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)

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 3

Start date: Dec. 4, 2025

Planned enrollment: 1100

Trial ID: NCT07221253
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More trial details at ClinicalTrials.gov More info

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chevron Show for: Rilvegostomig (AZD2936)

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Goal: To compare the efficacy and safety of rilvegostomig plus gemcitabine/cisplatin versus durvalumab plus gemcitabine/cisplatin as first-line therapy for unresectable locally advanced or metastatic biliary tract cancer, with a primary focus on improving overall survival in PD-L1–positive disease.

Patients: Adults with histologically confirmed biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, or gallbladder carcinoma) that is unresectable locally advanced or metastatic and previously untreated in the advanced setting. Patients must have centrally assessed PD-L1 status, measurable disease by RECIST 1.1, ECOG performance status 0–1, and adequate organ function. Key exclusions include ampullary carcinoma, prior systemic therapy for advanced disease, prior exposure to immune checkpoint/immune-regulatory therapies, and active autoimmune/inflammatory disorders requiring immunosuppression, as well as active/ongoing interstitial lung disease or other significant inflammatory toxicities that could be exacerbated by immunotherapy.

Design: Phase III, randomized, open-label, global multicenter comparative study with approximately 1100 planned participants. Randomization assigns patients to experimental versus active comparator immunotherapy, each given with the same chemotherapy backbone in the first-line advanced setting, with efficacy assessed over approximately 4 years.

Treatments: Experimental arm: rilvegostomig administered by IV infusion in combination with gemcitabine and cisplatin. Rilvegostomig (AZD2936) is a humanized IgG1 bispecific antibody targeting PD-1 and TIGIT to enhance antitumor T-cell activity; it incorporates Fc modifications intended to reduce Fc-mediated effector functions. Early phase data in heavily pretreated advanced NSCLC suggested an acceptable safety profile with predominantly grade 1–3 treatment-related adverse events (commonly pruritus, rash, and increased lipase) and low rates of serious treatment-related events; preliminary antitumor activity included confirmed partial responses and durable disease control in a subset, supporting phase III evaluation. Control arm: durvalumab (anti–PD-L1 monoclonal antibody) by IV infusion combined with gemcitabine and cisplatin, representing an established immunotherapy-plus-chemotherapy approach in advanced biliary tract cancer.

Outcomes: Primary endpoint is overall survival in the PD-L1 ≥1% population. Key secondary endpoints include overall survival in the intent-to-treat population; progression-free survival (PD-L1 ≥1% and intent-to-treat); objective response rate and duration of response (PD-L1 ≥1% and intent-to-treat); and PFS2 (time to second progression or death) in both PD-L1 ≥1% and intent-to-treat populations. Additional secondary objectives include comparative safety/tolerability (CTCAE v5.0), rilvegostomig immunogenicity (anti-drug antibodies), pharmacokinetics (Ctrough, Cmax, and serum concentrations), and patient-reported outcomes assessing pain and global health status/quality of life through customized EORTC item library measures.

Burden on patient: Moderate burden. Treatment requires repeated IV infusions of chemotherapy plus immunotherapy and standard safety monitoring typical for gemcitabine/cisplatin regimens, along with serial imaging (CT or MRI) for RECIST-based assessments over long follow-up. Requirements that add incremental burden beyond routine care include central PD-L1 testing on tumor tissue (may necessitate providing archival tissue and, if inadequate, could require an additional biopsy depending on local practice), immunogenicity sampling, and additional pharmacokinetic blood draws for rilvegostomig through progression and for up to 12 weeks afterward, as well as completion of patient-reported symptom and quality-of-life questionnaires. The open-label design does not reduce visit frequency, and global multicenter participation may entail regular travel to infusion centers consistent with standard first-line IV therapy.

Last updated: Jan 2026

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