A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

Overall Survival (OS) in the PDL1 ≥ 1% population

Timeframe: approximately 4 years

Overall Survival is defined as time from randomization until the date of death due to any cause.

Overall Survival in the intent to treat (ITT) population

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: Up to 12 weeks after disease progression

Maximum observed plasma concentration of rilvegostomig

Serum rilvegostomig concentration

Timeframe: Up to 12 weeks after disease progression

To assess drug exposure (serum concentration) of IV rilvegostomig.

Assess patient reported biliary tract cancer symptoms (pain)

Timeframe: 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)

Timeframe: 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).