BG34-200 plus immunotherapy for canine malignant melanoma

• Dogs diagnosed with cytologically or histologically confirmed oral malignant melanoma
• The tumor must be at least 2 cm and no larger than 7 cm in size
• Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
• ANC≥1000/μL and platelet count ≥ 100,000/μL
• Liver: Total bilirubin < 1.5X the institutional upper limit of normal (ULN), ALT < 3X ULN
• ECOG performance score of 0-1
• Otherwise medically healthy with no clinically significant physical findings upon examination, medical history, and clinical laboratory profile, as deemed by the Principal Investigators
• Dogs must have an estimated life expectancy of at least 1 month
• Dogs but must be off all drugs that could impact the immune response for at least 7 days prior to enrollment
• Informed written consent must be obtained

Exclusion Criteria

• Pregnant or lactating dogs
• Prior treatment with radiation therapy or immunotherapy
• Concurrent use of complementary or alternative medicines that confound the interpretation of data generated from this study
• Dogs with significant liver or cardiovascular disease
• Any serious systemic disorder incompatible with the Study (at the discretion of the PI)
• Use of any other investigational drug within 2 weeks of study entry

Client Benefits

The study will cover all costs associated with the study, including screening and BG34-200 administration, as well as any costs associated with side effects from study-related procedures. The study will not cover any costs due to unrelated conditions (ear infection, bladder infection, etc.).

Sample or Data Requirements

Your dog will need to have a diagnosis of melanoma based on either a biopsy or a needle aspiration of the tumor. Bloodwork and chest x-rays will also need to be performed to check for evidence of tumor spread (metastasis) and to make sure that the liver, kidneys and other body systems are functioning normally. If your dog is enrolled in the study, he/she will be sedated and undergo a baseline tumor biopsy, collection of a blood sample (16 ml, approximately 1 tablespoon), and, if possible a needle aspiration of a lymph gland close to the tumor. Your dog will then receive 4 weekly intravenous infusions of BG34-200 followed by another 2 infusions every 2 weeks alone, or in combination with another treatment designed to stimulate the immune system. The first is an antibody called Gilvetmab which blocks a protein on immune cells that prevents them from being activated. Gilvetmab is a canine antibody that has been conditionally approved by the USDA to treat dogs with melanoma. The second is the ONCEPT canine melanoma vaccine which is a fully approved treatment for canine melanoma, usually given after surgical removal. A second tumor biopsy will be taken before the 5th treatment (Week 6 of the study).

Contact Information

For questions regarding the clinical trial, please email clinicaltrials@tufts.edu.