A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Melanoma

Treatments: Drug: Dacarbazine; Biological: Immunotherapeutic GSK2132231A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00849875

111714

Details and patient eligibility

About

The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate the safety of this combination.

Full description

This Protocol Posting has been updated following amendment 3, dated 16 October 2009. The sections impacted are :

• Enrollment, number of subjects
• Outcome measures
• Exclusion criteria

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma
2. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
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).
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, 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 the 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 the requirements of the protocol.

Exclusion criteria

1. The patient has at any time received systemic (bio)-chemotherapy.
2. The patient is scheduled to receive any other anticancer treatments than those specified in the protocol, including but not limited to (bio)-chemotherapy, immunomodulating agents and radiotherapy.
3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
4. The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Group A

Experimental group

Description:

All patients are to receive the same treatment consisting of 24 injections of the immunotherapeutic GSK2132231A combined with a course of 8 cycles of dacarbazine given at the beginning of the treatment

Treatment:

Drug: Dacarbazine

Biological: Immunotherapeutic GSK2132231A