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A trial to learn how safe the combination of rilvegostomig and chemotherapy is and how well it works compared to durvalumab and chemotherapy in adults with advanced biliary tract cancer
EU CTIS ID: 2025-523085-24-00
What this study is testing
To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of Overall Survival (OS) in the PD-L1 ≥ 1% population.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Ampullary carcinoma.
- Any prior systemic therapy received for unresectable locally advanced or metastatic BTC.
- Any prior exposure to any 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Thailand
- Canada
- China
- Brazil
- India
- United Kingdom
- Australia
- Japan
- Taiwan
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Thailand; Canada; China; Brazil; India and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.