New Haven, Conn. -- Yale University has launched a multicenter clinical trial, sponsored by Stand Up to Cancer and Melanoma Research Alliance, that will apply the latest in personalized medicine technology to treat metastatic melanoma. The trial, for which Yale is a lead site, will enroll patients lacking a particular genetic mutation for whom immune therapy did not work or was not an option.
Metastatic melanoma is a type of cancer that has spread from the skin to other parts of the body, most frequently the lungs, muscle, and liver. It is the most advanced and deadly type of melanoma, and notoriously difficult to treat.
"Metastatic melanoma is one of those cancers for which we have distressingly few treatment options after immune therapy has failed," said Patricia M. LoRusso, associate director of Innovative Medicine at Yale Cancer Center and national co-principal investigator of the Melanoma Dream Team. "This partnership of cancer centers, research organizations, and industry offers the best chance we've had in long time to find solutions for melanoma patients. We think the personalized medicine approach is the way forward."
Nearly half of all patients with metastatic melanoma have an alteration to the BRAF gene, which has been shown to be a promising target for certain new drugs, including some immune therapy drugs. However, for patients whose tumors lack the BRAF alteration, and for whom immunotherapy fails, there is a critical need for better options.
Since every patient's tumor is different at the genomic level, treatment may vary for each patient. This trial uses the latest molecular sequencing techniques to best match targeted drugs to the unique genetic alterations present in tumors missing the BRAF mutation. It is designed to evaluate if using this personalized therapy approach improves outcomes over current treatments which are limited and largely ineffective.
At Yale, patients will be enrolled in the trial through Smilow Cancer Hospital at Yale-New Haven.
The project, titled Stand Up To Cancer Consortium Genomics-Enabled Medicine for Melanoma (G.E.M.M.): Using Molecularly-Guided Therapy for Patients with BRAF wild-type (BRAFwt) Metastatic Melanoma, includes seven other institutions.
Additional support was provided by the Gateway for Cancer Research foundation and the American Association for Cancer Research (AACR). Seven different pharmaceutical companies are supplying commercially available and investigational targeted agents.
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