Text Size

Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00636168
First received: March 7, 2008
Last updated: March 28, 2013
Last verified: July 2011
History of Changes
  Purpose

The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma


Condition Intervention Phase
High Risk Stage III Melanoma
 Drug: ipilimumab
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To determine whether post-operative adjuvant therapy with ipilimumab improves recurrence-free survival (RFS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether post-operative adjuvant therapy with ipilimumab improves overall survival (OS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • To determine whether post-operative adjuvant therapy with ipilimumab improves distant metastases-free survival (DMFS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • To compare adverse event profiles between patients receiving ipilimumab versus patients receiving placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • To compare quality of life and quality-of-life-adjusted survival between the two treatment groups (ipilimumab versus placebo) [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

Estimated Enrollment: 950
Study Start Date: June 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: ipilimumab
IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 or progression, 3 years
Other Names:
  • BMS-734016
  • MDX-010
Placebo Comparator: B Drug: Placebo
IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 or progression, 3 years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
  • Disease-free
  • ECOG PS 0 or 1
  • Randomization within 12 weeks of surgery

Exclusion Criteria:

  • No prior therapy for melanoma except surgery
  • No auto-immune disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636168

  Show 125 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00636168     History of Changes
Other Study ID Numbers: CA184-029, EORTC 18071
Study First Received: March 7, 2008
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Laegmiddeistyrelsen
Finland: Laakelaitos
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Isituto Supiore di Sanita Commissione per l'accertamento dei requisti dei prodotti farmaceuticidi nuova istituzione
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Statens legemiddelverk
Poland: Urzad Rejestracji Produktow Leczniczych Wyrobow Medycznych i Produktow Biobojczych
Spain: AEMPS - Agencia Espanola der Medicamento y Productos Sanitarios
Sweden: Ladenmedeisverket
Switzerland: Swissmedic
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 21, 2013