A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
- Conditions
- Biliary Tract Cancer
- Interventions
- Registration Number
- NCT07221253
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Durvalumab Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) Control Arm Gemcitabine/Cisplatin Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) Experimental Arm Rilvegostomig Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) Experimental Arm Gemcitabine/Cisplatin Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
- Primary Outcome Measures
Name Time Method Overall Survival (OS) in the PDL1 ≥ 1% population approximately 4 years Overall Survival is defined as time from randomization until the date of death due to any cause.
- Secondary Outcome Measures
Name Time Method Overall Survival in the intent to treat (ITT) population approximately 4 years Overall Survival is defined as time from randomization until the date of death due to any cause.
Progression Free Survival (PFS) in the PDL1 ≥ 1% population approximately 4 years 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.
Progression Free Survival (PFS) in the intent to treat (ITT) population approximately 4 years 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.
Objective Response Rate (ORR) in the PDL1 ≥ 1% population approximately 4 years ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.
Objective Response Rate (ORR) in the intent to treat (ITT) population approximately 4 years ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.
Duration of Response (DoR) in the PDL1 ≥ 1% population approximately 4 years 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.
Duration of Response (DoR) in the intent to treat (ITT) population approximately 4 years 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 to Second Progression or death (PFS2) in the PDL1 ≥ 1% population approximately 4 years 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 to Second Progression or death (PFS2) in the intent to treat (ITT) population approximately 4 years 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.
Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy approximately 4 years Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs and SAEs as assessed by CTCAE v5.0.
Immunogenicity of Rilvegostomig approximately 4 years Presence of ADA for rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).
PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough) Up to 12 weeks after disease progression Lowest observed plasma concentration of the study drug (Ctrough) prior to next dose
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax) Up to 12 weeks after disease progression Maximum observed plasma concentration of rilvegostomig
Serum rilvegostomig concentration Up to 12 weeks after disease progression To assess drug exposure (serum concentration) of IV rilvegostomig.
Assess patient reported biliary tract cancer symptoms (pain) Up to 12 weeks post disease progression 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).
Assess patient reported global health status/quality of life (GHS/QoL) Up to 12 weeks post disease progression 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).
Trial Locations
- Locations (1)
Research Site
🇹🇭Ongkharak, Thailand
Research Site🇹🇭Ongkharak, Thailand