SurVaxM + Temozolomide for Glioblastoma
(SURVIVE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had prior or concurrent immunotherapy for brain tumors or certain other treatments. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.
What data supports the effectiveness of the drug SurVaxM + Temozolomide for treating glioblastoma?
Temozolomide, when used with radiation, has shown benefits in treating glioblastoma, improving progression-free survival and quality of life. Additionally, combining temozolomide with other treatments like bevacizumab has been active in improving response rates and survival in elderly patients with glioblastoma.12345
Is the combination of SurVaxM and Temozolomide safe for humans?
Temozolomide, a drug used in treating glioblastoma, is generally considered safe but can cause side effects like nausea, vomiting, fatigue, and blood-related issues. Most side effects are mild, but some can be severe, such as myelotoxicity (bone marrow damage). There is no specific safety data available for SurVaxM in the provided research.678910
What makes the SurVaxM + Temozolomide treatment unique for glioblastoma?
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.
Research Team
Robert Fenstermaker, MD
Principal Investigator
Chief Medical Officer
Michael Ciesielski, PhD
Principal Investigator
Chief Executive Officer
Manmeet S Ahluwalia, MD, MBA
Principal Investigator
Study Principal Investigator
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either SurVaxM plus temozolomide or placebo plus temozolomide, with injections repeated at regular intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- SurVaxM
SurVaxM is already approved in United States for the following indications:
- None approved yet; under investigation for glioblastoma, malignant gliomas, neuroendocrine tumors, multiple myeloma, medulloblastoma, high-grade glioma, ependymoma, and diffuse intrinsic pontine glioma
Find a Clinic Near You
Who Is Running the Clinical Trial?
MimiVax, LLC
Lead Sponsor
Merit
Collaborator
Imaging Endpoints
Collaborator
Translational Drug Development
Collaborator