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Rilvegostomig + Chemotherapy for Biliary Tract Cancer (ARTEMIDE-Bil01 Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1)
Eastern Cooperative Oncology Group performance status of 0 or 1
Must not have
Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors
Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug called rilvegostomig to see if it can help prevent biliary tract cancer from coming back after surgery. The study includes patients who have had surgery to remove their cancer but are still at risk of it returning. Rilvegostomig will be used along with standard chemotherapy to see if this combination is more effective.

Who is the study for?
This trial is for individuals who've had surgery to remove biliary tract cancer and are now disease-free. They should have a performance status indicating they can carry out daily activities with ease or minor limitations, and must not have used immunosuppressive drugs recently, nor have autoimmune disorders, severe diseases, recent thromboembolic events, or active hepatitis infections.
What is being tested?
The study compares the effectiveness of Rilvegostomig plus chemotherapy against a placebo combined with chemotherapy in patients who've undergone surgery for biliary tract cancer. The goal is to see if Rilvegostomig can prevent the cancer from coming back.
What are the potential side effects?
Possible side effects include reactions related to the immune system due to Rilvegostomig, as well as typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bile duct cancer was confirmed by a lab test and has been fully removed.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is ampullary, neuroendocrine, mixed, or non-epithelial.
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My cancer was advanced or had spread at the time of diagnosis.
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I have an autoimmune or severe uncontrolled disease.
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I haven't taken immunosuppressive drugs in the last 14 days.
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I have treated my hepatitis B or C infection.
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I have received cancer treatment for bile duct cancer before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence free survival (RFS) for Arm A vs. Arm B
Secondary study objectives
Overall Survival (OS) for Arm A vs. Arm B
Other study objectives
Patient-reported tolerability Arm A vs. Arm B.
Progression Free Survival (PFS) following recurrence Arm A vs. Arm B.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment4 Interventions
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Group II: Arm BPlacebo Group4 Interventions
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~4280
Gemcitabine/Cisplatin
2007
Completed Phase 3
~750

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,121,983 Total Patients Enrolled
~500 spots leftby Jun 2029
Unbiased ResultsWe believe in providing patients with all the options.
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