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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651703

Enrollment

Registered

2008-04-03

Start date

2008-04-30

Completion date

2010-07-31

Last updated

2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Brief summary

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.

Interventions

BIOLOGICALCYT004-MelQbG10 + Montanide

BIOLOGICALCYT004-MelQbG10 + Montanide + Imiquimod

BIOLOGICALCYT004-MelQbG10 + Imiquimod

BIOLOGICALCYT004-MelQbG10 intra nodal injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026