SurVaxM Expanded Access Protocol

NCT04802447 | Unknown

• 1 other identifier: I 546319
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Data from clinical trials suggest that SurVaxM administered as a single agent, or in combination with standard glioblastoma chemotherapy treatment regimens to patients with recurrent or newly diagnosed glioblastoma, is generally well tolerated and may increase progression free survival and overall survival in some patients

Conditions

Glioblastoma

Interventions

SurVaxM DRUG

Each participant will receive 4 doses of SVN53-67/M57-KLH (SurVaxM) spaced two weeks apart. This phase of treatment is known as the prime-boost phase and will take 6 weeks to complete. After completion of the prime-boost phase of treatment, the participant will receive a dose ofSVN53-67/M57-KLH (SurVaxM) every 3 months for up to two years

Also known as: SVN53-67/M57-KLH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Karnofsky performance status ≥ 70 (refer to Appendix A).
• A pathologically confirmed diagnosis of glioblastoma of the brain or spinal cord is required, unless biopsy is determined by the PI not to be in the patient's best interest.
• Have the following clinical laboratory values obtained within 28 days prior to registration:
• Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
• Creatinine ≤ 1.8 mg/dL
• Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin or oral anticoagulants) must meet the following criteria:
• No active bleeding or pathological condition that carries a high risk of bleeding (e.g., coagulopathy)
• For participants of child-bearing potential: must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to enrollment and, have a negative pregnancy test prior to starting treatment under this protocol.
• Dose of corticosteroids reduced to the minimum required to control neurologic symptoms.
• Patients with newly diagnosed glioblastoma must have completed radiation therapy and temozolomide or "standard of care" treatment of their glioblastoma, unless it is determined by their treating physician that it is not in the best interest of the patient to do so.
• Participant must understand the investigational nature of this study drug and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving SurVaxM.
• Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
• Patient has previously participated in a clinical trial in which randomization to an arm with SurVaxM treatment was part of the trial design..
• Patients with newly diagnosed or recurrent glioblastoma who have not had standard of care treatment with fractionated radiation therapy and temozolomide, unless these treatments have been determined to be medically contraindicated or are not tolerate.
• Patient's brain tumor has not been biopsied, unless biopsy is determined by the PI not to be in the patient's best interest.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Ajay Abad, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 17, 2021
• Last Updated: September 16, 2025

Record last verified: 2025-09