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Cancer Vaccine

SurVaxM + Temozolomide for Glioblastoma (SURVIVE Trial)

Phase 2
Waitlist Available
Led By Manmeet S Ahluwalia, MD, MBA
Research Sponsored by MimiVax, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status ≥ 70
No evidence of progressive disease at post-chemoradiation timepoint
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

SURVIVE Trial Summary

This trial is testing whether adding SurVaxM to temozolomide chemotherapy helps people with newly diagnosed glioblastoma live longer than temozolomide chemotherapy alone.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy such as flu-like symptoms, fatigue, skin reactions at injection sites, and possible autoimmune responses. Temozolomide can cause nausea, hair loss, blood disorders like low platelet counts or anemia.

SURVIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but may not be able to do active work.
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My cancer did not worsen after my last treatment.
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I am 18 years old or older.
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I do not have any ongoing bleeding or conditions that increase my risk of bleeding.
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I have been diagnosed with glioblastoma in my brain.
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I completed radiation therapy with TMZ following the Stupp protocol.
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I am taking 4 mg or less of dexamethasone daily.
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My tumor has been tested for the IDH-1 mutation.

SURVIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Grade 3 & Grade 4 Toxicities
Overall Survival at Specified Time Points
Progression Free Survival Comparison
+1 more
Other outcome measures
Evaluate molecular predictors of response to SurVaxM
Objective Image Based Tumor Response Rate
Predictive Value of perfusion-weighted imaging - pseudo-progression

SURVIVE Trial Design

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

Find a Location

Who is running the clinical trial?

MeritUNKNOWN
MimiVax, LLCLead Sponsor
Imaging EndpointsUNKNOWN
2 Previous Clinical Trials
38 Total Patients Enrolled

Media Library

SurVaxM (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05163080 — Phase 2
Glioblastoma Research Study Groups: Arm A, Arm B
Glioblastoma Clinical Trial 2023: SurVaxM Highlights & Side Effects. Trial Name: NCT05163080 — Phase 2
SurVaxM (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163080 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this experiment at its maximum capacity?

"MimiVax, LLC is responsible for the oversight of this trial which requires 265 eligible patients to proceed. Participants can be found in locations such as Dana Farber Cancer Institute (Boston), and University of California (San Francisco)."

Answered by AI

Are there still possibilities to join this research initiative?

"Affirmative. Clinicaltrials.gov has information that this clinical experiment is currently recruiting participants, with the initial posting dating back to November 18th 2021 and most recent modification on August 23rd 2022. A total of 265 patients are sought for enrolment across 11 locations."

Answered by AI

Where are the sites offering this clinical trial?

"The trial is being conducted in 11 locations, such as the Dana Farber Cancer Institute of Boston and Miami Cancer Institute of Miami. Additionally, there are 8 other sites across the United States that are taking part in this study."

Answered by AI

To what degree is Arm A regarded as secure for individuals?

"The safety of Arm A is rated a 2, as it has been through Phase 2 trials which have demonstrated some assurance of safety but not efficacy."

Answered by AI
Recent research and studies
~30 spots leftby Aug 2024