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Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

PHASE3RECRUITING

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

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Study details:

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)

Provision of a tumor sample collected at surgical resection.

Randomization within 12 weeks after resection with adequate healing and removal of drains.

Confirmed to be disease-free by imaging within 28 days prior to randomization.

Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion criteria

Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.

Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.

Any anti-cancer therapy for BTC prior to surgery

Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease

Current or prior use of immunosuppressive medication within 14 days before the first dose

Thromboembolic event within 3 months

Active HBV or HCV infection unless treated.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-12-04

Primary completion: 2029-06-29

Study completion finish: 2030-09-30

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06109779

Intervention or treatment

DRUG: Rilvegostomig

DRUG: Placebo

DRUG: Capecitabine

DRUG: Gemcitabine/Cisplatin

DRUG: S-1 [Tegafur/Oteracil/gimeracil]

Conditions

• Biliary Tract Cancer

Condition: Biliary Tract Cancer
DRUG: Rilvegostomig and other drugs
Camperdown, Not Specified, Australia and more
Sponsor: AstraZeneca

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Research Site

Research sites nearby

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Research Site
Camperdown, Not Specified, Australia
Research Site
Clayton, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)	DRUG: Rilvegostomig Rilvegostomig IV (intravenous) Q3W
PLACEBO_COMPARATOR: Arm B Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)	DRUG: Placebo Placebo IV (intravenous) Q3W

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Recurrence free survival (RFS) for Arm A vs. Arm B	Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.	Approximately 5 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Overall Survival (OS) for Arm A vs. Arm B	Overall survival is defined as the time from randomization until the date of death due to any cause.	up to 7 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)