Immunotherapy, engaging the power of the immune system against cancer, has become a standard part of oncology care. One such approach utilizes the STimulator of INterferon Genes (STING) pathway. Our colleagues at University of Michigan, led by Dr. James Moon, have developed a drug that activates the STING pathway. This drug, called CMP-002, has been shown to combat cancer in a laboratory setting, with and without the use of another modulator of immune system, PD-1 blockade. This success prompted a collaboration with Michigan State University College of Veterinary Medicine as we hope to contribute to efforts that can help veterinary oncology patients and humans alike. Our initial studies, led by Dr. Vilma Yuzbasiyan-Gurkan at MSU, established the dose range tolerated in healthy dogs.

The purpose of this study is to confirm the best dose of CMP-002 with or without PD-1 blockade for tumor-bearing dogs. CMP-002 has already been tested in healthy dogs. It is not uncommon for patients with cancer to process drugs differently, which is why we intend to confirm the best dose for tumor-bearing dogs. The findings of this study will then be used in future studies assessing the anti-cancer properties of CMP-002 with or without PD-1 blockade.

• Inclusion criteria:
  • Confirmed diagnosis of soft tissue sarcoma, lymphoma, osteosarcoma, histiocytic sarcoma, or malignant melanoma via cytology or histopathology.
  • Visible tumor at the time of enrollment.
  • Adequate organ function indicated by standard laboratory tests.
  • Minimum weight requirement of 5 kg (11 lbs).
• Exclusion criteria:
  • Prior anti-cancer treatment, including steroids, within 7 days.
  • Indolent forms of lymphoma, such as T zone lymphoma.
  • Expected survival < 4 weeks with treatment.

Prior to study entry, pet owners will be charged an initial consultation fee and be financially responsible and required to have the following diagnostics performed in their dog:

1. Diagnosis of select tumor type, if not already documented
2. Screening blood work and urinalysis, if not performed within 7 days

The first group of patients (6–9 dogs) will receive CMP-002 alone. Their tumor will be measured and they will receive the CMP-002 infusion. They will then be observed overnight and blood samples will be taken at set timepoints. The dogs will visit their primary veterinarians one week later for blood sampling. Three weeks after the first treatment, the dogs will return to the MSU Veterinary Medical Center for a second infusion. Depending on previous response, they may be hospitalized again or sent home the same day. If tolerated, these treatments can be repeated every 3 weeks for a set number of cycles. Tumor biopsy samples may be collected at various timepoints.

The second group of dogs (6–9 dogs) will receive CMP-002 with PD-1 blockade. Their tumor will measured and they will receive the CMP-002 infusion. They will then be observed overnight and blood samples will be taken at set timepoints. The dogs will return one week later for tumor measurements, blood sampling, and anti-PD-1 infusion. Three weeks after the first treatment, the dogs will return to the MSU Veterinary Medical Center for a second CMP-002 infusion. Depending on previous response, they may be hospitalized again or sent home the same day. If tolerated, these treatments can be repeated every 3 weeks for a set number of cycles. Tumor biopsy samples may be collected at various timepoints.

• This is a funded trial. All tests and treatments associated with the trial will be covered once a dog is enrolled.
• Complications associated with the trial will be covered. Clients are financially responsible for all treatments and diagnostics that are unrelated to the trial. Association between complications and trial treatment will be determined by the overseeing clinician and investigators.
• Initial evaluation appointments will be charged. For dogs accepted to the study, recheck exams during clinical trial appointments will be free of cost ($60 value per visit).
• CMP-002 (and PD-1 blockade, if included) treatment will be administered free of cost. Hospitalization immediately after CMP-002 administration and associated treatments will be free of cost. Blood sampling and tumor biopsies associated with the trial will be free of cost.
• One week after CMP-002, blood work will be needed. If performed at the MSU Veterinary Medical Center, the cost will be covered by the trial. If performed through your local veterinarian, you will be reimbursed up to $99 per test.

Note: Test and treatments associated with the trial are covered for enrolled dogs. This does not include any surgical procedures.

Please feel free to contact our Medical Oncology Team at (517) 353-5420 or cvm.oncoinfo@msu.edu to refer a patient or for any additional information. Referring veterinarian and client calls are welcome.