Evaluating a Novel Immunotherapy Treatment for Malignant Oral Melanoma in Dogs

Malignant oral melanoma clinical study (dogs).

Study details.

This is a randomized, blinded, placebo-controlled trial of approximately 182 days in duration. Dogs will be randomly assigned to receive a novel immunotherapy or a placebo (non-active saline).

Inclusion criteria:

Dog must be 1 year old or older

Dog must have a body weight of 3 kg or more

Cytological or histopathological diagnosis of stage III malignant oral melanoma (at least one measurable lesion with a longest diameter of ≥ 10 mm or a short axis of ≥15 mm for nodal lesions at baseline

If prior surgery was performed to remove masses, it was no less than 14 days prior to enrollment, and there must be measurable disease remaining to meet inclusion criteria

Exclusion criteria:

Oral melanoma confined to the lip

Any underlying disease that in the opinion of the Investigator and Medical Director will affect the study objectives or overall patient safety

Dog is pregnant, lactating, or likely to become pregnant

Dog is participating in another interventional therapy study

Dog may not be available for the entire study duration

Previous ONCEPT® Canine Melanoma Vaccine, DNA Treatment

Dog is receiving prohibited medications or treatments (please review and discuss with the study clinician)

Locations and contacts:

Covered costs.

The costs of all diagnostics and procedures required for the study are covered by the sponsor.