Trial · NCT05012098
Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
NCT05012098, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2025-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON). Trials, record NCT05012098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05012098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
- NCT number
- NCT05012098
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Olfactory Neuroblastoma, Esthesioneuroblastoma, Neoplasm of the Nasal Cavity
- Interventions
- Bintrafusp alfa/M7824, Ibuprofen, PET scan, CT scan, Tumor tissue biopsy, Brain MRI, Dotate scan, PET FDG scan, Nuclear bone scan, EKG
- First posted
- 2021-08-19
- Last updated
- 2025-08-08
- Results first posted
- 2025-08-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Cycle 1 (28 days) | 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. |
| Secondary | 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 | up to 2 years | 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. |
| Secondary | Overall Survival (OS) | Through study completion, an average of 2 years | OS is defined as the time from the date of first treatment to the date of death (any cause) using the Kaplan-Meier method. |
| Secondary | Duration of Response (DOR) | Through treatment completion, an average of 1 year | 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. |
| Secondary | Progression Free Survival (PFS) | Through treatment completion, an average of 1 year | 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. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 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. | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Cycle 1 (28 days) | Only the immune checkpoint-naïve participants will be included in the primary endpoint analysis as pre-specified by the protocol. 8/9 participants were analyzed because one participant was non-evaluable for response | Percentage of participants | NUMBER |
| SECONDARY | 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 | up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | Through study completion, an average of 2 years | Months | MEDIAN | |
| SECONDARY | Duration of Response (DOR) | Through treatment completion, an average of 1 year | No participants experienced Complete or Partial Response therefore Duration of Response could not be assessed. | ||
| SECONDARY | Progression Free Survival (PFS) | Through treatment completion, an average of 1 year | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group320
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint | Complete Response | 0 | 95% Confidence Interval 0 to 0 | Percentage of participants |
| Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint | Partial Response | 0 | 95% Confidence Interval 0 to 0 | Percentage of participants |
| Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint | Stable Disease | 37.5 | 95% Confidence Interval 8.5 to 75.5 | Percentage of participants |
| Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint | Progressive Disease | 62.5 | 95% Confidence Interval 24.5 to 91.5 | Percentage of participants |
| 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 | Participants in Cohort 1/Arm 1 With Grade 1 Toxicity | Serious: Metabolism and nutrition disorders: Immune-mediated diabetes | 0 | Participants | |
| 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 | Participants in Cohort 1/Arm 1 With Grade 2 Toxicity | Serious: Metabolism and nutrition disorders: Immune-mediated diabetes | 0 | Participants | |
| 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 | Participants in Cohort 1/Arm 1 With Grade 3 Toxicity | Serious: Metabolism and nutrition disorders: Immune-mediated diabetes | 1 | Participants | |
| 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 | Participants in Cohort 1/Arm 1 With Grade 4 Toxicity | Serious: Metabolism and nutrition disorders: Immune-mediated diabetes | 1 | Participants | |
| 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 | Participants in Cohort 1/Arm 1 With Grade 5 Toxicity | Serious: Metabolism and nutrition disorders: Immune-mediated diabetes | 0 | Participants | |
| 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 | Participants in Cohort 2/Arm 1 With Grade 1 Toxicity | Serious: Metabolism and nutrition disorders: Immune-mediated diabetes | 0 | Participants |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa -Immune Checkpoint | 9 | |
| Overall Study | STARTED | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) | 2 | |
| Overall Study | Completed Study | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa -Immune Checkpoint | 1 | |
| Overall Study | Completed Study | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) | 0 | |
| Overall Study | Lost to Further Follow-up | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa -Immune Checkpoint | 1 | |
| Overall Study | Lost to Further Follow-up | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) | 0 | |
| Overall Study | COMPLETED | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa -Immune Checkpoint | 1 | |
| Overall Study | COMPLETED | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa -Immune Checkpoint | 8 | |
| Overall Study | NOT COMPLETED | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint Blockade Resistant (ICB-R) | 2 |
Source ClinicalTrials.gov
Adverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute kidney injury | Renal and urinary disorders | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 1 | 9 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 1 | 2 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 1 | 9 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 0 | 2 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 1 | 9 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 0 | 2 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 5 | 9 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 2 | 2 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 0 | 9 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 1 | 2 | 1 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 1 | 9 |
| Total, all-cause mortality | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 1 | 2 |
| Total, other adverse events | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 9 | 9 |
| Total, other adverse events | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 2 | 2 |
| Total, serious adverse events | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | 3 | 9 |
| Total, serious adverse events | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 2 | 2 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort 1/Arm 1: Treatment With Bintrafusp Alfa - Immune Checkpoint vs 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) | Trial comparisons |
| Cohort 1/Arm 1: Treatment With Bintrafusp Alfa vs Cohort 2/Arm 1: Treatment With Bintrafusp Alfa: deaths from any cause | Trial comparisons |
| Cohort 1/Arm 1: Treatment With Bintrafusp Alfa vs Cohort 2/Arm 1: Treatment With Bintrafusp Alfa: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05012098
GET https://conductscience.org/api/trials/v1/NCT05012098/results?page=2