Safety of Intranodal ECI-006 in Melanoma Patients

Inclusion Criteria

• •1. Age greater than or equal to 18 years and less than or equal to 80 years.
• •2. Patients must have histologically proven primary malignant melanoma of skin which has been surgically removed (see exclusion criterion on patients with primary uveal melanoma or melanoma of the mucosae).
• •3. Patients with American Joint Committee on Cancer (AJCC) Stage IIc, III or IV.
• •4. Patients must have no evidence of disease as evidenced by a whole body 18F fluorodeoxyglucose (FDG) positron emission tomography \[PET\]/computed tomography \[CT\] scan to be done at maximum 2 weeks before Visit 2. To exclude the presence of tumor lesions in the brain magnetic resonance imaging (MRI) may be performed.
• •5. Full recovery from all prior therapies. A maximum period of 12 weeks following major surgery, or any other major invasive procedure is allowed before start of the study medication; at least 4 weeks should be between major surgery and the start of the immunotherapy
• •6. Female patients of childbearing potential should have a negative serum pregnancy test at Visit 1 (Screening) and should use an efficient method of birth control from screening until the first menses after a 4 week period after the last dose of study medication.
• •1. Histologically confirmed AJCC Stage III or Stage IV unresectable disease.
• •2. Patient must be free of progression and have stable disease after at least 3 months but less than 12 months of first-line immunotherapy (pembrolizumab, nivolumab or combination of nivolumab and ipilimumab). Patients with clinically stable disease can be either:
• •1. Patients with stable disease as defined by RECIST1.1 criteria as assessed on 2 consecutive imagings, or
• •2. Patients deemed unlikely to respond further to the standard of care immunotherapy by the investigator, after an initial partial response.
• •3. Patient must continue with standard of care pembrolizumab or nivolumab during the study.
• •4. Measurable disease by means of clinical examination, computed tomography (CT) or magnetic resonance imaging (MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, defined as:
• •* At least 1 tumor lesion that can be accurately and serially measured in at least 1 dimension, and for which the greatest diameter is ≥ 10 mm or at least one malignant lymph node for which the short axis is ≥ 15 mm as measured by contrast enhanced or spiral CT scan and/or
• •* At least 1 superficial cutaneous melanoma lesion ≥ 10 mm as measured by calipers and/or
• •* At least 1 subcutaneous melanoma ≥ 10 mm lesion and/or
• •* Multiple superficial melanoma lesions which in aggregate have a total diameter of ≥ 10 mm
• •3. Patients with primary uveal or mucosal melanoma.
• •4. Patients that are deemed at risk for autoimmune flare up (e.g. patients that had an ongoing/recurrent irAE in the last 3 months), as determined by the investigator.
• •5. Patients who have received prior treatment for advanced melanoma other than standard of care first-line immunotherapy (pembrolizumab, nivolumab or nivolumab/ipilimumab combination) and targeted therapy (encorafenib, dabrafenib and trametinib) for BRAF positive patients preceding standard of care immunotherapy..