A Phase 2 interventional study of Ferumoxytol and Laboratory Biomarker Analysis in Glioblastoma, sponsored by OHSU Knight Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by OHSU Knight Cancer Institute · Phase 2, Interventional, and Treatment
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Among 1,302 studies in Glioblastoma with a site in United States — 195 open to participants now, 326 under way, 16 of them phase 3. Glioblastoma · United States.
Among the 1,302 studies in Glioblastoma with a site in United States, this one is the 377th largest by enrollment of the 1,155 interventional ones that give a count, is one of 56 that started in 2017, is one of 396 in phase 2, and was the 818th registered.
2,135 studies on the registry are indexed under Glioblastoma; 467 are open to participants now.
Browse Glioblastoma studies →195 of the 1,302 studies in Glioblastoma with a site in United States are open now. Recruiting first, the newest first:
Macarena De La Fuente, MD · Sites in United States
Ages 18+
Alpheus Medical, Inc. · Sites in United States
Ages 18–80
Beijing Inno Medicine Co., Ltd. · Sites in United States, China
Ages 18–70
City of Hope Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
Inova Health Care Services · Sites in United States
Ages 18–98
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,302 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 671 · Phase 2 592 · Phase 3 55 · Phase 4 4
First in 1979; this study’s year is marked. 56 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is above the median of 36 across 1,756 interventional studies indexed under Glioblastoma.
Median enrollment 33 across the 1,155 interventional studies, 60 across the 79 observational. Of the 881 that completed or were terminated, 344 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
321 of 1,302 have an industry lead sponsor. The 10 most frequent:
OHSU Knight Cancer Institute is the lead sponsor of 243 studies on the registry; 44 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
OHSU Knight Cancer Institute has 4 studies filed under Glioblastoma — fewer than ten, so there is no comparison to draw.
105 of the studies in Glioblastoma with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05271240Phase 3Northwell HealthRepeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM | 2027-04-01 |
| NCT03743662Memorial Sloan Kettering Cancer CenterNivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma | 2026-11 |
| NCT04574856University of Michigan Rogel Cancer CenterMultiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma | 2026-11-19 |
| NCT02704858Neonc Technologies, Inc.Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma | 2026-11-30 |
| NCT05781321Mayo ClinicShort Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study | 2026-11-30 |
Add all 105 to your calendar (.ics) → With an account.
Among the 1,302 studies in Glioblastoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This pilot phase II trial studies how well ferumoxytol magnetic resonance imaging (MRI) works in assessing response to pembrolizumab in patients with glioblastoma. Diagnostic procedures, such as ferumoxytol MRI, may help measure a patient's response to pembrolizumab treatment.
PRIMARY OBJECTIVE:
I. Determine the sensitivity and specificity of relative cerebral blood volume (rCBV) measured by steady state MRI with ferumoxytol in identifying true versus (vs) pseudoprogression in patients with newly diagnosed glioblastoma multiforme (GBM) receiving pembrolizumab with standard of care chemo-radiation.
SECONDARY OBJECTIVES:
I. Determine the safety and toxicity of pembrolizumab when used in combination with standard of care chemo radiation.
II. Determine the progression free survival (PFS), overall survival (OS), clinical response and duration of best response.
EXPLORATORY OBJECTIVES:
I. Compare the immune response as determined by the volume, pattern and intensity of delayed (24 hour [hr]) ferumoxytol uptake between subjects who develop true vs pseudoprogression.
II. Investigate the serum immunological parameters (serum biomarker) and correlate clinical as well as radiological response with systemic immune response to pembrolizumab as measured by immunological panel.
III. Compare the changes in PDL-1 expression in the biopsy tissue before and after therapy at the time of progression and correlate PD-L1 expression with response rates and survival.
IV. Investigate the feasibility of measuring vascular volume fraction (VVF), vessel size index (VSI) and vessel density index (VDI) as surrogate for response (true vs pseudoprogression, as determined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 and immune related response criteria [irRC]).
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, and then every 6 months thereafter.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have a confirmed diagnosis of:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Drug: Ferumoxytol · Other: Laboratory Biomarker Analysis · Procedure: Magnetic Resonance Imaging · Biological: Pembrolizumab
Given IV
Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite
Correlative studies
Undergo ferumoxytol MRI
Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Specificity of Identifying Pseudoprogression
Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Time frame: At suspected progression, up to two years.
Sensitivity of Identifying True Progression
The calculation of sensitivity is based on steady state rCBV (relative cerebral blood volume) at suspected progression. Cutoff point 1.75. Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Time frame: At suspected progression, up to two years.
Progression Free Survival
Will be assessed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame: Until off study, up to 5 years.
Overall Survival
Will be assessed using the Kaplan-Meier product limit estimates.
Time frame: Until off study, up to 5 years.
Duration of Best Response
Will be analyzed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame: Until off study, up to 5 years.
Disease Response
Disease response was assessed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame: Until off study, up to 5 years.
Determine the Safety and Toxicity of Pembrolizumab When Used in Combination With Standard of Care Chemo Radiation.
Number of participants with adverse events possibly related or related to pembrolizumab in combination with standard of care. Will be analyzed using proportions and exact 95% confidence intervals.
Time frame: 30 days after last dose of pembrolizumab, up to 2 years.
| Milestone | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Started | 52 |
| Completed | 43 |
| Not completed | 9 |
Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
| percentage | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Specificity of Identifying Pseudoprogression | 58.3 (27.9 to 84.8) |
The calculation of sensitivity is based on steady state rCBV (relative cerebral blood volume) at suspected progression. Cutoff point 1.75. Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
| percentage | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Sensitivity of Identifying True Progression | 46.7 (21.3 to 73.4) |
Will be assessed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
| Months | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Progression Free Survival | 10.4 (7.1 to 11.7) |
Will be assessed using the Kaplan-Meier product limit estimates.
| Months | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Overall Survival | 15.2 (12.5 to 17.1) |
Will be analyzed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
| Months | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Duration of Best Response | 6.4 (4.1 to 8.5) |
Disease response was assessed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
| Participants | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Complete response | 8 |
| Partial response | 18 |
| Stable disease | 9 |
| Disease progression | 8 |
Number of participants with adverse events possibly related or related to pembrolizumab in combination with standard of care. Will be analyzed using proportions and exact 95% confidence intervals.
| participants | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Grade 3 or above possibly related to pembrolizumab | 27 |
| Grade 3 or above related to pembrolizumab | 2 |
Collected over All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (Ferumoxytol MRI, Pembrolizumab) | 45/52 (86.5%) | 15/52 (28.8%) | 51/52 (98.1%) |
| Event | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| SepsisInfections and infestations | 3/52 |
| SeizuresNervous system disorders | 3/52 |
| EncephalopathyNervous system disorders | 2/52 |
| Edema cerebralNervous system disorders | 2/52 |
| LeukocytosisBlood and lymphatic system disorders | 2/52 |
| ConfusionPsychiatric disorders | 2/52 |
| AphasiaNervous system disorders | 2/52 |
| Myocardial infarctionCardiac disorders | 1/52 |
| Flu like symptomsGeneral disorders | 1/52 |
| Acute kidney injuryRenal and urinary disorders | 1/52 |
| Event | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Lymphocyte count decreasedBlood and lymphatic system disorders | 41/52 |
| FatigueGeneral disorders | 38/52 |
| Platelet count decreasedBlood and lymphatic system disorders | 31/52 |
| NauseaGastrointestinal disorders | 30/52 |
| ConstipationGastrointestinal disorders | 28/52 |
| HeadacheNervous system disorders | 26/52 |
| Alanine aminotransferase increasedGastrointestinal disorders | 25/52 |
| AnemiaBlood and lymphatic system disorders | 24/52 |
| LDH increasedMetabolism and nutrition disorders | 21/52 |
| HyperglycemiaMetabolism and nutrition disorders | 20/52 |
| Age, Categorical(Participants) | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 37 |
| >=65 years | 15 |
| Sex: Female, Male(Participants) | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Female | 19 |
| Male | 33 |
| Ethnicity (NIH/OMB)(Participants) | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 51 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 51 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Diagnostic (Ferumoxytol MRI, Pembrolizumab) |
|---|---|
| United States | 52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Dec 2023, 72 months.
Results were first posted in Sep 2025, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferrosoferric Oxide
OHSU Knight Cancer Institute →