Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01515189
First received: January 18, 2012
Last updated: September 15, 2014
Last verified: January 2014
  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: After 540 death events have occurred (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)


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: February 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515189

  Show 88 Study Locations
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: September 15, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Chile: Instituto de Salud Pública 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 September 18, 2014