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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00796445 |
Purpose
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.
This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Resected Stage III Melanoma With Macroscopic Involvement |
Drug: GSK 2132231A Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma |
| Estimated Enrollment: | 1300 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Drug: GSK 2132231A
IM solution, a course of 13 injections will be administered over 27 months
|
| Placebo Comparator: Group B |
Drug: Placebo
IM solution, a course of 13 injections will be administered over 27 months
|
"http://www.immunotherapyforcancer.info provides information on the cancer immunotherapeutic approach in an easy-to-understand format" "http://www.ascitrials.com gives practical information on the MAGRIT clinical study"
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 264 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00796445 History of Changes |
| Other Study ID Numbers: | 111482 |
| Study First Received: | November 21, 2008 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
DERMA Tumor antigen Immunotherapeutic |
Adjuvant cancer therapy Melanoma ASCI |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |