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

Purpose

This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.

Conditions

  • Hnscc
  • Head and Neck
  • Squamous Cell Cancer
  • Squamous Carcinoma
  • Squamous Cell Cancer of Head and Neck (SCCHN)
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
  • Squamous Cell Carcinoma Mouth
  • Squamous Carcinoma Poorly Differentiated
  • Squamous Cell Cancer of the Head and Neck
  • Squamous Cell Carcinoma (SCC) of the Oral Cavity
  • Squamous Cell Carcinoma (SCC)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion). - Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2. - Negative hepatitis B surface antigen (HBsAg) test at screening

Exclusion Criteria

  • Patients not planning for SOC surgical resection - Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions: 1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. 2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. 3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met: 1. Rash must cover < 10% of body surface area 2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids 3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months - History of hepatitis C that has not been treated with curative intent. - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy. - History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. - Severe unresolved infection within 4 weeks prior to initiation of study treatment. - Prior allogeneic stem cell or solid organ transplantation. - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins - Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (>10 mg/day of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions: 1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study. 2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted. 3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if >30 days from first infusion. 4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate. 5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted. - Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration. - Participants presenting with a baseline QTcF interval > than 480 milliseconds.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nivo - 10 mg / Nivo800 - 10 mg 		All participants will receive 10mg of unlabeled nivolumab and nivo800.
  • Drug: Nivo800
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
    Other names:
    • nivolumab
  • Drug: Nivolumab
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Experimental
Nivo - 20 mg / Nivo800 - 20 mg 		Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
  • Drug: Nivo800
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
    Other names:
    • nivolumab
  • Drug: Nivolumab
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Experimental
Nivo - 40 mg / Nivo800 - 40 mg 		Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
  • Drug: Nivo800
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
    Other names:
    • nivolumab
  • Drug: Nivolumab
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Experimental
Nivo - 240 mg / Nivo800 - 100 mg and Nivo - 140 mg 		Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
  • Drug: Nivo800
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
    Other names:
    • nivolumab
  • Drug: Nivolumab
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Nicole Jones
615-936-2807
nicole.l.jones@vumc.org

More Details

Status
Recruiting
Sponsor
Vanderbilt-Ingram Cancer Center

Study Contact

Makenna Brown
(615)421-4370
makenna.l.brown@vumc.org