Phase 1 Study of Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With High-Risk Stage D1 or Advanced Prostate Cancer
This is an open-label, fixed-dose study of immunization with NY-ESO-1 protein combined with
CpG 7909 as adjuvant in patients with histopathologically confirmed metastatic cancer of the
prostate, who have progressive disease under hormonal and/or chemotherapeutic treatment
(duration of treatment > 3 months).
Eligible patients will receive vaccinations consisting of 100µg NY-ESO-1 protein combined
with 2.5 mg CpG 7909 administered intradermally every 3 weeks for 4 doses. Twelve (12)
patients will be enrolled into this study.
Blood samples will be obtained at baseline, prior to the second, third and fourth injection
and three weeks after the fourth injection for clinical hematology, biochemistry and immune
response assessments. Blood samples for antinuclear antibody (ANA) and anti-dsDNA will be
collected at baseline and end of each study cycle.
A tumor sample, resected prior to immunization, will be tested to determine NY-ESO-1 and/or
DTH testing will be performed with NY-ESO-1b in HLA-A2+ patients and with NY-ESO-1 DP4 in
HLA-DP4+ patients at baseline and at the 3-week visit following the second and fourth
NY-ESO-1 and/or LAGE-1 specific antibodies will be assessed in all patients by Western Blot
and ELISA. NY-ESO-1 specific CD4+ and CD8+ T cells will be assessed by ELISPOT analysis in
Disease status will be assessed at baseline and 3 weeks after the fourth vaccination in
patients with measurable disease.
Patients who demonstrate stable disease, minor response, partial response, or complete
response on week 13 may continue to receive vaccinations until disease progression. In
patients with mixed response, single progressive lesions may be resected and vaccination may
Resected metastases should be typed for NY-ESO- and/or LAGE-1 expression.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
to assess the safety of intradermal immunization with NY-ESO-1 protein combined with CpG 7909 in patients with high-risk stage D1 or advanced prostate cancer
Alexander Knuth, Prof. Dr. med.
Clinic of Oncology, University Hospital Zürich, Switzerland