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NBTXR3 With or Without Cetuximab in locally advanced head & neck squamous cell carcinoma

The purpose of this study is to find out if an investigational medication (NBTXR3) could help elderly patients with locally advanced head & neck squamous cell carcinoma who are otherwise ineligible to receive platinum-based chemotherapy. This study will help to determine the recommended dose/s of NBTXR3. The study medication is injected directly into the tumor and is activated by radiation therapy in combination with anti-PD1 therapy.

Age & Gender

  • 65 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

This study aims to treat your cancer and closely resembles routine care that you would receive regardless of participating in a research study. To participate in the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study involves research blood draws in addition to routine blood work, a diagnostic imaging scan (ex: MRI/PET/CT Scan), a single injection of NBTXR3 into the tumor, and 3-5 sessions of radiation therapy every other day followed up with the standard of care (either Pembrolizumab or Nivolumab).

Incentives

In-person visits:
16
Total length of participation:
About 2 years

Looking for Specific Volunteers

Able to participate:

  • You have locally advanced head & neck or metastic squamous cell carcinoma
  • Are at least 65 years old on the day of signing the informed consent*

Not eligible if:

  • You have a known history of HIV, Chronically ongoing active hepatitis B, or chronically ongoing active hepatitis C
  • You are pregnant

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Colette Shen
Radiation Oncology - Chapel Hill

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck, Liver, Lung, Sarcoma (bone and soft tissue), Phase 1 Trials (all cancers))

IRB Number

18-0943

ClinicalTrials.gov

NCT03589339

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