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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002030-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Nivolumab + docetaxel + prednisone | Experimental |
| |
| Arm B: Placebo + docetaxel + prednisone | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months) |
| 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. | From randomization to the date of death from any cause (Up to approximately 31 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0305 | Mobile | Alabama | 36608-1753 | United States | ||
| Local Institution - 0012 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41449150 | Derived | Fizazi K, Saad F, Alonso-Gordoa T, Zurawski B, Barthelemy P, Voog E, Cutuli HJ, Buchler T, Ye D, Castellano D, Kwiatkowski M, Arslan C, Richardet M, Alifrangis C, Goh JC, Vianna K, Han W, Hatano K, Todenhofer T, Retz M, Srivastava A, Jin C, Gupta S, Trandafirescu G, Campos A, Lee CW, van Kooten Losio M, Subudhi SK. Nivolumab plus docetaxel versus placebo plus docetaxel for androgen receptor pathway inhibitor-pretreated and chemotherapy-naive metastatic castration-resistant prostate cancer (CheckMate 7DX): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):68-78. doi: 10.1016/S1470-2045(25)00566-2. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2023 |
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Double-Blinded
| Prednisone | Drug | Specified dose on specified days |
|
| Docetaxel | Drug | Specified dose on specified days |
|
| Placebo | Other | Specified dose on specified days |
|
| 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) |
| 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. | From randomization to the date of the first documented CR or PR (Up to approximately 52 months) |
| 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. | 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) |
| 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. | Up to approximately 52 months |
| 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. | from randomization to the date of PSA Progression (Up to approximately 31 months) |
| 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. | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
| 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. | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
| 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. | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
| 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. | From first dose and 100 days after last dose of study therapy (Up to approximately 13 months) |
| 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. | From first dose and 100 days after last dose of study therapy (Up to approximately 13 months) |
| 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. | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
| Number of Participants Who Died | Up to approximately 52 months |
| 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. | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
| 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. | From first dose and 30 days after last dose of study therapy (Up to approximately 11 months) |
| 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. | From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months |
| Anchorage |
| Alaska |
| 99503 |
| United States |
| Local Institution - 0293 | Tucson | Arizona | 85724 | United States |
| Local Institution - 0269 | Jonesboro | Arkansas | 72401 | United States |
| Local Institution - 0179 | Orange | California | 92868 | United States |
| Local Institution - 0055 | Rancho Mirage | California | 92270 | United States |
| Local Institution - 0260 | Redondo Beach | California | 90277 | United States |
| Local Institution - 0081 | Santa Monica | California | 90404 | United States |
| Local Institution - 0087 | Denver | Colorado | 80211-5222 | United States |
| Local Institution - 0190 | West Haven | Connecticut | 06516-5907 | United States |
| Local Institution - 0366 | Washington D.C. | District of Columbia | 20010-3017 | United States |
| Local Institution - 0196 | Hollywood | Florida | 33021 | United States |
| Local Institution - 0397 | Jacksonville | Florida | 32256 | United States |
| Local Institution - 0164 | Lakeland | Florida | 33805 | United States |
| Local Institution - 0181 | Orlando | Florida | 32806 | United States |
| Local Institution - 0285 | Pensacola | Florida | 32503 | United States |
| Local Institution - 0177 | Weston | Florida | 33331 | United States |
| Local Institution - 0117 | Atlanta | Georgia | 30342 | United States |
| Local Institution - 0126 | Marietta | Georgia | 30060 | United States |
| Local Institution - 0382 | Thomasville | Georgia | 31792 | United States |
| Local Institution - 0287 | Niles | Illinois | 60714 | United States |
| Local Institution - 0183 | Fort Wayne | Indiana | 46804 | United States |
| Local Institution - 0302 | Louisville | Kentucky | 40202 | United States |
| Local Institution - 0150 | Baltimore | Maryland | 21201 | United States |
| Local Institution - 0332 | Brandywine | Maryland | 20613 | United States |
| Local Institution - 0299 | Omaha | Nebraska | 68130 | United States |
| Local Institution - 0365 | East Brunswick | New Jersey | 08816 | United States |
| Local Institution - 0139 | Florham Park | New Jersey | 07932 | United States |
| Local Institution - 0300 | Albany | New York | 12208 | United States |
| Local Institution - 0028 | Port Jefferson Station | New York | 11776 | United States |
| Local Institution - 0333 | Columbus | Ohio | 43210 | United States |
| Local Institution - 0180 | Allentown | Pennsylvania | 18103-6218 | United States |
| Local Institution - 0074 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Local Institution - 0292 | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 0233 | Charleston | South Carolina | 29414 | United States |
| Local Institution - 0115 | Myrtle Beach | South Carolina | 29572-4607 | United States |
| Local Institution - 0149 | Germantown | Tennessee | 38138 | United States |
| Local Institution - 0286 | Austin | Texas | 75251 | United States |
| Local Institution - 0303 | Dallas | Texas | 75251 | United States |
| Local Institution - 0284 | Houston | Texas | 77024-2843 | United States |
| Local Institution - 0195 | Houston | Texas | 77030-3721 | United States |
| Local Institution - 0011 | San Antonio | Texas | 78229 | United States |
| The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center | Tyler | Texas | 75701 | United States |
| Local Institution - 0110 | Seattle | Washington | 98109 | United States |
| Local Institution - 0289 | Spokane | Washington | 99208 | United States |
| Local Institution - 0129 | Mar del Plata | Buenos Aires | B7602CBM | Argentina |
| Local Institution - 0061 | Pergamino | Buenos Aires | B2700 | Argentina |
| Local Institution - 0153 | Parana | Córdoba Province | 5000 | Argentina |
| Local Institution - 0393 | Río Cuarto | Córdoba Province | 5800 | Argentina |
| Local Institution - 0083 | Viedma | Río Negro Province | 8500 | Argentina |
| Local Institution - 0077 | Buenos Aires | 1280 | Argentina |
| Local Institution - 0178 | Buenos Aires | 1426 | Argentina |
| Local Institution - 0185 | Buenos Aires | C1012 | Argentina |
| Local Institution - 0369 | La Rioja | F5300COE | Argentina |
| Local Institution - 0394 | San Juan | J5402DIL | Argentina |
| Local Institution - 0152 | Gosford | New South Wales | 2250 | Australia |
| Local Institution - 0091 | Lismore | New South Wales | 2480 | Australia |
| Local Institution - 0132 | Wahroonga | New South Wales | 2076 | Australia |
| Local Institution - 0127 | Westmead | New South Wales | 2145 | Australia |
| Local Institution - 0006 | South Brisbane | Queensland | 4101 | Australia |
| Local Institution - 0084 | Woolloongabba | Queensland | 4102 | Australia |
| Local Institution - 0010 | North Adelaide | South Australia | 5006 | Australia |
| Local Institution - 0379 | Ballarat | Victoria | 3350 | Australia |
| Local Institution - 0040 | Frankston | Victoria | 3199 | Australia |
| Local Institution - 0032 | Malvern | Victoria | 3144 | Australia |
| Local Institution - 0118 | Linz | Upper Austria | 4020 | Austria |
| Local Institution - 0038 | Salzburg | 5020 | Austria |
| Local Institution - 0157 | Vienna | 1020 | Austria |
| Local Institution - 0131 | Vienna | 1090 | Austria |
| Local Institution - 0122 | Anderlecht | Brussels Capital | 1070 | Belgium |
| Local Institution - 0121 | Bruges | 8000 | Belgium |
| Local Institution - 0114 | Ghent | 9000 | Belgium |
| Local Institution - 0162 | Ghent | 9000 | Belgium |
| Local Institution - 0137 | Turnhout | 2300 | Belgium |
| Local Institution - 0029 | Wilrijk | 2610 | Belgium |
| Local Institution - 0097 | Belo Horizonte | Minas Gerais | 30110022 | Brazil |
| Local Institution - 0022 | Belo Horizonte | Minas Gerais | 30130090 | Brazil |
| Local Institution - 0100 | Curitiba | Paraná | 80530-010 | Brazil |
| Local Institution - 0082 | Curitiba | Paraná | 80810050 | Brazil |
| Local Institution - 0321 | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| Local Institution - 0058 | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Local Institution - 0063 | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Local Institution - 0056 | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution - 0057 | Porto Alegre | Rio Grande do Sul | 90110-270 | Brazil |
| Local Institution - 0086 | Campinas | São Paulo | 13083 970 | Brazil |
| Local Institution - 0059 | Santo André | São Paulo | 09060-650 | Brazil |
| Local Institution - 0096 | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Local Institution - 0189 | Rio de Janeiro | 22250-905 | Brazil |
| Local Institution - 0060 | Rio de Janeiro | 22793-080 | Brazil |
| Local Institution - 0080 | São Paulo | 01321-001 | Brazil |
| Local Institution - 0273 | São Paulo | 01327-0001 | Brazil |
| Local Institution - 0328 | São Paulo | 05652- 900 | Brazil |
| Local Institution - 0151 | Brampton | Ontario | L6R 3J7 | Canada |
| Local Institution - 0191 | Toronto | Ontario | M2K 1E1 | Canada |
| Local Institution - 0143 | Montreal | Quebec | H2X 0A9 | Canada |
| Local Institution - 0026 | Santiago | RM | 7630372 | Chile |
| Local Institution - 0378 | Providencia | Santiago Metropolitan | 1234 | Chile |
| Local Institution - 0025 | Santiago | Santiago Metropolitan | 0 | Chile |
| Local Institution - 0377 | Santiago | Santiago Metropolitan | 7500653 | Chile |
| Local Institution - 0027 | Viña del Mar | Valparaiso | 2520598 | Chile |
| Local Institution - 0245 | Beijing | Beijing Municipality | 100020 | China |
| Local Institution - 0140 | Beijing | Beijing Municipality | 100034 | China |
| Local Institution - 0254 | Beijing | Beijing Municipality | 100036 | China |
| Local Institution - 0337 | Beijing | Beijing Municipality | 100050 | China |
| Local Institution - 0345 | Beijing | Beijing Municipality | 100730 | China |
| Local Institution - 0312 | Beijing | Bei | 100071 | China |
| Local Institution - 0256 | Fuzhou | Fujian | 350001 | China |
| Local Institution - 0319 | Guangzhou | Guangdong | 510000 | China |
| Local Institution - 0320 | Baoding Shi | Hebei | 071000 | China |
| Local Institution - 0224 | Harbin | Heilongjiang | 150081 | China |
| Local Institution - 0314 | Henan Sheng | Henan | 450003 | China |
| Local Institution - 0275 | Zhengzhou | Henan | 450003 | China |
| Local Institution - 0313 | Wuhan | Hubei | 430000 | China |
| Local Institution - 0168 | Changsha | Hunan | 410031 | China |
| Local Institution - 0165 | Nanjing | Jiangsu | 210000 | China |
| Local Institution - 0317 | Nanjing | Jiangsu | 210009 | China |
| Local Institution - 0325 | Nanjing | Jiangsu | 210009 | China |
| Local Institution - 0347 | Nanchang | Jiangxi | 330006 | China |
| Local Institution - 0330 | Nanchang | Jiangxi | 330029 | China |
| Local Institution - 0161 | Shenyang | Liaoning | 110042 | China |
| Local Institution - 0326 | Jinan | Shandong | 250012 | China |
| Local Institution - 0155 | Shanghai | Shanghai Municipality | 200032 | China |
| Local Institution - 0353 | Xi'an | Shannxi | 710061 | China |
| Local Institution - 0253 | Chengdu | Sichuan | 610041 | China |
| Local Institution - 0310 | Ürümqi | Xinjiang | 830011 | China |
| Local Institution - 0316 | Hangzhou | Zhejiang | 310003 | China |
| Local Institution - 0344 | Hangzhou | Zhejiang | 310014 | China |
| Local Institution - 0108 | Brno | 656 53 | Czechia |
| Local Institution - 0093 | Brno | 656 91 | Czechia |
| Local Institution - 0049 | Olomouc | 779 00 | Czechia |
| Local Institution - 0088 | Ostrava | 70852 | Czechia |
| Local Institution - 0050 | Prague | 140 59 | Czechia |
| Local Institution - 0361 | Prague | 180 81 | Czechia |
| Local Institution - 0105 | Strasbourg | Alsace | 67200 | France |
| Local Institution - 0079 | Lille | Nord | 59020 | France |
| Local Institution - 0167 | Le Mans | Sarthe | 72000 | France |
| Local Institution - 0107 | Angers | 49055 | France |
| Local Institution - 0202 | Brest | 29200 | France |
| Local Institution - 0398 | Dijon | 21079 | France |
| Local Institution - 0030 | Hyères | 83400 | France |
| Local Institution - 0395 | Montpellier | 34070 | France |
| Local Institution - 0109 | Montpellier | 34295 | France |
| Local Institution - 0384 | Nice | 06189 | France |
| Local Institution - 0068 | Nîmes | 30029 | France |
| Local Institution - 0381 | Paris | 75013 | France |
| Local Institution - 0106 | Paris | 75014 | France |
| Local Institution - 0071 | Paris | 75015 | France |
| Local Institution - 0133 | Pierre-Bénite | 69310 | France |
| Local Institution - 0399 | Reims | 51100 | France |
| Local Institution - 0380 | Rennes | 35042 Rennes | France |
| Local Institution - 0387 | Strasbourg | 67000 | France |
| Local Institution - 0271 | Villejuif | 94805 | France |
| Local Institution - 0023 | Nürtingen | Baden-Wurttemberg | 72622 | Germany |
| Local Institution - 0014 | Koblenz | Rheinland Pfa | 56068 | Germany |
| Local Institution - 0090 | Dresden | Saxony | 01307 | Germany |
| Local Institution - 0089 | Bonn | 53127 | Germany |
| Local Institution - 0376 | Düsseldorf | 40225 | Germany |
| Local Institution - 0172 | Emmendingen | 79312 | Germany |
| Local Institution - 0142 | Erlangen | 91054 | Germany |
| Local Institution - 0018 | Frankfurt am Main | 60590 | Germany |
| Local Institution - 0064 | Hamburg | 20246 | Germany |
| Local Institution - 0069 | Hamburg | 22763 | Germany |
| Local Institution - 0389 | Heidelberg | 69120 | Germany |
| Local Institution - 0004 | Magdeburg | 39120 | Germany |
| Local Institution - 0372 | Marburg | 35043 | Germany |
| Local Institution - 0204 | München | 81675 | Germany |
| Local Institution - 0036 | Münster | 48149 | Germany |
| Local Institution - 0169 | Tübingen | 72076 | Germany |
| Local Institution - 0145 | Hong Kong | 852 | Hong Kong |
| Local Institution - 0045 | Hong Kong | NT | Hong Kong |
| Local Institution - 0146 | Hong Kong | Hong Kong |
| Local Institution - 0072 | Haifa | 3109601 | Israel |
| Local Institution - 0388 | Jerusalem | 9112001 | Israel |
| Local Institution - 0368 | Kfar Saba | 4428164 | Israel |
| Local Institution - 0128 | Petah Tikva | 4941492 | Israel |
| Local Institution - 0135 | Ramat Gan | 5265601 | Israel |
| Local Institution - 0138 | Tel Aviv | 6423906 | Israel |
| Local Institution - 0099 | Benevento | 82100 | Italy |
| Local Institution - 0001 | Bergamo | 24127 | Italy |
| Local Institution - 0111 | Bologna | 40138 | Italy |
| Local Institution - 0039 | Brescia | 25123 | Italy |
| Local Institution - 0053 | Cremona | 26100 | Italy |
| Local Institution - 0066 | Milan | 20141 | Italy |
| Local Institution - 0120 | Naples | 80131 | Italy |
| Local Institution - 0070 | Orbassano | 10043 | Italy |
| Local Institution - 0037 | Parma | 43126 | Italy |
| Local Institution - 0199 | Pisa | 56126 | Italy |
| Local Institution - 0046 | Rome | 00128 | Italy |
| Local Institution - 0385 | Rome | 00152 | Italy |
| Local Institution - 0067 | Trento | 38122 | Italy |
| Local Institution - 0362 | Nagoya | Aichi-ken | 4678602 | Japan |
| Local Institution - 0340 | Akita | Akita | 010-8543 | Japan |
| Local Institution - 0358 | Hirosaki-shi | Aomori | 036-8563 | Japan |
| Local Institution - 0346 | Chiba | Chiba | 260-8717 | Japan |
| Local Institution - 0339 | Sakura-Shi | Chiba | 285-8741 | Japan |
| Local Institution - 0307 | Matsuyama | Ehime | 791-0280 | Japan |
| Local Institution - 0280 | Fukuoka | Fukuoka | 8128582 | Japan |
| Local Institution - 0281 | Sapporo | Hokkaido | 0608543 | Japan |
| Local Institution - 0296 | Sapporo | Hokkaido | 608648 | Japan |
| Local Institution - 0283 | Yokohama | Kanagawa | 2320024 | Japan |
| Local Institution - 0324 | Kumamoto | Kumamoto | 860-0008 | Japan |
| Local Institution - 0342 | Kamigyō-ku | Kyoto | 602-8566 | Japan |
| Local Institution - 0355 | Kashihara-shi | Nara | 6348522 | Japan |
| Local Institution - 0343 | Osaka | Osaka | 5418567 | Japan |
| Local Institution - 0323 | Ōsaka-sayama | Osaka | 5898511 | Japan |
| Local Institution - 0309 | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Local Institution - 0279 | Toyama | Toyama | 9300194 | Japan |
| Local Institution - 0282 | Ube Shi | Yamaguchi | 7550046 | Japan |
| Local Institution - 0341 | Nagasaki | 8528501 | Japan |
| Local Institution - 0327 | Niigata | 951-8520 | Japan |
| Local Institution - 0354 | Okayama | 7000914 | Japan |
| Local Institution - 0338 | Osaka | 565-0871 | Japan |
| Local Institution - 0308 | Tokyo | 1608582 | Japan |
| Local Institution - 0278 | Wakayama | 641-8510 | Japan |
| Local Institution - 0017 | Mexico City | D.F. | 3100 | Mexico |
| Local Institution - 0015 | Zapopan | Jalisco | 45030 | Mexico |
| Local Institution - 0016 | Zapopan | Jalisco | 45070 | Mexico |
| Local Institution - 0062 | Morelia | Michoacán | 58260 | Mexico |
| Local Institution - 0184 | Palmerston North | Manawatu-Wanganui | 4414 | New Zealand |
| Local Institution - 0101 | Hamilton | 3204 | New Zealand |
| Local Institution - 0102 | Tauranga | 3112 | New Zealand |
| Local Institution - 0383 | Bydgoszcz | 85-796 | Poland |
| Local Institution - 0136 | Koszalin | 75-581 | Poland |
| Local Institution - 0009 | Lodz | 93-513 | Poland |
| Local Institution - 0013 | Lublin | 20-090 | Poland |
| Local Institution - 0065 | Poznan | 60-848 | Poland |
| Local Institution | Warsaw | 02 797 | Poland |
| Local Institution - 0095 | Warsaw | 04-073 | Poland |
| Local Institution - 0329 | Rio Piedras | 00935 | Puerto Rico |
| Local Institution - 0359 | San Juan | 00927 | Puerto Rico |
| Local Institution - 0041 | Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Local Institution - 0042 | Bucharest | 022328 | Romania |
| Local Institution - 0043 | Cluj-Napoca | 400015 | Romania |
| Local Institution - 0020 | Constanța | 900591 | Romania |
| Local Institution - 0052 | Craiova | 200347 | Romania |
| Local Institution - 0035 | Timișoara | 300425 | Romania |
| SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | 163045 | Russia |
| SAHI Republican Clinical Oncology Dispensary of MoH of RT | Kazan' | 163045 | Russia |
| Clinical Hospital MEDSI in Otradnoye | Krasnogorsk Moscow Region | 143442 | Russia |
| Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the | Moscow | 115478 | Russia |
| Sechenov University | Moscow | 119435 | Russia |
| P.A. Herzen Moscow Oncology Research Institute | Moscow | 125284 | Russia |
| FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre | Obninsk | 249036 | Russia |
| Budgetary Healthcare Institution of Omsk Region ",Clinical Oncological Dispensary", | Omsk | 644013 | Russia |
| Andros Clinic LLC | Saint Petersburg | 197136 | Russia |
| Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A. | Saint Petersburg | 197758 | Russia |
| Local Institution - 0116 | Singapore | 169610 | Singapore |
| Local Institution - 0005 | Singapore | 258499 | Singapore |
| Local Institution - 0170 | Singapore | 308430 | Singapore |
| Local Institution - 0297 | Jung-gu | Daejeon | 35015 | South Korea |
| Local Institution - 0186 | Songnam-si | Gyeonggi-do | 13620 | South Korea |
| Local Institution - 0391 | Daegu | 42601 | South Korea |
| Local Institution - 0298 | Incheon | 405-760 | South Korea |
| Local Institution - 0375 | Jeollanam-do | 58128 | South Korea |
| Local Institution - 0374 | Seodaemun-Gu | 3722 | South Korea |
| Local Institution - 0370 | Seoul | 02841 | South Korea |
| Local Institution - 0171 | Seoul | 03080 | South Korea |
| Local Institution - 0193 | Seoul | 05505 | South Korea |
| Local Institution - 0187 | Seoul | 06351 | South Korea |
| Local Institution - 0373 | Seoul | 6591 | South Korea |
| Local Institution - 0158 | Yangsan | 50612 | South Korea |
| Local Institution - 0141 | Manresa | Barcelona | 8243 | Spain |
| Local Institution - 0073 | Barcelona | 08916 | Spain |
| Local Institution - 0123 | Barcelona | 8908 | Spain |
| Local Institution - 0360 | Córdoba | 14004 | Spain |
| Local Institution - 0044 | Girona | 17007 | Spain |
| Local Institution - 0034 | Lugo | 27003 | Spain |
| Local Institution - 0076 | Madrid | 28006 | Spain |
| Local Institution - 0024 | Madrid | 28033 | Spain |
| Local Institution - 0003 | Madrid | 28034 | Spain |
| Local Institution - 0031 | Madrid | 28041 | Spain |
| Local Institution - 0364 | Madrid | 28222 | Spain |
| Local Institution - 0124 | Sabadell (Barcelona) | 08208 | Spain |
| Local Institution - 0363 | Seville | 41013 | Spain |
| Local Institution - 0192 | Niaosng | Kaohsiung | 833 | Taiwan |
| Local Institution - 0194 | Taichung | 404 | Taiwan |
| Local Institution - 0371 | Taichung | 40705 | Taiwan |
| Local Institution - 0386 | Tainan | 704 | Taiwan |
| Local Institution - 0175 | Taipei | 10002 | Taiwan |
| Local Institution - 0188 | Taipei | 111217 | Taiwan |
| Local Institution - 0094 | Adana | 01330 | Turkey (Türkiye) |
| Local Institution - 0119 | Ankara | 06620 | Turkey (Türkiye) |
| Local Institution - 0130 | Ankara | 6100 | Turkey (Türkiye) |
| Local Institution - 0113 | Istanbul | 34098 | Turkey (Türkiye) |
| Local Institution - 0104 | Izmir | 35575 | Turkey (Türkiye) |
| Local Institution - 0112 | Malatya | 44280 | Turkey (Türkiye) |
| Local Institution - 0173 | London | Greater London | SW3 6JJ | United Kingdom |
| Local Institution - 0098 | Manchester | Lancashire | M20 4BX | United Kingdom |
| Local Institution - 0008 | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Local Institution - 0051 | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Local Institution - 0265 | Oxford | Oxfordshire | OX4 6LB | United Kingdom |
| Local Institution - 0048 | Guildford | Surrey | GU2 7XX | United Kingdom |
| Local Institution - 0154 | London | NW1 2PG | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| FG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
| BG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | All randomized participants | Posted | Median | 95% Confidence Interval | months | from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months) |
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| Primary | 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. | All randomized participants | Posted | Median | 95% Confidence Interval | months | From randomization to the date of death from any cause (Up to approximately 31 months) |
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| Secondary | 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. | All response evaluable participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| Secondary | 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. | All Confirmed Responders (PR + CR) | Posted | Median | Full Range | months | From randomization to the date of the first documented CR or PR (Up to approximately 52 months) |
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| Secondary | 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. | All Confirmed Responders (PR + CR) | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | All randomized participants with baseline and at least one post-baseline PSA assessments | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 52 months |
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| Secondary | 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. | All randomized participants | Posted | Median | 95% Confidence Interval | months | from randomization to the date of PSA Progression (Up to approximately 31 months) |
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| Secondary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
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| Secondary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
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| Secondary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
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| Secondary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 100 days after last dose of study therapy (Up to approximately 13 months) |
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| Secondary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 100 days after last dose of study therapy (Up to approximately 13 months) |
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| Secondary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
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| Secondary | Number of Participants Who Died | All treated participants | Posted | Count of Participants | Participants | Up to approximately 52 months |
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| Secondary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (Up to approximately 25 months) |
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| Secondary | 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. | All treated participants with at least One on-treatment thyroid stimulating hormone (TSH) measurement | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (Up to approximately 11 months) |
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| Secondary | 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. | All randomized participants | Posted | Median | 95% Confidence Interval | months | From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months |
|
All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. | 259 | 514 | 256 | 510 | 479 | 510 |
| EG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. | 227 | 516 | 242 | 510 | 494 | 510 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Blood disorder | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Bone marrow infiltration | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated hypophysitis | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | 27.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Cyclic vomiting syndrome | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Leukoplakia oral | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophagitis haemorrhagic | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 27.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Death | General disorders | 27.0 | Systematic Assessment |
| |
| Disease progression | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 27.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 27.0 | Systematic Assessment |
| |
| Pain | General disorders | 27.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 27.0 | Systematic Assessment |
| |
| Acute cholecystitis necrotic | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Klebsiella urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Chemical peritonitis | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 27.0 | Systematic Assessment |
| |
| Eastern Cooperative Oncology Group performance status worsened | Investigations | 27.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | 27.0 | Systematic Assessment |
| |
| Hepatitis B DNA assay positive | Investigations | 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated arthritis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated myositis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Bronchial neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Ependymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Tongue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Basal ganglia stroke | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Malignant spinal cord compression | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Superior sagittal sinus thrombosis | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | 27.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | 27.0 | Systematic Assessment |
| |
| Needle issue | Product Issues | 27.0 | Systematic Assessment |
| |
| Adjustment disorder with anxiety | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Calculus urethral | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Urinary tract inflammation | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 27.0 | Systematic Assessment |
| |
| Pain | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| May 30, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D011241 | Prednisone |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Completed treatment as per protocol |
|
| Maximum clinical benefit |
|
| Adverse event unrelated to study drug |
|
| Study drug toxicity |
|
| Disease Progression |
|
| Administrative reasons by sponsor |
|
| Poor/Non-Compliance |
|
| Lost to Follow-up |
|
| Death |
|
| Participant withdrew consent |
|
| Participant request to discontinue study treatment |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or other pacific islander |
|
| Chinese |
|
| Japanese |
|
| Asian other |
|
| Other |
|
| Not Reported |
|
| Asian Indian |
|
|
|
|
| OG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
|
|
|
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|
| OG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
|
|
|
|
|
| OG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
|
|
|
|
|
|
|
|
|
| OG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
|
|
| OG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
|
|
|
|
| OG001 | Placebo + Docetaxel + Prednisone | Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent. |
|
|