EGFR/HER2 Vaccine Clinical Trial – Intake & Communication Policy

Thank you for your interest in the EGFR/HER2 vaccine clinical trial through Veterinary Cancer Concierge Services (VCCS). Due to the high volume of inquiries we receive, we have implemented the following processes to ensure we can provide thoughtful, efficient care to all patients while maintaining the integrity of the trial.

There are two ways to have your pet enrolled in the EGFR/HER2 Clinical Trial:

Option 1: VCCS Oncology Consultation

Families may request an oncology consultation directly through VCCS. This option is appropriate for patients who do not already have an oncologist, or for families who would like VCCS to take the lead in reviewing the case and guiding trial eligibility. This consultation is $495 and includes:

• Collection and review of all medical records
• A 60-minute telemedicine consultation with a VCCS oncologist
• A written summary with recommendations and next steps
• NOTE: The VCCS oncologist will determine if the patient is eligible for enrollment in the trial based on the information discussed during the consultation and review of medical records

Option 2: Enrollment Through an Existing Oncologist

If your pet is already under the care of a board-certified or board-eligible veterinary oncologist, a VCCS consultation is not required (though it may still be scheduled if desired).

For enrollment without a VCCS consultation, all of the following criteria must be met:

1. Your pet must already have an oncologist overseeing care.
   
   
2. The oncologist must complete the required trial enrollment form (see link above) and submit all required medical records.
   
   
3. Once we have received the completed form and all necessary records, our team will reach out directly to you regarding next steps.

Checklist for trial enrollment/appointment scheduling:

• Medical history
• Summary of diagnostics
• 3-view thoracic radiographs with radiology report
• Abdominal ultrasound with report (for hemangiosarcoma and bladder carcinoma)

• Bloodwork (CBC/chemistry panel) and urinalysis within 1 week of first vaccine (note: this can be done with VCCS at time of first vaccine)
• 3-view thoracic radiographs with radiology report within 1 week of first vaccine
• Abdominal ultrasound within 1 month of first vaccine (hemangiosarcoma and bladder carcinoma only)

• 3-view thoracic radiographs with radiology report at 3, 6, 9, and 12 months
• Abdominal ultrasound with report at 3, 6, 9, and 12 months (for hemangiosarcoma and bladder carcinoma)
• Patient will be eligible for 1-year booster vaccine only if the above testing is performed 

• Cost of each vaccine visit (there are two visits up front, then yearly booster appointments if desired) – $695 each visit
• NOTE: there is no charge for the vaccine itself. The cost above is for the examination, visit time, supplies, vaccine administration and data analysis/communications

• We are unable to communicate with clients regarding trial eligibility until either a VCCS consultation has been completed or all required forms and records have been received. 
• VCCS is unable to contact referring veterinarians to obtain records. Due to time constraints, it is the responsibility of the client and/or primary oncology team to ensure all required documentation is submitted to us.

WE WILL NOT REACH OUT TO SCHEDULE AN APPOINTMENT UNTIL EVERYTHING ON THE ABOVE CHECKLIST IS COMPLETED

PLEASE NOTE THAT WE WILL NOT RESPOND TO EMAILS OR CALLS UNTIL THE ABOVE CHECKLIST IS COMPLETED.

The EGFR/HER2 vaccine is a type of immunotherapy that directly targets the Epidermal Growth Factor Receptor (EGFR/HER2) pathway. EGFR is overexpressed in many different types of cancers, and the goal of this treatment is to induce a polyclonal anti-EGFR/HER2 tumor antigen response (or in simpler terms, to activate the immune system to help kill off cancer cells in the body).

• Your pet must have a diagnosis of one of the following cancers:
  • Osteosarcoma
    • Patients with a probable diagnosis of osteosarcoma can be enrolled (this can be based on imaging and patient history)
  • Hemangiosarcoma
    • For hemangiosarcoma, your pet MUST have a definitive diagnosis (this means a diagnosis based on cell aspirates/cytology or a tissue sample/biopsy)
    • Exceptions will be made for patients with right atrial masses
  • Urothelial carcinoma involving the bladder/urethra/prostate (transitional cell carcinoma of the bladder/urethra/prostate)
    • Patients with a BRAF positive urine test result and bladder/urethral/prostatic mass on ultrasound are eligible for this study, even without a cell or tissue sample confirming a diagnosis
  • Please note: we are NOT accepting any other patients/diagnoses for the EGFR/HER2 vaccine at this time. This vaccine CANNOT be given outside of the clinical trial for other cancer types (no exceptions).
• Your pet must have thoracic radiographs (lung x-rays) performed within 1 week of receiving the first vaccine (or at the time of the first vaccine, which can be done with VCCS). For hemangiosarcoma and urothelial carcinoma patients, an abdominal ultrasound must be completed within 1 month of receiving the first vaccine.
• Your pet must have an expected survival of >3 months. This will depend on the extent of cancer present (ie if the cancer has already spread and what treatments the patient is receiving), and what other conditions/diseases your pet has. This will be determined by our doctors on staff.

• Your pet has hemangiosarcoma with metastatic disease (pulmonary nodules, regional lymph nodes, confirmed masses in the liver or abdomen, etc)
• Your pet has been diagnosed with a second cancer within the past 6 months
• Your pet has been or is currently being treated with another immunotherapy, or is enrolled in any other clinical trials (namely cancer-directed therapies such as Torigen vaccine, ELIAS ECI vaccine, and Immunocidin, etc)
• Your pet is taking steroids (prednisone, prednisolone, dexamethasone). NOTE: for clients wishing to discontinue steroids at the advice of their veterinarian, a wash out period of 1 month prior to vaccination is acceptable for enrollment)

• Two required visits with VCCS: Your pet will receive a series of 2 vaccines, spaced 3-4 weeks apart. Your pet can receive a third booster vaccine 1 year from the first vaccine if you are interested.
  • NOTE: the vaccines must be given with VCCS. We are unable to ship these vaccines to a location closer to you.
• The vaccine is a very small amount of liquid injected under the skin (usually between the shoulder blades)
• The following monitoring schedule is required (and can be done with your local veterinarian or oncologist if more convenient for you):
  • Baseline bloodwork (CBC/chemistry panel) and a urinalysis at the time of the first vaccine (if not done within the past week)
  • Baseline blood draw for serum sample collection (this will be sent to Yale for monitoring an immune response; please note that no results are reported for this)
  • Blood draw for serum sample collection at the time of the second vaccine
  • Continued monitoring at the following time points (can be done with your local veterinarian or oncologist):
    • Day 45-55 (from the first vaccine) blood draw for serum sample collection to be sent directly to Yale
    • 3, 6, 9, and 12 months (from the first vaccine) for: blood draw for serum sample collection to be sent directly to Yale, three-view thoracic radiographs with radiology report, and an abdominal ultrasound (for hemangiosarcoma and urothelial carcinoma/TCC patients only; the abdominal ultrasound is not required for osteosarcoma patients)

The only reported side effect is the potential for swelling or the development of a sterile abscess at the injection site. This occurs in 20% of patients. Usually this is self-limiting and resolves with minimal supportive care. Rarely the abscess ruptures or leaks fluid for varying periods of time.

It is important to understand that the Yale EGFR/HER2 vaccine clinical trial ​​is not funded. The only financial benefit is that the vaccine is provided free of charge​, but there are other visit-associated fees associated with each vaccine visit (​including consultation/exam​/data analysis fees, drug administration ​and biohazard fees,​ test fees involved in monitoring​ if done with VCCS). ​Pre-enrollment testing and monitoring​ at 3, 6, 9, and 12 months is ​also required, so the cost of enrolling your pet will add up over time. As a result, we understand that this may not be possible for everyone and this may not be a good fit for you and your family.

Please note that the cost of each vaccine appointment with VCCS is $695, which is the responsibility of the client. This does not include additional testing or treatment if needed.

• If you already have a local oncologist managing your pet’s care, then a consultation is not required. In this case, we will need your oncologist to fill out the referral form on our website. Please note that we will not schedule the first vaccine appointment until receiving all of your pet’s medical records. Referral Form
• For clients that do not have an oncologist managing their pet’s cancer care, an oncology consultation with VCCS is required. For naive patients, a full oncology consultation will be provided and additional therapies discussed if applicable. For more information, please contact us directly.

VCCS is a mobile oncology concierge practice that services Fairfield and Westchester Counties. All appointments are completed in our mobile suite (truck). We do NOT have a brick-and-mortar hospital location, and will meet clients and patients at a specified location.

For patients that have not had a consultation with VCCS, all vaccine appointments are scheduled on Wednesdays only (NO EXCEPTIONS) at 1086 Long Ridge Road in Stamford, CT.