Spots Global Cancer Trial Database for Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
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Trial Identification
Brief Title: Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
Official Title: A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors
Study ID: NCT02646748
Study Description
Brief Summary: This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part 2). Two treatment groups (Group A and Group B) will be evaluated Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination. Once the recommended dose has been identified in Part 1a, subjects with select solid tumor types will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer (UC).
Detailed Description: This is an open-label, Phase 1b, 3 Part (Part 1a, Part 1b, and Part 2), multi-center study. Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination. Once the recommended dose has been identified in Part 1a, subjects with endometrial cancer, gastric cancer, melanoma, microsatellite unstable (MSI) colorectal cancer or other MMR-deficient tumors, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, triple negative breast cancer, pancreatic ductal carcinoma, or transitional cell carcinoma of the genitourinary tract will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer (UC).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
John Wayne Cancer Institute at Providence Saint John's Health Center, Santa Monica, California, United States
Georgetown University Medical Center Lombardi CCC, Washington, District of Columbia, United States
Hematology-Oncology Associates of Treasure Coast, Port Saint Lucie, Florida, United States
Emory University, Winship Cancer Institute, Atlanta, Georgia, United States
University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States
The Center for Cancer and Blood Disorders (RCCA MD LLC-Maryland Vidision), Bethesda, Maryland, United States
Beth Israel Medical Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer institute, Boston, Massachusetts, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Henry Ford Hospital System, Detroit, Michigan, United States
St. Luke's Hospital of Kansas City, Kansas City, Missouri, United States
NYU Laura & Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
UPMC CancerCenters, Hilman Cancer Center, Pittsburgh, Pennsylvania, United States
HOPE Cancer Center of East Texas, Tyler, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Contact Details
Name: Peter B. Langmuir, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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