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RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID

NCT02316457 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

IVAC_W_bre1_uID/IVAC_M_uID

vaccination

BIOLOGICAL

IVAC_W_bre1_uID

vaccination

Sponsors & Collaborators

  • Seventh Framework Programme

    collaborator OTHER

  • BioNTech SE

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-05-13
Completion
2023-05-17

Countries

  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316457 on ClinicalTrials.gov