Newswise — Baylor Charles A. Sammons Cancer Center at Dallas, in collaboration with the Translational Genomics Research Institute (TGen), is helping launch a multi-center clinical trial that will investigate the application of innovations in precision medicine to treat advanced melanoma skin cancer.

Baylor Sammons Cancer Center is the only clinical site in Texas to offer this clinical trial, sponsored by Stand Up To Cancer (SU2C) and the Melanoma Research Alliance. These clinical trials are the culmination of nearly four years of research under a SU2C Melanoma Dream Team grant.

The study leverages advances in genomics, informatics and health information technology, which may yield more precise medical treatments for patients with this devastating disease. It is unique in researching more than 20 different treatment options in a single trial. By leveraging the power of cancer genomics, researchers believe they can provide each patient with the best drug for his or her individual situation. This design offers patients a huge advantage over the old model of treating all patients the same way and only testing one drug at a time.

“Inherent in the phrase ‘trial and error’ is the word error. This new way of approaching cancer therapy greatly increases the chance of getting the right treatment to the right patient the first time, without having to try multiple treatments, hoping to find one that works,” said Alan Miller, MD, chief of oncology for Baylor Scott & White Health – North Texas. “By offering over 20 different investigational treatments directed by analyzing the tumor at the molecular level, the odds of successful outcomes should increase dramatically. We are honored to be part of the SU2C team.”

Metastatic melanoma is a type of cancer that has spread from the skin to other parts of the body, most frequently the lungs, muscles, brain and liver. Metastatic melanoma is responsible for more than 9,000 deaths a year in the United States, so there remains an urgent need for new treatment options.

Baylor Scott & White Health, Baylor Research Institute and TGen researchers have a long history of innovative research into improving treatments for patients with metastatic melanoma. This new clinical trial investigates the next generation of precision medicine for this disease.

Recent dramatic advances in melanoma rest on the twin pillars of immunotherapy and genetically targeted therapy. Immunotherapy may lead to long-term disease control in 30 to 50 percent of patients. For the remainder of patients, approximately half, an alteration to the BRAF gene can be targeted by a new generation of pills. For the remaining patients, however, there are no other treatments proven to prolong life.

“We are addressing a continuing and significant unmet medical need for advanced melanoma patients who have progressed on our most promising current treatments,” said Jeffrey Trent, MD, TGen President and Research Director. "The Stand Up To Cancer-Melanoma Research Alliance grant gives us the ability to align cutting edge genomic research with world-recognized clinical centers like Baylor Sammons Cancer Center, all joining forces to conquer this terrible disease."

The SU2C Melanoma Dream Team is led by Dr. Trent and Pat LoRusso, DO, of the Yale University Cancer Center in New Haven, Conn. C. Lance Cowey, MD, co-chair of the Baylor University Medical Center Skin Malignancy Research and Treatment Center, serves as principal investigator for the site in Texas.

The clinical trial will enroll patients lacking a particular genetic mutation and for whom immune therapy did not work or was not an option. The multi-center trial, launched initially at Yale University, uses the latest molecular sequencing techniques to best match targeted drugs to the unique genetic alterations present in tumors missing the BRAF mutation. The study will evaluate whether using this precision therapy approach improves outcomes over current treatments.

The clinical trials for the project, titled Stand Up To Cancer Consortium Genomics-Enabled Medicine for Melanoma (GEMM): Using Molecularly-Guided Therapy for Patients with BRAF wild-type (BRAFwt) Metastatic Melanoma, is being led by Yale University and includes 12 other institutions:• Mayo Clinic Cancer Center (Scottsdale, Ariz.)• Smilow Cancer Hospital at Yale-New Haven (New Haven, Conn.)• Mayo Clinic Cancer Center (Jacksonville, Fla.)• Indiana University Cancer Center (Indianapolis, Ind.)• Biometrics Research Branch, National Cancer Institute, National Institutes of Health (Bethesda, Md.)• University of Michigan Comprehensive Cancer Center (UMCCC) (Ann Arbor, Mich.)• Barbara Ann Karmanos Cancer Institute, Wayne State University (Detroit, Mich.)• Mayo Clinic Cancer Center (Rochester, Minn.)• Memorial Sloan-Kettering Cancer Center (New York, N.Y.)• Columbia University Medical Center (New York, N.Y.)• UPMC Cancer Center – Pittsburgh (Pittsburgh, Penn.)• Vanderbilt University Medical Center (Nashville, Tenn.)

Additional support for this trial 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.

For further information regarding this study, please contact Baylor’s Office of Clinical Oncology Research Coordination at 214.818.8472 (or 817.698.8472) or via email at [email protected]. # # #

For interviews with Dr. Miller or a patient with metastatic melanoma, contact Kristine Hughes, Baylor Scott & White Health public relations, at 214.820.7556; [email protected].

For interviews with Dr. Trent, please contact: Steve Yozwiak, TGen senior science writer, at 602-343-8704; [email protected].

About TGenTranslational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with cancer, neurological disorders and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.

About Stand Up To CancerStand Up To Cancer (SU2C) – a program of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization – raises funds to accelerate the pace of groundbreaking translational research that will get new therapies to patients quickly.

About the Melanoma Research AllianceThe Melanoma Research Alliance is a public charity formed under the auspices of the Milken Institute, with the generous founding support of Debra and Leon Black. It supports an international, cross-disciplinary group of biomedical researchers possessing clinical and scientific expertise to explore, identify and pursue innovative solutions to critical research questions, leading to better treatments and a cure for melanoma patients. Since its founding in 2007, MRA has become the largest private funder of melanoma research. For more information about MRA's research programs, visit www.melanomaresearchalliance.org.

About Baylor Scott & White HealthBaylor Scott & White Health, the organization formed from the 2013 merger between Baylor Health Care System and Scott & White Healthcare, is today the largest not-for-profit health care system in the state of Texas. With total assets of $9 billion* and serving a population larger than the state of Virginia, Baylor Scott & White Health has the vision and resources to provide its patients continued quality care while creating a model system for a dramatically changing health care environment. The organization now includes 49 hospitals, more than 800 access points, more than 5,800 active physicians, 35,000 employees and the Scott & White Health Plan. For More Information visit: BaylorScottandWhite.com* based on unaudited 2014 fiscal year statements# # #