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Brief Title: A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer
Official Title: A Phase 2, Multicenter, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of AK104 in Subjects With Recurrent or Metastatic Cervical Cancer
Study ID: NCT04380805
Brief Summary: This is a Phase 2, global, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Womens Cancer Research Foundation, Newport Beach, California, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
BRCR Medical Center, Plantation, Florida, United States
Augusta University Medical Center, Augusta, Georgia, United States
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
Maryland Oncology Hematology (Plum Orchard), Silver Spring, Maryland, United States
Monter Cancer Center, Lake Success, New York, United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai, New York, New York, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa, Oklahoma, United States
Chattanooga's Program In Women's Oncology, Chattanooga, Tennessee, United States
Tennessee Oncology - Centennial Clinic, Nashville, Tennessee, United States
University of Texas Southwestern, Dallas, Texas, United States
Texas Oncology-Fort Worth Cancer Center, Fort Worth, Texas, United States
Lyndon B. Johnson Hospital (MD Anderson), Houston, Texas, United States
Texas Oncology (Woodlands), The Woodlands, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Pacific Gynecology Specialists, P. C., Seattle, Washington, United States
Monash Health, Clayton, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Ashford Cancer Centre Research, Adelaide, , Australia
Blacktown Hospital, Blacktown, , Australia
ICON Cancer Centre, Brisbane, , Australia
Auckland City Hospital, Grafton, Auckland, New Zealand
Name: Leslie Randall, MD
Affiliation: Virginia Commonwealth University
Role: STUDY_CHAIR