SurVaxM + Temozolomide for Glioblastoma (SURVIVE Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen ByRobert Fenstermaker, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: MimiVax, LLC

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This trial is testing if adding SurVaxM to standard chemotherapy helps patients with newly diagnosed glioblastoma live longer. SurVaxM works by boosting the immune system to fight cancer more effectively. SurVaxM is a vaccine developed for patients with malignant gliomas.

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed glioblastoma of the cerebrum, who've completed initial radiation and chemotherapy without disease progression. They must be able to care for themselves mostly, have certain lab values within normal ranges, agree to contraception if applicable, and not be on high doses of steroids.

Inclusion Criteria

I am able to care for myself but may not be able to do active work.

My cancer did not worsen after my last treatment.

I am 18 years old or older.

I do not have any ongoing bleeding or conditions that increase my risk of bleeding.

I have been diagnosed with glioblastoma in my brain.

I completed radiation therapy with TMZ following the Stupp protocol.

I am taking 4 mg or less of dexamethasone daily.

My tumor has been tested for the IDH-1 mutation.

Exclusion Criteria

I have had a second brain surgery for my tumor after undergoing chemotherapy and radiation.

I am HIV positive or have an AIDS-related illness.

I cannot have MRI scans or use gadolinium contrast.

I have had carmustine wafers surgically implanted.

I do not have a serious illness or infection that could interfere with treatment.

My brain cancer has come back or gotten worse.

I have had tuberculosis or a similar disease in the past.

I have been treated with bevacizumab.

I have had cancer before, but it was successfully treated.

I received a unique radiation treatment for my brain cancer.

I cannot take temozolomide due to health reasons.

My cancer is not glioblastoma.

I have been treated with chemotherapy or experimental drugs before.

My brain cancer affects multiple areas or specific parts of my brain.

I have received immunotherapy for my brain tumor.

Participant Groups

The SURVIVE study tests whether adding a new drug called SurVaxM to standard temozolomide chemotherapy improves survival in patients with newly diagnosed glioblastoma compared to temozolomide alone. The effects on immune response against cancer cells are also studied.

2Treatment groups

Active Control

Placebo Group

Group I: Arm AActive Control1 Intervention

Peptide Vaccine (SurVaxM) in emulsion with Montanide given together with locally administered Sargramostim plus adjuvant oral Temozolomide

Group II: Arm BPlacebo Group1 Intervention

Saline-Montanide emulsion with locally administered saline (instead of sargramostim) plus adjuvant oral temozolomide

SurVaxM is already approved in United States for the following indications:

🇺🇸 Approved in United States as SurVaxM for:

None approved yet; under investigation for glioblastoma, malignant gliomas, neuroendocrine tumors, multiple myeloma, medulloblastoma, high-grade glioma, ependymoma, and diffuse intrinsic pontine glioma