Clinical trial · Interventional
Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery
Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
- 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)
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give vaccine therapy together with resiquimod in treating patients with stage II, stage III, or stage IV melanoma that has been completely removed by surgery.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| resiquimod | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunization with NY-ESO-1b
- description
- Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine.
- interventionNames
- Drug: resiquimod
Primary outcomes (3)
- measure
- Number and severity of hematologic and non-hematologic toxicities
- timeFrame
- 4 weeks
- measure
- Toxicity profile of each dose level
- timeFrame
- 4 weeks
- measure
- Percent of patients who mount an immune response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Prior diagnosis of melanoma meeting the following criteria: * Stage II-IV disease * Complete resection of disease * No current evidence of disease * HLA-A2 positive * No known standard therapy for disease that is potentially curative or proven capable of extending life expectancy exists PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 75,000/mm³ * AST ≤ 3 times upper limit of normal * No uncontrolled or current infection * No known allergy to vaccine or adjuvant components * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known immune deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior chemotherapy and recovered * More than 4 weeks since prior biologic therapy * No concurrent immunosuppressive therapy
References
Publications (0)
Data not yet available