A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) (AB02)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Biliary Tract Cancer

Treatments: Drug: Rilvegostomig; Drug: Gemcitabine/Cisplatin; Drug: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07221253

D702NC00001

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Treatment:

Drug: Durvalumab

Drug: Gemcitabine/Cisplatin

Experimental Arm

Experimental group

Description:

Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Treatment:

Drug: Gemcitabine/Cisplatin

Drug: Rilvegostomig