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OncoMatch/Clinical Trials/NCT07221253

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

Is NCT07221253 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Rilvegostomig and Durvalumab for biliary tract cancer.

Phase 3RecruitingAstraZenecaNCT07221253Data as of Jun 2026Location: International · 19 countries

Treatment: Rilvegostomig · Durvalumab · Gemcitabine/CisplatinThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

RilvegostomigDurvalumab

Chemotherapy

Gemcitabine/Cisplatin

Cancer type

Cholangiocarcinoma

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.

Cannot have received: immune-regulatory receptor or mechanism targeting therapy

Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.

Lab requirements

Blood counts

adequate bone marrow function

Kidney function

adequate organ function

Liver function

adequate organ function

Adequate bone marrow and organ function.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Birmingham, Alabama
  • Research Site · Phoenix, Arizona
  • Research Site · Tucson, Arizona
  • Research Site · Duarte, California
  • Research Site · Orange, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07221253 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CD274?

Yes, CD274 any tested is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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