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

Status
Active
Cancer Type
Bile Duct Cancer
Gallbladder Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06109779
Protocol IDs
D7025C00001 (primary)
NCI-2024-04612
2023-506054-20-00
Study Sponsor
AstraZeneca Pharmaceuticals LP

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.

Objectives

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.

Eligibility

  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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.