Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003615

Trial Description

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Title

GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

"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"

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Organizational Data

  •   DRKS00003615
  •   2012/04/16
  •   2008/11/21
  •   no
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Secondary IDs

  •   NCT00796445  (ClinicalTrials.gov)
  •   111482  (GlaxoSmithKline)
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Health Condition or Problem studied

  •   Melanoma
  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   Drug: GSK 2132231A
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Disease Free Survival; time frame: Once the pre-defined number of events is reached

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Secondary Outcome

- Overall Survival; time frame: At the time of analysis
- Disease-free specific survival; time frame: At the time of analysis
- Distant metastasis-free survival; time frame: At the time of analysis
- Anti-MAGE-A3 and anti-protein D seropositivity status.; time frame: Post-treatment and 1 year after concluding visit.
- Occurrence of adverse events including abnormal haematological and biochemical parameters.; time frame: Up to 30 days after each study dose.
- 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.
- 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.

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Bulgaria
  •   Canada
  •   Czech Republic
  •   Estonia
  •   France
  •   Germany
  •   Greece
  •   Ireland
  •   Israel
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Norway
  •   Poland
  •   Romania
  •   Russian Federation
  •   Serbia
  •   Spain
  •   Sweden
  •   Switzerland
  •   Taiwan, Province of China
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2008/12/31
  •   1300
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • GlaxoSmithKline
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    • GlaxoSmithKline
    • GSK Clinical Trials 
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    • GlaxoSmithKline
    • GSK Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.