Clinical trial · Interventional
Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma Patients
Phase I/II Clinical Trial for the Evaluation of the Interaction Between Chemotherapy and Immunotherapy in Melanoma Patients
NCT00559026CI-TRIAL-00000980DTIC-melvacccompletedPhase 1ClinicalTrials.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)
This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma peptide vaccine in combination or not with Dacarbazine administration in melanoma patients
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melan-A | Biological | — | UNRESOLVED |
| Melan-A plus Dacarbazine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Biological: Melan-A
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Other: Melan-A plus Dacarbazine
Primary outcomes (1)
- measure
- Assessment of safety by evaluating local and systemic adverse reactions during the trial. Assessment of the vaccine-specific cellular immune responses
- timeFrame
- one year
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven diagnosis of melanoma stage II, III, and IV without clinical/radiological evidence of disease * Age \>18 years * life expectancy of more than 6 months * ECOG performance status of 0-2 * adequate blood cell counts and kidney-liver function * use of adequate contraceptive methods * signed informed consent Exclusion Criteria: * concomitant or previous history of malignant disease, except for in situ cervical carcinoma or non melanomatous skin cancer * severe cardiovascular disease * clinically active infections and/or significant autoimmune diseases * concomitant or previous (within 6 weeks) treatment with immunosuppressive drugs * previous treatments with chemotherapy and/or interferon alpha or beta within 4 weeks and/or radiotherapy within 6 weeks an/or biological therapy within 8 weeks before starting vaccination * psychiatric illness interfering with patient compliance, pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.