Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT00651703
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00651703
Study Brief:
Protocol Section:
NCT00651703