Glioblastoma, IDH-WildtypePhase 2NCT07708961
Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma
A Phase 2 study testing Archive Sample Retrieval, Biospecimen Collection and Chest Radiography in people with Glioblastoma, IDH-Wildtype, run by Mayo Clinic at 3 sites in United States.
Trial summary
This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, IDH-Wildtype
- What is being tested?
- Archive Sample Retrieval, Biospecimen Collection and Chest Radiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Aug 2026to 31 Aug 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Histopathologic diagnosis of glioblastoma, IDH-wildtype [as defined by the 2021 World Health Organization (WHO) classification of central nervous system (CNS) tumors] on primary pathology review
- NOTE: MGMT promoter methylation status must have been performed
- Glioblastomas must have a pathogenic EGFR mutation, with or without EGFR amplification, detected by Clinical Laboratory Improvement Act (CLIA)-certified next-generation sequencing
- EGFR mutation includes both deoxyribonucleic acid (DNA) sequence variants (e.g. point mutations, etc.) and transcript variants (e.g. EGFRvIII, etc.)
- EXCEPTIONS: Glioblastomas which are EGFR wildtype with amplification are excluded. Glioblastomas which only have EGFR variants of unknown significance (without any pathogenic EGFR mutations) are also excluded
Show all 22Show fewer
- Patients must have completed standard radiation (60 Gy in 30 fractions) with concurrent temozolomide (missing no more than 2 weeks of temozolomide), and adequately recovered from treatment related toxicities
- NOTE: Adjuvant temozolomide must not have been initiated
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Hemoglobin > 9.0 g/dL (obtained =< 14 days prior to registration)
- Leukocytes > 3.0 x 10^9/L (obtained =< 14 days prior to registration)
- Absolute neutrophil count (ANC) > 1.5 x 10^9/L (obtained =< 14 days prior to registration)
- Platelet count > 100 x 10^9/L (obtained =< 14 days prior to registration)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (< 3 x ULN for patients with Gilbert's disease) (obtained =< 14 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to registration)
- Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =< 14 days prior to registration)
- Calculated creatinine clearance >= 45 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
- Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Must be willing to take light-protective measures during the study and for two weeks after last dose of WSD0922-FU
- Willingness to provide mandatory tissue specimens for correlative research
Who cannot join
- Patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field
- EXCEPTION: Patients deemed to have pseudoprogression are eligible; however, this should be controlled on =< 4 mg of dexamethasone and should not require bevacizumab at study onset
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
Show all 43Show fewer
- Any of the following prior therapies:
- Surgery for glioblastoma =< 3 weeks prior to registration
- Radiation therapy =< 2 weeks prior to registration
- Systemic therapies intended for the management of the glioblastoma, including but not limited to:
- Targeted therapies
- EGFR inhibitors
- Alkylating chemotherapy
- Adjuvant temozolomide (note that temozolomide administered concurrent with radiation is NOT an exclusion criterion)
- Immunotherapy
- Biologics
- Any other systemic therapies [Food and Drug Administration (FDA) approved, off-label, investigational]
- Bevacizumab
- Non-enzyme-inducing anticonvulsants < 2 weeks prior to registration
- Strong inducers and strong inhibitors of CYP3A < 14 days prior to registration
- Failure to adequately recover from any adverse events or complications related to any of the following therapies received prior to registration:
- Craniotomy and resection of tumor
- Stereotactic biopsy of tumor
- Other major surgical procedure
- Radiation therapy < 2 weeks prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Examples include (but are not limited to) refractory nausea and vomiting (if not controlled by supportive therapy), inability to swallow the formulated product, previous significant bowel resection, other chronic gastrointestinal diseases, etc
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Severe skin lesions such as skin/pressure ulcers, chronic leg ulcers or non-healing wounds.
- Active history of keratitis
- Symptomatic CNS complications that require urgent neurosurgical or medical (e.g. mannitol) intervention
- Known intracranial hemorrhage which is unrelated to tumor
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
- Or psychiatric illness/social situations that would limit compliance with study requirements
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy within the last 3 years that would interfere with treatment on this protocol
- EXCEPTIONS: non-melanoma skin cancer, carcinoma in situ of the cervix, patients on hormonal therapy for treated breast or prostate cancer
- History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Center Clinical Trials contact
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Cancer Center Clinical Trials, 507-293-6386
Wendy J. Sherman, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Cancer Center Clinical Trials, 507-293-6386
Sani H. Kizilbash, MD, MPH
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Cancer Center Clinical Trials, 507-293-6386
Shannon P Fortin Ensign, MD, PhD
About this study
Official title: Randomized Phase II Trial to Evaluate the Efficacy of WSD0922-FU When Combined With Adjuvant Temozolomide in Patients With EGFR Mutant Glioblastoma
This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. WSD0922-FU is a targeted treatment which blocks EGFR. It is able to get into the brain and spinal cord and help treat those types of tumors. Adding WSD0922-FU to the usual treatment with temozolomide may be more effective in slowing disease progression, compared to temozolomide alone, in patients with EGFR-mutant, IDH-wildtype glioblastoma.
- Conditions
- Glioblastoma, IDH-Wildtype
- Being tested
- Archive Sample Retrieval, Biospecimen Collection, Chest Radiography, Echocardiography Test, EGFR/EGFRvIII Inhibitor WSD0922-FU
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Archive Sample RetrievalProcedure or surgery
Archived tumor specimens will be retrieved if available from original surgery for glioblastoma.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood, cerebrospinal fluid (CSF), and/or tumor tissue samples
Chest RadiographyProcedure or surgery
Also called Chest X-ray
Undergo chest x-ray
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
EGFR/EGFRvIII Inhibitor WSD0922-FUDrug
Also called BBB Penetrable EGFR/EGFRvIII Inhibitor WSD0922-FU, EGFR Mutant Inhibitor WSD0922-FU, WSD 0922-FU, WSD-0922-FU
Given PO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo brain MRI
TemozolomideDrug
Also called CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (temozolomide, WSD0922-FU) | Experimental | Patients receive temozolomide PO QD on days 1-5 of cycles 1-6 and WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment continue receiving WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or cerebrospinal fluid (CSF) samples throughout the trial. Receives: Procedure: Archive Sample Retrieval; Procedure: Biospecimen Collection; Procedure: Chest Radiography; Procedure: Echocardiography Test; Drug: EGFR/EGFRvIII Inhibitor WSD0922-FU; Procedure: Magnetic Resonance Imaging; Drug: Temozolomide |
| Arm B (temozolomide) | Active comparator | Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment may initiate WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or CSF samples throughout the trial. Receives: Procedure: Archive Sample Retrieval; Procedure: Biospecimen Collection; Procedure: Chest Radiography; Procedure: Echocardiography Test; Drug: EGFR/EGFRvIII Inhibitor WSD0922-FU; Procedure: Magnetic Resonance Imaging; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Defined as the time from randomization to the time of documented disease progression or death.
PFS will be evaluated for each arm, where patients will be evaluated based on the treatment arm to which they were randomized and will include only those who are eligible and have received any protocol therapy to be considered evaluable. PFS distributions will be graphically and quantitatively compared using Kaplan-Meier methods. These methods will be used to estimate the median PFS as well as 1-year estimates for PFS by treatment arm along with corresponding 95% confidence intervals. Cox proportional hazards models will also be used to assess influential factors on PFS both in the univariate and the multivariable settings.
Measured: Up to 5 years
Secondary outcomes (3)
Incidence of adverse events (safety and tolerability)
Safety and tolerability will be evaluated by treatment regimen. Adverse events (AEs) will be summarized per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 , and where toxicities will be defined as adverse events that are deemed to be at least possibly treatment-related (i.e., attribution of "possibly", "probably", or "definite"). The maximum grade for each type of treatment-related AE will be recorded for each patient, and the frequency of each will be summarized by treatment arm. Frequency tables and graphical evaluations of AEs and treatment-related AEs will be summarized and evaluated to assess if there are any patterns or differences in the rates or types of AEs.
Measured: Up to 30 days after last dose
Overall survival
Defined as the time from randomization to the time of death. Kaplan Meier methods will be used to estimate key aspects of the overall survival distributions for each of the treatment arms, and log rank tests will be used to compare these distributions between arms. If patients randomized to the control arm choose to receive WSD0922-FU upon documented recurrence/progressive disease, then will also utilize more complex approaches to evaluate overall survival that accommodates different time periods of receiving treatment.
Measured: Up to 5 years
Overall response rate (ORR)
The objective response classifications and best responses observed for patients will be summarized by treatment arm. These will be classified based on review as the proportion of patients who achieve any response to treatment (ORR, including minor, partial, or complete response) as well as those who achieve a partial or complete response to therapy divided by the total number of patients randomized and treated on that arm. Assuming that the number of patients who respond to therapy on each arm is binomially distributed, will estimate these proportions along with corresponding 95% confidence intervals.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start28 Aug 2026
- Primary completion31 Aug 2036 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, IDH-WildtypeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sani H. Kizilbash, MD, MPH, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708961
- Sponsor's protocol ID
- MC250711
- Other IDs
- 26-000481
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial to Evaluate the Efficacy of WSD0922-FU When Combined With Adjuvant Temozolomide in Patients With EGFR Mutant Glioblastoma
- ClinicalTrials.gov ID
- NCT07708961
- Acronym / sponsor ID
- MC250711
- Conditions
- Glioblastoma, IDH-Wildtype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 31 Aug 2036 (estimated)
- Study completion
- 31 Aug 2036 (estimated)
- First posted
- 16 Jul 2026 (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.
This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. WSD0922-FU is a targeted treatment which blocks EGFR. It is able to get into the brain and spinal cord and help treat those types of tumors. Adding WSD0922-FU to the usual treatment with temozolomide may be more effective in slowing disease progression, compared to temozolomide alone, in patients with EGFR-mutant, IDH-wildtype glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (temozolomide, WSD0922-FU) | Experimental | Procedure: Archive Sample Retrieval, Procedure: Biospecimen Collection, Procedure: Chest Radiography, Procedure: Echocardiography Test, Drug: EGFR/EGFRvIII Inhibitor WSD0922-FU, Procedure: Magnetic Resonance Imaging, Drug: TemozolomidePatients receive temozolomide PO QD on days 1-5 of cycles 1-6 and WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment continue receiving WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or cerebrospinal fluid (CSF) samples throughout the trial. |
| Arm B (temozolomide) | Active comparator | Procedure: Archive Sample Retrieval, Procedure: Biospecimen Collection, Procedure: Chest Radiography, Procedure: Echocardiography Test, Drug: EGFR/EGFRvIII Inhibitor WSD0922-FU, Procedure: Magnetic Resonance Imaging, Drug: TemozolomidePatients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment may initiate WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or CSF samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age >= 18 years
- Histopathologic diagnosis of glioblastoma, IDH-wildtype [as defined by the 2021 World Health Organization (WHO) classification of central nervous system (CNS) tumors] on primary pathology review
- Glioblastomas must have a pathogenic EGFR mutation, with or without EGFR amplification, detected by Clinical Laboratory Improvement Act (CLIA)-certified next-generation sequencing
- Patients must have completed standard radiation (60 Gy in 30 fractions) with concurrent temozolomide (missing no more than 2 weeks of temozolomide), and adequately recovered from treatment related toxicities
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Key exclusion criteria (43 listed)
- Patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:
- Any of the following prior therapies:
- Failure to adequately recover from any adverse events or complications related to any of the following therapies received prior to registration:
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Examples include (but are not limited to) refractory nausea and vomiting (if not controlled by supportive therapy), inability to swallow the formulated product, previous significant bowel resection, other chronic gastrointestinal diseases, etc
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 |
|---|---|---|
| Archive Sample RetrievalArchived tumor specimens will be retrieved if available from original surgery for glioblastoma. | Procedure or surgery | Arm A (temozolomide, WSD0922-FU), Arm B (temozolomide) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood, cerebrospinal fluid (CSF), and/or tumor tissue samples | Procedure or surgery | Arm A (temozolomide, WSD0922-FU), Arm B (temozolomide) |
| Chest RadiographyAlso: Chest X-rayUndergo chest x-ray | Procedure or surgery | Arm A (temozolomide, WSD0922-FU), Arm B (temozolomide) |
| Echocardiography TestAlso: EC, EchocardiographyUndergo ECHO | Procedure or surgery | Arm A (temozolomide, WSD0922-FU), Arm B (temozolomide) |
| EGFR/EGFRvIII Inhibitor WSD0922-FUAlso: BBB Penetrable EGFR/EGFRvIII Inhibitor WSD0922-FU, EGFR Mutant Inhibitor WSD0922-FU, WSD 0922-FU, WSD-0922-FUGiven PO | Drug | Arm A (temozolomide, WSD0922-FU), Arm B (temozolomide) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo brain MRI | Procedure or surgery | Arm A (temozolomide, WSD0922-FU), Arm B (temozolomide) |
| TemozolomideAlso: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831Given PO | Drug | Arm A (temozolomide, WSD0922-FU), Arm B (temozolomide) |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 5 years
Defined as the time from randomization to the time of documented disease progression or death. PFS will be evaluated for each arm, where patients will be evaluated based on the treatment arm to which they were randomized and will include only those who are eligible and have received any protocol therapy to be considered evaluable. PFS distributions will be graphically and quantitatively compared using Kaplan-Meier methods. These methods will be used to estimate the median PFS as well as 1-year estimates for PFS by treatment arm along with corresponding 95% confidence intervals. Cox proportional hazards models will also be used to assess influential factors on PFS both in the univariate and the multivariable settings.
3 secondary outcomes
Incidence of adverse events (safety and tolerability)
Time frame: Up to 30 days after last dose
Overall survival
Time frame: Up to 5 years
Overall response rate (ORR)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Cancer Center Clinical Trials contact
Sani H. Kizilbash, MD, MPH principal investigator
Mayo Clinic in Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Archive Sample Retrieval, Biospecimen Collection and Chest Radiography in people with Glioblastoma, IDH-Wildtype, run by Mayo Clinic at 3 sites in United States.
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 22 inclusion and 43 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
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 26 Oct 2026.