Phase 1
N=39
Immunotherapy of Stage III/IV Melanoma Patients
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00112242 ↗Enrolled (actual)
39
Serious AEs
20.5%
Results posted
Jun 2020
Primary outcome: Primary: Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events) — 13.40; 18.40; 23.80; 19.60 Number of adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Melan-A ELA + Montanide (Biological); Melan-A ELA + NY-ESO-1b + MAGE-A10 + Montanide (Biological); Melan-A -ELA + NY-ESO-1b + MAGE-A10 peptide + Montanide + CpG (Biological); Melan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG (Biological); Melan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG+ IL-2 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre Hospitalier Universitaire Vaudois
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events) |
13.40; 18.40; 23.80; 19.60; 31.75; 10.44 | — |
| PRIMARY Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period |
0.03; 0.01; 0.08; 0.18; 0.04; 0.08 | — |
| PRIMARY Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period |
0.001; 0.004; 0.065; 0.008; 0.150; 0 | — |
| PRIMARY Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period |
0.69; 0.01; 0.96; 0.21; 2.37; 0.19 | — |
| PRIMARY Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period |
0.004; 0.218; 0.001; 0.010; 0.050; -0.001 | — |
| PRIMARY Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period |
0; 0; 0; 0.04; 0.03; 0.03 | — |
| PRIMARY Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period |
0.001; 0.003; 0.014; 0; 0.09; 0 | — |
| PRIMARY Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period |
0.12; 071; 0.20; 1.05; 2.86; 16.24 | — |
| PRIMARY Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period |
0.03; 0.12; 0.02; 0.15; 0.88; 7.21 | — |
| SECONDARY Disease Status Assessment During the Vaccination Period |
7; 2; 4; 7; 9; 1 | — |
Summary
The purpose of this study is to determine whether vaccination with melanoma antigen peptides [Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10] and Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed stage III or stage IV melanoma with at least one metastatic lymph node and/or at least one in-transit metastasis. According to the AJCC rules, this includes all patients with stage IV and stage III. Patients with or without measurable disease may be included.
- Tumor expression of Melan-A by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis for patients of group I.
Tumor expression of Melan-A and at least one of the tumor antigens MAGE-A10, NY-ESO-1, or LAGE-1 by rt-PCR analysis for patients of group II and III and for HLA-A2+ patients of groups IV and V. HLA-A2 negative patients of groups IV and V must only have NY-ESO-1 positive tumors to be eligible, while expression of Melan-A and MAGE-A10 is unimportant.
If no frozen tissue is available, immunohistochemistry may be performed to detect tumor expression of Melan-A and NY-ESO-1.
- HLA-A2 positive (serological or molecular typing of Peripheral Blood Lymphocytes (PBL) for patients of groups 1 to 3. Patients of groups 4 and 5 may either be HLA-A2+ or HLA-A2-.
- Expected survival of at least five months.
- Full recovery from surgery.
- Karnofsky scale performance status of 70% or more.
- The following laboratory results:
Neutrophil count sup or equal 2.0 x 10^9/L Lymphocyte count sup or equal 0.5 x 10^9/L Platelet count sup or equal 100 x 10^9/L Creatinine ≤ 2 mg/dL (180 micromol/L) Bilirubin ≤ 2mg/dL (34 micromol/L) Granulocyte count > 2.5x10^9/L AST 18 years.
- Able to give written informed consent.
Exclusion Criteria
- Clinically significant heart disease (NYHA Class III or IV).
- Other serious illnesses, e.g., serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders with major dysfunction.
- History of immunodeficiency disease or autoimmune disease.
- Known HIV positivity.
- Known seropositivity for hepatitis B surface antigen.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
- Concomitant treatment with steroids, antihistamine drugs. Topical or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or lactation.
- Women of childbearing potential not using a medically acceptable means of contraception.
- Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
- Coagulation or bleeding disorders.
- Metastatic disease to the central nervous system, unless treated and stable.
Data sourced from ClinicalTrials.gov (NCT00112242). 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.