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:
- Malvern, PA: Dr. Craig A. Clifford at 610.296.2099
- Overland Park, KS: Dr. Heather Heeb at 913.642.9563
Covered costs.
The costs of all diagnostics and procedures required for the study are covered by the sponsor.
