A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer
Status: Terminated
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histological or cytological confirmation of recurrent or metastatic HNSCC
• Measurable disease as defined by RECIST v1.1
• PD-L1 positive
Locations
United States
Alabama
University of Alabama Comprehensive Cancer Center
Birmingham
Arizona
University of Arizona Cancer Center
Tucson
California
UC San Diego Moores Cancer Center
La Jolla
Connecticut
Yale University Cancer Center
New Haven
Florida
Moffitt Cancer Center
Tampa
Georgia
Emory University Hospital
Atlanta
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Kansas
University of Kansas
Westwood
Kentucky
James Graham Brown Cancer Center
Louisville
Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore
Michigan
Karmanos Cancer Institute
Detroit
Minnesota
Regions Cancer Care Center
Saint Paul
Missouri
Washington University School of Medicine
Saint Louis
Pennsylvania
University Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh
South Carolina
MUSC Hollings Cancer Center
Charleston
Tennessee
Vanderbilt-Ingram Cancer Center
Nashville
Texas
Baylor University Medical Center
Dallas
Time Frame
Start Date: 2019-08-26
Completion Date: 2021-06-10
Participants
Target number of participants: 16
Treatments
Experimental: ADU-S100 and pembrolizumab
All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
Authors
Sponsors
Leads: Chinook Therapeutics, Inc. (formerly Aduro)