NCT07221253 A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
| NCT ID | NCT07221253 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Biliary Tract Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2029-07-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,100 participants in total. It began in 2025-12-04 with a primary completion date of 2029-07-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07221253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Biliary Tract Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07221253 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,100 participants.
Is NCT07221253 currently recruiting?
Yes, NCT07221253 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07221253 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Tucson, United States, Duarte, United States and 11 additional locations.
Who is sponsoring the NCT07221253 clinical trial?
NCT07221253 is sponsored by AstraZeneca. The trial plans to enroll 1,100 participants.
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