
Olomouc, Hovedstaden 775 20
Czechia
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Study Coordinator
+3726172323
Facility: 2. LF UK a FN Motol ( Site 0555)
Praha 5, Syddanmark 150 06
Czechia
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Study Coordinator
+3727318815
Facility: Herlev og Gentofte Hospital. ( Site 0401)
Herlev, Tartumaa 2730
Denmark
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Study Coordinator
+3332022087996
Facility: Odense Universitetshospital ( Site 0403)
Odense, Provence-Alpes-Cote-d Azur 5000
Denmark
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Study Coordinator
+33172389445
Facility: North Estonia Medical Centre Foundation ( Site 0081)
Tallin, Somme 13419
Estonia
Status: Recruiting Contact: Contact
Study Coordinator
+33140258935
Facility: Tartu University Hospital ( Site 0079)
Tartu, Bacs-Kiskun 51014
Estonia
Status: Recruiting Contact: Contact
Study Coordinator
+502 42142081
Facility: Institut Sainte Catherine ( Site 0121)
Avignon, Borsod-Abauj-Zemplen 84918
France
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Study Coordinator
50222781268
Facility: CHU Amiens Picardie Site Sud Amiens ( Site 0123)
Amiens, Gyor-Moson-Sopron 80000
France
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Study Coordinator
+50223857572
Facility: Institut Curie ( Site 0112)
Paris, Lombardia 75005
France
Status: Recruiting Contact: Contact
Study Coordinator
+50223752222
Facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)
Paris, Puglia 75018
France
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Study Coordinator
+50259458053
Facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)
Guatemala, Aomori 01010
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+3676516719
Facility: Oncomedica ( Site 0145)
Guatemala, Ibaraki 01010
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+3646515200
Facility: Grupo Medico Angeles ( Site 0143)
Guatemala, Osaka 01015
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+3696507900
Facility: Medi-K Cayala ( Site 0142)
Guatemala, Kyonggi-do 01016
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+3652255585
Facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)
Quetzaltenango, Kyonggi-do 09002
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+36306554043
Facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095)
Kecskemét, Seoul 6000
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+972508946244
Facility: BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)
Miskolc, Taejon-Kwangyokshi 3526
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97247773811
Facility: Petz Aladar Megyei Oktato Korhaz ( Site 0099)
Gyor, Kelantan 9024
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97226776760
Facility: Debreceni Egyetem Klinikai Kozpont ( Site 0097)
Debrecen, Pulau Pinang 4032
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97235302542
Facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)
Kaposvar, Noord-Holland 7400
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97236973413
Facility: Soroka Medical Center-Oncology ( Site 7031)
Be'er Sheva, Zuid-Holland 8400000
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390226435668
Facility: Rambam Health Care Campus-Oncology Division ( Site 0088)
Haifa, Malopolskie 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390805555355
Facility: Hadassah Medical Center. Ein Kerem ( Site 0086)
Jerusalem, Zachodniopomorskie 9112001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390557947019
Facility: Chaim Sheba Medical Center ( Site 0087)
Ramat Gan, Cluj 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+3907332572881
Facility: Sourasky Medical Center ( Site 0089)
Tel Aviv, Cluj 6423906
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390223903818
Facility: Ospedale San Raffaele ( Site 0194)
Milano, Dolj 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390594224767
Facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)
Bari, Timis 70124
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390815903637
Facility: AOU Careggi ( Site 0191)
Firenze, Barcelona 50134
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81172335111
Facility: Ospedale Civile di Macerata ( Site 0190)
Macerata, Valenciana, Comunitat 62100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81298533900
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)
Milano, Tainan 20133
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81726831221
Facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)
Modena, Dnipropetrovska Oblast 41124
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81958197200
Facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)
Napoli, Kharkivska Oblast 80131
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3823-2101
Facility: Hirosaki University Hospital ( Site 0602)
Hirosaki, Kharkivska Oblast 036-8563
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81338136111
Facility: University of Tsukuba Hospital ( Site 0605)
Tsukuba, Kirovohradska Oblast 305-8576
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82319203679
Facility: Osaka Medical and Pharmaceutical University Hospital ( Site 0604)
Takatsuki, Kyivska Oblast 569-8686
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82317877071
Facility: Nagasaki University Hospital ( Site 0600)
Nagasaki, Denbighshire 852-8510
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82230105614
Facility: Tokyo Metropolitan Komagome Hospital ( Site 0606)
Tokyo, Devon 113-8677
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82422808369
Facility: Tokyo Medical and Dental University Hospital ( Site 0601)
Tokyo, London, City Of 10408
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82222288138
Facility: National Cancer Center ( Site 0202)
Gyeonggi-do, London, City Of 13620
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+37129262596
Facility: Seoul National University Bundang Hospital ( Site 0204)
Seongnam-si, Nottinghamshire 05505
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+6097676684
Facility: Asan Medical Center ( Site 0200)
Songpagu, 35015
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+6042225768
Facility: Chungnam National University Hospital ( Site 0203)
Daejeon, 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+60326155810
Facility: Severance Hospital Yonsei University Health System ( Site 0201)
Seoul, LV-1002
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+31205122569
Facility: Pauls Stradins Clinical University Hospital ( Site 0073)
Riga, 16150
Latvia
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Study Coordinator
+31107041505
Facility: Hospital Universiti Sains Malaysia ( Site 0237)
Kubang Kerian, 10990
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
48606751459
Facility: Hospital Pulau Pinang ( Site 0239)
Penang, 50586
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+48943488931
Facility: Hospital Kuala Lumpur ( Site 0238)
Kuala Lumpur, 59100
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+351239400457
Facility: University Malaya Medical Centre ( Site 0236)
Kuala Lumpur, 1066 CX
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+351210431703
Facility: Netherlands Cancer Institute (NKI) ( Site 0183)
Amsterdam, 3015 GD
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+351217805000
Facility: Erasmus MC ( Site 0182)
Rotterdam, 31-826
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
7872843333
Facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)
Krakow, 75-581
Poland
Status: Recruiting Contact: Contact
Study Coordinator
7874073333
Facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)
Koszalin, 3000-075
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+40745976913
Facility: Centro Hospitalar e Universitario de Coimbra ( Site 0306)
Coimbra, 1449-005
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40742206212
Facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302)
Lisboa, 1649-035
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40727774974
Facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305)
Lisboa, 00716
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40745100495
Facility: Advance Urology and Laparoscopic Center ( Site 0281)
Ponce, 00935
Puerto Rico
Status: Recruiting Contact: Contact
Study Coordinator
+34932607744
Facility: PAN American Center Oncologic ( Site 0280)
San Juan, Rio Piedras, 400015
Puerto Rico
Status: Recruiting Contact: Contact
Study Coordinator
+34961244188
Facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)
Cluj Napoca, 407280
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+34955013068
Facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)
Cluj-Napoca, 200347
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+88662812811
Facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)
Craiova, 300239
Romania
Status: Recruiting Contact: Contact
Study Coordinator
88677317123
Facility: Policlinica Oncomed SRL ( Site 0254)
Timisoara, 700483
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+8886423592525
Facility: Instituto Catalan de Oncologia - ICO ( Site 0103)
L Hospitalet De Llobregat, 46026
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+886228757519304
Facility: Hospital La Fe de Valencia ( Site 0105)
Valencia, 41013
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+886 3-3281200 ext8825
Facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106)
Sevilla, 71004
Spain
Status: Recruiting Contact: Contact
Study Coordinator
905366401020
Facility: Chi Mei Medical Center ( Site 0215)
Tainan City, 83301
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905337483275
Facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0209)
Kaohsiung, 407
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905333682319
Facility: Taichung Veterans General Hospital ( Site 0213)
Taichung, 704
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905063509061
Facility: National Taiwan University Hospital ( Site 0210)
Taipei, 11217
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905052180361
Facility: Taipei Veterans General Hospital ( Site 0211)
Taipei, 333
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+441745445231
Facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0212)
Taoyuan, 06010
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+441803614567
Facility: University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)
Ankara, 06100
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+4420 3456 7014
Facility: Ankara Universitesi Tip Fakultesi. ( Site 0502)
Ankara, 34098
Turkey
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Study Coordinator
+442078082788
Facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)
Istanbul, 34722
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+441159691169 x71985
Facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)
Istanbul, 35100
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+441325743654
Facility: Ege University Medical Faculty ( Site 0508)
Izmir, 61080
Turkey
Status: Recruiting Contact: N/A
Facility: Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)
Trabzon, 49055
Turkey
Status: Recruiting Contact: N/A
Facility: Betsi Cadwaladr University Health Board ( Site 0447)
Rhyl, TQ2 7AA
United Kingdom
Status: Recruiting Contact: N/A
Facility: South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)
Torquay, NW1 2PG
United Kingdom
Status: Recruiting Contact: N/A
Facility: University College London Hospitals NHS Foundation Trust ( Site 0445)
London, SW3 6JJ
United Kingdom
Status: Recruiting Contact: N/A
Facility: The Royal Marsden NHS Foundation Trust. ( Site 0442)
London, NG5 1PB
United Kingdom
Status: Recruiting Contact: N/A
Facility: Nottingham University Hospital NHS Trust ( Site 0250)
Nottingham, DL3 6HX
United Kingdom
Status: Recruiting Contact: N/A
Facility: Darlington Memorial Hospital NHS Trust ( Site 0446)
Darlington,
United Kingdom
Status: Recruiting Contact: N/A