A Study of Safety and Clinical Activity of Cancer Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients
- Conditions
- Patients with unresectable and progressive metastatic cutaneous melanoma, whose tumor expresses MAGE-A3.MedDRA version: 16.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-001918-25-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma.
According to the American Joint Committee on Cancer 2002 classification, all melanoma patients with stage IV M1b and stage IV M1c with serum lactate dehydrogenase (LDH) <= 1.5 Upper Normal Limit and no involvement of the central nervous system (CNS) are candidates for inclusion.
2. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure. Note: Procedures performed before obtaining this informed consent and that are part of standard institution practices or of another clinical research study are accepted provided protocol intervals are observed.
3. Patient is >= 18 years of age at the time of signature of the Informed Consent.
4. The patient’s tumor shows expression of MAGE-A3 antigen, detected by Reverse-Transcription Polymerase Chain Reaction (RT-PCR). A tumor biopsy performed in the context of institution standard practice or another research study may be used for the MAGE-A3 testing (or the use of the result of the MAGE-A3 testing) provided this biopsy was preserved in RNAlater, was taken no more than 12 weeks before the first administration of study treatment and after obtention of the Sponsor’s agreement.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. The patient has normal organ functions
7. 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 administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the treatment administration series.
8. In the view of the investigator, the patient can and will comply with all the study procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. The patient has at any time received systemic (bio-)chemotherapy (except for
isolated limb perfusion, as long as this was performed at least 4 weeks before the
first study treatment administration).
2. The patient is scheduled to receive any other anticancer treatments than those
specified in the protocol, including but not limited to (bio-)chemotherapeutic,
immunomodulating agents and radiotherapy.
3. The patient requires concomitant treatment with systemic corticosteroids, or any
other immunosuppressive agents.
The use of prednisone, or equivalent, < 0.125 mg/kg/day (absolute maximum
10 mg/day), or inhaled corticosteroids for chronic obstructive pulmonary disease
(COPD), or topical steroids is permitted.
4. The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen
or any cancer immunotherapeutic for his/her metastatic disease.
Note: previous adjuvant treatment with a cancer immunotherapeutic containing a
tumor antigen other than MAGE-A3 is allowed if the last administration took place
at least 8 weeks before the first study treatment administration.
5. The patient has received any investigational or non-registered drug or vaccine other
than the study medication within the 30 days preceding the first dose of study
treatment, or plans to receive such a drug during the study period.
6. The patient has (or has had) previous or concomitant malignancies at other sites,
except effectively treated malignancy that is considered by the investigator highly
likely to have been cured.
7. History of allergic disease or reactions likely to be exacerbated by any component of
the study investigational product.
8. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis,
lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
9. The patient has a family history of congenital or hereditary immunodeficiency.
10. The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
11. The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent, or to comply with the trial procedures.
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. For female patients: the patient is pregnant or lactating.
14. The patient has an uncontrolled bleeding disorder
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