NCT05012098View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

June 21, 2022

Primary Completion Date

July 9, 2024

Study Completion Date

July 9, 2024

Conditions
Olfactory NeuroblastomaEsthesioneuroblastomaNeoplasm 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

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH