The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,100
Rilvegostomig IV (intravenous) Q3W
Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle
Overall Survival (OS) in the PDL1 ≥ 1% population
Overall Survival is defined as time from randomization until the date of death due to any cause.
Time frame: approximately 4 years
Overall Survival in the intent to treat (ITT) population
Overall Survival is defined as time from randomization until the date of death due to any cause.
Time frame: approximately 4 years
Progression Free Survival (PFS) in the PDL1 ≥ 1% population
PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression), whichever occurs first.
Time frame: approximately 4 years
Progression Free Survival (PFS) in the intent to treat (ITT) population
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first.
Time frame: approximately 4 years
Objective Response Rate (ORR) in the PDL1 ≥ 1% population
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.
Time frame: approximately 4 years
Objective Response Rate (ORR) in the intent to treat (ITT) population
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.
Time frame: approximately 4 years
Duration of Response (DoR) in the PDL1 ≥ 1% population
AstraZeneca Clinical Study Information Center
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Research Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Duarte, California, United States
NOT_YET_RECRUITINGResearch Site
Orange, California, United States
NOT_YET_RECRUITINGResearch Site
Santa Monica, California, United States
NOT_YET_RECRUITINGResearch Site
Stanford, California, United States
NOT_YET_RECRUITINGResearch Site
Aurora, Colorado, United States
NOT_YET_RECRUITINGResearch Site
Hartford, Connecticut, United States
NOT_YET_RECRUITINGResearch Site
New Haven, Connecticut, United States
NOT_YET_RECRUITING...and 155 more locations
DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first.
Time frame: approximately 4 years
Duration of Response (DoR) in the intent to treat (ITT) population
DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first.
Time frame: approximately 4 years
Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
Time frame: approximately 4 years
Time to Second Progression or death (PFS2) in the intent to treat (ITT) population
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
Time frame: approximately 4 years
Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy
Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs and SAEs as assessed by CTCAE v5.0.
Time frame: approximately 4 years
Immunogenicity of Rilvegostomig
Presence of ADA for rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).
Time frame: approximately 4 years
PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough)
Lowest observed plasma concentration of the study drug (Ctrough) prior to next dose
Time frame: Up to 12 weeks after disease progression
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of rilvegostomig
Time frame: Up to 12 weeks after disease progression
Serum rilvegostomig concentration
To assess drug exposure (serum concentration) of IV rilvegostomig.
Time frame: Up to 12 weeks after disease progression
Assess patient reported biliary tract cancer symptoms (pain)
Patient reported biliary tract cancer symptoms (pain) will be evaluated by the proportion of randomized patients with maintained or improved pain as assessed by the EORTC Item Library 445 and EORTC Item Library 446 (custom questionnaires that include measures of pain-in back, in stomach area, during the night; min/max values from 1-4, with higher scores indicating a worse outcome).
Time frame: Up to 12 weeks post disease progression
Assess patient reported global health status/quality of life (GHS/QoL)
Patient reported GHS/QoL will be evaluated by the proportion of randomized patients with maintained or improved GHS/QoL as assessed by the EORTC Item Library 172 (custom questionnaire that includes measures of overall health and overall quality of life; min/max values from 1-7, with higher scores indicating a better outcome).
Time frame: Up to 12 weeks post disease progression