A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)
Summary
This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.
Detailed description
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
Arms & interventions
- BiologicalVolrustomig
IV Infusion
- OtherPlacebo
IV Infusion
Outcome measures
Primary
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
Time frame: Up to approximately 7 years
Secondary
Overall Survival (OS) in all randomized participants
Time frame: Up to approximately 7 years
Objective Response Rate (ORR) in all randomized participants
Time frame: Up to approximately 7 years
Duration of Response (DoR) in all randomized participants
Time frame: Up to approximately 7 years
Time to First Subsequent Therapy or death (TFST) in all randomized participants
Time frame: Up to approximately 7 years
Time to second progression or death (PFS2) in all randomized participants
Time frame: Up to approximately 7 years
PFS by BICR in all randomized participants
Time frame: Up to approximately 7 years
The incidence of local progression, and distant disease progression as the first documented progression event in all randomized participants
Time frame: Up to approximately 7 years
PK of volrustomig
Time frame: Up to approximately 7 years
The immunogenicity of volrustomig
Time frame: Up to approximately 7 years
Incidence of adverse events of volrustomig compared to placebo
Time frame: Up to approximately 7 years
Participant-reported disease-related symptoms
Time frame: Up to approximately 7 years
Participant-reported physical functioning
Time frame: Up to approximately 7 years
Participant-reported global health status/Quality of Life
Time frame: Up to approximately 7 years
Eligibility criteria
Study locations (28)
Research Site
Birmingham, Alabama, 35233
Research Site
Phoenix, Arizona, 85016
Research Site
Tucson, Arizona, 85711
Research Site
Little Rock, Arkansas, 72205
Research Site
La Jolla, California, 92093
Research Site
West Hollywood, California, 90048
Research Site
Atlanta, Georgia, 30322
Research Site
Augusta, Georgia, 30912
Research Site
Savannah, Georgia, 31405
Research Site
Melrose Park, Illinois, 60160
Research Site
Indianapolis, Indiana, 46202
Research Site
New Orleans, Louisiana, 70112
Research Site
New Orleans, Louisiana, 70121
Research Site
Shreveport, Louisiana, 71103
Research Site
New York, New York, 10016
Research Site
Syracuse, New York, 13210
Research Site
Cleveland, Ohio, 44195
Research Site
Columbus, Ohio, 43210
Research Site
Eugene, Oregon, 97401
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Providence, Rhode Island, 02905
Research Site
Dallas, Texas, 75390
Research Site
Fort Worth, Texas, 76104
Research Site
Houston, Texas, 77030
Research Site
Tyler, Texas, 75702
Research Site
Charlottesville, Virginia, 22908
Research Site
Fairfax, Virginia, 22031
Research Site
Richmond, Virginia, 23298