MedTrace Logo

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

NCT07733466 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Peter Brett, MD

    lead OTHER

Principal Investigators

  • Peter Brett, MD · CHCC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2030-07-31
Completion
2031-06-30
FDA Drug
Yes

Countries

  • Northern Mariana Islands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733466 on ClinicalTrials.gov