deltatrials
Completed PHASE1 INTERVENTIONAL 3-arm NCT02316457

RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID (TNBC-MERIT)

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

Sponsor: BioNTech SE

Conditions Breast Cancer (Triple Negative Breast Cancer (TNBC))
Interventions IVAC_W_bre1_uID IVAC_W_bre1_uID/IVAC_M_uID
Updated 18 times since 2017 Last updated: Mar 12, 2026 Started: Oct 31, 2016 Primary completion: May 13, 2020 Completion: May 17, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Breast Cancer (Triple Negative Breast Cancer (TNBC)), this trial is completed. The trial is conducted by BioNTech SE and has accumulated 18 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~May 2017 · 4 months · monthly snapshot~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Jul 2019 · 7 months · monthly snapshot~Jul 2019 – ~Dec 2019 · 5 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Aug 2020 · 6 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2022 · 13 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Aug 2023 · 13 months · monthly snapshot~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2026 · 18 months · monthly snapshot~Mar 2026 – present · 2 months · monthly snapshot

Change History

18 versions recorded

  1. Mar 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Mar 2026 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  5. Jul 2022 — Aug 2023 [monthly]

    Active Not Recruiting PHASE1

▶ Show 13 earlier versions

  1. Apr 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  2. Mar 2021 — Apr 2022 [monthly]

    Active Not Recruiting PHASE1

  3. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE1

  4. Aug 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  5. Feb 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE1

  6. Dec 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  7. Jul 2019 — Dec 2019 [monthly]

    Recruiting PHASE1

  8. Dec 2018 — Jul 2019 [monthly]

    Recruiting PHASE1

  9. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  10. Oct 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  11. Jul 2017 — Oct 2017 [monthly]

    Recruiting PHASE1

  12. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE1

  13. Jan 2017 — May 2017 [monthly]

    Recruiting PHASE1

    First recorded

Oct 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • BioNTech SE
  • Seventh Framework Programme
Data source: BioNTech SE

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations