Patients

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TNBC

Triple negative breast cancer (TNBC) is the most aggressive type of breast cancer characterized by a molecular heterogeneity. Due to the molecular heterogeneity, the lack of common targetable molecular alterations, there are only limited therapeutic options.

Therefore there is a high medical need for new therapeutic approaches. Encouragingly, recent studies report a high immunogenicity of TNBC tumors. Thus, the proposed approach to induce an integrated anti-tumoral immune response directed against both shared and mutated tumor-antigens on a single-patient basis is particularly suitable to meet the high unmet medical need in these patients.

TNBC is an aggressive, molecularly heterogeneous cancer defined by a lack of estrogen receptor (ER), a lack of progesterone receptor (PR) and absence of Her2/neu overexpression. TNBC accounts for approximately 15-25% of all patients with breast cancer, is more likely to affect younger women and is frequently associated with a progressed clinical stage at diagnosis. Due to the molecular heterogeneity, lack of common targetable molecular alterations, many targeted therapies have failed to provide clinical benefit in a significant fraction of TNBC patients. Encouragingly, recent studies report a high immunogenicity of TNBC tumors. Thus, the proposed approach to induce an integrated anti-tumoral immune response directed against both shared and mutated tumor-antigens on a single-patient basis is particularly suitable to meet the high unmet medical need in these patients.

The MERIT study will be a non-randomized, non-controlled therapeutic phase I/II trial in patients with TNBC. The vaccine will be administered on top of first line adjuvant chemotherapy. The scientific rationale is that a vaccine tailored to the individual genotype of a patient’s tumor will have enhanced efficacy compared to classical vaccines.

The MERIT phase I/II clinical trial will be conducted at 5 European clinical centers. Three centers are partners in the MERIT consortium. All selected clinical trial centers have a documented track record in clinical care of breast cancer patients and strong involvement in early immunotherapy trials with complex biomarker logistics.

Institut Gustave Roussy (IGR), France
Vrije Universiteit Brussel (VUB), Belgium
Uppsala University (UU), Sweden
Universitätsmedizin der Johannes Gutenberg-Universität, Mainz, Germany
Nationales Centrum für Tumorerkrankungen (NCT), Germany

Several characteristics make RNA particularly attractive as a vaccine. Multiple different RNA sequences can be manufactured using a uniform, fast and simple manufacturing process and can be qualified using the same analytical methods. The RNA vaccine of the MERIT project is modified to improve the processing of the antigens and to create an efficient stimulation of the immune system against the tumor cells.

Strikingly, the RNA platform will be combined with a personalized therapy concept that integrates personal disease genomics and on-demand vaccine manufacturing to create customized therapies. As every patient’s tumor mutanome bears a highly individual mutation “signature”, the MERIT project proposes a new therapeutic concept integrating tumor profiling by next-generation sequencing to guide design of recombinant vaccines that simultaneously target multiple mutations.

Under what circumstances could I consider participating in a clinical study?

Clearly structured treatment guidelines exist for most diseases in which scientifically validated knowledge is applied for the optimal treatment of patients. This is also the case for treatment of cancer. The guidelines contain treatment methods which optimally suit most treatment situations and they are therefore primarily conside­red when making a treatment decision. In certain situations or advanced disease stages, where regularly available treatment options are not feasible or no longer effective, participation in a clinical trial can be taken into consideration.

The most important contact person for a patient is always his or her treating physician who is best able to assess the patient and his or her disease.

How can I participate in a clinical study and where can I get information about ongoing clinical trials?

If you or a member of your family is interested in participating in a clinical study, please talk to your treating physician about your intentions and ask for advice. Your treating physician will be able to answer your questions and to refer you to a clinical study center.

Who is competent to decide whether a study participation is feasible or not?

Only the investigating physician at a clinical study center (mostly specialized departments in university medical hospitals) where cli­nical studies are conducted is competent to decide which patients fulfill the necessary requirements to participate in a clinical study.

What are “Clinical study centers“?

The location where clinical studies are conducted is called a clinical study center. Only the investiga­ting physicians in theses study centers have the scientific competence to decide which patients qualify for a study participation. The decision is taken according to the rules in the relevant study protocols and according to the individual characteristics of the patient´s disease and the criteria which apply to in- or exclude participants from a specific study.

What does a clinical study protocol define?

The study protocol defines the conditions under which a patient is accepted for participation in a study. Further, it describes in detail the process of a clinical study. Criteria about the different requirements for a patient such as the disease stage, co-medication and coexisting diseases are determined in these protocols. Only patients who exactly fulfill the requirements of the study protocol are allowed to participate in the respective clinical trial.

How can I contact clinical study centers?

At http://clinicaltrials.gov you have the ability to “Search for Studies” using for example an indication or a company name. The web­site provides a list of all clinical studies that correspond with your search criteria.