Colorado Animal Specialty & Emergency (CASE)
Description
The purpose of this study is to evaluate the safety and efficacy of K9-ACV, an autologous killed tumor cell vaccine combined with a novel checkpoint inhibitor (CD200AR-L), compared to standard-of-care carboplatin chemotherapy for the treatment of canine appendicular osteosarcoma (OSA). K9-ACV has safely been used in over 2,000 dogs, and the vaccine has been shown to display safety and efficacy in a previous study (without the addition of the checkpoint inhibitor). By evaluating K9-ACV, this trial aims to advance safer, immune-based treatment options for canine cancer that may offer comparable or superior outcomes to chemotherapy.
Screening Eligibility
Suspected of having osteosarcoma of the limb
Dogs >1 year of age and weighing more than 20 kg
Dogs cannot have received immune-modulating drugs (cyclosporine, Apoquel, Cytopoint, prednisone, chemotherapy) within 30 days of trial enrollment
No prior radiation or bisphosphonate (zoledronate or pamidronate) therapy
Enrollment criteria
Confirmed non-metastatic appendicular osteosarcoma treated with amputation at CASE
The vaccine is produced from the dog's tumor.
Benefits of Participation
Participating pet owners will receive:
Screening testing, including: blood work, urinalysis, chest x-rays, abdominal ultrasound
$4,000 towards the cost of surgery
Costs associated with rechecks, diagnostics, and treatment with K9-ACV and carboplatin treatment groups.
Side effects associated with K9-ACV treatment.
Dogs randomized to the carboplatin treatment group will be responsible for the cost of supportive care medications and associated side effects.
What to Expect
Participating patients will be required to complete standard pre-enrollment screening that involves a physical exam, blood work, radiographs, and an ultrasound. If the patient passes the screening, they will undergo limb amputation and be assigned to the K9-ACV group or the carboplatin group. Patients in the K9-ACV group will receive an intradermal injection of the checkpoint inhibitor and then will return to the study site 24 hours later for the vaccine administration. This will occur in a series of three with 21 days in between. Patients will return at 4, 6, and 8 months after initial vaccine administration for a physical exam, blood work, and radiographs. Patients in the carboplatin group will receive four treatments of chemotherapy with 21 days in between. Patients will return at 4, 6, and 8 months after initial carboplatin treatment for a physical exam, blood work, and radiographs.
Pet Owner Resources
More recently in the human field, studies are being designed to combine personalized vaccines and checkpoint inhibitors.
Personalized Vaccine for Liver Cancer Shows Promise in Clinical Trial
University of Minnesota Approach
Interested?
Email: [email protected]
