SurVaxM + Temozolomide for Glioblastoma

(SURVIVE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding SurVaxM, a type of vaccine, to the standard glioblastoma treatment can extend patient survival compared to using only the chemotherapy drug temozolomide. Glioblastoma is an aggressive brain cancer. The study aims to determine if SurVaxM can enhance the immune system's ability to combat the cancer. Individuals recently diagnosed with glioblastoma, who have completed initial radiation therapy and show no disease progression, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SurVaxM, when combined with the chemotherapy drug temozolomide, is generally safe and well-tolerated. In earlier studies, patients with glioblastoma (a type of brain cancer) who received this combination did not experience any serious side effects directly caused by SurVaxM. SurVaxM has also demonstrated a good safety record in both past and ongoing studies. Most patients experienced only mild to moderate side effects, if any. These findings suggest that adding SurVaxM to standard treatment is unlikely to cause severe problems for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glioblastoma?

SurVaxM is unique because it targets survivin, a protein that helps cancer cells avoid death, making it an innovative approach for treating glioblastoma. Unlike traditional therapies that primarily involve surgery, radiation, and chemotherapy like temozolomide, SurVaxM is a peptide vaccine designed to stimulate the immune system specifically against tumor cells. Researchers are excited about its potential to enhance the body's natural defenses and improve outcomes by working in conjunction with existing treatments, potentially leading to better survival rates for patients with this aggressive brain cancer.

What evidence suggests that this trial's treatments could be effective for glioblastoma?

Research has shown that SurVaxM, when combined with standard chemotherapy, may help treat glioblastoma. In this trial, participants in Arm A will receive SurVaxM with the chemotherapy drug temozolomide. One study found that 95.2% of patients who received SurVaxM and temozolomide did not experience cancer progression six months after diagnosis. Another study suggested that patients treated with SurVaxM might live longer after one year compared to those receiving only standard treatments. SurVaxM enhances the immune system's ability to fight cancer cells. Early results are promising, indicating that this combination might extend the lives of patients with glioblastoma. ^{4 6 7 8 9}

Who Is on the Research Team?

Manmeet S Ahluwalia, MD, MBA

Principal Investigator

Study Principal Investigator

Michael Ciesielski, PhD

Principal Investigator

Chief Executive Officer

Robert Fenstermaker, MD

Principal Investigator

Chief Medical Officer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. roswellpark.org roswellpark.org/newsroom/202505-roswell-park-announces-positive-progress-clinical-trial-novel-immunotherapy-survaxm

Roswell Park Announces Positive Progress in Clinical ... “SurVaxM continues to show promise as a treatment option for patients with glioblastoma when paired with standard-of-care chemotherapy and ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00996

Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide ... Of the 63 patients who were evaluable for outcome, 60 (95.2%) remained progression-free 6 months after diagnosis (prespecified primary end point) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41066027/?utm_source=SimplePie&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1bAXfGTh08tVk-e1kpwuqxoVfiUn_5olMN9ewCML2bdAMGPEOD&fc=20220524054416&ff=20251009134725&v=2.18.0.post9+e462414

Intratumoral B cell and interferon signatures in ... - PubMed In a single arm phase IIa trial (NCT02455557), treatment of newly diagnosed GBM patients with the peptide vaccine SurVaxM resulted in promising ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05163080

NCT05163080 | SurVaxM Plus Adjuvant Temozolomide for ... This study is designed to compare the length of survival in patients with newly diagnosed glioblastoma who receive temozolomide plus SurVaxM to that of patients ...

5. onclive.com onclive.com/view/dr-ahluwalia-on-the-survive-trial-of-survaxm-plus-chemoradiation-in-newly-diagnosed-glioblastoma

Dr Ahluwalia on the SURVIVE Trial of SurVaxM Plus ... The study is designed to detect a 1-year OS of 75% in the SurVaxM arm compared with 60% in the control arm, he explains. With an anticipated ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36521103/

Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for ... Conclusion: SurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM ...

7. physicianresources.roswellpark.org physicianresources.roswellpark.org/news/roswell-park-announces-positive-progress-in-clinical-trial-of-novel-immunotherapy-survaxm

Roswell Park Announces Positive Progress in Clinical ... “SurVaxM's excellent safety profile and tolerability to date also help optimize quality of life for patients with this highly aggressive cancer, ...

8. mimivax.com mimivax.com/survaxm/

SurVaxM SurVaxM demonstrated safety and tolerability in a Phase I study in patients with recurrent or progressive malignant glioma as well as a Phase II study of newly ...

9. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/survaxm-promise-glioblastoma-survive-trial

SurVaxM Shows Continued Promise in Glioblastoma as ... SurVaxM's excellent safety profile and tolerability to date also help optimize quality of life for patients with this highly aggressive cancer, ...