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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
CYT004-MelQbG10 + Montanide
CYT004-MelQbG10 + Montanide + Imiquimod
CYT004-MelQbG10 + Imiquimod
CYT004-MelQbG10 intra nodal injection
Sponsored by
Cytos Biotechnology AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ludwig Institute for Cancer Research; CHUV
  • Dermatologische Klinik, UniversitätsSpital Zürich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 1, 2008
Last Updated
November 11, 2010
Sponsor
Cytos Biotechnology AG
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1. Study Identification

Unique Protocol Identification Number
NCT00651703
Brief Title
Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
Official Title
Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cytos Biotechnology AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CYT004-MelQbG10 + Montanide
Intervention Type
Biological
Intervention Name(s)
CYT004-MelQbG10 + Montanide + Imiquimod
Intervention Type
Biological
Intervention Name(s)
CYT004-MelQbG10 + Imiquimod
Intervention Type
Biological
Intervention Name(s)
CYT004-MelQbG10 intra nodal injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ludwig Institute for Cancer Research; CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
CH-1005
Country
Switzerland
Facility Name
Dermatologische Klinik, UniversitätsSpital Zürich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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