Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
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|ClinicalTrials.gov Identifier: NCT05012098|
Recruitment Status : Not yet recruiting
First Posted : August 19, 2021
Last Update Posted : December 8, 2021
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.
To learn if giving immunotherapy drug bintrafusp alfa can help ONB shrink or disappear.
People aged 18 years and older diagnosed with recurrent or metastatic ONB that has not responded to standard treatment.
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
|Condition or disease||Intervention/treatment||Phase|
|Olfactory Neuroblastoma Esthesioneuroblastoma Neoplasm of the Nasal Cavity||Drug: Bintrafusp alfa / M7824||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).|
|Estimated Study Start Date :||December 13, 2021|
|Estimated Primary Completion Date :||August 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: 1/Arm 1
Treatment with Bintrafusp alfa
Drug: Bintrafusp alfa / M7824
Participants will be treated with bintrafusp alfa 1200 mg every 2 weeks for 26 doses.
- objective response rate (ORR) [ Time Frame: 1 year ]The fraction of evaluable participants who experience a response will be reported along with a 95% two-sided confidence interval.
- safety and tolerability of M7824 [ Time Frame: study end ]The fraction of participants who experience a toxicity, by grade and type of toxicity; Overall safety will be assessed by descriptive analyses using frequencies of AEs by grade.
- Overall Survival (OS) [ Time Frame: study end ]The time from the date of first treatment to the date of death (any cause).
- Duration of Response (DOR) [ Time Frame: study end ]The time measurement for CR or PR (whichever is first recorded) until the first documented date of PD or death.
- Progression Free Survival (PFS) [ Time Frame: study end ]The time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05012098
|Contact: Sheri A McMahon, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Charalampos Floudas, M.D.||National Cancer Institute (NCI)|