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Two New Melanoma Trials for Children Opening at UPMC Children’s Hospital of Pittsburgh

July 26, 2019

Two new clinical trial opportunities are opening at UPMC Children’s Hospital of Pittsburgh in the Division of Pediatric Hematology/Oncology for young patients with melanoma.

 The first trial, “A Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma” will use a combined targeted therapy for advanced melanoma. This same regimen has been shown to be well-tolerated and efficacious in adults with melanoma in previous studies.

This international, multicenter study is now open and recruiting patients at UPMC Children’s. UPMC Children’s is the first site in the United States to open for this trial, and only two other U.S. sites are currently planning participation (Houston and Baltimore).

 Brittani Seynnaeve, MD, MS, assistant professor of pediatrics, director of the pediatric melanoma program, and associate fellowship program director in the Division of Pediatric Hematology/Oncology at UPMC Children’s is the site principal investigator for this study.

 Full details and trial information can be found at (NCT03878719).

 KEYNOTE-716 Study

The second new study for pediatric melanoma patients, currently planned to open in the summer of 2019 is the “Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716).” This study will investigate the efficacy of the immunotherapy agent pembrolizumab in fully resected, localized high-risk stage II melanoma. This investigation is designed to determine if an increase in recurrence-free survival can be obtained by using pembrolizumab in patients aged 12 to 17 years. Dr. Seynnaeve will lead this study when it opens at UPMC Children’s.

This multicenter, international trial is a two-part study to evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants that complete 17 cycles of pembrolizumab and experience disease recurrence may be eligible to receive additional cycles of pembrolizumab in Part 2 in an open-label design.

 Complete details of the trial are available at (NCT03553836).

 A corollary study is currently open at UPMC Hillman Cancer Center for patients 18 years and older. John Kirkwood, MD, Usher Professor of Medicine, Dermatology, and Translational Science, principal investigator of the melanoma and skin cancer SPORE, and co-leader of the Melanoma and Skin Cancer Program at UPMC Hillman Cancer Center is the site principal investigator of the trial for adult patients under the same NCT trial number.

 About the UPMC Children’s Division of Pediatric Hematology/Oncology

Under the leadership of Linda M. McAllister-Lucas, MD, PhD, division chief and associate professor of pediatrics at the University of Pittsburgh School of Medicine, UPMC Children’s Division of Pediatric Hematology/Oncology boasts the largest and most comprehensive care center in western Pennsylvania, eastern Ohio, and northern West Virginia for pediatric and young adult patients with all forms of cancer and disorders of the blood. The Division supports an extensive research program of basic science, translational investigations, and clinical trials. This work is collectively dedicated to uncovering new insights and knowledge with respect to how and why cancers develop and spread, and to developing the next generation of therapies.

 UPMC Children’s Hospital of Pittsburgh

Regionally, nationally, and globally, UPMC Children’s Hospital of Pittsburgh is a leader in the treatment of childhood conditions and diseases, a pioneer in the development of new and improved therapies, and a top educator of the next generation of pediatricians and pediatric subspecialists. With generous community support, UPMC Children’s has fulfilled this mission since its founding in 1890. UPMC Children’s is recognized consistently for its clinical, research, educational, and advocacy-related accomplishments, including ranking 15th among children’s hospitals and schools of medicine in funding for pediatric research provided by the National Institutes of Health (FY2018).

 Affiliated with the University of Pittsburgh School of Medicine and ranked among the nation’s best children’s hospitals by U.S. News & World Report.