SurVaxM + Temozolomide for Glioblastoma

(SURVIVE Trial)

Recruiting at 11 trial locations

Overseen By Danielle M Casucci, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MimiVax, LLC

Must be taking: Temozolomide

Must not be taking: Immunotherapy, Bevacizumab

Disqualifiers: Recurrent glioblastoma, Gliosarcoma, Multicentric glioblastoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

247 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

What makes the SurVaxM + Temozolomide treatment unique for glioblastoma?

SurVaxM is a novel treatment that, when combined with Temozolomide, offers a new approach for glioblastoma by potentially enhancing the immune response against the tumor, which is different from traditional chemotherapy that directly targets cancer cells. ^{1 5 10 11 12}

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

I was enrolled in the study within 4 months after my surgery.

Clinical laboratory values within specified ranges

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

Exclusion Criteria

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

I cannot have MRI scans or use gadolinium contrast.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SurVaxM plus temozolomide or placebo plus temozolomide, with injections repeated at regular intervals

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• SurVaxM

Trial Overview 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.

Participant Groups

Group I: Arm A Active Control 1 Intervention

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

Group II: Arm B Placebo Group 1 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

Who Is Running the Clinical Trial?

MimiVax, LLC

Lead Sponsor

Trials

1

Recruited

250+

Merit

Collaborator

Trials

1

Recruited

250+

Imaging Endpoints

Collaborator

Trials

3

Recruited

290+

Translational Drug Development

Collaborator

Trials

19

Recruited

1,000+

Findings from Research

Dexamethasone (DXM) significantly reduces the apoptosis (cell death) induced by the chemotherapy drug temozolomide (TMZ) in human glioblastoma U87MG cells, suggesting that DXM may interfere with the effectiveness of TMZ treatment.

The study found that DXM pretreatment decreased the Bax:Bcl-2 ratio and the production of spectrin breakdown products associated with apoptosis, indicating that using DXM before TMZ could lead to less effective cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone protected human glioblastoma U87MG cells from temozolomide induced apoptosis by maintaining Bax:Bcl-2 ratio and preventing proteolytic activities. Das, A., Banik, NL., Patel, SJ., et al.[2022]

Adding nitrosourea-based chemotherapy to radiotherapy has been shown to increase progression-free survival in patients with grade II and III gliomas, although it does not improve overall survival.

Upcoming phase III trials will investigate whether adding temozolomide to radiotherapy can enhance overall survival in grade II/III gliomas, while also assessing cognitive function and quality of life for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide and radiation in low-grade and anaplastic gliomas: temoradiation. Schiff, D.[2018]

In a study of 87 newly diagnosed glioblastoma patients, only 5% experienced severe myelotoxicity during treatment with temozolomide (TMZ) and radiation therapy, indicating that while the risk exists, it is relatively low.

Factors such as female sex, low pretreatment platelet counts, and specific genetic markers were identified as potential predictors of severe myelotoxicity, suggesting that personalized treatment approaches could help mitigate risks in vulnerable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Genetic Factors Associated With Severe Hematological Toxicity in Glioblastoma Patients During Radiation Plus Temozolomide Treatment: A Prospective Study. Lombardi, G., Rumiato, E., Bertorelle, R., et al.[2018]

Temozolomide, a new chemotherapy drug, was tested on 16 patients with recurrent glioblastoma multiforme, showing a median overall survival of 6.5 months and a 1-year survival rate of 16%.

The survival outcomes with temozolomide were comparable to other studies, indicating its potential effectiveness, and suggesting the need for further randomized trials to explore its use in initial treatment and combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide in second-line treatment after prior nitrosurea-based chemotherapy in glioblastoma multiforme: experience from a Portuguese institution. Teixeira, MM., Garcia, I., Portela, I., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Dexamethasone protected human glioblastoma U87MG cells from temozolomide induced apoptosis by maintaining Bax:Bcl-2 ratio and preventing proteolytic activities. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Temozolomide and radiation in low-grade and anaplastic gliomas: temoradiation. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Short-term radiotherapy followed by adjuvant chemotherapy in poor-prognosis patients with glioblastoma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Temozolomide Plus Bevacizumab in Elderly Patients with Newly Diagnosed Glioblastoma and Poor Performance Status: An ANOCEF Phase II Trial (ATAG). [2019]

5. Cyprus pubmed.ncbi.nlm.nih.gov

Benefit and outcome of using temozolomide-based chemoradiotherapy followed by temozolomide alone for glioblastoma in clinical practice. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Hematological adverse events in the management of glioblastoma. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Drug-induced hypersensitivity syndrome following temozolimide for glioblastoma multiforme and the role of desensitization therapy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical and Genetic Factors Associated With Severe Hematological Toxicity in Glioblastoma Patients During Radiation Plus Temozolomide Treatment: A Prospective Study. [2018]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Toxicity profile of temozolomide in the treatment of 300 malignant glioma patients in Korea. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Phase II study of temozolomide without radiotherapy in newly diagnosed glioblastoma multiforme in an elderly populations. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Temozolomide in second-line treatment after prior nitrosurea-based chemotherapy in glioblastoma multiforme: experience from a Portuguese institution. [2018]

12. England pubmed.ncbi.nlm.nih.gov

RNOP-09: pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma--a phase II study. [2021]