Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Safety and Immunogenicity of Vaccination With Multi-Epitope Peptide Vaccine Containing MART-1, gp100, and Tyrosinase Peptides Given With the Combination of GMCSF and CpG Oligonucleotide (CpG 7909) in ISA-Oil Adjuvant for Patients With Recurrent Inoperable Stage III or Stage IV Melanoma
- 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 GM-CSF, CpG 7909, and incomplete Freund's adjuvant may make a stronger immune response and kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Malignant Conjunctival Neoplasm | Malignant Conjunctival Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Biological | — | UNRESOLVED |
| Peptide vaccine | Biological | — | UNRESOLVED |
| PF3512676 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Peptide Vaccine + GM-CSF + Pfizer 3512676 in-ISA Oil
- description
- The water-in-oil emulsion will consist of peptide (100 mcg/0.1 mL), GM-CSF (80 mcg/0.16 mL using lyophilized 500 mcg/vial reconstituted with 1 mL of sterile water), Pfizer PF3512676 (0.6 mg/0.04 mL using 15mg/mL vial) and 0.20 mLl of sterile saline. Vaccination will be given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).
- interventionNames
- Biological: Peptide vaccine
- Biological: GM-CSF
- Biological: PF3512676
Primary outcomes (1)
- measure
- Safety
- timeFrame
- up to 1 year
- description
- Number of grade 2 or greater allergic reactions (including generalized urticaria) or any grade 3 or greater adverse event
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma meeting the following criteria: * Unresectable recurrent disease * Stage III or IV disease * Cutaneous, ocular, or mucosal melanoma * Measurable disease as defined by the RECIST criteria * HLA-A2 positive * Prior brain metastases allowed provided adequate surgical or radiologic treatment for brain disease PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * WBC ≥ 3,000/mm³ * Lymphocytes ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN * Lactic dehydrogenase ≤ 2.0 times ULN * aPTT \< 40 seconds * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after completion of study therapy * No conditions of immunosuppression * Negative titers for antinuclear antibody (≤ 1/80) and antidouble stranded DNA (≤ 1/10) * No serious illnesses including, but not limited to, any of the following: * Bleeding disorders * Autoimmune diseases * Severe obstructive or restrictive pulmonary diseases * Active systemic infections * Inflammatory bowel disorders * No serious cardiovascular disease including, but not limited to, any of the following: * Uncontrolled congestive heart failure * Hypertension * Cardiac ischemia * Myocardial infarction, * Severe cardiac arrhythmia * HIV1 and 2 negative * HTLV-1 negative * Hepatitis B and C negative * No significant psychiatric disease, medical intervention, or other condition that, in the opinion of the principal investigator, would limit study compliance * No active infection within the past week, including unexplained fever (temperature \> 38.1°C) PRIOR CONCURRENT THERAPY: * Fully recovered from prior major surgery * More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas), hormonal therapy, radiotherapy, or biological therapy * More than 1 week since prior antibiotics * More than 28 days since prior investigational agent * No prior vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides alone or in combination * Patients with history of vaccination with peptides other than MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides allowed * More than 4 weeks since prior and no concurrent systemic immunosuppressive therapy, including steroids * Patients on maintenance steroids given at physiologic doses because of adrenal insufficiency are eligible * More than 2 weeks since prior and no concurrent treatment with systemic steroids, including oral steroids, continuous use of topical steroid creams or ointments, or any inhaled steroids * No concurrent anticoagulants, except to keep an indwelling line patent * No other concurrent anticancer therapy, including chemotherapy, immunotherapy, radiotherapy, experimental programs, and/or surgery
References
Publications (1)
- RESULTTarhini AA, Leng S, Moschos SJ, Yin Y, Sander C, Lin Y, Gooding WE, Kirkwood JM. Safety and immunogenicity of vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) in adjuvant with PF-3512676 and GM-CSF in metastatic melanoma. J Immunother. 2012 May;35(4):359-66. doi: 10.1097/CJI.0b013e31825481fe. PMID 22495394