18 and older, any sex, with Cancer or Neoplasm. 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 NY-ESO-1 Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.Primary· up to 27 weeks
Blood samples were obtained at baseline (prior to the first dose), prior to the second, third and fourth injection and 2 weeks after the fourth injection in both cycles 1 and 2 for the assessment of NY-ESO-1 specific antibodies by an enzyme-linked immunosorbent assay (ELISA). A positive response was a readable optical density at 280 nm.
Number of patients with negative titers both pre- and post-treatment
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
8
Number of patients with positive titers both pre- and post-treatment
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
5
Number of patients with negative titers at baseline and positive titers after treatment
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
1
Number of Patients With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1b Specific CD8+ T-cells Following Treatment.Primary· up to 27 weeks
Blood samples were obtained at baseline, prior to the second, third and fourth injection and 2 weeks after the fourth injection in both cycles 1 and 2 for the assessment of NY-ESO-1b specific CD8+ T-cells by ELISPOT assays.
Number of patients with an increase in NY-ESO-1b specific CD8+ T-cells during cycle 1
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
4
Number of patients without an increase in NY-ESO-1b specific CD8+ T-cells during cycle 1
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
10
Number of patients with an increase in NY-ESO-1b specific CD8+ T-cells during cycle 2
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
5
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b PeptidePrimary· up to 25 weeks
10 mcg NY-ESO-1b peptide was injected intradermally at a separate site from the vaccination at baseline and after the second and fourth injection of each cycle.
Assessment of DTH reactions as evidenced by redness and induration was performed 48 h after injection.
The number of patients with DTH positive skin reactions was reported at each timepoint.
Baseline
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
2
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
12
Week 4
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
0
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
13
Week 10
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
1
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
7
Week 19
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
3
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
2
Week 25
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
1
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
4
Safety as Measured by the Number of Patients With Dose Limiting Toxicities (DLT)Primary· up to 28 weeks
DLT was defined as the following toxicities definitely, probably, or possibly related to the administration of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51:
* ≥ Grade 2 autoimmune phenomena
* Asymptomatic bronchospasm or generalized urticaria
* ≥ Grade 3 hematological and non hematological toxicities.
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
0
Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)Secondary· up to 28 weeks
Computed tomography (CT) scans were performed at screening, and during 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): small changes that do not meet above criteria. No evidence of di
Stable Disease
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
3
Complete Response
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
0
Partial Response
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
0
No Evidence of Disease
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
2
Progressive Disease
Group
Value
95% CI
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
9
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 28 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
Serious: 6/14 (43%)
Deaths: 2/14
Serious adverse events (10 terms)
Reaction
System
Patients With Cancer Expre…
Angina pectoris
Cardiac disorders
—
Asthenia
General disorders
—
Brain metastases
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system. Peptides are small fragments of protein. NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been found on various types of cancer cells. The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 10 October 2022
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/NCT00199836.