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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06109779




Registration number
NCT06109779
Ethics application status
Date submitted
26/10/2023
Date registered
31/10/2023

Titles & IDs
Public title
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
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)
Secondary ID [1] 0 0
2023-506054-20-00
Secondary ID [2] 0 0
D7025C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary Tract Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence free survival (RFS) for Arm A vs. Arm B
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS) for Arm A vs. Arm B
Timepoint [1] 0 0
up to 7 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2030
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Murdoch
Recruitment hospital [4] 0 0
Research Site - Reservoir
Recruitment hospital [5] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
3021 - Reservoir
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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United States of America
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Florida
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Georgia
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Illinois
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Minnesota
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Missouri
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New York
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Pennsylvania
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Texas
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United States of America
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Washington
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Leuven
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Natal
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Santa Maria
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Santo Andre
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Sao Paulo
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Vitória
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British Columbia
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New Brunswick
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Nova Scotia
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Ontario
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China
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Nanjing
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Shanghai
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China
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Zhengzhou
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Herlev
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Marseille
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Rennes
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France
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Villejuif
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Germany
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Berlin
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Bonn
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Ulm
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Mysuru
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India
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Vadodara
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India
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Varanasi
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Italy
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Firenze
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Milano
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Padova
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Pisa
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Italy
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Rozzano
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Tricase, Lecce
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Kashiwa
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Kitaadachi-gun
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Nagoya-shi
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Sendai-shi
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Japan
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Suita-shi
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Japan
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Wakayama-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Norway
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Oslo
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Bydgoszcz
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Lublin
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Przemysl
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Tomaszów Mazowiecki
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Warszawa
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Spain
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Barcelona
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L'Hospitalet de Llobregat
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Madrid
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Málaga
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Spain
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Pamplona
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Spain
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Santander
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Taiwan
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Kaohsiung
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Taichung
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Taiwan
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Tainan City
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Taipei
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Taoyuan
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Thailand
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Hat Yai
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Thailand
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Khon Kaen
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Thailand
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Muang
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Thailand
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Naimuang
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Thailand
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Sisaket
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Turkey
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Ankara
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Antalya
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Erzurum
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Fatih-Istanbul
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Istanbul
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Turkey
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Samsun
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United Kingdom
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Cambridge
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United Kingdom
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Edgbaston
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United Kingdom
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Glasgow, Scotland
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United Kingdom
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London
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United Kingdom
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Manchester
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06109779