Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07221253

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Clayton, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
  • Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
  • Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
  • Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
  • ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.
  • Adequate bone marrow and organ function.

Key exclusion Criteria:

  • Ampullary carcinoma
  • Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
  • Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
  • Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.

Treatment and study plan

Rilvegostomig

Drug

Rilvegostomig IV (intravenous) Q3W

Other names: AZD2936

Durvalumab

Drug

Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.

Other names: IMFINZI

Gemcitabine/Cisplatin

Drug

Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Primary outcomes

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

    Time frame: approximately 4 years

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

Secondary outcomes

  1. Overall Survival in the intent to treat (ITT) population

    Time frame: approximately 4 years

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

  2. Progression Free Survival (PFS) in the PDL1 ≥ 1% population

    Time frame: 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.

  3. Progression Free Survival (PFS) in the intent to treat (ITT) population

    Time frame: 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.

  4. Objective Response Rate (ORR) in the PDL1 ≥ 1% population

    Time frame: approximately 4 years

    ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.

  5. Objective Response Rate (ORR) in the intent to treat (ITT) population

    Time frame: approximately 4 years

    ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.

  6. Duration of Response (DoR) in the PDL1 ≥ 1% population

    Time frame: 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.

  7. Duration of Response (DoR) in the intent to treat (ITT) population

    Time frame: 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.

  8. Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population

    Time frame: 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.

  9. Time to Second Progression or death (PFS2) in the intent to treat (ITT) population

    Time frame: 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.

  10. Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy

    Time frame: 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.

  11. Immunogenicity of Rilvegostomig

    Time frame: approximately 4 years

    Presence of ADA for rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).

  12. PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough)

    Time frame: Up to 12 weeks after disease progression

    Lowest observed plasma concentration of the study drug (Ctrough) prior to next dose

  13. PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)

    Time frame: Up to 12 weeks after disease progression

    Maximum observed plasma concentration of rilvegostomig

  14. Serum rilvegostomig concentration

    Time frame: Up to 12 weeks after disease progression

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

  15. Assess patient reported biliary tract cancer symptoms (pain)

    Time frame: 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).

  16. Assess patient reported global health status/quality of life (GHS/QoL)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)

Acronym: AB02

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 27, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.