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Breast Cancer (Triple Negative Breast Cancer (TNBC))Phase 1TNBC-MERITNCT02316457

RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID

A Phase 1 study testing IVAC_W_bre1_uID and IVAC_W_bre1_uID/IVAC_M_uID in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)), run by BioNTech SE at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
IVAC_W_bre1_uID and IVAC_W_bre1_uID/IVAC_M_uID
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesin 2 countries
Study dates
Oct 2016to 17 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed invasive adenocarcinoma triple negative breast cancer (TNBC), pT1cN0M0 - anyTanyNM0 confirmed by physical examination or imaging
  • Triple negative breast cancer was defined as:
  • HER2 negative
  • IHC 0-1+
  • IHC 2+ and FISH negative (ratio < 2.0 or < 4 gene copies / cell, as per new ASCO guideline)
  • ER and PR negative confirmed< 1%
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  • For patients with surgery of primary tumor followed by adjuvant chemotherapy, treatment with IVAC_W_bre1_uID was initiated after completion of the adjuvant chemotherapy. The adjuvant chemotherapy should contain anthracyclines and taxanes - except for patients with contraindications for treatment with one or both substances.
  • For patients with neoadjuvant chemotherapy according to local standard followed by surgery of primary tumor, treatment with IVAC_W_bre1_uID was initiated after the surgery. The neoadjuvant chemotherapy should contain anthracyclines and taxanes - except for patients with contraindications for treatment with one or both substances.
  • Patients with planned radiotherapy (as per local policy) were eligible and should be irradiated in parallel to the vaccination cycles
  • Patients after completion of standard of care therapy e. g. surgery and/or chemotherapy and/or radiotherapy (as per local policy) were eligible at the discretion of the investigator after no clinical sings of recurrence and/or metastasis, if the treatment with IVAC_W_bre1_uID starts within one year after completion of the radiotherapy.
  • Adequate organ function (hematopoietic, hepatic and renal function):
  • Hemoglobin ≥ 9 g/dl
  • ANC ≥ 1500/µl
  • Platelet count ≥ 100,000/mm³
  • ALT/AST <2 x ULN
  • Serum creatinine ≤ 1.5 ULN
  • Expression of at least two tumor-specific antigens of the WAREHOUSE_bre1 confirmed by RT-qPCR on FFPE tumor tissue for ARM1 and ARM3
  • Female patients, ≥ 18 years of age
  • Written informed consent
  • ECOG performance status (PS) 0-1
  • Recovered pre-existing toxicities < grade 2 according to NCI CTCAE 4.03, except alopecia
  • Negative pregnancy test (measured by β-HCG) for females of childbearing age
  • Not pregnant or nursing

Who cannot join

  • Patients with stage pT1a,bN0M0 and anyTanyNM1disease were excluded
  • Patients with recurrence of breast cancer prior to the start of study treatment with IVAC_W_bre1_uID
  • Any serious local infection (e. g. cellulitis, abscess) or systemic infection (e. g. pneumonia, septicemia, viral or fungal infection) which requires systemic treatment with antibiotics or corticoid therapy within two weeks prior to the first dose of study medication
  • Previous splenectomy
  • Concurrence of a second malignancy other than squamous or basal cell carcinoma or cervical carcinoma in situ within 5 years prior to the start of study treatment
  • Known hypersensitivity to the active substance or to any of the excipients
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  • Prior solid organ transplantation or hematopoietic stem cell transplantation
  • Positive test for acute Hepatitis A, acute or chronic active Hepatitis B or C infection
  • Clinically relevant active autoimmune disease
  • Systemic immune suppression:
  • HIV disease
  • Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
  • Other clinically relevant systemic immune suppression
  • Symptomatic congestive heart failure (NYHA 3 or 4)
  • Unstable angina pectoris
  • Adjuvant chemotherapy within 14 days before the first treatment of IVAC_W_bre1_uID
  • Other major surgeries within 28 days before the first treatment
  • Other investigational agents within 28 days or 5 half-lives depending on what gives the longer range before the first treatment
  • Ongoing participation in another clinical study (except of Follow-Up observation)
  • Fertile females who were unwilling to use a highly effective method of birth control (less than 1% per year, e.g. birth control pills, injections, patches, intrauterine device, or intrauterine hormone-releasing system) during study treatment and until End of Trial visit (EOT) at day 120
  • Presence of a severe concurrent illness or another condition (e. g. psychological, family, sociological, or geographical circumstances) that did not permit adequate Follow-Up and compliance with the protocol

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Germany3 sites

  • National Center for Tumor Diseases (NCT)

    Heidelberg, 69120

  • Johannes Gutenberg University

    Mainz, RLP, 55131

  • Dr. Horst Schmidt-Kliniken Wiesbaden

    Wiesbaden, 65199

Other trials in Germany

Sweden1 site

  • Uppsala University Hospital

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: 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

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.

Read the detailed description
  • The WAREHOUSE concept is based on RNA drug products shelved in a warehouse and targeting shared tumor-associated antigens (TAAs). The BioNTech Group (henceforward the "company") has identified a set of target antigens commonly expressed in TNBC. The selected breast cancer-associated antigens have been shown by immunogenicity testing to constitute suitable targets for immunotherapy and form the basis for the development of a novel RNA-based immunotherapy approach.
  • The IVAC® MUTANOME concept is based on the identification of tumor-specific mutations by next-generation sequencing (NGS) and on-demand RNA manufacturing for use in single patients to target multiple neo-antigens derived from mutated epitopes. The novel therapeutic concept is supported by a series of research projects and high level publications that have led to a broad acceptance that mutation-specific T cells bear enormous potential to confer anti-tumoral activity in cancer patients.
  • The TNBC-MERIT study introduced the novel therapeutic concept for the individualized treatment of breast cancer that is based on (i) treatment with a patient-specific liposome complexed RNA tailored to the antigen-expression profile of any given patient's tumor (WAREHOUSE immunotherapy - IVAC_W_bre1_uID) and (ii) on treatment with de novo synthesized RNAs targeting up to 20 individual tumor mutations (IVAC® MUTANOME immunotherapy - IVAC_M_uID) following optional treatment with WAREHOUSE. The scientific rationale for the combination of the two IVAC® approaches is based on the assumption that immunotherapies that (1) acknowledge tumor heterogeneity on a single-patient level and (2) target the whole range of antigens selectively expressed on tumors ("cancer antigenome"), including immunogenic shared and unique antigens, bear the highest potential to constitute an effective treatment of tumors.
Being tested
IVAC_W_bre1_uID, IVAC_W_bre1_uID/IVAC_M_uID
Keywords
TNBC, Breast Cancer, Warehouse, Mutanome, RNA, Vaccine
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVAC_W_bre1_uIDBiological

    vaccination

  • IVAC_W_bre1_uID/IVAC_M_uIDBiological

    vaccination

Study groups in NCT02316457
Study groupRoleWhat they receive
ARM1 IVAC_W_bre1_uIDExperimentalPatients enrolled in ARM1 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient.
Receives: Biological: IVAC_W_bre1_uID
ARM2 IVAC_W_bre1_uID/IVAC_M_uIDExperimentalPatients enrolled in ARM2 will optionally receive the WAREHOUSE treatment as described above followed by the personalized IVAC® MUTANOME immunotherapy. The mutation selection process constitutes a multi-step process including identification of somatic mutations by NGS, mutation confirmation and prioritization, selection, and on demand manufacturing.
Receives: Biological: IVAC_W_bre1_uID/IVAC_M_uID
ARM3 IVAC_W_bre1_uID + RBLTet.1ExperimentalPatients enrolled in ARM3 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient. RBLTet.1 RNA will be added to each RNA applied.
Receives: Biological: IVAC_W_bre1_uID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uID

    Assessment of AEs

    Measured: day 120

  2. Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uID plus IVAC_M_uID

    Assessment of AEs, End of treatment visit is depending on treatment schedule

    Measured: up to day 246

Secondary outcomes (2)

  1. Change of induced T-cell responses for IVAC_W_bre_uID change from Visit 1 to V10

    Vaccine induced T-cell responses assessed by immuno assays in peripheral blood

    Measured: up to 78 days

  2. Change of induced T-cell responses for IVAC_M_uID change from Visit 18 to Follow-up Visit

    Vaccine induced T-cell responses assessed by immuno assays in peripheral blood

    Measured: up to 78 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2014 (estimated)
  2. Study startOct 2016
  3. Primary completion13 May 2020
  4. Study completion17 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02316457
Sponsor's protocol ID
BN_0002-01
Acronym
TNBC-MERIT
Status last verified
Mar 2026
First submitted
21 Nov 2014
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Sahin U, Schmidt M, Derhovanessian E, Cortini A, Vogler I, Omokoko T, Godehardt E, Attig S, Newrzela S, Grutzner J, Bidmon N, Bolte S, Brachtendorf S, Stuhlmann T, Langer D, Brune D, Blake J, Feldner A, Lindman H, Schneeweiss A, Eichbaum M, Tureci O. Individualized mRNA vaccines evoke durable T cell immunity in adjuvant TNBC. Nature. 2026 Mar;651(8107):1088-1096. doi: 10.1038/s41586-025-10004-2. Epub 2026 Feb 18.

    PubMed 41708868

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IVAC_W_bre1_uID and IVAC_W_bre1_uID/IVAC_M_uID in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)), run by BioNTech SE at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uID (time frame: day 120). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02316457, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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