This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
The purpose of this study is to assess the efficacy and tolerability of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line treatment in participants with advanced HCC. The study comprises 2 parts - a safety lead-in and a randomised period. Prior to the start of the randomised period of the study, a single-arm safety lead-in period will be applied to evaluate the safety and tolerability of rilvegostomig in combination with bevacizumab and tremelimumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,220
To demonstrate the efficacy of Arm A relative to Arm C by assessment of OS in participants with advanced HCC
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C by assessment of OS in participants with advanced HCC
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Up to approximately 6 years
To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relateive to Arm C in participants with advanced HCC
PFS according to RECIST 1.1
Time frame: Up to approximately 6 years
To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relateive to Arm C in participants with advanced HCC
ORR according to RECIST 1.1
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
OS
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
PFS
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
ORR
Time frame: Up to approximately 6 years
AstraZeneca Clinical Study Information Center
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IV therapy
Research Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Palo Alto, California, United States
RECRUITINGResearch Site
Santa Monica, California, United States
NOT_YET_RECRUITINGResearch Site
New Haven, Connecticut, United States
NOT_YET_RECRUITINGResearch Site
Newark, Delaware, United States
NOT_YET_RECRUITINGResearch Site
Jacksonville, Florida, United States
NOT_YET_RECRUITINGResearch Site
Atlanta, Georgia, United States
WITHDRAWNResearch Site
Fayetteville, Georgia, United States
NOT_YET_RECRUITINGResearch Site
Chicago, Illinois, United States
NOT_YET_RECRUITING...and 194 more locations
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
DoR
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: • OS
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: • PFS per RECIST 1.1
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: • ORR per RECIST 1.1
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: •DoR per RECIST 1.1
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: OS
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: PFS per RECIST 1.1
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: ORR per RECIST 1.1
Time frame: Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups
Association of PD-L1 expression level with: DoR per RECIST 1.1
Time frame: Up to approximately 6 years
To investigate the immunogenicity of Arm A and Arm B
Presence of ADAs for tremelimumab and rilvegostomig
Time frame: Up to approximately 6 years
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.
Time frame: Up to approximately 6 years