Health Trials

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

ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rilvegostomig

    Drug

    Rilvegostomig IV (intravenous) Q3W

  • Durvalumab

    Drug

    Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.

  • Gemcitabine/Cisplatin

    Drug

    Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Treatment groups

1,100 Participants
are divided into 2 treatment groups
Group A: Control ArmActive comparator 2 interventions
Group B: Experimental ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS) in the PDL1 ≥ 1% population

Overall Survival is defined as time from randomization until the date of death due to any cause.

Time frame
approximately 4 years

Secondary outcomes

1

Overall Survival in the intent to treat (ITT) population

Overall Survival is defined as time from randomization until the date of death due to any cause.

Time frame
approximately 4 years
2

Progression Free Survival (PFS) in the PDL1 ≥ 1% population

PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression), whichever occurs first.

Time frame
approximately 4 years
3

Progression Free Survival (PFS) in the intent to treat (ITT) population

PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first.

Time frame
approximately 4 years
4

Objective Response Rate (ORR) in the PDL1 ≥ 1% population

ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.

Time frame
approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
Apply now