Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
This study is currently recruiting participants.
Verified July 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01515189
First received: January 18, 2012
Last updated: March 28, 2013
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: Ipilimumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Overall survival (OS) [ Time Frame: Approximately 44 months after the first subject is randomized ] [ Designated as safety issue: No ]
OS is defined for each subject as the time between randomization date and death. If a subject has not died, the subject will be censored at the time of last contact (last known alive date)
OS will be assessed after 540 death events have occurred. Interim analysis after 360 deaths have occurred
Secondary Outcome Measures:
- Progression Free Survival (PFS) [ Time Frame: Approximately 44 months after the first subject is randomized ] [ Designated as safety issue: No ]
PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first
PFS will be assessed after 540 death events have occurred
- Best Overall Response Rate (BORR) [ Time Frame: Approximately 44 months after the first subject is randomized ] [ Designated as safety issue: No ]
BORR is defined by treatment arm as the total number of randomized subjects in the arm whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR), divided by the total number of randomized subjects in the arm
BORR will be assessed after 540 death events have occurred
- Disease Control Rate (DCR) [ Time Frame: Approximately 44 months after the first subject is randomized ] [ Designated as safety issue: No ]
DCR is as the total number of randomized subjects in each arm with BOR of CR, PR or Stable Disease (SD), divided by the total number of randomized subjects in the arm
DCR will be assessed after 540 death events have occurred
- Duration of Response [ Time Frame: Approximately 44 months after the first subject is randomized ] [ Designated as safety issue: No ]
A subject's duration of response is defined as the time between the date measurement criteria are first met for overall response of PR or CR (whichever status is recorded first, and if subsequently confirmed) and the date of disease progression or death, whichever occurs first
Duration of Response will be assessed after 540 death events have occurred
- Duration of Stable Disease [ Time Frame: Approximately 44 months after the first subject is randomized ] [ Designated as safety issue: No ]
Duration of stable disease is defined for subjects whose BOR is SD as the time between when SD is first documented and the date of Progressive Disease (PD) or death (whichever occurs first)
Duration of Stable Disease will be assessed after 540 death events have occurred
| Estimated Enrollment: | 700 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Ipilimumab (3 mg/kg) |
Biological: Ipilimumab
Intravenous (IV) solution, IV, 3 mg/kg, Once every 3 weeks for 4 doses; option for Re-induction, Until disease progression or unacceptable toxicity
Other Names:
|
| Experimental: Arm 2: Ipilimumab (10 mg/kg) |
Biological: Ipilimumab
IV solution, IV, 10 mg/kg, Once every 3 weeks for 4 doses; option for Re-induction, Until disease progression or unacceptable toxicity
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515189
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Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Hide Study LocationsLocations
| United States, California | |
| The Angeles Clinic And Research Institute | Active, not recruiting |
| Los Angeles, California, United States, 90025 | |
| University Of California Los Angeles | Active, not recruiting |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| Liberty Irb, Inc | Recruiting |
| DeLand, Florida, United States, 32720 | |
| Contact: Geoffrey Gibney, Site 124 386-740-9278 | |
| Baptist Cancer Institute | Active, not recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Md Anderson Cancer Center Orlando | Active, not recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Illinois | |
| Oncology Specialists, Sc | Active, not recruiting |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Terminated |
| Boston, Massachusetts, United States, 02215 | |
| United States, New Mexico | |
| New Mexico Cancer Care Alliance | Terminated |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Active, not recruiting |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Blumenthal Cancer Center | Active, not recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University Hospital | Completed |
| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
| Providence Portland Medical Center | Active, not recruiting |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| St. Luke'S Cancer Center - Anderson Campus | Active, not recruiting |
| Easton, Pennsylvania, United States, 18045 | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Terminated |
| Nashville, Tennessee, United States, 37203 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | Completed |
| Seattle, Washington, United States, 98109 | |
| Argentina | |
| Local Institution | Active, not recruiting |
| Capital Federal, Buenos Aires, Argentina, 1425 | |
| Local Institution | Terminated |
| Rosario, Santa Fe, Argentina, S2000KZE | |
| Local Institution | Active, not recruiting |
| San Miguel De Tucuman, Tucuman, Argentina, 4000 | |
| Australia, New South Wales | |
| Local Institution | Active, not recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Local Institution | Completed |
| Coffs Harbour, New South Wales, Australia, 2450 | |
| Australia, Queensland | |
| Local Institution | Active, not recruiting |
| Southport, Queensland, Australia, 4215 | |
| Local Institution | Active, not recruiting |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, South Australia | |
| Local Institution | Active, not recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Tasmania | |
| Local Institution | Terminated |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Local Institution | Active, not recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Austria | |
| Local Institution | Completed |
| Linz, Austria, 4020 | |
| Local Institution | Active, not recruiting |
| Vienna, Austria, 1090 | |
| Belgium | |
| Local Institution | Terminated |
| Brussels, Belgium, 1090 | |
| Local Institution | Active, not recruiting |
| Bruxelles, Belgium, 1200 | |
| Local Institution | Active, not recruiting |
| Leuven, Belgium, 3000 | |
| Canada, Alberta | |
| Local Institution | Active, not recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Nova Scotia | |
| Local Institution | Active, not recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Quebec | |
| Local Institution | Active, not recruiting |
| City, Quebec, Canada, H2w 1s6 | |
| Czech Republic | |
| Local Institution | Active, not recruiting |
| Brno, Czech Republic, 656 53 | |
| Local Institution | Completed |
| Olomouc, Czech Republic, 775 20 | |
| Local Institution | Active, not recruiting |
| Praha 2, Czech Republic, 128 08 | |
| Denmark | |
| Local Institution | Active, not recruiting |
| Aarhus, Denmark, 8000 | |
| Local Institution | Active, not recruiting |
| Herlev, Denmark, 2730 | |
| Local Institution | Active, not recruiting |
| Odense, Denmark, 5000 | |
| France | |
| Local Institution | Active, not recruiting |
| Bordeaux, France, 33075 | |
| Local Institution | Active, not recruiting |
| Dijon Cedex, France, 21079 | |
| Local Institution | Active, not recruiting |
| Grenoble, France, 38043 | |
| Local Institution | Active, not recruiting |
| Lille, France, 59037 | |
| Local Institution | Active, not recruiting |
| Marseille, France, 13009 | |
| Local Institution | Active, not recruiting |
| Nantes Cedex 1, France, 44093 | |
| Local Institution | Active, not recruiting |
| Paris, France, 75010 | |
| Local Institution | Active, not recruiting |
| Pierre Benite, France, 69495 | |
| Local Institution | Active, not recruiting |
| Reims Cedex, France, 51092 | |
| Local Institution | Active, not recruiting |
| Toulouse Cedex 9, France, 31059 | |
| Local Institution | Active, not recruiting |
| Villejuif, France, 94805 | |
| Germany | |
| Local Institution | Active, not recruiting |
| Buxtehude, Germany, 21614 | |
| Local Institution | Active, not recruiting |
| Essen, Germany, 45122 | |
| Local Institution | Active, not recruiting |
| Hannover, Germany, 30449 | |
| Local Institution | Active, not recruiting |
| Heidelberg, Germany, 69120 | |
| Local Institution | Active, not recruiting |
| Kiel, Germany, 24105 | |
| Local Institution | Active, not recruiting |
| Mainz, Germany, 55131 | |
| Local Institution | Active, not recruiting |
| Munich, Germany, 81675 | |
| Local Institution | Active, not recruiting |
| Tubingen, Germany, 72076 | |
| Hungary | |
| Local Institution | Active, not recruiting |
| Budapest, Hungary, 1122 | |
| Local Institution | Active, not recruiting |
| Kaposvar, Hungary, 7400 | |
| Local Institution | Active, not recruiting |
| Szeged, Hungary, 6720 | |
| Israel | |
| Local Institution | Completed |
| Jerusalem, Israel, 71908 | |
| Italy | |
| Local Institution | Not yet recruiting |
| Genova, Italy, 16132 | |
| Contact: Site 0157 | |
| Local Institution | Active, not recruiting |
| Meldola (Fc), Italy, 47014 | |
| Local Institution | Active, not recruiting |
| Milano, Italy, 20133 | |
| Local Institution | Active, not recruiting |
| Napoli, Italy, 80131 | |
| Local Institution | Active, not recruiting |
| Padova, Italy, 35128 | |
| Local Institution | Active, not recruiting |
| Roma, Italy, 00144 | |
| Local Institution | Active, not recruiting |
| Siena, Italy, 53100 | |
| Mexico | |
| Local Institution | Not yet recruiting |
| Mexico City, Distrito Federal, Mexico, 06720 | |
| Contact: Site 099 | |
| Local Institution | Not yet recruiting |
| Tlalpan, Distrito Federal, Mexico, 14000 | |
| Contact: Site 138 | |
| Local Institution | Not yet recruiting |
| Leon, Guanajato, Guanajuato, Mexico, 37000 | |
| Contact: Site 119 | |
| Local Institution | Not yet recruiting |
| San Luis Potosi, Mexico, 78416 | |
| Contact: Site 120 | |
| Netherlands | |
| Local Institution | Completed |
| Amsterdam, Netherlands, 1081 HV | |
| Local Institution | Completed |
| Groningen, Netherlands, 9713 GZ | |
| Local Institution | Completed |
| Leiden, Netherlands, 2300 RC | |
| Norway | |
| Local Institution | Active, not recruiting |
| Bergen, Norway, 5021 | |
| Local Institution | Active, not recruiting |
| Oslo, Norway, 0379 | |
| Poland | |
| Local Institution | Active, not recruiting |
| Gdansk, Poland, 80-219 | |
| Local Institution | Active, not recruiting |
| Poznan, Poland, 60-693 | |
| Local Institution | Active, not recruiting |
| Warszawa, Poland, 02-781 | |
| South Africa | |
| Local Institution | Terminated |
| Port Elizabeth, Eastern Cape, South Africa, 6045 | |
| Local Institution | Terminated |
| Groenkloof, Gauteng, South Africa, 0181 | |
| Local Institution | Completed |
| Cape Town, Western Cape, South Africa, 7570 | |
| Local Institution | Active, not recruiting |
| George, Western Cape, South Africa, 6530 | |
| Local Institution | Completed |
| Rondebosch, Western Cape, South Africa, 7700 | |
| Spain | |
| Local Institution | Active, not recruiting |
| Barcelona, Spain, 08036 | |
| Local Institution | Active, not recruiting |
| Barcelona, Spain, 08908 | |
| Local Institution | Completed |
| Madrid, Spain, 28041 | |
| Local Institution | Active, not recruiting |
| Navarra, Spain, 31008 | |
| Local Institution | Active, not recruiting |
| Valencia, Spain, 46009 | |
| Local Institution | Active, not recruiting |
| Valencia, Spain, 46014 | |
| Sweden | |
| Local Institution | Active, not recruiting |
| Gothenberg, Sweden, 413 45 | |
| Local Institution | Active, not recruiting |
| Lund, Sweden, 221 85 | |
| Local Institution | Active, not recruiting |
| Stockholm, Sweden, 171 76 | |
| Local Institution | Active, not recruiting |
| Umea, Sweden, 901 85 | |
| Switzerland | |
| Local Institution | Not yet recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Site 103 | |
| Local Institution | Not yet recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Site 102 | |
| United Kingdom | |
| Local Institution | Active, not recruiting |
| Swansea, Carmarthenshire, United Kingdom, SA2 8QA | |
| Local Institution | Active, not recruiting |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
| Local Institution | Active, not recruiting |
| Glasgow, Scotland, Strathclyde, United Kingdom, G12 OYN | |
| Local Institution | Active, not recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01515189 History of Changes |
| Other Study ID Numbers: | CA184-169, 2011-004029-28 |
| Study First Received: | January 18, 2012 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Chile: Instituto de Salud Publica de Chile Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Poland: National Institute of Medicines Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Austria: Federal Office for Safety in Health Care Germany: Federal Institute for Drugs and Medical Devices Switzerland: Federal Office of Public Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Peru: Instituto Nacional de Salud Mexico: Federal Commission for Sanitary Risks Protection Denmark: Danish Dataprotection Agency Norway: Data Protection Authority Norway: Directorate of Health Sweden: Medical Products Agency Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 16, 2013