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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. 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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05012098
The ClinicalTrials.gov registry entry for NCT05012098 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ibuprofen is the first listed.
NCT05012098 reports 0 study locations.
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.
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