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Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

ConditionsHnsccHead and NeckSquamous Cell CancerSquamous CarcinomaSquamous Cell Cancer of Head and Neck (SCCHN)Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)Squamous Cell Carcinoma MouthSquamous Carcinoma Poorly DifferentiatedSquamous Cell Cancer of the Head and NeckSquamous Cell Carcinoma (SCC) of the Oral CavitySquamous Cell Carcinoma (SCC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

The goal of this Phase 1 clinical trial is to evaluate the safety and feasibility of nivolumab-IRDye800CW (nivo800) as a molecular imaging agent in adults with biopsy-confirmed or presumed head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo standard-of-care surgical resection.

The main questions it aims to answer are:

* Is nivolumab-IRDye800CW (nivo800) safe when administered before surgery, as measured by the occurrence of clinically significant Grade ≥2 adverse events that are possibly, probably, or definitely related to the study drug? * What is the extent of pathological response at each dose level, including residual viable tumor, fibrosis, necrosis, and tumor-infiltrating lymphocyte characteristics?

Participants will:

* Receive two intravenous infusions during the preoperative period, approximately 2-3 weeks before surgery and again 1-2 days before surgery. * Undergo standard-of-care surgical resection with collection of tumor and lymph node specimens for pathological and imaging studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Age ≥ 18 years

Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.

Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).

Disqualifiers

Patients not planning for SOC surgical resection

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.

Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

Rash must cover < 10% of body surface area

Trial design

Design model

Sequential

Treatments tested in this trial

  • Nivo800

    Drug

    Participants will receive nivo800 prior to their standard of care surgery.

  • Nivolumab

    Drug

    Participants in Cohort 4 will receive nivolumab and nivo800 prior to their standard of care surgery.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Cohort 1 - Nivo800 (10 mg)Experimental treatment 1 intervention
Group B: Cohort 2 - Nivo800 (25 mg)Experimental treatment 1 intervention
Group C: Cohort 3 - Nivo800 (50 mg)Experimental treatment 1 intervention
Group D: Cohort 4 - Nivo800 (50 mg) and Nivolumab (190 mg)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Determine the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent.

As defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered possibly, probably, or definitely related to nivo800. Safety data will be summarized by grade, severity, and type.

Time frame
Within 15 days of drug administration

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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