Our study population consists of melanoma patients, with proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional lymph node metastasis in whom a radical lymph node dissection is planned or performed within 2 months of inclusion in this study (further referred to as stage III) and melanoma patients with measurable distant metastases (further referred to as stage IV) will be included.
Conditions
Interventions
Product Name: Toll-like receptor ligand-matured mRNA-electroporated Dendritic cell product
Product Code: TLR-DC
Pharmaceutical Form: Solution for injection
Product Name: Trimix mRNA-electroporated De
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For both stage III and IV melanoma - histologically documented evidence of melanoma - stage III or IV melanoma according to the 2001 AJCC criteria - HLA-A2.1 phenotype is required - melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory) - WHO performance status 0-1 (Karnofsky 100-70%) - life expectancy >3 months - age 18-70 years - no clinical signs or symptoms of CNS metastases - WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l, serum crea-tinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - prior chemotherapy, immunotherapy or radiotherapy <4 weeks prior to planned vaccination or presence of treatment-related toxicity - history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix serious active infections, HbsAg or HIV positive or autoimmune diseases or organ allografts - concomitant use of immunosuppressive drugs - known allergy to shell fish (since it contains KLH) - rapidly progressive disease - any serious clinical condition that may interfere with the safe administration of DC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the toxicity of intranodally injected Trimix DC and TLR-DC by dose escalation of DC numbers. ;Secondary Objective: Secondary study endpoints are: (a) The activation of immune cells in vivo. (c) The immunological response induced with Trimix DC loaded with mRNA encoding melanoma-associated tumor antigens (gp100 and tyrosinase). (d) The clinical efficacy of vaccination with Trimix DC. ;Primary end point(s): The primary objectives of the study are to investigate the toxicity of intranodally injected Trimix DC and TLR-DC by dose escalation of DC numbers in part I, and to investigate immunological responses upon TLR-DC vaccination in part II of the study. Immunological responses are: (a) The activation of immune cells in vivo. (b) The immunological response induced with TLR-ligand matured DC loaded with mRNA encoding melanoma-associated tumor antigens (gp100 and tyrosinase). Safety and clinical efficacy are secondary objectives. | — |
Countries
Netherlands
Outcome results
None listed