Under the leadership of principal investigator Timothy Fuller, MD, Texas Retina will soon begin enrolling patients in the OptimUM-10 clinical trial, a randomized, Phase III, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (neoadjuvant means therapy before definitive treatment like plaque placement or eye removal).
Although rare, uveal melanoma can be aggressive and spread to other parts of the body. The standard-of-care radiation therapy used to treat it is called plaque therapy. A small disc-shaped shield made of gold, known as a plaque, encases radioactive seeds which are used to treat the tumor. It is surgically attached to the outside surface of the eye, over the tumor. The gold protects the surrounding areas from radiation damage. The plaque is left in place for several days, allowing the radiation to treat the tumor. Once complete, it is then removed, and no radioactive material remains on or within the patient. For tumors that are too large to be treated with plaque therapy, enucleation, which is surgical removal of the eye, is often the only treatment option.
“This new trial will determine if neoadjuvant therapy with an oral agent called darovasertib, which is given before plaque radiation, will lead to less vision loss from plaque therapy,” explains Dr. Fuller. “In addition, for patients with tumors too large for radiation, this therapy could possibly provide an option to maintain their eye rather than have it enucleated. Our hope is that darovasertib can shrink the tumor enough to allow for plaque treatment.”
More About Darovasertib
GNAQ and GNA11 are human genes that encode the alpha subunits of G proteins, which are involved in cell signaling, and their mutations are linked to various conditions, especially uveal melanoma. Specifically, GNAQ and GNA11 activate protein kinase C (PKC) signaling. Darovasertib is an oral, selective PKC inhibitor.
Currently, there are no approved systemic therapies for neoadjuvant treatment of primary uveal melamona. In Phase II studies, darovasertib has shown tumor shrinkage in medium and large sized tumors prior to primary local treatment with an approximately 60% eye preservation rate in those destined for enucleation.
For more information about the OptimUM-10 clinical trial, email Jennifer Rinn (jerinn@texasretina.com).
Click HERE to learn more about uveal melanoma or HERE for a full listing of Texas Retina’s current clinical trials.