At a glance
ClinicalIndex Comparison Record- ✓High-risk Stage D1 or metastatic (D2) prostate cancer confirmed by histology review
- ✓Stable or progressive disease on hormonal and/or chemotherapeutic treatment for ≥3 months
- ✓Prior chemo- or radiotherapy discontinued ≥4 weeks before first dose; hormone therapy allowed throughout
- ✓Expected survival ≥3 months
- ✕Clinically significant heart disease (NYHA Class 3 CHF, MI within 6 months, unstable angina, coronary angioplasty within 6 months, uncontrolled arrhythmias)
- ✕Active infections requiring antibiotics or bleeding disorders
- ✕Concomitant systemic corticosteroid treatment (topical/inhalational allowed)
- ✕CNS metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating NY-ESO-1 protein/CpG 7909 for Prostate Cancer. Completed, enrolled 15 participants across 2 sites in 2 countries.
Detailed Summary
This was a Phase 1, open-label, fixed-dose study of immunization with the NY-ESO-1 protein combined with CpG 7909 as an adjuvant in patients with histopathologically confirmed, high-risk Stage D1 or advanced prostate cancer. The primary study objective was to assess the safety of NY-ESO-1 protein/CpG 7909 immunization, and the secondary objective was to evaluate the immunity induced by immunization.
Study Details
Timeline
Interventions
Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle).