A New Immunotherapy Trial for Dogs with Lung Metastases: The CAALM Study

A clinical trial is evaluating a PD-L1 antibody therapy for dogs with metastatic melanoma or carcinoma.

Introduction

Metastatic cancer is a devastating diagnosis, often leaving families with few treatment options. Standard approaches, such as surgery, chemotherapy, or radiation, provide only modest benefit once the cancer has spread to the lungs.

A new clinical trial led by UC Davis School of Veterinary Medicine is investigating a novel immunotherapy designed to help the immune system recognize and attack cancer cells. If proven effective, this treatment has the potential to extend survival and improve outcomes for dogs with metastatic cancer.

Here’s a summary.

1. What is the CAALM Study and what does it aim to do?

The CAALM Study is a clinical trial testing the safety, tolerability, and early effectiveness of a new immune checkpoint inhibitor: canine-specific PD-L1 antibody (UCD-PDL1). This immunotherapy may help dogs with melanoma or carcinoma that has spread to the lungs by boosting the immune system’s ability to recognize and attack cancer cells. The study also seeks to determine optimal dosing.

The antibodies block the PDL-1 molecule so T cells do not get inactivated. This is in contrast to Gilvetmab, which blocks PD-1.

2. Which dogs are eligible to participate in the trial?

Inclusion Criteria:

• Weight over 15 kg (33 lbs)

• Confirmed diagnosis of melanoma or carcinoma (via cytology or biopsy)

• One or more lung nodules consistent with metastasis

• Expected survival of more than 4 weeks

• Other health criteria assessed at the first visit

Exclusion Criteria:

• Prior treatment with checkpoint inhibitors

• Chemotherapy, corticosteroids, or other immunotherapies within 2 weeks of treatment

• Uncontrolled medical conditions that could interfere with treatment or data

• Pregnant or breeding dogs

  
  

  

  Handsome, a ten-year-old Doberman pinscher, was diagnosed with thyroid cancer that had metastasized to the lungs. He is the first participant of the CAALM clinical trial.

3. What is required from dog owners who join the study?

Dog owners must:

• Be at least 18 years old

• Provide informed consent

• Bring their dog to all scheduled visits at UC Davis

• Report any changes in their dog’s health

• Complete study questionnaires and follow all instructions

  
  

4. What does participation in the trial involve?

Participation lasts around 98 days and includes:

• Pre-enrollment screening (Days -7 to -1): Physical exam, bloodwork, chest imaging

• Treatment days (Days 0, 14, 28, 42, 56, 70): Exams, radiographs, blood sampling, and antibody infusions

  • Dogs will stay overnight after the first infusion for observation

• Follow-up visits (Days 4, 7, and post-treatment): Exams, lab tests, quality-of-life monitoring

  
  

5. What are the potential benefits of joining the CAALM Study?

By participating in this trial, a canine patient gains access to an advanced and potentially life-extending immunotherapy at no cost. The study also covers imaging and diagnostic evaluations directly related to the trial. Beyond direct benefits to your dog, participation contributes to veterinary cancer research and the development of more effective treatments for future canine patients.

6. What are the possible risks or side effects?

As with any clinical trial, there are risks involved. Dogs may experience mild infusion-related reactions, such as lethargy, fever, or changes in bloodwork. Additionally, repeated travel to the hospital and overnight stays may cause stress. Though rare, immune-related complications are possible and will be closely monitored by the study team to ensure safety.

7. Where is the study taking place?

The CAALM Study is being conducted at the UC Davis School of Veterinary Medicine in Davis, California.

8. What costs are covered by the study? Will I be compensated?

The study covers up to $2,000 in trial-related expenses, including the antibody treatments, diagnostic imaging, and management of any study-related side effects. Pet parents are responsible for the cost of pre-enrollment screening, including initial consultations and any tests required to confirm eligibility. While there is no monetary compensation for participation, the treatment and diagnostics provided through the study offer substantial financial value.

9. Can my dog withdraw from the study if needed?

Yes. Participation is voluntary, and owners may withdraw their dog at any time. Data collected up to that point will still contribute to the study’s findings.

Learn more here: https://studypages.com/s/innovative-immunotherapy-for-canine-lung-metastases-the-caalm-study-276511/?ref=gallery

Read Handsome's story here:

https://www.vetmed.ucdavis.edu/giving-articles/meet-handsome-groundbreaking-studys-first-participant

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Questions? Email us at info@ccralliance, and we'll get back to you as soon as we can!

Canine Cancer Alliance is a non-profit organization supporting research for canine cancer cures.

All information on the Canine Cancer Alliance website is for educational purposes only. It is not intended to be a substitute for professional veterinary advice.

Always seek guidance from your veterinarian with any questions regarding your pet’s health and medical condition.