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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06109779
Registration number
NCT06109779
Ethics application status
Date submitted
26/10/2023
Date registered
31/10/2023
Date last updated
3/04/2024
Titles & IDs
Public title
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
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Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
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Secondary ID [1]
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2023-506054-20-00
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Secondary ID [2]
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D7025C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biliary Tract Cancer
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Condition category
Condition code
Cancer
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Biliary tree (gall bladder and bile duct)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rilvegostomig
Treatment: Drugs - Placebo
Treatment: Drugs - Capecitabine
Treatment: Drugs - Gemcitabine/Cisplatin
Treatment: Drugs - S-1 [Tegafur/Oteracil/gimeracil]
Experimental: Arm A - Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Placebo Comparator: Arm B - Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Treatment: Drugs: Rilvegostomig
Rilvegostomig IV (intravenous) Q3W
Treatment: Drugs: Placebo
Placebo IV (intravenous) Q3W
Treatment: Drugs: Capecitabine
Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
Treatment: Drugs: 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
Treatment: Drugs: S-1 [Tegafur/Oteracil/gimeracil]
S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recurrence free survival (RFS) for Arm A vs. Arm B
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Assessment method [1]
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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.
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Timepoint [1]
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Approximately 5 years
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Secondary outcome [1]
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Overall Survival (OS) for Arm A vs. Arm B
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Assessment method [1]
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Overall survival is defined as the time from randomization until the date of death due to any cause.
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Timepoint [1]
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up to 7 years
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Eligibility
Key inclusion criteria
- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or
extrahepatic) 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2030
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Actual
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Sample size
Target
750
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Research Site - Clayton
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Research Site - Murdoch
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Research Site - Westmead
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3168 - Clayton
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6150 - Murdoch
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3021 - Reservoir
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2145 - Westmead
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Sutton
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT06109779
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Contacts
Principal investigator
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AstraZeneca Clinical Study Information Center
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1-877-240-9479
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06109779
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