GlioblastomaEAPNCT04802447
SurVaxM Expanded Access Protocol
A study testing SurVaxM in people with Glioblastoma, run by Roswell Park Cancer Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- SurVaxM
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient has newly diagnosed or recurrent or progressive glioblastoma who falls under one or more exclusion criteria of another SurVaxM clinical study currently recruiting, or has completed participation in another non-randomized clinical trial of SurVaxM for glioblastoma and is off study but wishes to receive SurVaxM as part of his/her treatment
- 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
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- 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.
Who cannot join
- Patient meets all inclusion criteria for another SurVaxM clinical study that is open and recruiting.
- 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.
- Patient has serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
- History of tuberculosis, granulomatous disease or systemic autoimmune disorder.
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- Patient is pregnant or breast-feeding.
- Concurrent participation in any clinical therapeutic studies involving investigational drug(s) (Phases 1-4).
- Patient has concurrent or prior malignancy except curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 2 years may be eligible for treatment under this protocol.
- Patient who is receiving any other concurrent chemotherapeutic agents or investigational drugs.
- Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness.
- Patient is unwilling or unable to follow protocol requirements.
- Any condition which in the Investigator's opinion makes the candidate unsuitable to receive the study drug or protocol procedures.
About this study
Official title: Expanded Access to SurVaxM for Treatment of Patients With Glioblastoma Who Have No Access to Other Comparable or Alternative Therapy or Have Completed Treatment on a Non-Randomized Clinical Trial of SurVaxM and May Benefit From Further Treatment
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
- Being tested
- SurVaxM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurVaxMDrug
Also called SVN53-67/M57-KLH
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Abad, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802447
- Sponsor's protocol ID
- I 546319
- Acronym
- EAP
- Status last verified
- Sep 2025
- First submitted
- 8 Mar 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to SurVaxM for Treatment of Patients With Glioblastoma Who Have No Access to Other Comparable or Alternative Therapy or Have Completed Treatment on a Non-Randomized Clinical Trial of SurVaxM and May Benefit From Further Treatment
- ClinicalTrials.gov ID
- NCT04802447
- Acronym / sponsor ID
- EAP / I 546319
- Conditions
- Glioblastoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient has newly diagnosed or recurrent or progressive glioblastoma who falls under one or more exclusion criteria of another SurVaxM clinical study currently recruiting, or has completed participation in another non-randomized clinical trial of SurVaxM for glioblastoma and is off study but wishes to receive SurVaxM as part of his/her treatment
- 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
Key exclusion criteria (13 listed)
- Patient meets all inclusion criteria for another SurVaxM clinical study that is open and recruiting.
- 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.
- Patient has serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurVaxMAlso: SVN53-67/M57-KLHEach 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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Abad, MD principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing SurVaxM in people with Glioblastoma, run by Roswell Park Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.