Spots Global Cancer Trial Database for Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
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Trial Identification
Brief Title: Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
Official Title: A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.
Study ID: NCT05945823
Study Description
Brief Summary: This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
Detailed Description: Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. Subjects will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy during induction phase of the study and will continue on futibatinib in combination with pembrolizumab in consolidation phase.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles UCLA - Cancer Care - Santa Monica, Santa Monica, California, United States
Rocky Mountain Cancer Centers Midtown, Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Henry Ford Health System, Detroit, Michigan, United States
The Minniti Center - Medical Oncology and Hematology, Mickleton, New Jersey, United States
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)), Buffalo, New York, United States
NYU Langone, New York, New York, United States
Gabrail Cancer Center Research LLC, Canton, Ohio, United States
Alliance Cancer Specialists, Horsham, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Dallas VA Medical Center, Dallas, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Gundersen Lutheran Health System, La Crosse, Wisconsin, United States
Centre Hospitalier Regional Universitaire de Lille, Lille Cedex, , France
Centre Hospitalier Regional Universitaire Poitiers, Poitiers, , France
Krankenhaus Nordwest gGmbH, Frankfurt, , Germany
Universitaetsmedizin Mainz, Mainz, , Germany
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Contact Details
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