ClinicaliQ Trial Snapshot
- A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) — Recruiting • Phase III • Oncology • NCT07221253.
- Treatment being tested: Two immunotherapy-based regimens for advanced biliary tract cancer (BTC)—rilvegostomig combined with gemcitabine/cisplatin versus durvalumab combined with gemcitabine/cisplatin—compared as first-line therapy in treatment-Phase IIIïve patients.
- Patient eligibility overview: Adults with advanced (unresectable or metastatic) biliary tract cancer who have not received prior systemic chemotherapy and have adequate organ function; enrolled across multiple centres to evaluate both agents' efficacy and tolerability.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.