At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
First-in-human Clinical Study With RNA-Immunotherapy Combination of IVAC_W_bre1_uID and IVAC_M_uID for Individualized Tumor Therapy in Triple Negative Breast Cancer Patients
In Brief
A Phase 1 clinical trial evaluating IVAC_W_bre1_uID and IVAC_W_bre1_uID/IVAC_M_uID for Breast Cancer (Triple Negative Breast Cancer (TNBC)). Completed, enrolled 42 participants across 4 sites in 2 countries.
Detailed Summary
The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduced a novel concept for Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and immunogenic RNA vaccines for a given patient's tumor. The TNBC-MERIT trial used two complementary strategies, the WAREHOUSE and the IVAC® MUTANOME concept, resulting in two custom-made IVAC® investigational medicinal products (IMPs) (IVAC\_W\_bre1\_uID and IVAC\_M\_uID) for each individual patient.
Study Details
Timeline
Interventions
vaccination
vaccination