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CompletedNCT00651703Updated Nov 15, 2010

Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients

A Phase 2 interventional study of CYT004-MelQbG10 + Montanide and CYT004-MelQbG10 + Montanide + Imiquimod in Malignant Melanoma, sponsored by Cytos Biotechnology AG. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-15.

Sponsored by Cytos Biotechnology AG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Malignant Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 21 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

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Lead sponsor

Cytos Biotechnology AG is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    1

    Biological: CYT004-MelQbG10 + Montanide

  • Experimental
    2

    Biological: CYT004-MelQbG10 + Montanide + Imiquimod

  • Experimental
    3

    Biological: CYT004-MelQbG10 + Imiquimod

  • Experimental
    4

    Biological: CYT004-MelQbG10 intra nodal injection

Interventions

  • BiologicalCYT004-MelQbG10 + Montanide
  • BiologicalCYT004-MelQbG10 + Montanide + Imiquimod
  • BiologicalCYT004-MelQbG10 + Imiquimod
  • BiologicalCYT004-MelQbG10 intra nodal injection
06

Study locations

2 sites
  • Ludwig Institute for Cancer Research; CHUV
    Lausanne, VD CH-1005, Switzerland
  • Dermatologische Klinik, UniversitätsSpital Zürich
    Zurich, CH-8091, Switzerland
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00651703
Lead sponsor
Cytos Biotechnology AG
First posted
Apr 3, 2008
Start date
Apr 2008
Primary completion
Dec 2009
Completion
Jul 2010
Last update
Nov 15, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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