A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00796445
First received: November 21, 2008
Last updated: September 11, 2014
Last verified: September 2014
  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
Drug: GSK 2132231A
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: Once the pre-defined number of events is reached ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Disease-free specific survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Distant metastasis-free survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Anti-MAGE-A3 and anti-protein D seropositivity status. [ Time Frame: Post-treatment and 1 year after concluding visit. ] [ Designated as safety issue: No ]
  • Occurrence of adverse events including abnormal haematological and biochemical parameters. [ Time Frame: Up to 30 days after each study dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events and autoimmunity events. [ Time Frame: During the whole study duration up to 30 days after the last administration of study treatment. ] [ Designated as safety issue: No ]
  • Health-related quality of life (utility) assessment using the EuroQoL 5D (EQ-5D) questionnaire. [ Time Frame: At regular intervals from Visit 1 (baseline) till 6 months after the concluding visit or 1 year post-recurrence. ] [ Designated as safety issue: No ]

Enrollment: 1351
Study Start Date: December 2008
Estimated Study Completion Date: October 2016
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Drug: GSK 2132231A
IM solution, a course of 13 injections will be administered over 27 months
Placebo Comparator: Group B
Not Applicable
Drug: Placebo
IM solution, a course of 13 injections will be administered over 27 months

Detailed Description:

"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
Criteria

Inclusion Criteria:

  • Written informed consent signed.
  • Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.
  • The patient must have been surgically rendered free of disease before the randomization.
  • Patient is ≥ 18 years old at the time of signing the informed consent form.
  • The patient's lymph node tumor shows expression of the MAGE-A3 gene.
  • The patient has fully recovered from surgery.
  • ECOG performance status of 0 or 1 at the time of randomization.
  • The patient must have adequate organ functions as assessed by standard laboratory criteria.
  • If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
  • In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.

Exclusion Criteria:

  • The patient suffers from a mucosal or ocular melanoma.
  • The patient has or has had any history of in-transit metastases
  • The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.
  • The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
  • The patient has a history of autoimmune disease.
  • The patient has a family history of congenital or hereditary immunodeficiency.
  • The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
  • History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
  • The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
  • The patient has an uncontrolled bleeding disorder.
  • For female patients: the patient is pregnant or lactating.
  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: NCT00796445

  Show 305 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00796445     History of Changes
Other Study ID Numbers: 111482
Study First Received: November 21, 2008
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
DERMA
Tumor antigen
Immunotherapeutic
Adjuvant cancer therapy
Melanoma
ASCI

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 October 01, 2014