A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced Melanoma (PREDICT)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: July 9, 2009
Last updated: November 7, 2013
Last verified: October 2013
The objective of this study is to evaluate the clinical activity of the GSK2132231A immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma presenting with the predictive gene signature.
Biological: Immunotherapeutic GSK2132231A
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma
Primary Outcome Measures:
- Overall survival rate of patients with the predictive gene signature [ Time Frame: 1 year after the registration of the last patient with the predictive gene signature ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Progression status [ Time Frame: At 6 months and 1 year after the registration of the last patient with the predictive gene signature ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Time to Treatment Failure (TTF) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Best clinical response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Duration of response for patients with Complete Response, Partial Response or Stable Disease status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Evaluation of humoral immune response in terms of antibody titers, seropositivity and seroconversion rates against the investigational treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Evaluation of cellular immune response against the investigational treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Occurrence of adverse events [ Time Frame: 30 days after the last treatment administration ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events and autoimmunity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
Experimental: Single Group
Patients will receive a treatment consisting of 24 injections of the GSK2132231A immunotherapeutic
Biological: Immunotherapeutic GSK2132231A
Other Name: MAGE-A3 ASCI
In order to achieve the target enrolment of 51 gene signature (GS) positive patients, it is planned to enrol approximately 110 patients (both GS positive and negative).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable.
- Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification, this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.
- Written informed consent obtained from the patient prior to performance of any study specific procedure.
- Patient is >= 18 years at the time of signature of the informed consent form.
- The patient's tumor shows expression of MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
- Fresh tissue from the same lesion as used for MAGE-A3 expression testing must be available for the testing of the predictive gene signature.
- Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing.
- Patient fully recovered from any previous intervention (i.e., biopsy).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria
- If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to registration in the trial, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.
- In the opinion of the investigator, the patient can and will comply with the protocol requirements.
- Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
- The patient has at any time received any systemic anticancer treatment.
- Prior systemic treatment with an immunomodulator or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial;
- Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial.
- Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial
- The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
- The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents.
- The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
- The patient has a family history of congenital or hereditary immunodeficiency.
- The patient is known to be positive for Human Immunodeficiency Virus (HIV).
- History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.
- The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix and effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
- The patient has psychiatric or addictive disorders
- The patient has an uncontrolled bleeding disorder.
- 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.
- Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first investigational treatment injection or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). For female patients: the patient is pregnant or lactating
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942162
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 9, 2009
||November 7, 2013
||Ireland: Irish Medicines Board
United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas