the study (recruitment closed)

GAPVAC Study (GAPVAC-101): A phase I trial of actively personalized peptide vaccinations plus polyimmunomodulators in patients with newly diagnosed glioblastoma concurrent to first line temozolomide maintenance therapy

Study Principles

This phase I clinical study is being carried out in order to evaluate a concept of actively personalized cancer vaccination for treatment of patients suffering from glioblastoma, a highly aggressive form of brain cancer. Personalized cancer vaccination means that patients are treated with vaccines which are specifically produced for each patient after analyzing his/her individual tumor and immune system. This takes into account that each patient’s tumor has unique properties. Because the vaccines in this study are specifically designed for each patient, they are called actively personalized vaccines or APVACs. APVAC vaccines attempt to activate specific white blood cells which are part of the immune system (the body’s system of defense against infections and foreign substances) in the body to attack and destroy tumor cells.

Within this study, samples of a patient’s tumor and blood are analyzed using various methods to determine the unique properties of the tumor (e.g. structures of the cancer cells presented to the immune system, so-called antigens as well as genetic information). Using this knowledge, APVACs, that are supposed to activate the immune system highly specifically against the patient’s unique disease, are defined for each patient.

During the study, two types of vaccines (APVAC1 and APVAC2 vaccines) are applied.

Both APVAC vaccines are given in addition to temozolomide (e.g. Temodar®) after surgery and initial combination of radio-/chemotherapy. Thus, no patient is deprived of the established standard therapy for treatment of glioblastoma.

Who can particpate on the study?

Recruitment was closed in July 2016.

This study was open for patients with newly diagnosed glioblastoma who are eligible to receive standard chemoradiotherapy with temozolomide.

Patients usually enter the study before surgery of their tumor. In exceptional cases patients may also be eligible for the study directly after surgery if tumor material has been shock-frozen during surgery. The study site should be contacted at least 2 1/2 weeks before planned start of chemoradiotherapy because all checks whether a patient can participate have to be completed at least 10 days prior to start of chemoradiotherapy. This strict role is required as otherwise there is not sufficient time for all the process leading to APVAC vaccines. Unfortunately, this condition makes it really difficult for patients to enter the clinical study if they have not been operated at the participating clinical center. Further information with regard to this study and full eligibility criteria can be found on:

Study objectives:

The main goals of this clinical study are to:

  • ensure that APVAC vaccines can be produced individually for each patient within an acceptable timeframe,
  • explore any side effects the APVAC vaccines might have and how they can be managed,
  • describe how the body’s immune system responds to the APVAC vaccinations.

 It is planned to initially treat 20 patients in the GAPVAC-101 study.

Study Treatment

APVAC1 and APVAC2 vaccines are given together with GM-CSF and Hiltonol® (poly-ICLC). GM-CSF and Hiltonol® are drugs that helps the immune system to be activated by the vaccines.

Pre-vaccination phase

Before the vaccinations start, during the time needed for design and production of the personalized APVAC1 vaccine, patients receive the first block of the standard chemotherapy consisting of daily radiation and temozolomide. After recovery from this treatment, patients continue to receive temozolomide in 4-weekly treatment cycles (maintenance therapy). During maintenance therapy, patients receive up to 6 cycles of temozolomide for 5 days at the beginning of each 4-week cycle and are additionally treated with the two different vaccines APVAC1 and APVAC2 which are individually prepared for each patient.

Vaccination phase

APVAC1 vaccinations usually start during the first temozolomide maintenance cycle. Each vaccination usually consists of 3 injections: one injection of GM-CSF, one injection of Hiltonol® and one injection of APVAC1. Approximately 3 months later, APVAC2 vaccines are ready and vaccination with APVAC2 is applied in addition; during this phase, patients usually receive 4 injections with each immunization: one injection of GM-CSF, one injection of Hiltonol®, one injection of APVAC1 and one injection of APVAC2. GM-CSF and both APVAC vaccines are applied intradermally (into the skin) of the abdomen or thigh, while Hiltonol® is injected subcutaneously (under the skin).

Further information

Further information with regard to this study and full eligibility criteria can be found on:

This study is conducted in 6 hospitals in Europe (Heidelberg and Tübingen in Germany, Copenhagen in Denmark, Leiden in The Netherlands, Geneva in Switzerland, Barcelona in Spain).

The APVAC1 and APVAC2 vaccines are developed by immatics biotechnologies GmbH (Tuebingen) and BioNTech AG (Mainz), both biopharmaceutical companies located in Germany.

If you have any further questions about this study, do not hesitate to contact us by email ( or phone (07071 – 53 970).