Autologous Canine Cancer Vaccine with Checkpoint Inhibitor for Treatment of Osteosarcoma

Trial Summary

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.

Participating patients will be required to complete standard pre-enrollment screening that involves a physical exam, blood work, radiographs, and 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.

Inclusion Criteria:

• Dog is ≥ 1 year of age and greater or equal to 20 kilograms in weight.
• Dog is in good general health, with the exception of appendicular osteosarcoma, Stage IIB.
• Dog had cytologic and/or histologic confirmation of appendicular osteosarcoma, Stage IIB.
• Dog had a vaccine produced from its tumor according to the Outline of Production.

Exclusion Criteria:

• Dog received concurrent or previous therapy (within 30 days) with immune-modulating drugs (e.g., cyclosporine, Apoquel, Cytopoint, prednisone, any chemotherapy, etc.)
• Dog received NSAIDs less than three days before immunization with the IVP.
• Dogs have received prior radiation therapy or bisphosphonates for their appendicular osteosarcoma.
• Dog has any uncontrolled medical condition that is likely to be disruptive to the intent of the study.
• Dog is known to be pregnant or likely to become pregnant during the study.
• Dog is lactating or intended for breeding during the study.
• Dog is participating in another therapeutic study.
• Dog is not available for the duration of the study.