Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma
Secondarily to studying the efficacy of the treatment; the investigators examine if
treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when
the vaccine is given in combination with temozolomide treatment for melanoma patients.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit rate (CBR)
Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).
Trine Zeeberg Iversen, MD
Center for Cancer ImmuneTherapy
Denmark: Danish Medicines Agency