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

NCT07221253

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Biliary Tract Cancer

Interventions: Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin

Countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (174)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Duarte, California, United States
Orange, California, United States
Palo Alto, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Santa Fe, New Mexico, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Portland, Oregon, United States
Lancaster, Pennsylvania, United States
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