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mRNA Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Uveal Melanoma

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Trial Information

mRNA Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients

Inclusion Criteria:

- histological documented uveal melanoma

- HLA-A2.1 phenotype (intervention arm)

- non-HLA-A2.1 phenotype (control arm)

- melanoma expressing gp100 and/or tyrosinase

- high risk genetic profile (loss of chromosome 3) determined by FISH

- interval since local treatment of uveal melanoma < 12 months

- no signs of liver metastasis determined by diagnostic CT-abdomen

- normal serum LDH

- no signs of cerebral metastases

- bilirubin < 25 micromol/l

- WHO performance scale 0-1

- age 18-75 years

- written informed consent

- expected adequacy of followup

- no pregnant or lactating women

Exclusion Criteria:

- history of second malignancy, except adequately treated basal cell carcinoma

- serious active infections

- autoimmune disease or organ allografts

- concomitant use of immunosuppressive drugs

- known allergy to shell-fish

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

immunological response

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Cornelis JA Punt, prof.MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University Nijmegen Medical Centre, Dept of Medical Oncology


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

June 2009

Completion Date:

June 2014

Related Keywords:

  • Uveal Melanoma
  • uveal melanoma
  • chromosome 3
  • high risk
  • immunotherapy
  • adjuvant
  • high risk genetic profile
  • loss of chromosome 3
  • Melanoma
  • Uveal Neoplasms