18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Treatment-emergent Adverse Events (TEAEs)Primary· Up to 56 weeks
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (fatal). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, and any other medically indicated assessments, including patient interviews, from the first dose of study treatment through the final follow-up visit. AEs were considered to be tr
Any TEAE
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
15
Maximum TEAE severity Grade 1
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
2
Maximum TEAE severity Grade 2
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
10
Maximum TEAE severity Grade 3
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
2
Maximum TEAE severity Grade 4
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
1
Serious TEAE
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
4
TEAE leading to discontinuation
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
1
Number of Patients With Cellular Antibody Response to NY-ESO-1Secondary· Up to 28 weeks
Assays to assess cluster of differentiation (CD)4+ and CD8+ antigen-specific responses were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 4, 10, 16, 22, and 28) by enzyme-linked immune absorbent spot (ELISPOT) assay. A positive response was considered if the number of spots in the peptide-exposed well was 2-fold or more higher than the number of spots in the unstimulated well, and if there was a minimum of 10 (after subtraction of background spots) peptide-specific spots/25.000 T cells or less if T-cell clones were used.
CD4+ T cell response
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
9
CD8+ T cell response
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
6
Number of Patients With Humoral Antibody Response to NY-ESO-1Secondary· Up to 28 weeks
Assays to assess NY-ESO-1 specific antibodies were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 4, 7, 10, 13, 16, 19, 22, 25, and 28). Sera were assessed over a range of dilutions from 1:100 to 1:400,000. Vaccine-induced antibodies were mapped with a panel of overlapping 20 mer peptides (25 μg/mL) spanning the whole protein sequence by enzyme-linked immunosorbent assay (ELISA). Immunoglobulin (Ig) subclasses G1 and G3 were determined by Western blot analysis using secondary antibody mouse anti-human IgG1/IgG3 at a dilution of 1:
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
13
Number of Patients With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)Secondary· Up to 32 weeks
Appropriate imaging scans were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 13 and 28). Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD)
Stable disease
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
8
Progressive disease
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
3
No evidence of disease at baseline and on study
Group
Value
95% CI
NY-ESO-1 Protein + CpG 7909
2
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events (AEs), regardless of causality to study drug, were documented from the first dose of study treatment through the final follow-up visit, for an AE collection period of up to 56 weeks for each patient..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno)
· recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
· Phase 2
· recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer
· Phase 2
· recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris
· Phase 2
· recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate
· Phase 2, PHASE3
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ludwig Institute for Cancer Research
Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00292045.