Phase 1
N=9
NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00142454 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Patients With Treatment-emergent Adverse Events (TEAEs) — 8; 8; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Imiquimod (Drug); NY-ESO-1 protein (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- Apr 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Treatment-emergent Adverse Events (TEAEs) |
8; 8; 0; 0 | — |
| SECONDARY Number of Patients With Cellular Antibody Response to NY-ESO-1 at Two or More Post-vaccination Time Points |
7; 0 | — |
| SECONDARY Number of Patients With Humoral Antibody Response to NY-ESO-1 |
4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00142454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.