A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma. - DERMA
- Conditions
- Stage IIIB or IIIC cutaneous melanoma with macroscopic lymph node involvementMedDRA version: 9.1Level: LLTClassification code 10025670Term: Malignant melanoma stage III
- Registration Number
- EUCTR2008-002447-16-IT
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1300
1.Written informed consent for MAGE-A3 expression screening on resected tumor tissue has been obtained from the patient prior to shipment of the sample for expression testing, and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
2.Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery. In terms of the AJCC classification [AJCC, 2002, see Appendix E], this means that patients with T1-4a N1-2b M0 (stage IIIB with macroscopic nodal involvement) and patients with T1-4b N1-2bM0 or any TN3 macroscopic M0 (>= 4 macroscopic nodes or macroscopic matted nodes) may be enrolled. Macroscopic lymph-node involvement is defined as clinically detectable lymph node metastases confirmed by therapeutic lymphadenectomy.
3.The patient must have been surgically rendered free of disease no more than 8 weeks before the randomization.
4.Patient is >= 18 years old at the time of signing the informed consent form.
5.The patient?s lymph node tumor shows expression of the MAGE-A3 gene, as determined by RT-PCR analysis on formalin-fixed paraffin-embedded (FFPE) tissue.
6.The patient has fully recovered from surgery.
7.ECOG performance status of 0 or 1 at the time of randomization.
8.The patient must have adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria.
9.If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to randomization, 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.
10 In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.The patient suffers from a mucous membrane melanoma or ocular melanoma.
2.The patient has in-transit metastases.
3.The patient has been treated or is scheduled to be treated with an adjuvant anti-cancer therapy after the lymphadenectomy that qualifies the patient for inclusion in the present trial.
One prior systemic treatment with an immunomodulator (i.e., interferon and/or anti-CTL-A4) after a previous surgery is permitted, provided that the last dose has been administered at least 30 days before randomization in the present trial.
Previous radiotherapy is permitted, provided that the treatment has been completed before the lymphadenectomy that qualifies the patient for participation in the present trial
4. The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
The use of prednisone, or equivalent, at a dose of < 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
5.Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within 30 days preceding the randomization or planned use during the study period.
6.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.
7.The patient has a family history of congenital or hereditary immunodeficiency.
8.The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
9.History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
10. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
11. 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.
12.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.
13. The patient has an uncontrolled bleeding disorder.
14. For female patients: the patient is pregnant or lactating.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method