C114
A phase II study of NY-ESO-1 ISCOMATRIX vaccine and NY-ESO-1 ISCOMATRIX vaccine followed by recombinant fowlpox NY-ESO-1 (rF-NY-ESO-1) in patients with high-risk, resected melanoma
Ji-Li Chen1, Sarah Pratap5, Ioannis Karydis5, Andrea Tarlton1, Amina Dawoodji1, Martha Woodward2, Paul Nathan4, Christian Ottensmeier3, Mark Middleton2, Vincenzo Cerundolo1
1Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, University of Oxford, UK, 2Churchill Hospital, Oxford, UK, 3University of Southampton School of Medicine, UK, 4Mount Vernon Hospital, Northwood, UK, 5Churchill Hospital and Tumour Immunology Unit, University of Oxford, UK
Background
Patients with Stage II-IV melanoma have a significant more than 20% at 5 years- risk of often incurable recurrence. The cancer-testis antigen NY-ESO-1 is frequently over-expressed in melanomas. Spontaneous combined antibody and T cell responses against multiple NY-ESO-1 epitopes have been detected in melanoma patients, underscoring the importance of NY-ESO-1 specific responses in melanoma immunotherapy. Previous studies have demonstrated that vaccination using either the NY-ESO-1 ISCOMATRIX adjuvant formulation or the recombinant fowlpox (rF) NY-ESO-1 vector was safe and immunologically active.
Method
This is a 2-arm randomised study involving patients with high risk (stage II and above), fully resected melanoma. 43 patients fulfilled the eligibility criteria and were randomised to either receive 3 intramuscular injections of NY-ESO-1 ISCOMATRIX followed by 3 subcutaneous injections of rF-NY-ESO-1 (Arm A) or 6 injections of NY-ESO-1 ISCOMATRIX (Arm B). Each injection was given 4 weeks apart. Blood for immunological tests was collected at baseline, 2 and 4 weeks after the first and 4 weeks after each subsequent administration.
Aim
The primary objective is to evaluate the immunogenicity of NY-ESO-1 ISCOMATRIX vaccine on its own and followed by rF-NY-ESO-1 in patients with high-risk, resected melanoma. Secondary objectives include the safety evaluation of this treatment in the aforementioned patient population as well as the assessment of fowlpox specific humoral and cellular immune responses.
Results
Recruitment to the study was completed in March 2009. Preliminary safety and immunological data from the study will be presented in this meeting.
