Vaccine and Anti PD1 Study In Dogs with Oral Malignant Melanoma

The University of Florida College of Veterinary Medicine is currently recruiting dogs recently diagnosed with malignant melanoma for a clinical research trial. Dogs must have not had the oral tumor excised to qualify.

Enrollment Status: Currently Enrolling

• Inclusion Criteria: Any dog recently diagnosed with oral malignant melanoma that is resectable or minimal and does not have other life threatening diseases. Dogs must have not had the oral tumor excised to qualify.
• Treatment: Participation involves an initial staging visit and 5 follow up visits. The vaccine will be given 4 times approximately 4 weeks apart followed by 2 restaging visits. Enrolled dogs will receive an intravenous administration via an IV catheter in their leg of the Anti-PD1 antibody (Gilvetmab) at enrollment and then with each subsequent GD2/3 vaccine; for a total of 4 infusions. Booster vaccines will also be available 6 months after completion of the entire vaccine series at an additional charge. A biopsy of the oral mass (cancer) will be required for the study at enrollment and when disease is still present at later visits.  
•  Your dog will have blood collected through routine venipuncture (no more than 2-3 teaspoons worth) g at various time points throughout the study to measure immune response and as needed, for a general assessment of health, e.g., organ function.  
• Cost: This study does not provide any financial incentive or coverage towards treatments, other than covering the costs of the anti-PD1 drug and collections of the tumor tissue as it relates to the study (biopsy). Owners are expected to cover all other costs related to the study and treatment, including vaccines and initial examination. Subsequent visits will also be responsibility of the client.  Costs will be discussed prior to enrollment. You will need to schedule an Oncology Evaluation Appointment for your dog. This evaluation appointment is not covered by the study but is a pre-requisite for determining eligibility and does not guarantee that your dog will qualify to receive the vaccine.
• Contact:  Contact the Oncology Staff at (352) 392-2235 to schedule an evaluation, or complete the Study Interest Form to see if your dog qualifies.

Background:

Melanoma is a devastating cancer in humans and animals (both cats and dogs) with few options for treatment, outside of surgery and radiation. Melanoma often likes to spread to the lungs (metastasis) which can ultimately result in the passing of the person or pet. Through years of research, we have determined that dogs with naturally occurring melanoma, which is not induced by the sun, may be treated with immunotherapy. Immunotherapy is a form of treatment which uses the body’s own immune system to target and fight cancer. We developed a GD3 (ganglioside) based vaccine which has shown in past studies to improve time-to-progression of disease and overall survival in 75% patients in addition to standard of care (surgery or radiation). Our objective in continuing our research with this vaccine is to provide answers (more treatment) for the 25% of canines that don’t respond. To this end we recently added GD2 as an additional component to the vaccine (now a GD2/3 vaccine). We are also now, incorporating the anti-PD1 antibody (Gilvetmab) with the vaccine. The hope is that we can improve outcomes for our patients via this clinical trial designed to treat dogs with naturally occurring melanoma with the administration of the GD2/3 melanoma vaccine and infusions of Gilvetmab.