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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002987-34 | EudraCT Number |
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The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoyâ„¢) in patients with metastatic castration resistant prostate cancer.
Prostate Cancer Clinical Trials Working Group 2 (PCWG2)
Response Evaluation Criteria In Solid Tumors (RECIST)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Ipilimumab 3 mg/kg | Experimental | Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose |
|
| Arm 2: Ipilimumab 10 mg/kg | Experimental | Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-free Survival (rPFS) | rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown. | From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Immune-related Adverse Events (irAEs) | The total number of participants with immune-related adverse events of any grade is reported for each arm. | From first dose of ipilimumab to last dose plus 90 days |
| Overall Survival (OS) |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Oncology Associates | San Francisco | California | 94115 | United States | ||
| George Washington University Medical Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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82 participants were enrolled; 53 were randomized; 51 were treated with study drug. 29 were not randomized due to screening failures. 2 were randomized and not treated due to administrative reason by sponsor and "other" reason
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab 3 mg/kg | Ipilimumab at 3 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown. |
| From randomization to death from any cause (assessed up to December 2016, approximately 24 months) |
| Prostate Specific Antigen Progression-free Survival (PSA PFS) | Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown. | From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months) |
| Time to Pain Progression | Pain progression was defined as an increase in BPI-SF pain Item #3 score of >= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown. | From randomization until pain progression (assessed up to December 2016, approximately 24 months) |
| Prostate Specific Antigen Response Rate | PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown. | From baseline to PSA response (assessed up to December 2016, approximately 48 months) |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Cancer Center Of Kansas | Wichita | Kansas | 67214 | United States |
| North Mississippi Med Center | Tupelo | Mississippi | 38801 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Northwest Cancer Specialists, Pc | Tualatin | Oregon | 97062 | United States |
| University of Pittsburgh Cancer Institute Cancer Services | Pittsburgh | Pennsylvania | 15232-1305 | United States |
| Texas Oncology | Houston | Texas | 77024 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Local Institution | St Leonards | New South Wales | 2065 | Australia |
| Local Institution | Wahroonga | New South Wales | 2076 | Australia |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | Recoleta | Santiago de Chile | Chile |
| Local Institution | Santiago | Santiago Metropolitan | Chile |
| Local Institution | Viña del Mar | Valparaiso | 2540364 | Chile |
| Local Institution | Clermont-Ferrand | 63011 | France |
| Local Institution | Marseille | 13273 | France |
| Local Institution | Poitiers | France |
| Local Institution | Rennes | 35042 | France |
| Local Institution | Saint-Herblain | 44805 | France |
| Local Institution | Villejuif | 94805 | France |
| Universitaetsklinikum Aachen | Aachen | 52074 | Germany |
| Uniklinik Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Jena | Jena | 07743 | Germany |
| Universitaetsklinikum Magdeburg | Magdeburg | 39120 | Germany |
| Universitaetsklinikum Mannheim | Mannheim | 68167 | Germany |
| Local Institution | Marktredwitz | 95615 | Germany |
| Klinikum rechts der Isar der TU | München | 81675 | Germany |
| Urologische Praxis | Rostock | 18107 | Germany |
| Urologische Gemeinschaftspraxis Dres Stammel U. Garcia | Wesel | 46483 | Germany |
| Dgu Urologie | Wuppertal | 42103 | Germany |
| Local Institution | Milan | 20133 | Italy |
| Istituto Nazionale Tumori Fondazione Pascale | Naples | 80131 | Italy |
| Local Institution | Amsterdam | 1081 HV | Netherlands |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Hospitalet de Llobregat - Barcelona | 08908 | Spain |
| Local Institution | Seville | 41009 | Spain |
| Local Institution | Valencia | 46009 | Spain |
| Local Institution | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
| Local Institution | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Local Institution | Guildford | Surrey | GU2 7XX | United Kingdom |
| FG001 | Ipilimumab 10 mg/kg | Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
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All treated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab 3 mg/kg | Ipilimumab at 3 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria. |
| BG001 | Ipilimumab 10 mg/kg | Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants Who Experienced Immune-related Adverse Events (irAEs) | The total number of participants with immune-related adverse events of any grade is reported for each arm. | All treated participants | Posted | Count of Participants | Participants | From first dose of ipilimumab to last dose plus 90 days |
|
|
| |||||||||||||||||||||||||||||
| Primary | Radiographic Progression-free Survival (rPFS) | rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown. | All randomized participants | Posted | Count of Participants | Participants | From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown. | All randomized participants | Posted | Count of Participants | Participants | From randomization to death from any cause (assessed up to December 2016, approximately 24 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Prostate Specific Antigen Progression-free Survival (PSA PFS) | Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown. | All randomized participants | Posted | Count of Participants | Participants | From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Pain Progression | Pain progression was defined as an increase in BPI-SF pain Item #3 score of >= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown. | All randomized participants | Posted | Count of Participants | Participants | From randomization until pain progression (assessed up to December 2016, approximately 24 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Prostate Specific Antigen Response Rate | PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown. | All randomized participants | Posted | Count of Participants | Participants | From baseline to PSA response (assessed up to December 2016, approximately 48 months) |
|
From date of first dose to date of last dose of study therapy plus 90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 MG/KG IPILIMUMAB | Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria. | 15 | 26 | 22 | 26 | ||
| EG001 | 3 MG/KG IPILIMUMAB | Ipilimumab at 3 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria. | 6 | 25 | 22 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypophysitis | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
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| Autoimmune colitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
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| Bacterial diarrhoea | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Systemic infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
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After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data
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 | Clinical.Trials@bms.com |
| 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
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| 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 |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria. |
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