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Study of Rilvegostomig or Durvalumab +Chemo for 1st Line Tx of BTC (ARTEMIDE-Biliary02) (AB02)

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full 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)
Protocol number OCR49425
ClinicalTrials.gov ID NCT07221253
Phase Phase 3

Eligibility

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.

Lead researcher

  • Gahyun Gim, MD
    Cancer Specialist (Oncologist), Hematology and Oncology Specialist

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  1. Step
    1

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  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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