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Testing the Addition of Anti-Cancer Drug, Cetuximab to Standard of Care Treatment

To assess whether the combination of cetuximab and pembrolizumab (Arm 2) compared to pembrolizumab alone (Arm 1)

Age & Gender

18 years ~ 99 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will receive labs, meet with a provider for clinical assessment, see a member of the study team to fill out questionnaires and provide updates on any symptoms or changes. The study also involves imaging at indicated time points and willingness to return to the site as instructed.

In-person visits:
18

Total length of participation:
36 months

Looking for Specific Volunteers

Able to participate:

Confirmed Diagnosis of Head and Neck confirmed squamous cell carcinoma (HNSCC) of oral cavity, oropharynx, hypopharynx, and larynx.
Previously untreated for recurrent/metastatic disease incurable by local therapies.
Patients should not have received any prior treatment in the recurrent or metastatic setting.

Not eligible if:

Patient has received chronic systemic steroid therapy (in dosing exceeding 10
If patient have received any prior treatment in the recurrent or metastatic setting
If you are pregnant and nursing,

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Comprehensive Cancer Center
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Visit Study Website

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sid Sheth
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

24-3056

ClinicalTrials.gov

NCT06589804

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Questions?

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