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RecruitingInterventionalPhase 3

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)

NCT ID: NCT07221253Sponsor: AstraZenecaLast updated: 2026-06-18

Summary

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.

Arms & interventions

  • DrugRilvegostomig

    Rilvegostomig IV (intravenous) Q3W

  • DrugDurvalumab

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

  • DrugGemcitabine/Cisplatin

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

Outcome measures

Primary

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

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

    Time frame: approximately 4 years

Secondary

  • Overall Survival in the intent to treat (ITT) population

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

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

    Time frame: approximately 4 years

  • Immunogenicity of Rilvegostomig

    Time frame: approximately 4 years

  • 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

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

    Time frame: Up to 12 weeks after disease progression

  • Serum rilvegostomig concentration

    Time frame: Up to 12 weeks after disease progression

  • Assess patient reported biliary tract cancer symptoms (pain)

    Time frame: Up to 12 weeks post disease progression

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

    Time frame: Up to 12 weeks post disease progression

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (36)

Research Site

Birmingham, Alabama, 35233

Not Yet Recruiting

Research Site

Phoenix, Arizona, 85054

Not Yet Recruiting

Research Site

Tucson, Arizona, 85719

Recruiting

Research Site

Duarte, California, 91010

Recruiting

Research Site

Orange, California, 92868

Recruiting

Research Site

Palo Alto, California, 94304

Recruiting

Research Site

Santa Monica, California, 90404

Not Yet Recruiting

Research Site

Aurora, Colorado, 80045

Recruiting

Research Site

Hartford, Connecticut, 06102

Not Yet Recruiting

Research Site

New Haven, Connecticut, 06510

Not Yet Recruiting

Research Site

Washington D.C., District of Columbia, 20007

Not Yet Recruiting

Research Site

Washington D.C., District of Columbia, 20037

Not Yet Recruiting

Research Site

Jacksonville, Florida, 32209

Not Yet Recruiting

Research Site

Jacksonville, Florida, 32224

Not Yet Recruiting

Research Site

Marietta, Georgia, 30060

Recruiting

Research Site

Chicago, Illinois, 60612

Not Yet Recruiting

Research Site

Chicago, Illinois, 60637

Not Yet Recruiting

Research Site

Indianapolis, Indiana, 46202

Not Yet Recruiting

Research Site

Louisville, Kentucky, 40217

Not Yet Recruiting

Research Site

Baltimore, Maryland, 21231

Recruiting

Research Site

Ann Arbor, Michigan, 48109

Not Yet Recruiting

Research Site

Detroit, Michigan, 48202

Not Yet Recruiting

Research Site

Rochester, Minnesota, 55905

Not Yet Recruiting

Research Site

Omaha, Nebraska, 68198-5885

Not Yet Recruiting

Research Site

Santa Fe, New Mexico, 87505

Recruiting

Research Site

New York, New York, 10016

Not Yet Recruiting

Research Site

New York, New York, 10032

Not Yet Recruiting

Research Site

New York, New York, 10065

Withdrawn

Research Site

Portland, Oregon, 97239

Not Yet Recruiting

Research Site

Philadelphia, Pennsylvania, 19104

Not Yet Recruiting

Research Site

Philadelphia, Pennsylvania, 19111

Not Yet Recruiting

Research Site

Pittsburgh, Pennsylvania, 15212

Not Yet Recruiting

Research Site

Providence, Rhode Island, 02903

Recruiting

Research Site

Pierre, South Dakota, 57501

Recruiting

Research Site

Sioux Falls, South Dakota, 57105

Recruiting

Research Site

Houston, Texas, 77030

Not Yet Recruiting
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) | Cancerify