18 and older, any sex, with Malignant Melanoma. 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 4 months
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 time informed consent was signed through the last follow-up visit. AEs were considered to be
Any TEAE
Group
Value
95% CI
Imiquimod + NY-ESO-1
8
Maximum TEAE severity Grade 1
Group
Value
95% CI
Imiquimod + NY-ESO-1
8
Serious TEAE
Group
Value
95% CI
Imiquimod + NY-ESO-1
0
TEAE leading to discontinuation
Group
Value
95% CI
Imiquimod + NY-ESO-1
0
Number of Patients With Cellular Antibody Response to NY-ESO-1 at Two or More Post-vaccination Time PointsSecondary· Up to 4 months
Assays to assess cluster of differentiation (CD)8+ and CD4+ antigen-specific responses were performed at baseline (Cycle 1 Day 1), throughout the vaccination period (Day 1 of Cycles 2 through 4 and Day 10 of each cycle), and at the 2 post-treatment follow-up visits (Weeks 13 and 16) by enzyme-linked immune absorbent spot (ELISPOT) assay following prior in vitro sensitization. A 3-fold increase in spot-forming cells over baseline defined a positive response. Suitable antigens may have included recombinant viral vectors encoding NY-ESO-1, or NY-ESO-1 overlapping peptides, depending upon availabi
CD4+ T cell response
Group
Value
95% CI
Imiquimod + NY-ESO-1
7
CD8+ T cell response
Group
Value
95% CI
Imiquimod + NY-ESO-1
0
Number of Patients With Humoral Antibody Response to NY-ESO-1Secondary· Up to 4 months
Assays to assess NY-ESO-1 specific antibodies were performed at baseline (Cycle 1 Day 1), throughout the vaccination period (Day 1 of Cycles 2 through 4 and Day 10 of each cycle), and at the 2 post-treatment follow-up visits (Weeks 13 and 16) by enzyme-linked immunosorbent assay (ELISA). Samples were diluted serially. The induction and augmentation of immunity were defined as an increase in antibody titer of ≥ 3× over buffer alone or ≥ 4× the pre-vaccination titer, respectively. Sera from the responding patients were tested a second time against a pool of NY-ESO-1 overlapping peptides to confi
Group
Value
95% CI
Imiquimod + NY-ESO-1
4
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months 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, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant melanoma. The primary study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the secondary objective was to evaluate the immunogenicity of treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06356012 — Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
· Phase 4
· recruiting
NCT05838599 — Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
· EARLY_PHASE1
· unknown
NCT05740969 — Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
· Phase 2
· unknown
NCT04809662 — Comparing Immune Responses to Topical Imiquimod
· terminated
NCT03196180 — Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia
· EARLY_PHASE1
· completed
Other recruiting trials for Malignant Melanoma
Currently open trials in the same condition.
NCT07371663 — An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT06961006 — A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-0
· Phase 2
· recruiting
NCT06974734 — A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies
· Phase 1
· active not recruiting
NCT06560905 — Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
· Phase 2
· recruiting
Other Ludwig Institute for Cancer Research trials
Trials by the same sponsor.
NCT03164772 — Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC
· Phase 1, PHASE2
· completed
NCT02963831 — A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
· Phase 1, PHASE2
· completed
NCT02898116 — Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
· Phase 1, PHASE2
· completed
NCT02643303 — A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
· Phase 1, PHASE2
· completed
NCT02716805 — Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant
· Phase 1
· terminated
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/NCT00142454.