A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified April 2025 by Bristol-Myers Squibb
Sponsor
Bristol-Myers Squibb
Information Provided by (Responsible Party)
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
NCT04100018
Other Study ID Numbers:
CA209-7DX
First Submitted
September 19, 2019
First Posted
September 22, 2019
Results First Posted
May 29, 2024
Last Update Posted
June 11, 2025
Last Verified
April 2025

ClinicalTrials.gov processed this data on May 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Prostate Cancer
Biological: NivolumabDrug: Prednisone

Study Design

Study TypeInterventional
Actual Enrollment1030 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Study Start DateFebruary 5, 2020
Actual Primary Completion DateMay 31, 2023
Actual Study Completion DateJune 24, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A: Nivolumab + docetaxel + prednisone
Biological: Nivolumab
Specified dose on specified days
Arm B: Placebo + docetaxel + prednisone
Drug: Prednisone
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)
    rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
  2. Overall Survival (OS)
    OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.
Secondary Outcome Measures
  1. Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
    Objective Response Rate per PCWG3 (ORR-PCWG3) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
  2. Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
    Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  3. Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
    Duration of Response per PCWG3 (DOR-PCWG3) is time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3,as determined by BICR, or death due to any cause whichever occurs first. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Radiographic progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
  4. Prostate-specific Antigen (PSA) Response Rate (PSA-RR)
    PSA Response Rate (PSA-RR) is the percentage of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
  5. Time to PSA Progression (TTP-PSA)
    Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. PSA Progression: For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 weeks later. For participants with no PSA decline from baseline, the date of PSA progression is date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from baseline are documented at or beyond Week 13. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. Censored at date of last PSA evaluation on/prior to start of subsequent cancer therapy.
  6. Number of Participants With Adverse Events
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
  7. Number of Participants With Serious Adverse Events
    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death or Is life-threatening or requires inpatient hospitalization or causes prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
  8. Number of Participants With Adverse Events Leading to Discontinuation
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
  9. Number of Participants With Endocrine Immune-Mediated Adverse Events
    Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
  10. Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
    Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
  11. Number of Participants With Select Adverse Events
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
  12. Number of Participants Who Died
  13. Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
    The severity of laboratory test results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 0 is defined as absence of an AE or within normal limits; Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening. Number of participants with worst grade change results to Grade 3 or Grade 4 laboratory test results is presented. E.g., the row title HEMOGLOBIN Grade 0 to Grade 3, Grade 0 is baseline and Grade 3 is post baseline.
  14. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
    Blood samples were collected for conducting specific thyroid test. Baseline is defined as evaluations or events that occur before the date and time of the first dose of study treatment. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
  15. Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)
    The BPI-SF is an instrument to assess pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire designed to assess severity and impact of pain on daily function. Participants rate severity of pain at its "worst," "least," and "average" in last 24 hours using an 11-point numerical rating scale with anchors of "no pain" and "pain as bad. The participant's assessment of pain with BPI-SF Item number 3 (pain symptoms at their worst over the last 24 hours) form basis for analysis. Time to pain progression is time between date of randomization and date of first increase in worst pain intensity. Pain progression occurred if an increase in worst pain intensity of \>= 2 points is observed from baseline and maintained over 2 consecutive time periods. Baseline was evaluations or events that occur before date and time of first dose of study treatment or evaluations on same date and time of first dose of study treatment were also considered as baseline.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsBristol-Myers Squibb
Locations
Local Institution - 0305 | Mobile Alabama, United States, 36608-1753Local Institution - 0012 | Anchorage Alaska, United States, 99503Local Institution - 0293 | Tucson Arizona, United States, 85724Local Institution - 0269 | Jonesboro Arkansas, United States, 72401Local Institution - 0179 | Orange California, United States, 92868Local Institution - 0055 | Rancho Mirage California, United States, 92270Local Institution - 0260 | Redondo Beach California, United States, 90277Local Institution - 0081 | Santa Monica California, United States, 90404Local Institution - 0087 | Denver Colorado, United States, 80211-5222Local Institution - 0190 | West Haven Connecticut, United States, 06516-5907Local Institution - 0366 | Washington D.C. District of Columbia, United States, 20010-3017Local Institution - 0196 | Hollywood Florida, United States, 33021Local Institution - 0397 | Jacksonville Florida, United States, 32256Local Institution - 0164 | Lakeland Florida, United States, 33805Local Institution - 0181 | Orlando Florida, United States, 32806Local Institution - 0285 | Pensacola Florida, United States, 32503Local Institution - 0177 | Weston Florida, United States, 33331Local Institution - 0117 | Atlanta Georgia, United States, 30342Local Institution - 0126 | Marietta Georgia, United States, 30060Local Institution - 0382 | Thomasville Georgia, United States, 31792Local Institution - 0287 | Niles Illinois, United States, 60714Local Institution - 0183 | Fort Wayne Indiana, United States, 46804Local Institution - 0302 | Louisville Kentucky, United States, 40202Local Institution - 0150 | Baltimore Maryland, United States, 21201Local Institution - 0332 | Brandywine Maryland, United States, 20613Local Institution - 0299 | Omaha Nebraska, United States, 68130Local Institution - 0365 | East Brunswick New Jersey, United States, 08816Local Institution - 0139 | Florham Park New Jersey, United States, 07932Local Institution - 0300 | Albany New York, United States, 12208Local Institution - 0028 | Port Jefferson Station New York, United States, 11776Local Institution - 0333 | Columbus Ohio, United States, 43210Local Institution - 0180 | Allentown Pennsylvania, United States, 18103-6218Local Institution - 0074 | Bala-Cynwyd Pennsylvania, United States, 19004Local Institution - 0292 | Pittsburgh Pennsylvania, United States, 15232Local Institution - 0233 | Charleston South Carolina, United States, 29414Local Institution - 0115 | Myrtle Beach South Carolina, United States, 29572-4607Local Institution - 0149 | Germantown Tennessee, United States, 38138Local Institution - 0286 | Austin Texas, United States, 75251Local Institution - 0303 | Dallas Texas, United States, 75251Local Institution - 0284 | Houston Texas, United States, 77024-2843Local Institution - 0195 | Houston Texas, United States, 77030-3721Local Institution - 0011 | San Antonio Texas, United States, 78229The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center | Tyler Texas, United States, 75701Local Institution - 0110 | Seattle Washington, United States, 98109Local Institution - 0289 | Spokane Washington, United States, 99208Local Institution - 0129 | Mar del Plata Buenos Aires, Argentina, B7602CBMLocal Institution - 0061 | Pergamino Buenos Aires, Argentina, B2700Local Institution - 0153 | Parana Córdoba Province, Argentina, 5000Local Institution - 0393 | Río Cuarto Córdoba Province, Argentina, 5800Local Institution - 0083 | Viedma Río Negro Province, Argentina, 8500Local Institution - 0077 | Buenos Aires , Argentina, 1280Local Institution - 0178 | Buenos Aires , Argentina, 1426Local Institution - 0185 | Buenos Aires , Argentina, C1012Local Institution - 0369 | La Rioja , Argentina, F5300COELocal Institution - 0394 | San Juan , Argentina, J5402DILLocal Institution - 0152 | Gosford New South Wales, Australia, 2250Local Institution - 0091 | Lismore New South Wales, Australia, 2480Local Institution - 0132 | Wahroonga New South Wales, Australia, 2076Local Institution - 0127 | Westmead New South Wales, Australia, 2145Local Institution - 0006 | South Brisbane Queensland, Australia, 4101Local Institution - 0084 | Woolloongabba Queensland, Australia, 4102Local Institution - 0010 | North Adelaide South Australia, Australia, 5006Local Institution - 0379 | Ballarat Victoria, Australia, 3350Local Institution - 0040 | Frankston Victoria, Australia, 3199Local Institution - 0032 | Malvern Victoria, Australia, 3144Local Institution - 0118 | Linz Upper Austria, Austria, 4020Local Institution - 0038 | Salzburg , Austria, 5020Local Institution - 0157 | Vienna , Austria, 1020Local Institution - 0131 | Vienna , Austria, 1090Local Institution - 0122 | Anderlecht Brussels Capital, Belgium, 1070Local Institution - 0121 | Bruges , Belgium, 8000Local Institution - 0114 | Ghent , Belgium, 9000Local Institution - 0162 | Ghent , Belgium, 9000Local Institution - 0137 | Turnhout , Belgium, 2300Local Institution - 0029 | Wilrijk , Belgium, 2610Local Institution - 0097 | Belo Horizonte Minas Gerais, Brazil, 30110022Local Institution - 0022 | Belo Horizonte Minas Gerais, Brazil, 30130090Local Institution - 0100 | Curitiba Paraná, Brazil, 80530-010Local Institution - 0082 | Curitiba Paraná, Brazil, 80810050Local Institution - 0321 | Natal Rio Grande do Norte, Brazil, 59075-740Local Institution - 0058 | Ijuí Rio Grande do Sul, Brazil, 98700-000Local Institution - 0063 | Porto Alegre Rio Grande do Sul, Brazil, 90035-001Local Institution - 0056 | Porto Alegre Rio Grande do Sul, Brazil, 90035-903Local Institution - 0057 | Porto Alegre Rio Grande do Sul, Brazil, 90110-270Local Institution - 0086 | Campinas São Paulo, Brazil, 13083 970Local Institution - 0059 | Santo André São Paulo, Brazil, 09060-650Local Institution - 0096 | São José do Rio Preto São Paulo, Brazil, 15090-000Local Institution - 0189 | Rio de Janeiro , Brazil, 22250-905Local Institution - 0060 | Rio de Janeiro , Brazil, 22793-080Local Institution - 0080 | São Paulo , Brazil, 01321-001Local Institution - 0273 | São Paulo , Brazil, 01327-0001Local Institution - 0328 | São Paulo , Brazil, 05652- 900Local Institution - 0151 | Brampton Ontario, Canada, L6R 3J7Local Institution - 0191 | Toronto Ontario, Canada, M2K 1E1Local Institution - 0143 | Montreal Quebec, Canada, H2X 0A9Local Institution - 0026 | Santiago RM, Chile, 7630372Local Institution - 0378 | Providencia Santiago Metropolitan, Chile, 1234Local Institution - 0025 | Santiago Santiago Metropolitan, Chile, 0Local Institution - 0377 | Santiago Santiago Metropolitan, Chile, 7500653Local Institution - 0027 | Viña del Mar Valparaiso, Chile, 2520598Local Institution - 0245 | Beijing Beijing Municipality, China, 100020Local Institution - 0140 | Beijing Beijing Municipality, China, 100034Local Institution - 0254 | Beijing Beijing Municipality, China, 100036Local Institution - 0337 | Beijing Beijing Municipality, China, 100050Local Institution - 0345 | Beijing Beijing Municipality, China, 100730Local Institution - 0312 | Beijing Bei, China, 100071Local Institution - 0256 | Fuzhou Fujian, China, 350001Local Institution - 0319 | Guangzhou Guangdong, China, 510000Local Institution - 0320 | Baoding Shi Hebei, China, 071000Local Institution - 0224 | Harbin Heilongjiang, China, 150081Local Institution - 0314 | Henan Sheng Henan, China, 450003Local Institution - 0275 | Zhengzhou Henan, China, 450003Local Institution - 0313 | Wuhan Hubei, China, 430000Local Institution - 0168 | Changsha Hunan, China, 410031Local Institution - 0165 | Nanjing Jiangsu, China, 210000Local Institution - 0317 | Nanjing Jiangsu, China, 210009Local Institution - 0325 | Nanjing Jiangsu, China, 210009Local Institution - 0347 | Nanchang Jiangxi, China, 330006Local Institution - 0330 | Nanchang Jiangxi, China, 330029Local Institution - 0161 | Shenyang Liaoning, China, 110042Local Institution - 0326 | Jinan Shandong, China, 250012Local Institution - 0155 | Shanghai Shanghai Municipality, China, 200032Local Institution - 0353 | Xi'an Shannxi, China, 710061Local Institution - 0253 | Chengdu Sichuan, China, 610041Local Institution - 0310 | Ürümqi Xinjiang, China, 830011Local Institution - 0316 | Hangzhou Zhejiang, China, 310003Local Institution - 0344 | Hangzhou Zhejiang, China, 310014Local Institution - 0108 | Brno , Czechia, 656 53Local Institution - 0093 | Brno , Czechia, 656 91Local Institution - 0049 | Olomouc , Czechia, 779 00Local Institution - 0088 | Ostrava , Czechia, 70852Local Institution - 0050 | Prague , Czechia, 140 59Local Institution - 0361 | Prague , Czechia, 180 81Local Institution - 0105 | Strasbourg Alsace, France, 67200Local Institution - 0079 | Lille Nord, France, 59020Local Institution - 0167 | Le Mans Sarthe, France, 72000Local Institution - 0107 | Angers , France, 49055Local Institution - 0202 | Brest , France, 29200Local Institution - 0398 | Dijon , France, 21079Local Institution - 0030 | Hyères , France, 83400Local Institution - 0395 | Montpellier , France, 34070Local Institution - 0109 | Montpellier , France, 34295Local Institution - 0384 | Nice , France, 06189Local Institution - 0068 | Nîmes , France, 30029Local Institution - 0381 | Paris , France, 75013Local Institution - 0106 | Paris , France, 75014Local Institution - 0071 | Paris , France, 75015Local Institution - 0133 | Pierre-Bénite , France, 69310Local Institution - 0399 | Reims , France, 51100Local Institution - 0380 | Rennes , France, 35042 RennesLocal Institution - 0387 | Strasbourg , France, 67000Local Institution - 0271 | Villejuif , France, 94805Local Institution - 0023 | Nürtingen Baden-Wurttemberg, Germany, 72622Local Institution - 0014 | Koblenz Rheinland Pfa, Germany, 56068Local Institution - 0090 | Dresden Saxony, Germany, 01307Local Institution - 0089 | Bonn , Germany, 53127Local Institution - 0376 | Düsseldorf , Germany, 40225Local Institution - 0172 | Emmendingen , Germany, 79312Local Institution - 0142 | Erlangen , Germany, 91054Local Institution - 0018 | Frankfurt am Main , Germany, 60590Local Institution - 0064 | Hamburg , Germany, 20246Local Institution - 0069 | Hamburg , Germany, 22763Local Institution - 0389 | Heidelberg , Germany, 69120Local Institution - 0004 | Magdeburg , Germany, 39120Local Institution - 0372 | Marburg , Germany, 35043Local Institution - 0204 | München , Germany, 81675Local Institution - 0036 | Münster , Germany, 48149Local Institution - 0169 | Tübingen , Germany, 72076Local Institution - 0145 | Hong Kong , Hong Kong, 852Local Institution - 0045 | Hong Kong , Hong Kong, NTLocal Institution - 0146 | Hong Kong , Hong Kong, Local Institution - 0072 | Haifa , Israel, 3109601Local Institution - 0388 | Jerusalem , Israel, 9112001Local Institution - 0368 | Kfar Saba , Israel, 4428164Local Institution - 0128 | Petah Tikva , Israel, 4941492Local Institution - 0135 | Ramat Gan , Israel, 5265601Local Institution - 0138 | Tel Aviv , Israel, 6423906Local Institution - 0099 | Benevento , Italy, 82100Local Institution - 0001 | Bergamo , Italy, 24127Local Institution - 0111 | Bologna , Italy, 40138Local Institution - 0039 | Brescia , Italy, 25123Local Institution - 0053 | Cremona , Italy, 26100Local Institution - 0066 | Milan , Italy, 20141Local Institution - 0120 | Naples , Italy, 80131Local Institution - 0070 | Orbassano , Italy, 10043Local Institution - 0037 | Parma , Italy, 43126Local Institution - 0199 | Pisa , Italy, 56126Local Institution - 0046 | Rome , Italy, 00128Local Institution - 0385 | Rome , Italy, 00152Local Institution - 0067 | Trento , Italy, 38122Local Institution - 0362 | Nagoya Aichi-ken, Japan, 4678602Local Institution - 0340 | Akita Akita, Japan, 010-8543Local Institution - 0358 | Hirosaki-shi Aomori, Japan, 036-8563Local Institution - 0346 | Chiba Chiba, Japan, 260-8717Local Institution - 0339 | Sakura-Shi Chiba, Japan, 285-8741Local Institution - 0307 | Matsuyama Ehime, Japan, 791-0280Local Institution - 0280 | Fukuoka Fukuoka, Japan, 8128582Local Institution - 0281 | Sapporo Hokkaido, Japan, 0608543Local Institution - 0296 | Sapporo Hokkaido, Japan, 608648Local Institution - 0283 | Yokohama Kanagawa, Japan, 2320024Local Institution - 0324 | Kumamoto Kumamoto, Japan, 860-0008Local Institution - 0342 | Kamigyō-ku Kyoto, Japan, 602-8566Local Institution - 0355 | Kashihara-shi Nara, Japan, 6348522Local Institution - 0343 | Osaka Osaka, Japan, 5418567Local Institution - 0323 | Ōsaka-sayama Osaka, Japan, 5898511Local Institution - 0309 | Hamamatsu Shizuoka, Japan, 431-3192Local Institution - 0279 | Toyama Toyama, Japan, 9300194Local Institution - 0282 | Ube Shi Yamaguchi, Japan, 7550046Local Institution - 0341 | Nagasaki , Japan, 8528501Local Institution - 0327 | Niigata , Japan, 951-8520Local Institution - 0354 | Okayama , Japan, 7000914Local Institution - 0338 | Osaka , Japan, 565-0871Local Institution - 0308 | Tokyo , Japan, 1608582Local Institution - 0278 | Wakayama , Japan, 641-8510Local Institution - 0017 | Mexico City D.F., Mexico, 3100Local Institution - 0015 | Zapopan Jalisco, Mexico, 45030Local Institution - 0016 | Zapopan Jalisco, Mexico, 45070Local Institution - 0062 | Morelia Michoacán, Mexico, 58260Local Institution - 0184 | Palmerston North Manawatu-Wanganui, New Zealand, 4414Local Institution - 0101 | Hamilton , New Zealand, 3204Local Institution - 0102 | Tauranga , New Zealand, 3112Local Institution - 0383 | Bydgoszcz , Poland, 85-796Local Institution - 0136 | Koszalin , Poland, 75-581Local Institution - 0009 | Lodz , Poland, 93-513Local Institution - 0013 | Lublin , Poland, 20-090Local Institution - 0065 | Poznan , Poland, 60-848Local Institution | Warsaw , Poland, 02 797Local Institution - 0095 | Warsaw , Poland, 04-073Local Institution - 0329 | Rio Piedras , Puerto Rico, 00935Local Institution - 0359 | San Juan , Puerto Rico, 00927Local Institution - 0041 | Cluj-Napoca Cluj-Napoca, Romania, 400015Local Institution - 0042 | Bucharest , Romania, 022328Local Institution - 0043 | Cluj-Napoca , Romania, 400015Local Institution - 0020 | Constanța , Romania, 900591Local Institution - 0052 | Craiova , Romania, 200347Local Institution - 0035 | Timișoara , Romania, 300425SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk , Russia, 163045SAHI Republican Clinical Oncology Dispensary of MoH of RT | Kazan' , Russia, 163045Clinical Hospital MEDSI in Otradnoye | Krasnogorsk Moscow Region , Russia, 143442Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the | Moscow , Russia, 115478Sechenov University | Moscow , Russia, 119435P.A. Herzen Moscow Oncology Research Institute | Moscow , Russia, 125284FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre | Obninsk , Russia, 249036Budgetary Healthcare Institution of Omsk Region &quot,Clinical Oncological Dispensary&quot, | Omsk , Russia, 644013Andros Clinic LLC | Saint Petersburg , Russia, 197136Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A. | Saint Petersburg , Russia, 197758Local Institution - 0116 | Singapore , Singapore, 169610Local Institution - 0005 | Singapore , Singapore, 258499Local Institution - 0170 | Singapore , Singapore, 308430Local Institution - 0297 | Jung-gu Daejeon, South Korea, 35015Local Institution - 0186 | Songnam-si Gyeonggi-do, South Korea, 13620Local Institution - 0391 | Daegu , South Korea, 42601Local Institution - 0298 | Incheon , South Korea, 405-760Local Institution - 0375 | Jeollanam-do , South Korea, 58128Local Institution - 0374 | Seodaemun-Gu , South Korea, 3722Local Institution - 0370 | Seoul , South Korea, 02841Local Institution - 0171 | Seoul , South Korea, 03080Local Institution - 0193 | Seoul , South Korea, 05505Local Institution - 0187 | Seoul , South Korea, 06351Local Institution - 0373 | Seoul , South Korea, 6591Local Institution - 0158 | Yangsan , South Korea, 50612Local Institution - 0141 | Manresa Barcelona, Spain, 8243Local Institution - 0073 | Barcelona , Spain, 08916Local Institution - 0123 | Barcelona , Spain, 8908Local Institution - 0360 | Córdoba , Spain, 14004Local Institution - 0044 | Girona , Spain, 17007Local Institution - 0034 | Lugo , Spain, 27003Local Institution - 0076 | Madrid , Spain, 28006Local Institution - 0024 | Madrid , Spain, 28033Local Institution - 0003 | Madrid , Spain, 28034Local Institution - 0031 | Madrid , Spain, 28041Local Institution - 0364 | Madrid , Spain, 28222Local Institution - 0124 | Sabadell (Barcelona) , Spain, 08208Local Institution - 0363 | Seville , Spain, 41013Local Institution - 0192 | Niaosng Kaohsiung, Taiwan, 833Local Institution - 0194 | Taichung , Taiwan, 404Local Institution - 0371 | Taichung , Taiwan, 40705Local Institution - 0386 | Tainan , Taiwan, 704Local Institution - 0175 | Taipei , Taiwan, 10002Local Institution - 0188 | Taipei , Taiwan, 111217Local Institution - 0094 | Adana , Turkey (Türkiye), 01330Local Institution - 0119 | Ankara , Turkey (Türkiye), 06620Local Institution - 0130 | Ankara , Turkey (Türkiye), 6100Local Institution - 0113 | Istanbul , Turkey (Türkiye), 34098Local Institution - 0104 | Izmir , Turkey (Türkiye), 35575Local Institution - 0112 | Malatya , Turkey (Türkiye), 44280Local Institution - 0173 | London Greater London, United Kingdom, SW3 6JJLocal Institution - 0098 | Manchester Lancashire, United Kingdom, M20 4BXLocal Institution - 0008 | Northwood Middlesex, United Kingdom, HA6 2RNLocal Institution - 0051 | Nottingham Nottinghamshire, United Kingdom, NG5 1PBLocal Institution - 0265 | Oxford Oxfordshire, United Kingdom, OX4 6LBLocal Institution - 0048 | Guildford Surrey, United Kingdom, GU2 7XXLocal Institution - 0154 | London , United Kingdom, NW1 2PG
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full Text)
Documents provided by Bristol-Myers SquibbStudy Protocol and Statistical Analysis Plan  September 21, 2023