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 (TNBC-MERIT)

NCT02316457 Phase 1 COMPLETED

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.

Details

Lead sponsor	BioNTech SE
Phase	Phase 1
Status	COMPLETED
Enrolment	42
Start date	2016-10
Completion	2023-05-17

Conditions

• Breast Cancer (Triple Negative Breast Cancer (TNBC))

Interventions

• IVAC_W_bre1_uID
• IVAC_W_bre1_uID/IVAC_M_uID

Primary outcomes

• Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uID — day 120
  Assessment of AEs
• Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uID plus IVAC_M_uID — up to day 246
  Assessment of AEs, End of treatment visit is depending on treatment schedule

Countries

Germany, Sweden