Clinical trial · Interventional
Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens
Pilot Study of Intradermal Vaccination of Melanoma Patients With a Fixed Combination of mRNAs Compared to an Individualized Selection After Analysis of Antigen Expression in Tumor Tissue
NCT00204516CI-TRIAL-00008937completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
| mRNA coding for melanoma associated antigens | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mRNA Vacc
- interventionNames
- Biological: mRNA coding for melanoma associated antigens
- Drug: GM-CSF
Primary outcomes (1)
- measure
- Tolerability
- timeFrame
- every 4 weeks
- description
- Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * malignant melanoma stage III/IV * fresh frozen tumor tissue available * informed consent given * Karnofsky \>= 70% Exclusion Criteria: * brain metastasis * parallel chemotherapy * systemic treatment with glucocorticoids * other malignancies
References
Publications (0)
Data not yet available
No reference posted for this study.