Safety of Intranodal ECI-006 in Melanoma Patients
- Conditions
- Melanoma
- Interventions
- Biological: ECI-006
- Registration Number
- NCT03394937
- Lead Sponsor
- eTheRNA immunotherapies
- Brief Summary
The purpose of this study is to assess the safety and tolerability of cancer immunotherapy ECI-006 and to determine its ability to induce a measurable immune response against the tumor associated antigens.
In Cohort 1, ECI-006 will be administered 5 times by intranodal injection in melanoma patients after resection of their tumor.
In Cohort 2, ECI-006 will be administered 9 times by intranodal injection on top of standard of care anti PD1 in metastatic melanoma patients with stable disease after 3 to 12 months treatment.
ECI-006 activates key immunologically active cells to direct the immune system against the cancer. Expected potential risks for ECI-006 are non-serious and related to the local administration of the product. Hence, the therapy suggested here has the promise to offer considerable benefit to patients without any major risk.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 1800 µg ECI-006 ECI-006 Patients with melanoma are planned to be dosed intranodal with up to 5 doses of 1800 µg ECI-006 Cohort 2 1800 µg ECI-006 ECI-006 Patients with melanoma are planned to be dosed intranodal with up to 9 doses of 1800 µg ECI-006 Cohort 1 600 µg ECI-006 ECI-006 Patients with melanoma are planned to be dosed intranodal with up to 5 doses of 600 µg ECI-006 Cohort 2 3600 µg ECI-006 ECI-006 Patients with melanoma are planned to be dosed intranodal with up to 9 doses of 3600 µg ECI-006
- Primary Outcome Measures
Name Time Method Incidence and severity of treatment-emergent adverse events (TEAEs), including the incidence of dose-limiting toxicities (DLTs), graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 24 weeks Types of toxicities, incidences and severity will be summarized by descriptive statistics
- Secondary Outcome Measures
Name Time Method Immune response associated with ECI-006 administration 24 weeks Antigen-specific T cell responses will be investigated at several time points
Trial Locations
- Locations (9)
032-004_GZA Sint-Augustinus
🇧🇪Antwerpen, Belgium
Site 032-007_AZ Sint Maarten
🇧🇪Mechelen, Belgium
032-002_UCL Brussels
🇧🇪Brussel, Belgium
034-004_Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
034-002_MD Anderson Cancer Center
🇪🇸Madrid, Spain
034-001_Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
032-003_AZ Maria Middelares
🇧🇪Gent, Belgium
032-001_University Hospital Brussel
🇧🇪Jette, Belgium
034-003_Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain