Open-Label Neoadjuvant Pembrolizumab Plus Cetuximab in Betel Nut-Associated Locally Advanced Oral Cavity Squamous Cell Carcinoma

Официальное название

Neoadjuvant Pembrolizumab Plus Cetuximab in Betel Nut-Associated Locally Advanced Oral Cavity Squamous Cell Carcinoma in the Commonwealth of the Northern Mariana Islands: A Prospective, Open Label, Single Arm, Single Center, Non-randomized, Phase 2 Trial

Обзор

The goal of this clinical trial is to learn the overall response rate of giving immunothrapy before surgery in treatment-naive, advanced stage patients with Betal-nut-associated oral cavity cancer. The outcomes to be measured by CT scan are overall response rate of either partial or complete response.

Подробное описание

Neoajuvant treatment with IV pembrolizumab or pembroliumab and berahyaluronidase alfa-pmph SQ will be given every 6 weeks in 2, 6 week cycles, with IV cetuximab to be given every 2 weeks in 2, 6 week cycles. Disease will be measured by CT scan pre-teatment and at 6 and12 weeks. Following neoadjuvant treatment, patients will attend the University of Southern California 2 to 6 weeks later for SOC chemotherapy and radiation therapy if deemed necessary.

Вмешательства

• Препарат Pembrolizumab and cetuximab
  neoadjuvant immunotherapy using: 400 mg IV pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph 760 mg SQ given 2 times with cetuximab 500 mg/m2 IV every 2 weeks over a 12 week period.

Первичные конечные точки

• 1.Overall Response Rate to neoadjuvant immunotherapy in patients with treatment naive Stage IIII-IV betal-nut-associated oral cavity carcinoma [Срок оценки: Baseline through 84 weeks]

Вторичные конечные точки (1)

• 1. To evaluate median and 3-year disease-free survival (DFS) following treatment initiation [Срок оценки: Baseline to 36 months]

Критерии участия

Критерии включения

• Documented history of betel-nut chewing
• confirmed oral cavity squamous cell carcinoma
• measurable disease via RECIST 1.1
• Clinical stage III/IV per AJCC 8th edication
• treatment-naive
• ECOG 0-3

Критерии исключения

• Distant metastatic disease
• prior treatment for current cancer
• active immune diease or other condition requiring immunoupression or chronic corticosteroid use
• active pneumonitis
• known hypersensitivity to pembrolizumab or cetuximab
• pregnant or breast-feeding
• women of childbearing potential without willingness to use contraception during the trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Northern Mariana Islands · 1 центр

• Northern Marianas Oncology Center | Commonwealth Healthcare Corporation — Saipan

Публикации

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• Yang J, Wang ZY, Huang L, Yu TL, Wan SQ, Song J, Zhang BL, Hu M. Do betel quid and areca nut chewing deteriorate prognosis of oral cancer? A systematic review, meta-analysis, and research agenda. Oral Dis. 2021 Sep;27(6):1366-1375. doi: 10.1111/odi.13456. Epub 2020 Jun 26. PMID 32492239
• Narayanan AM, Finegersh A, Chang MP, Ogo J, Orosco RK, Moss WJ. The profound oral cavity cancer burden in the United States Commonwealth of the Northern Mariana Islands: A global health opportunity. Am J Otolaryngol. 2019 Nov-Dec;40(6):102267. doi: 10.1016/j.amjoto.2019.07.011. Epub 2019 Jul 19. PMID 31351740
• Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metas PMID 31679945
• Rumgay H, Nethan ST, Shah R, Vignat J, Ayo-Yusuf O, Chaturvedi P, Guerra ENS, Gupta PC, Gupta R, Liu S, Magnusson C, Parascandola M, Paulino YC, Rezaei N, Siddiqi K, Warnakulasuriya S, Lauby-Secretan B, Soerjomataram I. Global burden of oral cancer in 2022 attributable to smokeless tobacco and areca nut consumption: a population attributable fraction analysis. Lancet Oncol. 2024 Nov;25(11):1413-14 PMID 39393386
• Sacco AG, Chen R, Worden FP, Wong DJL, Adkins D, Swiecicki P, Chai-Ho W, Oppelt P, Ghosh D, Bykowski J, Molinolo A, Pittman E, Estrada MV, Gold K, Daniels G, Lippman SM, Natsuhara A, Messer K, Cohen EEW. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial. Lancet Oncol. 202 PMID 33989559
• Yao Z, Wang J, Jiang Y, Zhang Y, Liu J, Dai L, Shen S, Zhou X, Liu Q, Zheng L, Qian M, Li J. Pembrolizumab plus cetuximab with neoadjuvant chemotherapy for head and neck squamous cell carcinoma. Head Neck. 2025 Jan;47(1):289-299. doi: 10.1002/hed.27915. Epub 2024 Aug 13. PMID 39138647

Идентификаторы

NCT: NCT07733466 · NB600390

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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