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NCT05012098 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT05012098: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT05012098 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05012098, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
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
Primary Outcome
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 n
Interventions
- DRUG Ibuprofen
- DIAGNOSTIC_TEST PET scan
- DIAGNOSTIC_TEST CT scan
- DRUG Bintrafusp alfa/M7824
- PROCEDURE Tumor tissue biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2024-07-09 |
| Phase | Phase 2 |
What the finished NCT05012098 record still lists
NCT05012098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Ibuprofen is the first listed.
NCT05012098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05012098 about?
NCT05012098 is a clinical study titled "Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).". 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...
What is the current status of trial NCT05012098?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2022-06-21. Estimated completion is 2024-07-09.
What interventions are being tested in trial NCT05012098?
The interventions under investigation include: Ibuprofen (DRUG), PET scan (DIAGNOSTIC_TEST), CT scan (DIAGNOSTIC_TEST), Bintrafusp alfa/M7824 (DRUG), Tumor tissue biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT05012098?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05012098's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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