Clinical trial · Interventional
Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
NCT00651703CI-TRIAL-00004107completedPhase 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 this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYT004-MelQbG10 + Imiquimod | Biological | — | UNRESOLVED |
| CYT004-MelQbG10 intra nodal injection | Biological | — | UNRESOLVED |
| CYT004-MelQbG10 + Montanide | Biological | — | UNRESOLVED |
| CYT004-MelQbG10 + Montanide + Imiquimod | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: CYT004-MelQbG10 + Montanide
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Biological: CYT004-MelQbG10 + Montanide + Imiquimod
- type
- EXPERIMENTAL
- label
- 3
- interventionNames
- Biological: CYT004-MelQbG10 + Imiquimod
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmed Stage III or IV malignant melanoma * HLA-A\*0201 haplotype * Expected survival of at least 9 months * Willing and able to comply with all trial requirements (e.g. diaries, CTs) * Given written informed consent * Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception Exclusion Criteria: * Any contraindication to any study related test or assessment * Current or planned use of contraindicated concomitant medication * Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease * Infection with HIV, HBV or HCV * Pregnancy or lactation or females planning to become pregnant during the study * Abuse of alcohol or other drugs * Use of investigational drug within 30 days before enrolment * Previous participation in a clinical trial with a Qb-based Cytos vaccine.
References
Publications (0)
Data not yet available
No reference posted for this study.