Prospective Randomized Placebo-Controlled Trial of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (SURVIVE)

  • STATUS
    Recruiting
  • participants needed
    265
  • sponsor
    MimiVax, LLC
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Updated on 19 February 2024

Summary

The primary purpose of this study is to determine whether adding SurVaxM to standard chemotherapy with temozolomide is better than treatment with temozolomide alone for patients with newly diagnosed glioblastoma. This study is designed to compare the duration of survival in patients with newly diagnosed glioblastoma receiving temozolomide plus SurVaxM with that of patients treated with standard temozolomide plus placebo. This study is to find out what effects, both good and bad, this drug combination can have on you and to see if the study drug (SurVaxM) can create an immune response in your blood that is directed against cancer cells. This study also aims to find out if treatment with SurVaxM plus temozolomide improves survival for glioblastoma patients like you compared to treatment with temozolomide alone.

Description

This is a randomized, placebo-controlled study. That means that some patients will receive an active drug (SurVaxM) and some will receive an inactive drug (placebo). Patients who agree to participate will be randomized (chance) to one of two groups. Patients that are randomized by chance to receive SurVaxM will be treated with standard-of-care temozolomide plus an injection under the skin of SurVaxM in Montanide (a milky white substance that helps SurVaxM to be recognized by the patient's immune system). Patients in this group will also receive a second separate injection of a drug called sargramostim that boosts the patient's immune system at the site of the first injection. These injections will be repeated at regular intervals according to a schedule.
Patients that are randomized to receive placebo will be treated with standard-of-care temozolomide plus an injection under the skin of saline (salt water) in Montanide (a milky white substance). Patients in this group will also receive a second separate injection of saline to simulate the injection of sargramostim that patient's in the SurVaxM group receive. These injections will be repeated at regular intervals according to a schedule.
The treatments in the two groups (SurVaxM and placebo groups) will be completely indistinguishable to patients and their treating doctors.

Details
Condition Newly Diagnosed Glioblastoma
Age 18 years and older
Treatment SurVaxM
Clinical Study IdentifierNCT05163080
SponsorMimiVax, LLC
Last Modified on19 February 2024

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