A Phase 2 interventional study of Bintrafusp alfa/M7824 and Ibuprofen in Olfactory Neuroblastoma, Esthesioneuroblastoma and Neoplasm of the Nasal Cavity, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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Among 14 studies in Esthesioneuroblastoma, Olfactory by National Cancer Institute (NCI) — 3 open to participants now, 3 under way, none of them phase 3. Esthesioneuroblastoma, Olfactory · National Cancer Institute (NCI).
Among the 14 studies in Esthesioneuroblastoma, Olfactory by National Cancer Institute (NCI), this one is the 10th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2022, is one of 4 in phase 2, and was the 12th registered.
75 studies on the registry are indexed under Esthesioneuroblastoma, Olfactory; 11 are open to participants now.
Browse Esthesioneuroblastoma, Olfactory studies →3 of the 14 studies in Esthesioneuroblastoma, Olfactory by National Cancer Institute (NCI) are open now, in 1 country. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 3–120
By country, each count listing its studies:
Of the 11 Esthesioneuroblastoma, Olfactory studies recruiting now, 5 (45%) set no upper age limit and 1 (9%) stops at 75 or younger; 3 take children under 18; 1 takes 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.
14 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 8 · Phase 2 5
First in 1995; this study’s year is marked. 2 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 11 is below the median of 34 across 48 interventional studies indexed under Esthesioneuroblastoma, Olfactory.
Median enrollment 40 across the 11 interventional studies, 525 across the 1 observational. Of the 11 that completed or were terminated, 2 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Esthesioneuroblastoma, Olfactory by National Cancer Institute (NCI), from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Background:
Olfactory neuroblastoma (ONB) is a rare cancer of the nasal cavity. At diagnosis, it is usually locally advanced. It tends to spread to the neck. Sometimes it spreads to the lungs and bones. Researchers want to find a better way to treat it.
Objective:
To learn if giving immunotherapy drug bintrafusp alfa can help ONB shrink or disappear.
Eligibility:
People aged 18 years and older diagnosed with recurrent or metastatic ONB that has not responded to standard treatment.
Design:
Participants will be screened with a medical history, blood and urine tests, and physical exam. Their ability to perform their normal activities will be assessed. They will have an electrocardiogram to evaluate their heart. They will have imaging scans and/or a nuclear bone scan, as needed. For some scans, they may receive a contrast dye.
Some screening tests will be repeated during the study.
Participants will receive bintrafusp alfa once every 2 weeks for 26 doses. They will get it intravenously over 60 minutes. They may get other medicines to prevent side effects. They will complete health questionnaires. Visits will last 4-6 hours.
Participants may have optional tumor biopsies.
Participants will have an end of treatment visit within 7 days after they stop taking the study drug. About 28 days after treatment ends, they will have a safety visit. They will have follow-up visits every 3 months for the first year, then every 6 months for years 2-5, and then once a year after that for the rest of their life. If their disease progresses, they may be eligible for re-treatment with the study drug
Background:
Olfactory neuroblastoma (ONB, also known as esthesioneuroblastoma), is a rare malignant neoplasm of the nasal cavity. At diagnosis, ONB is often locally advanced. It tends to invade locally and has high rates of regional spread to the neck, and distally to the lungs and bones. The 10-year survival rate for ONB is reported at 46%.
Standard of care treatment is surgical resection followed by adjuvant radiation. In advanced unresectable or metastatic cases, systemic chemotherapy is used off label, with agent selection based on published case series. Genomic profiling of ONB has not yet informed the utilization of an appropriate molecularly targeted treatment.
High programmed death-ligand 1 (PD-L1) expression by immunohistochemistry was shown in ONB tumor samples, providing a rationale for immune checkpoint blockade in ONB. In addition, high expression of transforming growth factor beta (TGF-beta) ligands has been identified in ONB, implying that additional benefit may be achieved by combination of checkpoint blockade with TGF-beta inhibition.
Bintrafusp alfa is a novel bifunctional fusion protein composed of a blocking monoclonal antibody against PD-L1 fused with the soluble extracellular domain of the human TGF-beta receptor II (TGF-betaRII), acting as a decoy target for TGF-beta. The safety profile of bintrafusp alfa in clinical trials to date has been shown to be manageable.
Objective:
To assess the objective response rate (ORR) to bintrafusp alfa in participants with recurrent/metastatic ONB, immune checkpoint-naive (CN)
Eligibility:
Participants must have histologically confirmed recurrent or metastatic ONB, not amenable to potentially curative local therapies.
Participants should have received at least one line of systemic therapy including a platinum agent, with evidence of disease progression clinically or radiographically.
Presence of >= 1 lesion measurable by Response Evaluation Criteria in Solid Tumors, (RECIST) 1.1 criteria
Age >= 18 years, men and women
Adequate organ function, and without serious comorbidity (e.g., autoimmune disease), that would preclude concurrent systemic treatment.
Design:
Single-institution, single-arm Phase II trial to determine overall response rate (ORR) in participants with recurrent/metastatic ONB treated with bintrafusp alfa.
Participants will be treated with bintrafusp alfa 1200 mg every 2 weeks for 26 doses.
The trial will initially enroll 12 checkpoint-naive (CN) participants; if responses are observed in one or more participants, the second stage will enroll another 9 CN participants to define the response rate to bintrafusp alfa, for a total of 21 CN participants.
An additional cohort of checkpoint-resistant (CR) participants will be enrolled and evaluated separately. Initially 5 CR participants will be enrolled; if responses are observed in one or more participants, the second stage will enroll another 3 participants, for a total of up to 8 CR participants. Accrual for CR participants will end when the preset number of CN participants has been accrued.
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.
Participants must have adequate organ and marrow function as defined below:
The effects of immunotherapy on the developing human fetus are unknown. Therefore, participants must use effective methods of (such as implants, injectables, combined oral contraceptives, intrauterine device (IUDs), sexual abstinence or vasectomized partner).
Must co-enroll in the following two studies. A separate inform consent will be obtained from participant for these studies.
EXCLUSION CRITERIA:
Active or prior documented or inflammatory diseases that might deteriorate on immunostimulatory agent (including colitis or Crohn's disease, systemic lupus erythematosus, sarcoidosis, vasculitis, Grave's disease, hypophysitis, uveitis, rheumatoid arthritis etc.), except the following:
Current use of medication within 14 days before the first dose of the study medication, except the following:
Uncontrolled intercurrent chronic or acute illness including, but not limited to the following, that may limit interpretation of results or increase risk to the participant in the judgment of the investigator:
Impaired cardiovascular function or clinically significant cardiovascular disease, including, but not limited to, any of the following:
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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).
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 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.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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 US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
Treatment with Bintrafusp alfa
Drug: Bintrafusp alfa/M7824 · Drug: Ibuprofen · Diagnostic Test: PET scan · Diagnostic Test: CT scan · Procedure: Tumor tissue biopsy · Diagnostic Test: Brain MRI · Diagnostic Test: Dotate scan · Diagnostic Test: PET FDG scan · Diagnostic Test: Nuclear bone scan · Diagnostic Test: EKG
Drug page: Bintrafusp alfa
Participants will be treated with bintrafusp alfa 1200 mg every 2 weeks for 26 doses.
Also known as: M7824
400 mg or comparable non-steroidal anti-inflammatory drugs (NSAIDs) dose up to 2 hours before and 8 hours after the start of each dose for prophylaxis of flu-like symptoms.
Also known as: Advil, Advil Migraine
Screening
Also known as: Positron emission tomography scan
Screening
Also known as: Computed tomography scan
Baseline, and subsequent weeks as stipulated in the study calendar.
Also known as: Tumor tissue bx
Baseline
Also known as: Brain magnetic resonance imaging
Baseline
Also known as: Ga-68 dotatate positron emission tomography/computed tomography scan
Baseline
Also known as: fludeoxyglucose-18 (FDG) positron emission tomography (PET) scan
Baseline
Baseline
Also known as: Electrocardiogram
Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR is defined as the percentage of evaluable participants who experience a response evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 reported along with a 95% two-sided confidence interval. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: Cycle 1 (28 days)
Number of Participants Who Experience a Toxicity Related to Bintrafusp Alfa (M7824), by Grades (1, 2, 3, 4 and/or 5) and Type of Toxicity
The number of participants who experience toxicity, by grade and type of toxicity related to Bintrafusp alfa (M7824) was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: up to 2 years
Overall Survival (OS)
OS is defined as the time from the date of first treatment to the date of death (any cause) using the Kaplan-Meier method.
Time frame: Through study completion, an average of 2 years
Duration of Response (DOR)
DOR is defined as the time measurement for complete response (CR) or partial response (PR) (whichever is first recorded) until the first documented date of progressive disease (PD) or death. ORR was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using the Kaplan-Meier method and reported along with a 95% two-sided confidence interval. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions.
Time frame: Through treatment completion, an average of 1 year
Progression Free Survival (PFS)
PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first, using the Kaplan-Meier method and reported along with a 95% confidence interval. Disease progression was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of the diameters of target lesions.
Time frame: Through treatment completion, an average of 1 year
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Adverse Events were monitored/assessed from first drug administration through 30 days after the last dose of study drug is administered, an average of 6 months.
| Milestone | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa -Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) |
|---|---|---|
| Started | 9 | 2 |
| Completed study | 1 | 0 |
| Lost to further follow-up | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 8 | 2 |
| Withdrew: Disease progression | 5 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Discontinuation per protocol | 1 | 0 |
ORR is defined as the percentage of evaluable participants who experience a response evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 reported along with a 95% two-sided confidence interval. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
| Percentage of participants | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint |
|---|---|
| Complete Response | 0 (0 to 0) |
| Partial Response | 0 (0 to 0) |
| Stable Disease | 37.5 (8.5 to 75.5) |
| Progressive Disease | 62.5 (24.5 to 91.5) |
The number of participants who experience toxicity, by grade and type of toxicity related to Bintrafusp alfa (M7824) was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Participants in Cohort 1/Arm 1 With Grade 1 Toxicity | Participants in Cohort 1/Arm 1 With Grade 2 Toxicity | Participants in Cohort 1/Arm 1 With Grade 3 Toxicity | Participants in Cohort 1/Arm 1 With Grade 4 Toxicity | Participants in Cohort 1/Arm 1 With Grade 5 Toxicity | Participants in Cohort 2/Arm 1 With Grade 1 Toxicity | Participants in Cohort 2/Arm 1 With Grade 2 Toxicity | Participants in Cohort 2/Arm 1 With Grade 3 Toxicity | Participants in Cohort 2/Arm 1 With Grade 4 Toxicity | Participants in Cohort 2/Arm 1 With Grade 5 Toxicity |
|---|---|---|---|---|---|---|---|---|---|---|
| Serious: Metabolism and nutrition disorders: Immune-mediated diabetes | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious: Esophageal hemorrhage | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Acute kidney injury | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Anemia | 1 | 3 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Non-serious: Arthralgia | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Aspartate aminotransferase increased | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Atrioventricular block first degree | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Bruising | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Cardiac troponin I increased | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Constipation | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Diarrhea | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Non-serious: Dry eye | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Electrocardiogram T wave abnormal | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Epistaxis | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Non-serious: Flu like symptoms | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Folliculitis | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Headache | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Hemorrhoidal hemorrhage | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Hyperhidrosis | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Hypothyroidism | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Insomnia | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Lipase increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Non-serious: Neoplasms benign, malignant and unspecified: Keratoacanthoma | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Non-serious: Oral dysesthesia | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Oral hemorrhage | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Non-serious: Pharyngeal mucositis | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Platelet count decreased | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Pneumonitis | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Pruritus | 1 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Non-serious: Rash maculo-papular | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-serious: Skin hypopigmentation: Vitiligo | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
OS is defined as the time from the date of first treatment to the date of death (any cause) using the Kaplan-Meier method.
| Months | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa-Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa- Immune Checkpoint Blockade Resistant (ICB-R) |
|---|---|---|
| Overall Survival (OS) | NA (7.9 to NA) | 2.1 (2.1 to NA) |
DOR is defined as the time measurement for complete response (CR) or partial response (PR) (whichever is first recorded) until the first documented date of progressive disease (PD) or death. ORR was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using the Kaplan-Meier method and reported along with a 95% two-sided confidence interval. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions.
No measurements were reported for this outcome.
PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first, using the Kaplan-Meier method and reported along with a 95% confidence interval. Disease progression was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of the diameters of target lesions.
| Months | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) |
|---|---|---|
| Progression Free Survival (PFS) | 9.3 (1.8 to NA) | 2.99 (0.9 to NA) |
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 9 | 2 |
Collected over All-Cause Mortality was monitored/assessed an average of 6 months. Adverse Events were monitored/assessed from first drug administration through 30 days after the last dose of study drug is administered, an average of 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 1/9 (11.1%) | 3/9 (33.3%) | 9/9 (100%) |
| Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 1/2 (50%) | 2/2 (100%) | 2/2 (100%) |
| Event | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa |
|---|---|---|
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/9 | 1/2 |
| SepsisInfections and infestations | 0/9 | 1/2 |
| Metabolism and nutrition disorders - Other, Immune-mediated diabetesMetabolism and nutrition disorders | 2/9 | 0/2 |
| Esophageal hemorrhageGastrointestinal disorders | 1/9 | 0/2 |
| Eye disorders - Other, Corneal perforationEye disorders | 1/9 | 0/2 |
| Event | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 5/9 | 2/2 |
| Acute kidney injuryRenal and urinary disorders | 1/9 | 1/2 |
| AnorexiaMetabolism and nutrition disorders | 0/9 | 1/2 |
| Back painMusculoskeletal and connective tissue disorders | 1/9 | 1/2 |
| DiarrheaGastrointestinal disorders | 1/9 | 1/2 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 4/9 | 1/2 |
| FatigueGeneral disorders | 1/9 | 1/2 |
| HypokalemiaMetabolism and nutrition disorders | 0/9 | 1/2 |
| HypomagnesemiaMetabolism and nutrition disorders | 0/9 | 1/2 |
| InsomniaPsychiatric disorders | 1/9 | 1/2 |
| Age, Categorical(Participants) | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa-Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa- Immune Checkpoint Blockade Resistant (ICB-R) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 2 | 9 |
| >=65 years | 2 | 0 | 2 |
| Age, Continuous(years) | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa-Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa- Immune Checkpoint Blockade Resistant (ICB-R) | Total |
|---|---|---|---|
| Mean | 59.11 ± 7.57 | 53 ± 2.83 | 58 ± 7.27 |
| Sex: Female, Male(Participants) | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa-Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa- Immune Checkpoint Blockade Resistant (ICB-R) | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 7 | 1 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa-Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa- Immune Checkpoint Blockade Resistant (ICB-R) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 6 | 2 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa-Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa- Immune Checkpoint Blockade Resistant (ICB-R) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 2 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa-Immune Checkpoint | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa- Immune Checkpoint Blockade Resistant (ICB-R) | Total |
|---|---|---|---|
| United States | 9 | 2 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
Access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Ran from Jun 2022 to primary completion in Jul 2024, 24 months.
Results were first posted in Aug 2025, 1 year after primary completion.
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Studies of the drug tested here: Bintrafusp alfa
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National Cancer Institute (NCI) →