Clinical trial · Interventional
NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant
NCT00142454CI-TRIAL-00061340completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| NY-ESO-1 protein | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imiquimod + NY-ESO-1
- description
- Patients applied topical imiquimod followed by vaccination with intradermal injections of the NY-ESO-1 protein.
- interventionNames
- Drug: Imiquimod
- Biological: NY-ESO-1 protein
Primary outcomes (1)
- measure
- Number of Patients With Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Up to 4 months
- description
- 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 treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Had histologically confirmed, resected American Joint Committee on Cancer Stage IIB, IIC or III malignant melanoma * Fully recovered from surgery * Age ≥ 18 years; children were excluded from this study, as the safety of imiquimod had not been established in patients below the age of 18 * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Adequate organ and marrow function as defined below: * absolute neutrophil count: ≥ 1500/μL * hemoglobin: ≥ 9 g/dL * platelets: ≥ 100,000/μL * total bilirubin: ≤ 1.5 × institutional upper limit of normal (ULN) * aspartate aminotransferase/alanine aminotransferase (AST/ALT): ≤ 2.5 × institutional ULN * creatinine: ≤ 1.5 × institutional ULN * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Received chemotherapy, immunotherapy (including interferon), or radiotherapy within 4 weeks prior to first dosing of study agent * Prior treatment with NY-ESO-1 vaccines * Known human immunodeficiency virus infection or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus), as these conditions could have interfered with the evaluation of the induced immune response; patients with vitiligo or melanoma-associated hypopigmentation were not excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to imiquimod or other agents used in the study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would have limited compliance with study requirements * Pregnancy or lactation * Women of childbearing potential not using a medically acceptable means of contraception * Known history of inflammatory skin disorders, as imiquimod might have exacerbated these conditions * Chronic corticosteroid or immunosuppressive therapies, as these might have interfered with the evaluation of the induced immune response * Lack of availability for immunological and clinical follow-up assessments
References
Publications (1)
- RESULTAdams S, O'Neill DW, Nonaka D, Hardin E, Chiriboga L, Siu K, Cruz CM, Angiulli A, Angiulli F, Ritter E, Holman RM, Shapiro RL, Berman RS, Berner N, Shao Y, Manches O, Pan L, Venhaus RR, Hoffman EW, Jungbluth A, Gnjatic S, Old L, Pavlick AC, Bhardwaj N. Immunization of malignant melanoma patients with full-length NY-ESO-1 protein using TLR7 agonist imiquimod as vaccine adjuvant. J Immunol. 2008 Jul 1;181(1):776-84. doi: 10.4049/jimmunol.181.1.776. PMID 18566444