Evidence map›Paper›PMID 42307670›Full record

Trial reportCancer immunology, immunotherapy : CII2026

Bintrafusp alfa for patients with recurrent or metastatic olfactory neuroblastoma.

Nyall R London, Dara Bracken-Clarke, Elisabetta Xue, Isaac Brownell, Wojciech K Mydlarz, Evrim B Turkbey, Lisa M Cordes, Jennifer L Marté, Lisa M Rooper, Shrey B Shah and 4 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05012098 (Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05012098 phase2completednot on this map

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

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2022 to 2024Enrolled11ConditionsOlfactory Neuroblastoma, Esthesioneuroblastoma, Neoplasm of the Nasal CavityArmsBintrafusp alfa/M7824, Ibuprofen, PET scan, CT scan, Tumor tissue biopsy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Nyall R LondonSinonasal and Skull Base Tumor Section, Surgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Dara Bracken-ClarkeCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Elisabetta XueCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Isaac BrownellCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Wojciech K MydlarzDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Evrim B TurkbeyRadiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Lisa M CordesCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Jennifer L MartéCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Lisa M RooperDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Shrey B ShahDepartment of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA.
Michell ManuClinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Zoukaa B SargiDepartment of Otolaryngology-Head and Neck Surgery, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA.
James L GulleyCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Charalampos S FloudasCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. charalampos.floudas@nih.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is no established treatment for patients with recurrent/metastatic (R/M) olfactory neuroblastoma (ONB), a rare sinonasal tumor. We conducted the first immunotherapy clinical trial (NCT05012098) in patients with R/M ONB, to evaluate the activity of the bifunctional TGF-β "trap"/anti-PD-L1 fusion protein bintrafusp alfa (BA).

methodsPatients received BA (1200 mg, intravenously) every 2 weeks. Primary endpoint was overall response rate (ORR); secondary objectives included safety, progression-free survival (PFS), and overall survival (OS).

resultsBetween June 2022 and June 2023, 11 patients received treatment (Cohort 1, no prior immunotherapy, n=9; Cohort 2, prior immunotherapy received, n=2); enrollment was stopped due to BA development discontinuation. No objective responses were observed. In Cohort 1, 4 patients (of 8 evaluable, 50%) had stable disease (SD), three confirmed and long lasting; median PFS was 3.7 months, median OS was not reached; and one of SD patients had a complete metabolic response on

conclusionsAlthough the primary endpoint was not met, BA showed a manageable safety profile and a subset of patients derived clinical benefit with prolonged stable disease, including one patient with a complete metabolic response. This first clinical trial of systemic therapy in R/M ONB serves as proof of clinical trials feasibility in this setting and supports further investigation of combinatorial immunotherapy strategies in this patient population. Trial registration ClinicalTrials.gov Identifier: NCT05012098, https://clinicaltrials.gov/ct2/show/NCT05012098 . Registered 18 August 2021.

Indexed as

Esthesioneuroblastoma, OlfactoryNasal CavityNeoplasm Recurrence, LocalNose NeoplasmsRecombinant Fusion ProteinsAdultAgedFemaleHumansMaleMiddle AgedRecombinant Fusion Proteins68Ga-DOTATATE PET/CTImmune checkpoint blockadeOlfactory neuroblastomaRare tumorsTGF-beta inhibitionTrismus

Identifiers

PMID42307670
PMCPMC13522318

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.