Open-Label Neoadjuvant Pembrolizumab Plus Cetuximab in Betel Nut-Associated Locally Advanced Oral Cavity Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pembrolizumab and cetuximab.
- Who it may be relevant to
- Registry conditions: Betel-nut-associated Oral Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Northern Mariana Islands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug 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.
Primary outcome measures
- 1.Overall Response Rate to neoadjuvant immunotherapy in patients with treatment naive Stage IIII-IV betal-nut-associated oral cavity carcinoma [Time frame: Baseline through 84 weeks]
Secondary outcome measures (1)
- 1. To evaluate median and 3-year disease-free survival (DFS) following treatment initiation [Time frame: Baseline to 36 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Northern Mariana Islands · 1 center
- Northern Marianas Oncology Center | Commonwealth Healthcare Corporation — Saipan
Publications
- Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9. PMID 2702835
- 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
Identifiers
NCT: NCT07733466 · NB600390