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College of Veterinary Medicine

Immunotherapy Clinical Trial for Patients with Oral Melanoma

August 3, 2023

Principal Investigator

Dr. Michael Nolan

Description

NC State Veterinary Hospital is now recruiting dogs with oral malignant melanoma to evaluate the safety, tolerability, and efficacy of a novel immunotherapy. The immunotherapy is an antibody that aims to invigorate your dog’s immune system and help it eliminate cancer cells.

Study Requirements

  • Radiation therapy: Your pet will receive 3 doses of radiation therapy, given on an every-other-day basis. This treatment is intended to reduce pain and shrink the tumor. Although unlikely, the treatment may cause irritation of the skin, that looks and feels like a sunburn – we can give medicine to help with that, if needed. Similar irritation could affect the lining of the mouth and throat.  
  • VGS-001: Your pet will receive this investigational drug once every 21 days for a total of 4 doses.

Follow-up: After your screening appointment, you must agree to abide by a specific study schedule. You will need to return for radiation therapy in 1-2 weeks.  There will be 3 treatments on a Monday, Wednesday, and Friday schedule.  The following week your pet will receive the first dose of VGS-001, and in total, they will get 4 doses given approximately 21 days apart. After that, we will see you back once a month for the next four months.

Eligibility

  • Histopathologic diagnosis of oral malignant melanoma.
  • WHO Stage III or IV disease (i.e., history of an oral tumor >4 cm, and/or
    lymph node metastasis, and/or distant {e.g., lung, liver} metastasis).
    • Prior tumor-directed therapy is allowable, but no chemotherapy, radiotherapy, or immunotherapy (e.g., Oncept) within the last 4 weeks.
    • If there’s been prior surgery, a recurrent or residual oral mass must be present at
      the time of enrollment (even if it has not yet regrown to 4 cm)
  • Body weight between 5 and 60 kilograms.
  • No significant co-morbidities, and no history of autoimmunity or immune-mediated disease, colitis, IBD, or endocrinopathy
  • Lab values must be:
    • Creatinine < 3 mg/d
    • HCT > 25%
    • Platelet count > 50,000/uL
    • AST/ALT < 1.5 x ULN
    • Total bilirubin < 2 mg/dL
  • No steroid administration in the last 7 days.
  • No CYTOPOINT or APOQUEL use, ever.

Enrollment Start

August 2023

Enrollment Finish

August 2024

Flyer

View Flyer

Contact

Ashley Fuhrer: 919-515-3634 or cvmclinicalstudies@ncsu.edu