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

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.

Conditions

Biliary Tract Cancer

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Biliary Tract Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

Research Site, Birmingham, Alabama, United States, 35233

Phoenix

Research Site, Phoenix, Arizona, United States, 85054

Duarte

Research Site, Duarte, California, United States, 91010

Los Angeles

Research Site, Los Angeles, California, United States, 90089

Newport Beach

Research Site, Newport Beach, California, United States, 92663

Orange

Research Site, Orange, California, United States, 92868

Stanford

Research Site, Stanford, California, United States, 94305

West Hollywood

Research Site, West Hollywood, California, United States, 90048

Aurora

Research Site, Aurora, Colorado, United States, 80045

Denver

Research Site, Denver, Colorado, United States, 80206

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2030-09-30