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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02035956
Eligibility Criteria:
Inclusion Criteria:
* Malignant Melanoma, resectable stage IIIA-C and IV (AJCC 2009 melanoma classification)
* Patients with unresectable Malignant Melanoma stage IIIA-C in complete remission, partial remission or stable disease after treatment with vemurafenib or patients with slow progressive disease.
* Malignant Melanoma, unresectable stage IV (AJCC 2009 melanoma classification) in complete remission, partial remission or stable disease after treatment with vemurafenib
* All lines of treatment for malignant melanoma are accepted.
* First line therapy for subjects not eligible or declining other first line therapies after all available treatment options have been transparently disclosed (to be documented in patient medical record).
* ≥ 18 years of age
* Written informed consent
* ECOG performance status (PS) 0-1 (appendix G)
* Life expectancy \> 6 months
* WBC ≥ 3x109/L
* Haemoglobin ≥ 10 g/dl
* Platelet count ≥ 100,000/mm³
* LDH level \< 2.0 x ULN
* Negative pregnancy test (measured by β-HCG) for females which are childbearing potential
* Suitable lymph nodes for injection using ultrasound guidance
Exclusion Criteria:
* Pregnancy or breastfeeding
* Primary ocular melanoma
* History (\< 5 years) of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer or cervical carcinoma in situ
* Brain metastases
* Known or symptomatic pleural effusions and/or ascites
* Known hypersensitivity to the active substance or to any of the excipients
* A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of study medication
* Positive test for acute or chronic active hepatitis B or C infection, acute EBV or acute CMV injection
* Clinically relevant autoimmune disease
* Systemic immune suppression:
* HIV disease
* Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
* Other clinical relevant systemic immune suppression
* Symptomatic congestive heart failure (NYHA 3 or 4)
* Unstable angina pectoris
* Radiotherapy within two weeks, myelosuppressive chemotherapy, ipilimumab and major surgery within 4 weeks/28 days before the first treatment. Interferon and approved BRAF inhibitors will be allowed as concurrent treatment.
* Any investigational drug within 4 weeks/28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study
* Minor surgery within 14 days before the first treatment of this study
* Fertile males and females who are unwilling to use a highly effective method of birth control (less than 1% per year, e.g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches or intrauterine device) during study treatment and 28 days after the last dose of study treatment
* Presence of a serious concurrent illness or other condition (e.g. psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02035956
Study Brief:
Protocol Section:
NCT02035956