drugset / Trial / NCT02316457

RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID

NCT02316457 ↗

Phase 1 Completed 42 enrolled BioNTech SE Seventh Framework Programme · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-10
Primary completion
2020-05-13
Completion
2023-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject IVAC_M_uID Unknown — —
Subject IVAC_W_bre1_uID Unknown — —