Recruiting NCT07221253

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

Phase III Interventional Biliary Tract Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin.
Who it may be relevant to: Registry conditions: Biliary Tract Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, Canada +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)

Overview

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.

Interventions

Drug Rilvegostomig
Rilvegostomig IV (intravenous) Q3W
Drug Durvalumab
Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
Drug Gemcitabine/Cisplatin
Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Primary outcome measures

Overall Survival (OS) in the PDL1 ≥ 1% population [Time frame: approximately 4 years]

Secondary outcome measures (12)

Overall Survival in the intent to treat (ITT) population [Time frame: approximately 4 years]
Progression Free Survival (PFS) in the PDL1 ≥ 1% population [Time frame: approximately 4 years]
Progression Free Survival (PFS) in the intent to treat (ITT) population [Time frame: approximately 4 years]
Objective Response Rate (ORR) in the PDL1 ≥ 1% population [Time frame: approximately 4 years]
Objective Response Rate (ORR) in the intent to treat (ITT) population [Time frame: approximately 4 years]
Duration of Response (DoR) in the PDL1 ≥ 1% population [Time frame: approximately 4 years]
Duration of Response (DoR) in the intent to treat (ITT) population [Time frame: approximately 4 years]
Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population [Time frame: approximately 4 years]
Time to Second Progression or death (PFS2) in the intent to treat (ITT) population [Time frame: approximately 4 years]
Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy [Time frame: approximately 4 years]
Immunogenicity of Rilvegostomig [Time frame: approximately 4 years]
PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough) [Time frame: Up to 12 weeks after disease progression]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 36 centers

Research Site — Birmingham
Research Site — Phoenix
Research Site — Tucson
Research Site — Duarte
Research Site — Orange
Research Site — Palo Alto
Research Site — Santa Monica
Research Site — Aurora
… and 28 more centers

China · 22 centers

Research Site — Beijing
Research Site — Beijing
Research Site — Changchun
Research Site — Changde
Research Site — Changsha
Research Site — Changsha
Research Site — Chengdu
Research Site — Fuzhou
… and 14 more centers

Germany · 17 centers