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Brief Title: Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
Official Title: A Multicenter, Non-randomized, Open-label Phase 1b Study to Determine the Maximum Tolerated and Recommended Phase 2 Dose of the ATR Inhibitor Elimusertib in Combination With Pembrolizumab and to Characterize Its Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Participants With Advanced Solid Tumors
Study ID: NCT04095273
Brief Summary: The purpose of the study is to test how well patients with advanced solid tumors respond to treatment with elimusertib (BAY1895344) in combination with pembrolizumab. In addition researchers want to find for patients the optimal dose of elimusertib in combination with pembrolizumab, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication, elimusertib, works by blocking a substance (ATR Kinase) which is produced by the body and is important for the growth of tumor cells. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Palo Alto, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Johns Hopkins Hospital/Health System, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Weill Cornell Medical College, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Eberhard-Karls-Universität Tübingen, Tübingen, Baden-Württemberg, Germany
Fundacion Jimenez Diaz (Clinica de la Concepcion), Madrid, , Spain
Hospital Madrid Norte Sanchinarro, Madrid, , Spain
Kantonsspital St. Gallen, St. Gallen, Sankt Gallen, Switzerland
Ospedale Regionale di Bellinzona e Valli, Bellinzona, Ticino, Switzerland
Royal Marsden NHS Trust (Surrey), Sutton, Surrey, United Kingdom
Freeman Hospital, Newcastle, Tyne And Wear, United Kingdom