Sponsor: AstraZeneca (industry)
Phase: 3
Start date: Dec. 4, 2025
Planned enrollment: 1100
Rilvegostomig (AZD2936) is an investigational bispecific monoclonal antibody from AstraZeneca that targets PD‑1 and TIGIT. It is being studied across multiple tumor types, with ongoing phase 3 programs including first‑line metastatic non‑squamous NSCLC (ARTEMIDE‑Lung03), adjuvant biliary tract cancer after resection (ARTEMIDE‑Biliary01), first‑line advanced hepatocellular carcinoma (ARTEMIDE‑HCC01), and first‑line HER2‑positive, PD‑L1–positive gastric/GEJ cancer (ARTEMIDE‑Gastric01). (cdek.pharmacy.purdue.edu)
NSCLC (ARTEMIDE‑01, Phase I/II)
Ongoing phase 3 studies (no efficacy readouts yet)
Notes: Human efficacy data to date are from phase I/II NSCLC cohorts; phase 3 trials listed above are ongoing without reported outcomes as of October 7, 2025. (cdek.pharmacy.purdue.edu)
Last updated: Oct 2025
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
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.
Halifax, Nova Scotia, B3H 2Y9, Canada
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Seoul, 03080, South Korea
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Seoul, 05505, South Korea
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Taichung, 40447, Taiwan
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Taipei, 112, Taiwan
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Murdoch, 6150, Australia
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Darlinghurst, 2010, Australia
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Barretos, 14784-400, Brazil
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Natal, 59075-740, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Taoyuan District, 333, Taiwan
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Manchester, M20 4BX, United Kingdom
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Aurora, Colorado, 80045, United States
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Hartford, Connecticut, 06102, United States
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Washington D.C., District of Columbia, 20007, United States
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Jacksonville, Florida, 32224, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Ann Arbor, Michigan, 48109, United States
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Rochester, Minnesota, 55905, United States
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Omaha, Nebraska, 68198-5885, United States
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Santa Fe, New Mexico, 87505, United States
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Portland, Oregon, 97239, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Philadelphia, Pennsylvania, 19111, United States
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Providence, Rhode Island, 02903, United States
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Sioux Falls, South Dakota, 57105, United States
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Lishui, 323000, China
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Status: Withdrawn
New York, New York, 10065, United States
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Status: Withdrawn