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Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

Thank you

Trial Information

Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

Switzerland: Swissmedic

Study ID:

CYT004-MelQbG10 04

NCT ID:

NCT00651703

Start Date:

April 2008

Completion Date:

July 2010

Related Keywords:

  • Malignant Melanoma
  • Melanoma

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