Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).

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

Conditions

• Olfactory Neuroblastoma
• Esthesioneuroblastoma
• Neoplasm of the Nasal Cavity

Interventions

DRUG

Bintrafusp alfa/M7824

Participants will be treated with bintrafusp alfa 1200 mg every 2 weeks for 26 doses.

DRUG

Ibuprofen

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.

DIAGNOSTIC_TEST

PET scan

Screening

DIAGNOSTIC_TEST

CT scan

Screening

PROCEDURE

Tumor tissue biopsy

Baseline, and subsequent weeks as stipulated in the study calendar.

DIAGNOSTIC_TEST

Brain MRI

Baseline

DIAGNOSTIC_TEST

Dotate scan

Baseline

DIAGNOSTIC_TEST

PET FDG scan

Baseline

DIAGNOSTIC_TEST

Nuclear bone scan

Baseline

DIAGNOSTIC_TEST

EKG

Baseline

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Charalampos Floudas, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-21

Primary Completion

2024-07-09

Completion

2024-07-09

FDA Drug

Yes

Countries

• United States

Study Locations