MedElevator
Войти в исследования Cancer immunology, immunotherapy : CII · 2026
Bintrafusp alfa for patients with recurrent or metastatic olfactory neuroblastoma.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
London Nyall R, Bracken-Clarke Dara, Xue Elisabetta, Brownell Isaac, Mydlarz Wojciech K, Turkbey Evrim B, Cordes Lisa M, Marté Jennifer L, Rooper Lisa M, Shah Shrey B, Manu Michell, Sargi Zoukaa B, Gulley James L, Floudas Charalampos S
Аннотация
BACKGROUND: There 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).
METHODS: Patients 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).
RESULTS: Between 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 68Ga-DOTATATE imaging. In Cohort 2, 1 patient had SD; median PFS was 3 months, and median OS was 6.8 months. Grade 3/4 treatment-related adverse events occurred in 3 patients (immune-mediated diabetes, esophageal hemorrhage, anemia, epistaxis).
CONCLUSIONS: Although 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.
METHODS: Patients 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).
RESULTS: Between 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 68Ga-DOTATATE imaging. In Cohort 2, 1 patient had SD; median PFS was 3 months, and median OS was 6.8 months. Grade 3/4 treatment-related adverse events occurred in 3 patients (immune-mediated diabetes, esophageal hemorrhage, anemia, epistaxis).
CONCLUSIONS: Although 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.