Comparative Immunotherapy Program Clinical Trials

Through clinical trials, we can offer our canine companions the best possible care, while also contributing to the advancement of veterinary science for the benefit of all dogs and their human counterparts.
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Clinical Trials

Oral Melanoma Study

Pilot study to evaluate a fully canine anti-CTLA4 mAb (VGS-001) in combination with radiation therapy in dogs with stage III and IV oral malignant melanoma
 
Summary: Dogs with oral malignant melanoma may be eligible to participate in a pilot study using a novel anti-cancer immunotherapy. The goal of this study is to evaluate the safety, tolerability, and efficacy of an anti-CTLA4 antibody when combined with radiation therapy in dogs with oral malignant melanoma.

Contact
Ashley Fuhrer
Phone: 919-515-3634
Email: cvmclinicalstudies@ncsu.edu

  • Details of Study

    Project Description 

    An open-label, prospective, multi-institutional, fixed-schedule, prospective pre-clinical trial will be performed to evaluate 4VGS-001 (Anti-CTLA) in combination with radiation therapy in dogs with stage III or IV oral malignant melanoma. 

    The treatment period is 10 weeks during which 3 doses of radiation therapy will be administered over a one-week period followed by 4 doses of VGS-001 given at 3-week intervals. The total observation period will be 29 weeks. During this time, dogs will be evaluated for objective response (CR, PR, or SD). Dogs will be evaluated on an intent-to-treat basis. Dogs with documented progressive disease (increase in size of either the primary tumor or metastatic lesions) will undergo re-evaluation 2 weeks later to confirm disease progression and not pseudoprogression. Overall tolerability and biological activity will be based on clinical and pharmacodynamic endpoints. 

    Locations

    University of Missouri, Colombia, Missouri
    North Carolina State University,Raleigh, North Carolina

    Study Type 

    Interventional 

    Intervention 

    Biologic/vaccine 

    Inclusion Criteria 

    Dogs with a histopathological diagnosis of oral malignant melanoma (+/- documented LN involvement) 

    Inoperable or incompletely excised tumor 

    Stage III (primary tumor ≥4cm in diameter, or presence of lymph node metastases) or IV (distant metastasis) (historical MST with RT alone of 159 days and 90 daysrespectively) 

    Body weight >5kg 

    Modified ECOG score: Grade 0 or grade I 

    Newly diagnosed or relapsed 

    No significant co-morbidities  

    Expected survival time of at least 2 months at the time of enrollment (assumingreceipt of standard radiotherapy) 

    Informed owner consent 

    Owner 

    At least 18 years of age. 

    Ability to give informed consent and ability to read, understand and fill out questionnaires. 

    Exclusion Criteria 

    History of autoimmunity, immune-mediated disease (e.g., IMHA, ITP, IMPA etc.), colitis, IBD, endocrine disorders (e.g., hypothyroidism, hypoadrenocorticism, etc.) or hepatopathies (AST or ALT >1.5x ULN; bilirubin >2.0mg/dL) 

    Received chemotherapy, radiation therapy or immunotherapy within the last 4 weeks. 

    Significant co-morbidities: Creatinine > 3.0 mg/dL; Bilirubin > 2.0 mg/dL, or elevated bile acids; HCT < 25%, or platelets <50,000/μL; Any >grade 2 hematologic or biochemical abnormality 

    Glucocorticoid therapy within the last 7 days 

    Daily drug administration (insulin, fludrocortisone, etc.) for the control of unregulated chronic disease 

    Concurrent use of either CYTOPOINT or APOQUEL 

    Body weight >60kg 

    Clinically significant metastatic disease 

    Potential Medical Benefits to Enrolled Animals 

    Anti-tumor effect & potential extension of life 

    Potential Medical Risks to Enrolled Animals 

    Common infusion-related adverse events in humans include: 

    Fatigue 

    Nausea and vomiting 

    Diarrhea 

    Fever 

    Headache 

    Dizziness 

    Rash 

    Pruritus 

    Hypotension  

    Tachycardia 

    Financial Incentives for Study Participants 

    Costs associated with novel immunotherapy, radiation therapy, blood and tissue collections, and monitoring visits are covered. 

     

Bladder Cancer Study

Pilot study to evaluate the safety and pharmacodynamic effects of a fully canine anti-PD1 antibody in pet dogs with urothelial carcinoma
 
Summary: Dogs with urothelial carcinoma may be eligible to participate in a clinical trial. This study seeks to evaluate a novel immunotherapy that specifically targets an important molecule primarily expressed on immune cells. This molecule usually turns off the immune cells and prevents overactive immune responses. However, it also turns off anti-cancer immune responses and prevents the immune system controlling and killing cancer cells. Immunotherapies that can inhibit this molecule on immune cells that recognize cancer cells could make it possible for the immune system to recognize and attack the underlying cancer more effectively. This study seeks to evaluate the tolerability and efficacy of this novel immunotherapy in dogs with urothelial carcinoma.

Contact
Samuel Stewart
sstewart@ethosvet.com

  • Details of Study

    Project Description 

    Urothelial carcinoma (also known as transitional cell carcinoma) is the most common type of bladder cancer to affect dogs. Treatment often involves a combination of surgery, chemotherapy, and radiation therapy, with the aim being to reduce the size of the tumor, alleviate symptoms, and improve the dog's quality of life. In recent years, immunotherapy has emerged as a promising treatment approach for many types of cancer, including canine urothelial carcinoma. Immunotherapies aim to harness the body's immune system to recognize and attack cancer cells. They can be particularly attractive for treating cancers that are difficult to access surgically or that have metastasized (spread to other parts of the body).   

    This study seeks to evaluate a novel immunotherapy when used in dogs with urothelial carcinoma. The therapy specifically targets an important molecule primarily expressed on immune cells, which usually turns off the immune cells and prevents overactive immune responses. However, it also turns off anti-cancer immune responses and prevents the immune system controlling and killing cancer cells. Immunotherapies that can inhibit this molecule on immune cells that recognize cancer cells could make it possible for the immune system to recognize and attack the underlying cancer more effectively. Urothelial carcinoma in dogs shares many biological and molecular features with human urothelial carcinoma, including their ability to be shielded from the immune system. Human clinical trials in urothelial carcinoma investigating similar immunotherapies have shown these therapies to be more effective than traditional chemotherapies in some cases. Development of an immunotherapy that is safe and beneficial in canine urothelial carcinoma patients will advance veterinarians ability to treat this disease and will provide an important model to inform future canine and human clinical trials in this area. This study seeks to evaluate the tolerability and efficacy of this novel immunotherapy in dogs with urothelial carcinoma. 

    Locations

    Veterinary Specialty Hospital – North County San Marcos, California

    Colorado Animal Specialty & Emergency 
    Boulder, Colorado


    Study Type 

    Interventional 

    Intervention 

    Drug 

    Inclusion Criteria 

    Weigh ≥5kg and ≤35kg 

    Histologically confirmed urothelial carcinoma, with or without documented lymph node involvement (both newly diagnosed dogs and those with recurrent/relapsed disease are eligible) 

    Measurable tumor burden with primary intravesicular tumor amenable for cystoscopic biopsy 

    ECOG performance status of grade 0 or 1 

    Adequate hematologic, hepatic, and renal function 

    Creatinine ≤2.0 mg/dL 

    No significant comorbidities 

    Expected survival time of at least 8 weeks  

    Signed informed owner consent  

    Exclusion Criteria 

    Body weight of <5kg or >35kg 

    Pulmonary metastatic disease  

    History of any diagnosed or suspected autoimmune or immune-mediated disease, colitis, IBD, endocrine disorders 

    Significant comorbidities  

    Symptomatic urinary tract infection confirmed on urine culture 

    Any >grade 2 hematologic or biochemical abnormality 

    History of daily drug administration for unregulated chronic disease 

    Prior experimental therapy 

    Prior antibody therapies 

    Prior immunomodulatory therapies within six weeks of study enrollment.  

    Dogs receiving standard of care NSAID for UC for at least 2 weeks prior to study enrollment will be allowed to continue while on study 

    Concurrent chemotherapy or radiation therapy within 2 weeks of study enrollment  

    Treatment with corticosteroids within 7 days of study enrollment 

    Potential Medical Benefits to Enrolled Animals 

    Possible improvement in the status of your dog's urothelial carcinoma. 

    Potential Medical Risks to Enrolled Animals 

    The risk for complications from the routine diagnostics and imaging performed for the study are considered to be very low. Several study visits will require sedation or general anesthesia, which can be associated with complications. The veterinarian overseeing your dog’s care will discuss the potential complications associated with the sedation/anesthesia plan they intend to use in your dog. 

    Financial Incentives for Study Participants 

    Fully funded including initial screening  

Explore more of Penn Vet's clinical trials to get involved and learn more about our cutting-edge Cancer Research at the school.

The AVMA Veterinary Clinical Trials Registry can also be a resource to help you find a trial for your pet.