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Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

Phase 1
18 Years
Open (Enrolling)
Neoplasms, Malignant Melanoma

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Trial Information

Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

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

Inclusion Criteria:

1. Male or female patient with histologically proven, measurable metastatic cutaneous

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The occurrence of treatment related adverse events of Grade 3 or 4

Outcome Time Frame:

After the concluding visit of the last patient

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Agence Fédérale des Médicaments et des Produits de la Santé

Study ID:




Start Date:

May 2009

Completion Date:

December 2016

Related Keywords:

  • Neoplasms
  • Malignant Melanoma
  • ASCI
  • Dacarbazine
  • Cancer immunotherapeutic
  • MAGE-A3
  • Malignant melanoma
  • Neoplasms
  • Melanoma