ANTI-TUMOR mRNA VACCINE NEOONKOVAC

Indications for use of the personalized anti‑tumor mRNA vaccine NEOONKOVAC within the approved high‑tech medical care (HTMC) tariffs:

In combination with immune checkpoint therapy (ICT) for adjuvant treatment of adult patients with high‑risk cutaneous melanoma (stages III–IV) after complete surgical removal of all tumor lesions. This includes:

• patients who are primarily operable and have regional or distant metastatic involvement;
• patients with resectable disease recurrence (local satellite/transit, regional nodal, or oligometastatic distant recurrence) after its radical removal.

WHAT THIS MEANS:

1. If you have just been diagnosed with stage III cutaneous melanoma and have not yet received any antitumor treatment, and surgical treatment is planned.
2. If you have been diagnosed with stage IV cutaneous melanoma, but all tumor lesions can be surgically removed.
3. If you were previously diagnosed with stage I–II cutaneous melanoma, underwent surgery, and now have a disease recurrence in the form of:
   • lymph node involvement located close to the site of the removed primary tumor;
   • skin or subcutaneous lesions that have appeared near the site of the removed primary tumor;
   • isolated distant metastases that can be surgically removed.

Important! Tumor lesions must be removed directly at the P.  Hertsen MORI so that they can be immediately submitted for genetic analysis.

The patient should contact the P.  Hertsen MORI prior to starting any drug treatment.

It is important to understand: to create an mRNA vaccine, the presence of tumor tissue available for biopsy/operation (under the conditions of MORI) is REQUIRED. You will be given immunotherapy, and in 3-4 months, the mRNA vaccine will be added. This time is required to create the vaccine.

What does the treatment course involve?

Administration schedule: days 1, 8, 15 with dose escalation, then once every 21 days, up to 10 administrations. In combination with immunotherapy.

How to make an appointment?

Make an appointment with specialists through the MORI contact centre – +7 495-150-11-22 (when booking, specify the purpose – to receive treatment with mRNA vaccines). After additional examination, a consultation will be held with the commission on individual biotechnology-derived medicinal products (iBTMP) to decide whether the patient can be treated with mRNA vaccines.

Which medical documents should I take with me to a doctor’s appointment:

1) Discharge summary with diagnosis and full medical history (description of the treatment for the entire duration of the disease, if available: date and type of biopsy, date and extent of surgical treatment, the results of morphological examination, molecular-genetic results (presence/absence of mutations in the BRAF gene), dates and extent of radiotherapy, dates and extent of anti-tumor treatment with the description of response to therapy).

2) Instrumental examinations (not older than 1.5 months)

• CT scan of the chest, abdominal cavity, retroperitoneal space and pelvis with intravenous contrast or PET/CT of the whole body with intravenous contrast;
• MRI of the brain with intravenous contrast

International patient

1) Send medical documentation to the email: international@nmicr.ru. In response, you will receive a questionnaire, consent to personal data processing and an invoice for the telemedicine consultation. The questionnaire and the consent must be filled in in Russian and sent back as a scanned copy, along with the paid invoice.

2) After this, you will receive a link to authorize yourself in the Medsenger app. Once authorized, you will gain the access to a chat to communicate with an oncologist. In this chat, you will need to upload your medical documentation again, after which a video consultation will be conducted. Based on the results, you will receive the doctor’s decision regarding the possibility of undergoing mRNA vaccine treatment with a detailed description of the subsequent steps. It will also be possible to resolve all further issues promptly in this chat.