Phase I Study of NY-ESO-1 +AS15 in Melanoma Version 1

• Research type

  Research Study

• Full title

  An open Phase I Study of immunization with the recNY-ESO-1 + AS15 Antigen-Specific Cancer Immunotherapeutic in patients with NY-ESO-1-positive unresectable and progressive metastatic cutaneous melanoma.

• IRAS ID

  64008

• Contact name

  Stephen Nicholson

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2010-020663-20

• ISRCTN Number

  n/a

• Research summary

  Metastatic Cutaneous Melanoma is a disease whose incidence has doubled in the last 10 years. Patients with unresectable and progressive metastatic malignant melanoma have a very poor prognosis and there is currently no treatment able to extend survival. This study is investigating a new kind of anti-cancer treatment based on immunization. The treatment administered during the study is referred to as NY-ESO-1 Antigen-Specific Cancer Immunotherapeutic (NY-ESO-1 ASCI) The aim of this study is to evaluate the safety of NY-ESO-1 treatment and also to assess whether the treatment can trigger the immune system to work against the melanoma. The NY-ESO-1 gene is found in 1 out of 3 patients with metastatic melanoma, so these are the only patients likely to benefit from this treatment.Patients will initially need to have a biopsy to establish that their melanoma carries the NY-ESO_1 gene. Only these patients whose melanoma carries this gene will be able to participate in the trial. Patients will also need physical examination, scans (CT, MRI and/or ultrasound) to measure the cancer, photography of any melanoma involving the skin, and blood and urine tests (including a pregnancy test for women who are still able to get pregnant). All participants will receive injections of the vaccine into a muscle and all injections will be given in the hospital. There will be a maximum of 28 hospital visits in total during a treatment period of approximately 4 years. A maximum of 24 injections will be administered in the following sequence: 6 treatments at intervals of 2 weeks, then 6 treatments at intervals of 3 weeks, then 4 treatments at intervals of 6 weeks. In year 2, then every 3 months for one year, and finally every 6 months for 2 years. There will be follow up visits every 3 months for the first year after last treatment. The study is sponsored by GlaxoSmithKline Biologicals, Rue de l??Institut, 89, 1330 Rixensart, Belgium

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/106

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Further Information Favourable Opinion