College of Veterinary Medicine

Immunotherapy Vaccine

Immunotherapy Trial of New Cancer Vaccine

*8/8/25: This trial is not currently open for enrollment, but will be coming soon. At this time, we are not actively recruiting any patients.

Principal Investigator

Dr. Shawna Klahn, Associate Professor, Oncology

Dr. Nick Dervisis, Associate Professor, Oncology

Background

Cancer vaccines have potential to re-train the immune system to recognize and kill cancer cells. The vaccine in this study trains the immune system to recognize a protein that cancer cells use to block the immune system, Programmed Death Ligand 1 (PD-L1). Once trained, the immune system will prevent the interaction between PD-L1 on cancer cells and immune cells, releasing the immune "brakes", allowing the immune system to once again recognize and kill cancer cells.

Targeting PD-L1 is an immunotherapy strategy classified as "immune checkpoint inhibitor" therapy, which has dramatic anticancer effects in human cancer patients. Jimmy Carter, for example, benefited from a drug in this class to clear his metastatic melanoma several years ago, although not all people and not all cancers respond as well. Immune checkpoint inhibitors are expected to help dogs with cancer, but more knowledge is needed. This new vaccine has been developed specifically for dogs and has already been studied cell culture, in rodents, and in lab dogs but has not been studied in pet dogs with cancer.

In this study, the goals are to evaluate safety and effectiveness of the vaccine. All enrolled dogs will receive 3 treatments of the vaccine given into the muscle at the dose that has been determined to be safe and effective at stimulating the immune system in healthy lab dogs.

The advantages for a dog participating in this trial is that they will receive a new treatment that is expected to help fight cancer in dogs, at a cost that is lower than the cost of other therapies. There are no placebos in in this study. The advantages for the Purdue team is that we will learn important information about which cancers may be best to include in the next studies of this vaccine and lead to development and availability to all dogs with that cancer. 

Eligibility for Dogs to Participate in the Study

  • Pet owners must be willing and able to bring their pet to all scheduled study visits
  • To be at least 1 year old and weigh more than 8 kg (~18 lb)
  • Confirmed diagnosis of T-zone lymphoma, hepatocellular carcinoma, mammary carcinoma, squamous cell carcinoma, soft tissue sarcoma, melanoma, osteosarcoma, or mast cell tumor
  • Tumor must be accessible for biopsy
  • Be healthy enough to undergo sedation and anesthesia
  • Be expected to live at least 9 weeks without treatment

Exclusion Criteria

  • Recent treatment with steroids, chemotherapy, targeted therapy, or radiation therapy
  • Diagnosed or history of an autoimmune disorder, hyperadrenocorticism, or diabetes mellitus

What is involved for the dog/dog owner?

Prior to Enrollment (diagnosis and staging to determine eligibility):

Physical exam, lab work (CBC, chemistry, urinalysis), biopsy of tumor, CT scan. The cost of these tests would be out-of-pocket for the owner.

Commitment to the Trial:

This study is expected to last approximately five months. No other treatments can occur during this time, including herbal, complementary, alternative medicine, or integrative medicine treatments. 

If you dog's cancer begins to grow with the PD-L1 vaccine treatment, or if your dog develops bothersome side effects, or does not feel well, then he or she would go "off study" and could receive other types of therapy. Once going off study, you (the owner) would need to pay for the other therapies. 

Although we hope each dog will live a long time with good quality of life, we know each dog will reach the end of their life eventually. You are asked to allow a necropsy when your dog dies whether the death is due to cancer or some other condition. Examining the cancer tissues after death is very beneficial in helping us understand how the new drug worked at the molecular/cell signaling level, how it affected the immune system, and how to make it work even better.

Anti-PD-L1 Vaccine Treatments:

There are 3 vaccine treatments given into the muscle 3 weeks apart (days 0, 21, and 42 of the study). During these visits, an exam and blood work will be performed to monitor for progression of their cancer or any changes in blood cell counts or liver or kidney functions. Additional blood will also be taken to evaluate whether the vaccine has been able to stimulate the body to make antibodies against PD-L1, as well as identify any biomarkers that will be able to predict which patients respond to the vaccine and which may not.

Monitoring for Response to Treatment:

At specific timepoints, all dogs will have a CT scan and biopsy of their tumor to determine if their cancer is responding to treatment. This will happen at 3 weeks, 7 weeks, and 5 months of the study time period. This will occur under general anesthesia. Please plan to spend the majority of the day at the hospital during CT scan/biopsy days to allow for anesthesia planning and recovery.

Financial Support

  • Once enrolled, the cost of the trial will be $300 per month and the remainder of the cost of the vaccine treatments, blood work, CT scan(s), and sedation will be covered (worth ~$4,500).
  • Additionally, pet owners will receive $500 in hospital credit upon completion of each of the four follow-up visits at the end of the study period ($2,000 total).
  • If adverse events occur, the study will cover up to $1,500 to treat adverse events at Purdue Veterinary Hospital and that are determined to be probable or definitely related to the vaccine. It is expected that all treatments and monitoring will be performed at Purdue. Any visits to the primary veterinarian or another emergency or specialty clinic must be paid for by the pet owner. Similarly, any veterinary care that is not related to the cancer or the cancer treatment must be covered by the pet owner.

Trial Status

Not Started Recruiting

Questions

  • We recommend scheduling an appointment for evaluation with our team if you are interested in this clinical trial for your pet. That visit will allow us to determine if the trial is the best option for your pet and if they are eligible. If we determine that the trial is not the best option, we will assist with other treatments.
  • If interested in speaking to a member of our team directly about this trial, please call Ms. Araynna Holland, Clinical Trials Nurse, at 765-494-1130 and leave a call back message or call 765-494-1107 and ask to speak to Dr. Nick Dervisis or Dr. Shawna Klahn from Medical Oncology.