Prospective Randomized Placebo-Controlled Trial of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (SURVIVE)
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- STATUS
- Recruiting
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- participants needed
- 265
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- sponsor
- MimiVax, LLC
Updated on 2 December 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 | 18years or above |
| Treatment | SurVaxM |
| Clinical Study Identifier | NCT05163080 |
| Sponsor | MimiVax, LLC |
| Last Modified on | 2 December 2024 |
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Eligibility
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Get screened
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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Step
3
Enroll in the clinical study
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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Get your study results
Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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