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.
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
800
IV Infusion
IV Infusion
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
Overall Survival (OS) in all randomized participants
OS defined as time from randomization until the date of death due to any cause.
Time frame: Up to approximately 7 years
Objective Response Rate (ORR) in all randomized participants
ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1
Time frame: Up to approximately 7 years
Duration of Response (DoR) in all randomized participants
DoR in participants with a CR or PR: Time from date of first detection of CR or PR until the date of RECIST 1.1-defined radiological progression or histopathologically confirmed progression.
Time frame: Up to approximately 7 years
Time to First Subsequent Therapy or death (TFST) in all randomized participants
TFST: The time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.
Time frame: Up to approximately 7 years
Time to second progression or death (PFS2) in all randomized participants
PFS2: The time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death. The date of second progression will be recorded by the Investigator in the eCRF and defined according to local standard clinical practice.
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Research Site
Birmingham, Alabama, United States
WITHDRAWNResearch Site
Phoenix, Arizona, United States
WITHDRAWNResearch Site
Tucson, Arizona, United States
WITHDRAWNResearch Site
Little Rock, Arkansas, United States
WITHDRAWNResearch Site
La Jolla, California, United States
WITHDRAWNResearch Site
West Hollywood, California, United States
WITHDRAWNResearch Site
Atlanta, Georgia, United States
WITHDRAWNResearch Site
Augusta, Georgia, United States
WITHDRAWNResearch Site
Savannah, Georgia, United States
TERMINATEDResearch Site
Melrose Park, Illinois, United States
WITHDRAWN...and 195 more locations
Time frame: Up to approximately 7 years
PFS by BICR in all randomized participants
Endpoints based on the PFS by BICR assessment according to RECIST 1.1.
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
Incidence of Local Progression, and Distant Disease Progression: Number and percentage of participants who develop local progression, distant disease recurrence.
Time frame: Up to approximately 7 years
PK of volrustomig
Concentration of volrustomig in serum and PK parameters as data allow.
Time frame: Up to approximately 7 years
The immunogenicity of volrustomig
Incidence of ADAs against volrustomig in serum.
Time frame: Up to approximately 7 years
Incidence of adverse events of volrustomig compared to placebo
An AE is defined as the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a patient or clinical study participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to approximately 7 years
Participant-reported disease-related symptoms
Change from baseline as measured by the European Organization for Research and Treatment of Cancer IL318 (EORTC IL318, Symptom Experience subscale of the EORTC Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24)). The score of scale for EORTC IL318 is from 1-4.
Time frame: Up to approximately 7 years
Participant-reported physical functioning
Change from baseline of physical functioning as measured by the Patient Reported Outcomes Measurement Information System - Short Form - Physical Functioning 8c (PROMIS SF-PF 8c). The score of scale for PROMIS SF-PF 8c is from 1-5.
Time frame: Up to approximately 7 years
Participant-reported global health status/Quality of Life
Change from baseline of Global Health Status/ Quality of Life (GHS/QoL) as measured by the European Organization for Research and Treatment of Cancer IL172 (EORTC IL172). The score of scale for EORTC IL172 is from 1-7.
Time frame: Up to approximately 7 years