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Spots Global Cancer Trial Database for A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

Official Title: A Phase 1b/2 Study of ARRY-382 in Combination With Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients With Advanced Solid Tumors

Study ID: NCT02880371

Study Description

Brief Summary: This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in adult patients with selected advanced solid tumors (Part A/Phase 1b); and to estimate the efficacy of the combination in three separate cohorts: 1) patients with advanced solid tumors that have progressed on prior PD-1/PD-L1inhibitors, 2) patients with platinum-resistant ovarian cancer and 3) patients with pancreatic ductal adenocarcinoma (Phase 2).

Detailed Description: ARRY-382 is an inhibitor of CSF1R (colony-stimulating factor-1 receptor). Each phase of the study consists of a 28-day screening period; 21-day treatment cycles with the combination of ARRY-382 and pembrolizumab until disease progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, or death (or other discontinuation criteria are met), and a 30-day safety follow-up period. Patients in all cohorts/phases will be monitored for overall survival (OS) until 1 year after the date of the last patient's first visit.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

UCLA Hematology/Oncology, Los Angeles, California, United States

UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States

University of Colorado Denver, Aurora, Colorado, United States

University of Colorado Hospital, Aurora, Colorado, United States

Hem-Onc Associates of Treasure Coast, Port Saint Lucie, Florida, United States

Parkview Cancer Institute, Fort Wayne, Indiana, United States

Parkview Regional Medical Center, Fort Wayne, Indiana, United States

Parkview Research Center, Fort Wayne, Indiana, United States

PPG, Fort Wayne, Indiana, United States

Horizon Oncology Research, Inc., Lafayette, Indiana, United States

Hall-Perrine Cancer Center Laboratory, Cedar Rapids, Iowa, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Brigham and Women's 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

Mayo Clinic Labs - Rochester Superior, Rochester, Minnesota, United States

Regions Cancer Care Center, Saint Paul, Minnesota, United States

Regions Hospital Pharmacy, Saint Paul, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

HealthPartners Neurosciences Center, Saint Paul, Minnesota, United States

Tennessee Oncology PLLC, Nashville, Tennessee, United States

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

The Sarah Cannon Research Institute, Nashville, Tennessee, United States

UT Health Cancer Center, San Antonio, Texas, United States

UTAH Cancer Specialists, Salt Lake City, Utah, United States

ARUP Laboratories, Inc., Salt Lake City, Utah, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

UVA Health System, Charlottesville, Virginia, United States

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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