Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04100018




Registration number
NCT04100018
Ethics application status
Date submitted
20/09/2019
Date registered
23/09/2019
Date last updated
22/07/2024

Titles & IDs
Public title
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Scientific title
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Secondary ID [1] 0 0
2019-002030-36
Secondary ID [2] 0 0
CA209-7DX
Universal Trial Number (UTN)
Trial acronym
CheckMate 7DX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Drugs - Prednisone
Treatment: Drugs - Docetaxel
Other interventions - Placebo

Experimental: Arm A: Nivolumab + docetaxel + prednisone -

Placebo comparator: Arm B: Placebo + docetaxel + prednisone -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: Prednisone
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)
Timepoint [1] 0 0
from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization to the date of death from any cause (Up to approximately 31 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
Timepoint [1] 0 0
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 31 months)
Secondary outcome [2] 0 0
Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
Timepoint [2] 0 0
From randomization to the date of the first documented CR or PR (Up to approximately 31 months)
Secondary outcome [3] 0 0
Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
Timepoint [3] 0 0
From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 31 months)
Secondary outcome [4] 0 0
Prostate-specific Antigen (PSA) Response Rate (PSA-RR)
Timepoint [4] 0 0
Up to approximately 31 months
Secondary outcome [5] 0 0
Time to PSA Progression (TTP-PSA)
Timepoint [5] 0 0
from randomization to the date of PSA Progression (Up to approximately 31 months)
Secondary outcome [6] 0 0
Number of Participants With Adverse Events
Timepoint [6] 0 0
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Secondary outcome [7] 0 0
Number of Participants With Serious Adverse Events
Timepoint [7] 0 0
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Secondary outcome [8] 0 0
Number of Participants With Adverse Events Leading to Discontinuation
Timepoint [8] 0 0
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Secondary outcome [9] 0 0
Number of Participants With Endocrine Immune-Mediated Adverse Events
Timepoint [9] 0 0
From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
Secondary outcome [10] 0 0
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Timepoint [10] 0 0
From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
Secondary outcome [11] 0 0
Number of Participants With Select Adverse Events
Timepoint [11] 0 0
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Secondary outcome [12] 0 0
Number of Participants Who Died
Timepoint [12] 0 0
Up to approximately 31 months
Secondary outcome [13] 0 0
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Results
Timepoint [13] 0 0
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Secondary outcome [14] 0 0
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Timepoint [14] 0 0
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Secondary outcome [15] 0 0
Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)
Timepoint [15] 0 0
From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/06/2024
Sample size
Target
Accrual to date
Final
1030
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0152 - Gosford
Recruitment hospital [2] 0 0
Local Institution - 0091 - Lismore
Recruitment hospital [3] 0 0
Local Institution - 0132 - Wahroonga
Recruitment hospital [4] 0 0
Local Institution - 0127 - Westmead
Recruitment hospital [5] 0 0
Local Institution - 0006 - South Brisbane
Recruitment hospital [6] 0 0
Local Institution - 0084 - Woolloongabba
Recruitment hospital [7] 0 0
Local Institution - 0010 - North Adelaide
Recruitment hospital [8] 0 0
Local Institution - 0379 - Ballarat
Recruitment hospital [9] 0 0
Local Institution - 0040 - Frankston
Recruitment hospital [10] 0 0
Local Institution - 0032 - Malvern
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5006 - North Adelaide
Recruitment postcode(s) [8] 0 0
3350 - Ballarat
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Argentina
State/province [26] 0 0
RIO Negro
Country [27] 0 0
Argentina
State/province [27] 0 0
La Rioja
Country [28] 0 0
Argentina
State/province [28] 0 0
San Juan
Country [29] 0 0
Austria
State/province [29] 0 0
Upper Austria
Country [30] 0 0
Austria
State/province [30] 0 0
Salzburg
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussel
Country [33] 0 0
Belgium
State/province [33] 0 0
Brugge
Country [34] 0 0
Belgium
State/province [34] 0 0
Gent
Country [35] 0 0
Belgium
State/province [35] 0 0
Turnhout
Country [36] 0 0
Belgium
State/province [36] 0 0
Wilrijk
Country [37] 0 0
Brazil
State/province [37] 0 0
Minas Gerais
Country [38] 0 0
Brazil
State/province [38] 0 0
Parana
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio Grande Do Norte
Country [40] 0 0
Brazil
State/province [40] 0 0
Rio Grande Do Sul
Country [41] 0 0
Brazil
State/province [41] 0 0
RIO Grande DO SUL
Country [42] 0 0
Brazil
State/province [42] 0 0
RS
Country [43] 0 0
Brazil
State/province [43] 0 0
SAO Paulo
Country [44] 0 0
Brazil
State/province [44] 0 0
Sao Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
SP
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio de Janeiro
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Chile
State/province [49] 0 0
Metropolitana
Country [50] 0 0
Chile
State/province [50] 0 0
RM
Country [51] 0 0
Chile
State/province [51] 0 0
Valparaiso
Country [52] 0 0
China
State/province [52] 0 0
Beijing
Country [53] 0 0
China
State/province [53] 0 0
Bei
Country [54] 0 0
China
State/province [54] 0 0
Fujian
Country [55] 0 0
China
State/province [55] 0 0
Guangdong
Country [56] 0 0
China
State/province [56] 0 0
Hebei
Country [57] 0 0
China
State/province [57] 0 0
Heilongjiang
Country [58] 0 0
China
State/province [58] 0 0
Henan
Country [59] 0 0
China
State/province [59] 0 0
Hubei
Country [60] 0 0
China
State/province [60] 0 0
Hunan
Country [61] 0 0
China
State/province [61] 0 0
Jiangsu
Country [62] 0 0
China
State/province [62] 0 0
Jiangxi
Country [63] 0 0
China
State/province [63] 0 0
Liaoning
Country [64] 0 0
China
State/province [64] 0 0
Shandong
Country [65] 0 0
China
State/province [65] 0 0
Shanghai
Country [66] 0 0
China
State/province [66] 0 0
Shannxi
Country [67] 0 0
China
State/province [67] 0 0
Sichuan
Country [68] 0 0
China
State/province [68] 0 0
Xinjiang
Country [69] 0 0
China
State/province [69] 0 0
Zhejiang
Country [70] 0 0
Czechia
State/province [70] 0 0
Brno
Country [71] 0 0
Czechia
State/province [71] 0 0
Olomouc
Country [72] 0 0
Czechia
State/province [72] 0 0
Ostrava
Country [73] 0 0
Czechia
State/province [73] 0 0
Prague
Country [74] 0 0
Czechia
State/province [74] 0 0
Praha
Country [75] 0 0
France
State/province [75] 0 0
Alsace
Country [76] 0 0
France
State/province [76] 0 0
Nord
Country [77] 0 0
France
State/province [77] 0 0
Sarthe
Country [78] 0 0
France
State/province [78] 0 0
Angers Cedex 02
Country [79] 0 0
France
State/province [79] 0 0
Brest
Country [80] 0 0
France
State/province [80] 0 0
Dijon
Country [81] 0 0
France
State/province [81] 0 0
Hyeres
Country [82] 0 0
France
State/province [82] 0 0
Montpellier
Country [83] 0 0
France
State/province [83] 0 0
Nice cedex 2
Country [84] 0 0
France
State/province [84] 0 0
Nimes Cedex 9
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Pierre-Benite
Country [87] 0 0
France
State/province [87] 0 0
Reims
Country [88] 0 0
France
State/province [88] 0 0
Rennes
Country [89] 0 0
France
State/province [89] 0 0
Strasbourg
Country [90] 0 0
France
State/province [90] 0 0
Villejuif Cedex
Country [91] 0 0
Germany
State/province [91] 0 0
Baden-Wuerttemberg
Country [92] 0 0
Germany
State/province [92] 0 0
Rheinland Pfa
Country [93] 0 0
Germany
State/province [93] 0 0
Saxony
Country [94] 0 0
Germany
State/province [94] 0 0
Bonn
Country [95] 0 0
Germany
State/province [95] 0 0
Duesseldorf
Country [96] 0 0
Germany
State/province [96] 0 0
Emmendingen
Country [97] 0 0
Germany
State/province [97] 0 0
Erlangen
Country [98] 0 0
Germany
State/province [98] 0 0
Frankfurt am Main
Country [99] 0 0
Germany
State/province [99] 0 0
Hamburg
Country [100] 0 0
Germany
State/province [100] 0 0
Heidelberg
Country [101] 0 0
Germany
State/province [101] 0 0
Magdeburg
Country [102] 0 0
Germany
State/province [102] 0 0
Marburg
Country [103] 0 0
Germany
State/province [103] 0 0
Muenchen
Country [104] 0 0
Germany
State/province [104] 0 0
Muenster
Country [105] 0 0
Germany
State/province [105] 0 0
Tuebingen
Country [106] 0 0
Hong Kong
State/province [106] 0 0
Hong Kong
Country [107] 0 0
Israel
State/province [107] 0 0
Haifa
Country [108] 0 0
Israel
State/province [108] 0 0
Jerusalem
Country [109] 0 0
Israel
State/province [109] 0 0
Kfar Saba
Country [110] 0 0
Israel
State/province [110] 0 0
Petach tikva
Country [111] 0 0
Israel
State/province [111] 0 0
Ramat Gan
Country [112] 0 0
Israel
State/province [112] 0 0
Tel Aviv
Country [113] 0 0
Italy
State/province [113] 0 0
Benevento
Country [114] 0 0
Italy
State/province [114] 0 0
Bergamo
Country [115] 0 0
Italy
State/province [115] 0 0
Bologna
Country [116] 0 0
Italy
State/province [116] 0 0
Brescia
Country [117] 0 0
Italy
State/province [117] 0 0
Cremona
Country [118] 0 0
Italy
State/province [118] 0 0
Milan
Country [119] 0 0
Italy
State/province [119] 0 0
Napoli
Country [120] 0 0
Italy
State/province [120] 0 0
Orbassano
Country [121] 0 0
Italy
State/province [121] 0 0
Parma
Country [122] 0 0
Italy
State/province [122] 0 0
Pisa
Country [123] 0 0
Italy
State/province [123] 0 0
Rome
Country [124] 0 0
Italy
State/province [124] 0 0
Trento
Country [125] 0 0
Japan
State/province [125] 0 0
Aichi
Country [126] 0 0
Japan
State/province [126] 0 0
Akita
Country [127] 0 0
Japan
State/province [127] 0 0
Aomori
Country [128] 0 0
Japan
State/province [128] 0 0
Chiba
Country [129] 0 0
Japan
State/province [129] 0 0
Ehime
Country [130] 0 0
Japan
State/province [130] 0 0
Fukuoka
Country [131] 0 0
Japan
State/province [131] 0 0
Hokkaido
Country [132] 0 0
Japan
State/province [132] 0 0
Kanagawa
Country [133] 0 0
Japan
State/province [133] 0 0
Kumamoto
Country [134] 0 0
Japan
State/province [134] 0 0
Kyoto
Country [135] 0 0
Japan
State/province [135] 0 0
Nara
Country [136] 0 0
Japan
State/province [136] 0 0
Osaka
Country [137] 0 0
Japan
State/province [137] 0 0
Shizuoka
Country [138] 0 0
Japan
State/province [138] 0 0
Toyama
Country [139] 0 0
Japan
State/province [139] 0 0
Yamaguchi
Country [140] 0 0
Japan
State/province [140] 0 0
Nagasaki
Country [141] 0 0
Japan
State/province [141] 0 0
Niigata
Country [142] 0 0
Japan
State/province [142] 0 0
Okayama
Country [143] 0 0
Japan
State/province [143] 0 0
Tokyo
Country [144] 0 0
Japan
State/province [144] 0 0
Wakayama
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Daejeon
Country [146] 0 0
Korea, Republic of
State/province [146] 0 0
Gyeonggi-do
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Daegu
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Incheon
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Jeollanam-do
Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Seodaemun-Gu
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Seoul
Country [152] 0 0
Korea, Republic of
State/province [152] 0 0
Yangsan Si
Country [153] 0 0
Mexico
State/province [153] 0 0
D.f.
Country [154] 0 0
Mexico
State/province [154] 0 0
Jalisco
Country [155] 0 0
Mexico
State/province [155] 0 0
Michoacan
Country [156] 0 0
New Zealand
State/province [156] 0 0
Manawatu-Wanganui
Country [157] 0 0
New Zealand
State/province [157] 0 0
Hamilton
Country [158] 0 0
New Zealand
State/province [158] 0 0
Tauranga
Country [159] 0 0
Poland
State/province [159] 0 0
Bydgoszcz
Country [160] 0 0
Poland
State/province [160] 0 0
Koszalin
Country [161] 0 0
Poland
State/province [161] 0 0
Lodz
Country [162] 0 0
Poland
State/province [162] 0 0
Lublin
Country [163] 0 0
Poland
State/province [163] 0 0
Poznan
Country [164] 0 0
Poland
State/province [164] 0 0
Warsaw
Country [165] 0 0
Poland
State/province [165] 0 0
Warszawa
Country [166] 0 0
Puerto Rico
State/province [166] 0 0
Rio Piedras
Country [167] 0 0
Puerto Rico
State/province [167] 0 0
San Juan
Country [168] 0 0
Romania
State/province [168] 0 0
Cluj-Napoca
Country [169] 0 0
Romania
State/province [169] 0 0
Bucharest
Country [170] 0 0
Romania
State/province [170] 0 0
Cluj Napoca
Country [171] 0 0
Romania
State/province [171] 0 0
Constanta
Country [172] 0 0
Romania
State/province [172] 0 0
Craiova
Country [173] 0 0
Romania
State/province [173] 0 0
Timisoara
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Arkhangelsk
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Kazan
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Krasnogorsk Moscow Region
Country [177] 0 0
Russian Federation
State/province [177] 0 0
Moscow
Country [178] 0 0
Russian Federation
State/province [178] 0 0
Obninsk
Country [179] 0 0
Russian Federation
State/province [179] 0 0
Omsk
Country [180] 0 0
Russian Federation
State/province [180] 0 0
Saint-Petersburg
Country [181] 0 0
Singapore
State/province [181] 0 0
Singapore
Country [182] 0 0
Spain
State/province [182] 0 0
Barcelona
Country [183] 0 0
Spain
State/province [183] 0 0
Cordoba
Country [184] 0 0
Spain
State/province [184] 0 0
Girona
Country [185] 0 0
Spain
State/province [185] 0 0
Lugo
Country [186] 0 0
Spain
State/province [186] 0 0
Madrid
Country [187] 0 0
Spain
State/province [187] 0 0
Sabadell (Barcelona)
Country [188] 0 0
Spain
State/province [188] 0 0
Sevilla
Country [189] 0 0
Taiwan
State/province [189] 0 0
Kaohsiung
Country [190] 0 0
Taiwan
State/province [190] 0 0
Taichung
Country [191] 0 0
Taiwan
State/province [191] 0 0
Tainan
Country [192] 0 0
Taiwan
State/province [192] 0 0
Taipei
Country [193] 0 0
Turkey
State/province [193] 0 0
Adana
Country [194] 0 0
Turkey
State/province [194] 0 0
Ankara
Country [195] 0 0
Turkey
State/province [195] 0 0
Istanbul
Country [196] 0 0
Turkey
State/province [196] 0 0
Izmir
Country [197] 0 0
Turkey
State/province [197] 0 0
Malatya
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Greater London
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Lancashire
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Middlesex
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Nottinghamshire
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Oxfordshire
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Surrey
Country [204] 0 0
United Kingdom
State/province [204] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04100018
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04100018