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NCT07733466

Overview

NCT ID: NCT07733466
Lead Sponsor: Peter Brett, MDOTHER
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
Brief Summary: 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.
Conditions: Betel-nut-associated Oral Carcinoma
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Central Contacts: Peter Brett, MDContact
peter.brett@chcc.health(670) 234-8950