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Trial record 1 of 1 for:    CA184-169
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Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

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ClinicalTrials.gov Identifier: NCT01515189
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : March 24, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

Condition or disease Intervention/treatment Phase
Melanoma Biological: Ipilimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 831 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma
Actual Study Start Date : February 17, 2012
Actual Primary Completion Date : February 6, 2016
Actual Study Completion Date : August 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: Arm 1: Ipilimumab (3 mg/kg)
Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016

Experimental: Arm 2: Ipilimumab (10 mg/kg)
Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 48 months (assessed up to February 2016) ]
    OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) by mWHO Criteria [ Time Frame: From date of randomization until 540 death events occurred (approximately 48 months) ]
    PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.

  2. Best Overall Response Rate (BORR) by mWHO Criteria [ Time Frame: From date of randomization until 540 death events occurred (approximately 48 months) ]
    BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or "not evaluable" assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson.

  3. Disease Control Rate (DCR) by mWHO Criteria [ Time Frame: From date of randomization until 540 death events occurred (approximately 48 months) ]
    DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or "not evaluable" assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method.

  4. Duration of Response (DOR) by mWHO Criteria [ Time Frame: From date of randomization until 540 death events occurred (approximately 48 months) ]
    Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer Crowley method.

  5. Duration of Stable Disease by mWHO Criteria [ Time Frame: From date of randomization until 540 death events occurred (approximately 48 months) ]
    Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.

  6. Rate of Overall Survival [ Time Frame: Approximately 66 months ]
    OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.

  7. Overall Survival of Participants With Brain Metastases at Baseline [ Time Frame: From date of randomization until 540 death events occurred (approximately 48 months) ]
    OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Unresectable Stage III or Stage IV melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Brain metastases with symptoms or requiring treatment
  • History of autoimmune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515189


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Locations
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United States, California
The Angeles Clinic And Research Institute
Los Angeles, California, United States, 90025
University Of California Los Angeles
Los Angeles, California, United States, 90095
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Orlando Health, Inc
Orlando, Florida, United States, 32806
United States, Illinois
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Hospital
Durham, North Carolina, United States, 27710
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
St. Luke's Cancer Center - Anderson Campus
Easton, Pennsylvania, United States, 18045
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Argentina
Local Institution
San Miguel De Tucuman, Tucuman, Argentina, 4000
Fundacion Cidea
Buenos Aires, Argentina, 1121
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Coffs Harbour, New South Wales, Australia, 2450
Australia, Queensland
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Brisbane, Queensland, Australia, 4102
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Southport, Queensland, Australia, 4215
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Heidelberg, Victoria, Australia, 3084
Austria
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Linz, Austria, 4020
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Vienna, Austria, 1090
Belgium
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Bruxelles, Belgium, 1200
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Leuven, Belgium, 3000
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Nova Scotia
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Halfax, Nova Scotia, Canada, B3H 2Y9
Canada, Quebec
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Montreal, Quebec, Canada, H2W1S6
Czechia
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Brno, Czechia, 656 53
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Olomouc, Czechia, 775 20
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Praha 2, Czechia, 128 08
Denmark
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Aarhus, Denmark, 8000
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Herlev, Denmark, 2730
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Odense, Denmark, 5000
France
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Bordeaux, France, 33075
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Dijon Cedex, France, 21079
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Grenoble, France, 38043
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Lille, France, 59037
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Marseille Cedex 5, France, 13385
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Nantes Cedex 1, France, 44093
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Paris, France, 75010
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Pierre Benite, France, 69495
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Reims Cedex, France, 51092
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Toulouse, France, 31059
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Villejuif, France, 94805
Germany
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Buxtehude, Germany, 21614
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Essen, Germany, 45122
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Kiel, Germany, 24105
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Mainz, Germany, 55131
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Munich, Germany, 81675
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Tubingen, Germany, 72076
Hungary
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Budapest, Hungary, 1122
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Kaposvar, Hungary, 7400
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Szeged, Hungary, 6720
Israel
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Jerusalem, Israel, 71908
Italy
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Meldola (fc), Italy, 47014
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Milano, Italy, 20133
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Roma, Italy, 00144
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Siena, Italy, 53100
Mexico
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Leon, Guanajato, Guanajuato, Mexico, 37000
Netherlands
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Amsterdam, Netherlands, 1081 HV
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Groningen, Netherlands, 9713 GZ
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Leiden, Netherlands, 2300 RC
Norway
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Bergen, Norway, 5021
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Oslo, Norway, 0379
Poland
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Gdansk, Poland, 80-219
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Poznan, Poland, 60-693
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Warszawa, Poland, 02-781
South Africa
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Cape Town, Western CAPE, South Africa, 7570
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George, Western CAPE, South Africa, 6530
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Rondebosch, Western CAPE, South Africa, 7700
Spain
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Barcelona, Spain, 08036
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Barcelona, Spain, 08908
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Madrid, Spain, 28041
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Navarra, Spain, 31008
Instituto Valenciano De Oncologia
Valencia, Spain, 46009
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Valencia, Spain, 46014
Sweden
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Gothenberg, Sweden, 413 45
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Lund, Sweden, 221 85
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Stockholm, Sweden, 171 76
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Umea, Sweden, 901 85
Switzerland
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Lausanne, Switzerland, 1011
United Kingdom
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Manchester, Greater Manchester, United Kingdom, M20 4BX
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Glasgow, Scotland, Strathclyde, United Kingdom, G12 OYN
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London, Surrey, United Kingdom, SW3 6JJ
Local Institution
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01515189     History of Changes
Other Study ID Numbers: CA184-169
2011-004029-28 ( EudraCT Number )
First Posted: January 24, 2012    Key Record Dates
Results First Posted: March 24, 2017
Last Update Posted: September 13, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents