Study Details

Open

Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

Adverse event (AE) data collection and reporting, which are a required art of every clinical trial, are done so investigators and regulatory agencies can detect and analyze adverse events and risk situations to ensure the safety of the patients enrolled, as well as those who will enroll in future studies using similar agents.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)

Location

North Carolina (Statewide)

What will be asked of you

If you decide to take part in this study, you will either get the study drug pembrolizumab or the combination of cetuximab and pembrolizumab. Treatment will continue for 2 years (or 18 cycles) and will be stopped if your disease gets worse during the treatment or if you experience any severe side effects. After you finish your study treatment, your doctor will continue to follow your condition for 5 years and watch you for signs of your disease returning and side effects. You will have a clinical visit with your doctor 1 month after you stop study treatment. Then, you will have a clinical visit with your doctor every 3 months until 5 years from the start of your study treatment.

In-person visits:
6 visits, follow-up visits depending upon progression

Total length of participation:
Up to 5 years

Looking for Specific Volunteers

Able to participate:

Thyroid Cancer
Patient must have an ECOG Performance Status 0-2
Patient must have been previously treated with or deemed ineligible for treatment with Iodine-131 for DTC, and must be receiving thyroxine suppression therapy.
Patient must have measurable disease
Lab tests adequate per protocol

Not eligible if:

Have had major surgery within 8 weeks of enrolling
Have had prior treatment with cabozantinib or any prior BRAF targeted therapy for thyroid cancer.
Pregnant of breast feeding
Have evidence of chronic hepatitis B virus (HBV) infection

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Contact Name
cancerclinicaltrials@med.unc.edu

Primary Visit Location

NC Memorial Hospital
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 (Thyroid and Other Gland/Endocrine)

IRB Number

24-2532

ClinicalTrials.gov

NCT06475989