RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2023-12-04
Study Completion:2030-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06109779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Provision of a tumor sample collected at surgical resection.
  3. * Randomization within 12 weeks after resection with adequate healing and removal of drains.
  4. * Confirmed to be disease-free by imaging within 28 days prior to randomization.
  5. * Eastern Cooperative Oncology Group performance status of 0 or 1
  1. * Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
  2. * Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
  3. * Any anti-cancer therapy for BTC prior to surgery
  4. * Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
  5. * Current or prior use of immunosuppressive medication within 14 days before the first dose
  6. * Thromboembolic event within 3 months
  7. * Active HBV or HCV infection unless treated.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Phoenix, Arizona, 85054
United States
Research Site
Duarte, California, 91010
United States
Research Site
Los Angeles, California, 90089
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Orange, California, 92868
United States
Research Site
Stanford, California, 94305
United States
Research Site
West Hollywood, California, 90048
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Denver, Colorado, 80206
United States
Research Site
Littleton, Colorado, 80129
United States
Research Site
Washington, District of Columbia, 20007
United States
Research Site
Washington, District of Columbia, 20010
United States
Research Site
Altamonte Springs, Florida, 32701
United States
Research Site
Gainesville, Florida, 32611
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Iowa City, Iowa, 52242
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Lexington, Kentucky, 40506
United States
Research Site
New Orleans, Louisiana, 70121
United States
Research Site
Baltimore, Maryland, 21201
United States
Research Site
Grand Rapids, Michigan, 49546
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Commack, New York, 11725
United States
Research Site
Mineola, New York, 11501
United States
Research Site
Philadelphia, Pennsylvania, 19111
United States
Research Site
Philadelphia, Pennsylvania, 19144
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Tyler, Texas, 75702
United States
Research Site
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2030-09-30

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2030-09-30

Terms related to this study

Keywords Provided by Researchers

  • Adenocarcinoma of the biliary tract
  • Biliary tract Cancer
  • Gall bladder cancer
  • Intrahepatic Cholangiocarcinoma
  • Distal Cholangiocarcinoma
  • Perihilar Cholangiocarcinoma
  • Klatskin Tumors
  • Bile duct cancer
  • Immunotherapy
  • Cholangiocarcinoma
  • Rilvegostomig
  • S-1
  • Gemcitabine/cisplatin
  • Capecitabine

Additional Relevant MeSH Terms

  • Biliary Tract Cancer