Phase 1 Head and Neck Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have given written consent to participate
- People aged 18 or older
- People who have head and neck squamous cell cancer (a type of mouth, throat, or related cancer) confirmed by biopsy, shown on imaging as a returning cancer, or being surgically removed as a suspected case
- People whose blood, liver, and organ function are healthy enough to safely undergo surgery and anesthesia, as confirmed by tests done within 30 days of the study infusion
- People who are well enough to carry out daily activities, as measured by standard medical performance scales (confirm with trial site)
Who may not be able to join:
- People who are not already planning to have standard surgical removal of their cancer as part of their care
- People who have, or have had, an autoimmune disease or immune system deficiency — including conditions such as HIV, lupus, rheumatoid arthritis, multiple sclerosis, myasthenia gravis, inflammatory bowel disease, Sjögren syndrome, Guillain-Barré syndrome, and several others — though some exceptions may apply, including:
- People with autoimmune-related underactive thyroid who are already on thyroid hormone replacement
- People with well-managed Type 1 diabetes who use insulin
- People with certain skin conditions only (such as eczema, psoriasis, or vitiligo), provided the rash covers less than 10% of the body, is well controlled with only mild topical creams, and has not required stronger treatments in the past 12 months
- People with a history of hepatitis C that has not been fully treated with the aim of curing it
- People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, a type of lung inflammation called organizing pneumonia, medication-caused lung inflammation, or unexplained lung inflammation — or people who show signs of active lung inflammation on a chest scan while on active treatment
- People who have had a significant heart or blood vessel problem — such as a heart attack, stroke, or a moderate-to-severe heart condition — within the 3 months before starting the study, or who have an unstable heart rhythm or unstable chest pain
- People with a severe unresolved infection within 4 weeks before starting the study
- People who have previously received a bone marrow (stem cell) or organ transplant from another person
- People who have had a severe allergic reaction to certain types of laboratory-made antibody treatments in the past
- People who are currently taking ongoing, high-dose immune-suppressing medications — such as steroids above a low daily threshold, cyclophosphamide, methotrexate, or similar drugs — though several exceptions may apply, including people who use inhaled or topical steroids, short courses of steroids for specific reasons, or low-dose steroids for hormone deficiency conditions (confirm with trial site for specific details)
- People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 2 months after the last dose of the study drug
- People whose heart's electrical activity (measured by a specific interval on a heart tracing) is above a certain level at the start of the study (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Eben Rosenthal, MD, Vanderbilt University/Ingram Cancer Center
Phone: (615)421-4370
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Determine the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.