Clinical trial NCT04100018: A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Official title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 1030
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.


Eligibility criteria: Inclusion Criteria:

* Histologic confirmation of adenocarcinoma of the prostate without small cell features
* Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
* Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
* Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
* Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
* Men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Active brain metastases
* Active, known, or suspected autoimmune disease
* Condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)
timeFrame: from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death from any cause (Up to approximately 31 months)
Secondary outcomes:
measure: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
timeFrame: From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 52 months)
measure: Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
timeFrame: From randomization to the date of the first documented CR or PR (Up to approximately 52 months)
measure: Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
timeFrame: From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 52 months)
measure: Prostate-specific Antigen (PSA) Response Rate (PSA-RR)
timeFrame: Up to approximately 52 months
measure: Time to PSA Progression (TTP-PSA)
timeFrame: from randomization to the date of PSA Progression (Up to approximately 31 months)
measure: Number of Participants With Adverse Events
timeFrame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
measure: Number of Participants With Serious Adverse Events
timeFrame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
measure: Number of Participants With Adverse Events Leading to Discontinuation
timeFrame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
measure: Number of Participants With Endocrine Immune-Mediated Adverse Events
timeFrame: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
measure: Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
timeFrame: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
measure: Number of Participants With Select Adverse Events
timeFrame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
measure: Number of Participants Who Died
timeFrame: Up to approximately 52 months
measure: Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
timeFrame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
measure: Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Local Institution - 0305
state: Alabama
city: Anchorage
country: United States
facility: Local Institution - 0012
state: Alaska
city: Tucson
country: United States
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state: California
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state: California
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state: California
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state: Florida
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state: Florida
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state: Georgia
city: Marietta
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state: Georgia
city: Thomasville
country: United States
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state: Georgia
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city: Fort Wayne
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city: Brandywine
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state: Pennsylvania
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state: Pennsylvania
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country: United States
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city: Austin
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city: Houston
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state: Texas
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state: Texas
city: San Antonio
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facility: Local Institution - 0011
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0110
state: Washington
city: Spokane
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state: Washington
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country: Argentina
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state: Buenos Aires
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state: Buenos Aires
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country: Argentina
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state: New South Wales
city: Lismore
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state: New South Wales
city: Wahroonga
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state: New South Wales
city: Westmead
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state: New South Wales
city: South Brisbane
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facility: Local Institution - 0006
state: Queensland
city: Woolloongabba
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state: Queensland
city: North Adelaide
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facility: Local Institution - 0010
state: South Australia
city: Ballarat
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state: Victoria
city: Frankston
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state: Victoria
city: Malvern
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state: Victoria
city: Linz
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state: Upper Austria
city: Salzburg
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facility: Local Institution - 0038
city: Wien
country: Austria
facility: Local Institution - 0157
city: Wien
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facility: Local Institution - 0131
city: Anderlecht
country: Belgium
facility: Local Institution - 0122
state: Brussel
city: Brugge
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city: Gent
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city: Turnhout
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facility: Local Institution - 0029
city: Belo Horizonte
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state: Minas Gerais
city: Curitiba
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state: Parana
city: Curitiba
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facility: Local Institution - 0082
state: Parana
city: Natal
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facility: Local Institution - 0321
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: Local Institution - 0058
state: Rio Grande Do Sul
city: Porto Alegre
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facility: Local Institution - 0056
state: RIO Grande DO SUL
city: Porto Alegre
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facility: Local Institution - 0057
state: Rio Grande Do Sul
city: Porto Alegre
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facility: Local Institution - 0063
state: RS
city: Campinas
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state: SAO Paulo
city: Sao Jose Do Rio Preto
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state: Sao Paulo
city: Santo Andre
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state: SP
city: Rio de Janeiro
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state: Ontario
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state: Ontario
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country: Chile
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city: Hangzhou
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facility: Local Institution - 0050
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state: Nord
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state: Sarthe
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country: France
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country: France
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country: France
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country: France
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country: France
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facility: Local Institution - 0271
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country: Germany
facility: Local Institution - 0023
state: Baden-Wuerttemberg
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country: Germany
facility: Local Institution - 0014
state: Rheinland Pfa
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facility: Local Institution - 0090
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
facility: Local Institution - 0004
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country: Germany
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country: Germany
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country: Germany
facility: Local Institution - 0036
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country: Italy
facility: Local Institution - 0039
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city: Napoli
country: Italy
facility: Local Institution - 0120
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facility: Local Institution - 0070
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country: Italy
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country: Italy
facility: Local Institution - 0046
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facility: Local Institution - 0385
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country: Japan
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city: Kumamoto-Shi
country: Japan
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country: Japan
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country: Japan
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city: Osaka Sayama
country: Japan
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country: Japan
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country: Japan
facility: Local Institution - 0309
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city: Toyama-shi
country: Japan
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city: Ube shi
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
facility: Local Institution - 0308
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country: Japan
facility: Local Institution - 0278
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country: Korea, Republic of
facility: Local Institution - 0297
state: Daejeon
city: Songnam-si
country: Korea, Republic of
facility: Local Institution - 0186
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0391
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country: Korea, Republic of
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country: Korea, Republic of
facility: Local Institution - 0375
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country: Korea, Republic of
facility: Local Institution - 0374
city: Seoul
country: Korea, Republic of
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country: Korea, Republic of
facility: Local Institution - 0171
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0193
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0187
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0373
city: Yangsan Si
country: Korea, Republic of
facility: Local Institution - 0158
city: Mexico City
country: Mexico
facility: Local Institution - 0017
state: D.f.
city: Zapopan
country: Mexico
facility: Local Institution - 0015
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution - 0016
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution - 0062
state: Michoacan
city: Palmerston North
country: New Zealand
facility: Local Institution - 0184
state: Manawatu-Wanganui
city: Hamilton
country: New Zealand
facility: Local Institution - 0101
city: Tauranga
country: New Zealand
facility: Local Institution - 0102
city: Bydgoszcz
country: Poland
facility: Local Institution - 0383
city: Koszalin
country: Poland
facility: Local Institution - 0136
city: Lodz
country: Poland
facility: Local Institution - 0009
city: Lublin
country: Poland
facility: Local Institution - 0013
city: Poznan
country: Poland
facility: Local Institution - 0065
city: Warsaw
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution - 0095
city: Rio Piedras
country: Puerto Rico
facility: Local Institution - 0329
city: San Juan
country: Puerto Rico
facility: Local Institution - 0359
city: Cluj
country: Romania
facility: Local Institution - 0041
state: Cluj-Napoca
city: Bucharest
country: Romania
facility: Local Institution - 0042
city: Cluj Napoca
country: Romania
facility: Local Institution - 0043
city: Constanta
country: Romania
facility: Local Institution - 0020
city: Craiova
country: Romania
facility: Local Institution - 0052
city: Timisoara
country: Romania
facility: Local Institution - 0035
city: Arkhangelsk
country: Russian Federation
facility: SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
city: Kazan
country: Russian Federation
facility: SAHI Republican Clinical Oncology Dispensary of MoH of RT
city: Krasnogorsk Moscow Region
country: Russian Federation
facility: Clinical Hospital MEDSI in Otradnoye
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the
city: Moscow
country: Russian Federation
facility: Sechenov University
city: Moscow
country: Russian Federation
facility: P.A. Herzen Moscow Oncology Research Institute
city: Obninsk
country: Russian Federation
facility: FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region &quot,Clinical Oncological Dispensary&quot,
city: Saint-Petersburg
country: Russian Federation
facility: Andros Clinic LLC
city: Saint-Petersburg
country: Russian Federation
facility: Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.
city: Singapore
country: Singapore
facility: Local Institution - 0116
city: Singapore
country: Singapore
facility: Local Institution - 0005
city: Singapore
country: Singapore
facility: Local Institution - 0170
city: Manresa
country: Spain
facility: Local Institution - 0141
state: Barcelona
city: Barcelona
country: Spain
facility: Local Institution - 0073
city: Barcelona
country: Spain
facility: Local Institution - 0123
city: Cordoba
country: Spain
facility: Local Institution - 0360
city: Girona
country: Spain
facility: Local Institution - 0044
city: Lugo
country: Spain
facility: Local Institution - 0034
city: Madrid
country: Spain
facility: Local Institution - 0076
city: Madrid
country: Spain
facility: Local Institution - 0024
city: Madrid
country: Spain
facility: Local Institution - 0003
city: Madrid
country: Spain
facility: Local Institution - 0031
city: Madrid
country: Spain
facility: Local Institution - 0364
city: Sabadell (Barcelona)
country: Spain
facility: Local Institution - 0124
city: Sevilla
country: Spain
facility: Local Institution - 0363
city: Niaosng
country: Taiwan
facility: Local Institution - 0192
state: Kaohsiung
city: Taichung
country: Taiwan
facility: Local Institution - 0194
city: Taichung
country: Taiwan
facility: Local Institution - 0371
city: Tainan
country: Taiwan
facility: Local Institution - 0386
city: Taipei
country: Taiwan
facility: Local Institution - 0175
city: Taipei
country: Taiwan
facility: Local Institution - 0188
city: Adana
country: Turkey
facility: Local Institution - 0094
city: Ankara
country: Turkey
facility: Local Institution - 0119
city: Ankara
country: Turkey
facility: Local Institution - 0130
city: Istanbul
country: Turkey
facility: Local Institution - 0113
city: Izmir
country: Turkey
facility: Local Institution - 0104
city: Malatya
country: Turkey
facility: Local Institution - 0112
city: London
country: United Kingdom
facility: Local Institution - 0173
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution - 0098
state: Lancashire
city: Northwood
country: United Kingdom
facility: Local Institution - 0008
state: Middlesex
city: Nottingham
country: United Kingdom
facility: Local Institution - 0051
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Local Institution - 0265
state: Oxfordshire
city: Guildford
country: United Kingdom
facility: Local Institution - 0048
state: Surrey
city: London
country: United Kingdom
facility: Local Institution - 0154
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: