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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07733466

Enrollment

Registered

2026-07-29

Start date

2026-08-15

Completion date

2031-06-01

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Betel-nut-associated Oral Carcinoma

Keywords

cetuximab, pembrolizumab, immunotherapy, betel-nut

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.

Detailed description

Neoajuvant treatment with IV pembrolizumab or pembrolizumab 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-treatment 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

DRUGPembrolizumab 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

neoadjuvant

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 edition * treatment-naive * ECOG 0-3

Exclusion criteria

* Distant metastatic disease * prior treatment for current cancer * active immune disease or other condition requiring immunosuppression 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

Design outcomes

Primary

Measure	Time frame	Description
1.Overall Response Rate to neoadjuvant immunotherapy in patients with treatment naive Stage IIII-IV betal-nut-associated oral cavity carcinoma	Baseline through 84 weeks	Assess ORR by CT scan using RECIST 1.1 in patients with treatment naive, advanced Stage III-IV Betel-Nut Associated oral cavity squamous cell carcinoma

Secondary

Measure	Time frame	Description
1. To evaluate median and 3-year disease-free survival (DFS) following treatment initiation	Baseline to 36 months	CT scan results meaured by RECIST 1.1

Countries

Northern Mariana Islands

Contacts

CONTACTPeter Brett, MD

peter.brett@chcc.health(670) 234-8950

CONTACTAngela Figueroa, BSN, RN

angela.figueroa@chcc.health(670) 234-8951

STUDY_DIRECTORPeter Brett, MD

CHCC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026