Home › Trials › NCT07221253

Rilvegostomig or durvalumab with gemcitabine–cisplatin for first-line biliary tract cancer

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)

Phase 3 Interventional AstraZeneca · NCT07221253

This compares rilvegostomig plus gemcitabine–cisplatin to durvalumab plus gemcitabine–cisplatin as first treatment for people with advanced biliary tract cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1100 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, durvalumab
Locations168 sites (Birmingham, Alabama and 167 other locations)
Trial IDNCT07221253 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized interventional trial assigns adults with unresectable locally advanced or metastatic biliary tract adenocarcinoma to receive either rilvegostomig plus gemcitabine and cisplatin or durvalumab plus gemcitabine and cisplatin as first-line therapy. Patients must have measurable disease by RECIST 1.1, ECOG performance status 0–1, adequate organ function, and a tumor sample for central PD-L1 testing. Tumor responses will be followed with serial CT or MRI scans and participants will undergo ongoing safety monitoring during and after treatment. The main goals are to compare efficacy and safety between the two regimens in this patient population.

Who should consider this trial

Good fit: Adults with histologically confirmed intra- or extra-hepatic cholangiocarcinoma or gallbladder carcinoma that is unresectable or metastatic, untreated in the advanced setting, with measurable disease, ECOG 0–1, adequate organ function, and an available tumor sample for PD-L1 testing are ideal candidates.

Not a fit: Patients with ampullary carcinoma, prior systemic therapy for unresectable/metastatic BTC, prior exposure to immune-regulatory therapies, poor performance status (ECOG >1), or inadequate organ function are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, the rilvegostomig regimen could provide a more effective first-line immunotherapy option that improves response or survival for people with advanced biliary tract cancer.

How similar studies have performed: Durvalumab plus gemcitabine–cisplatin has shown improved outcomes in prior trials (e.g., TOPAZ-1), while rilvegostomig as a bispecific antibody is a newer approach with more limited clinical experience in biliary tract cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 167 other locations

+118 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Biliary Tract CancerRilvegostomigDurvalumabBispecific AntibodyPD-L1TIGITInitially UnresectableRecurrent
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.