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Brief Title: A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
Official Title: Phase 1/2a Study of Double-Immune Suppression Blockade By Combining a CSF1R Inhibitor (PLX3397) With An Anti-PD-1 Antibody (Pembrolizumab) To Treat Advanced Melanoma And Other Solid Tumors
Study ID: NCT02452424
Brief Summary: The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work together to affect cancer cells. PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to block the interaction between the receptor PD-1 and molecules that bind PD-1. In this study, PLX3397 and pembrolizumab are being given together in order to study their combined effects on patients' immune responses to their tumors. Tumor-specific immune responses have been shown to kill cancer cells and/or to stop tumors from growing. Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include an evaluation of efficacy of this combination in the following tumor types: * Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded * Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as defined by irRECIST while on therapy * Non-small cell lung cancer * Ovarian cancer * Gastrointestinal Stromal Tumor (GIST) * Squamous cell cancer of the head and neck
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Research Institute, Scottsdale, Arizona, United States
Marin Cancer Care, Greenbrae, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University St. Louis Siteman Cancer Center, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Medical University Health Hollings Cancer Center, Charleston, South Carolina, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States