NCT02637531 - A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 | Biotech Hunter

Enrollment

219

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

January 31, 2022

Study Completion Date

December 31, 2022

Conditions

Advanced Solid Tumors (Part A/B/C/D)Non-small Cell Lung Cancer (Part E)Melanoma (Part E)Squamous Cell Cancer of the Head and Neck (Part E)Triple Negative Breast Cancer (Part F)Adrenocortical Carcinoma (Part G)Mesothelioma (Part G)High-circulating Myeloid-derived Suppressor Cells (Part H)

Interventions

DRUG

IPI-549 (eganelisib)

IPI-549 daily dose administered orally in 28-day cycles (Part A/BC/D/D-Annex/E)

DRUG

Nivolumab

Nivolumab (240 mg, Q2W) administered intravenously (IV) in 28-day cycles (Part C/D-Annex/E).

Trial Locations (11)

10065

Memorial Sloan Kettering Cancer Center, New York

30322

Emory University, Atlanta

34952

Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie

77030

MD Anderson Cancer Center, Houston

78229

South Texas Accelerated Research and Treatment (START), San Antonio

90404

UCLA, Santa Monica

92093

UCSD, San Diego

02116

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack