Spots Global Cancer Trial Database for A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)
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Trial Identification
Brief Title: A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)
Official Title: A PHASE 1B, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (AG-013736) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED RENAL CELL CANCER
Study ID: NCT02493751
Conditions
Study Description
Brief Summary: This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered in combination with axitinib is estimated (dose finding portion), the dose expansion phase will be opened to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Scottsdale Healthcare Hospitals d/b/a HonorHealth, Scottsdale, Arizona, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Brigham & Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Laura & Isaac Perlmutter Cancer Center At NYU Langone, New York, New York, United States
NYU Langone Medical Center, New York, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Henry Joyce Cancer Clinic, Nashville, Tennessee, United States
University of Utah, Huntsman Cancer Hospital, Salt Lake City, Utah, United States
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States
Niigata University Medical & Dental Hospital, Chuo-ku, Niigata, Niigata, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
Keio University Hospital, Shinjuku-ku, Tokyo, Japan
Mount Vernon Cancer Center, East and North Herts. NHS Trust, London, Middlesex, United Kingdom
St Helier Hospital, Carshalton, Surrey, United Kingdom
St. Bartholomew's Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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