An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma - MAGE3-AS15-MEL-001 (MET)
- Conditions
- First-line treatment for patients with unresectable, MAGE-A3-positive stage III or stage IVa melanoma
- Registration Number
- EUCTR2008-004007-64-FI
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 125
1.Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable.
2.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.
3.Written informed consent obtained from the patient prior to performance of any study specific procedure.
4.Patient is at least 18 years old at the time of signature of the informed consent form.
5.The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
6.Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature.
7.Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing. This FFPE tissue should preferably come from the same (reference) lesion as the fresh tissue used for MAGE-A3 and gene signature testing but may be taken from a second lesion during the screening phase if the reference lesion does not provide sufficient tissue.
8.Patient fully recovered from any previous intervention (i.e., biopsy).
9.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
10.Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria.
11.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 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.
12.In the opinion of the investigator, the patient can and will comply with the protocol requirements.
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.Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
2.The patient has at any time received any systemic anticancer treatment.
•Prior systemic treatment with an immunomodulator (i.e., interferon or/and anti-CTL-A4 therapy) 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.
3.The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
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 no more than 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
5.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.
6.The patient has a family history of congenital or hereditary immunodeficiency.
7.The patient is known to be positive for Human Immunodeficiency Virus (HIV).
8.History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.
9.The patient has previous or concomitant malignancies at other sites, except
•Effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix
•Effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
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 an uncontrolled bleeding disorder.
12.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.
13.Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
14.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).
15.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