Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (NCT03875235)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
2. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
3. Patient with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
4. WHO/ECOG PS of 0 or 1 Exclusion
5. History of another primary malignancy
6. Brain metastases or spinal cord compression
7. Uncontrolled intercurrent illness
8. Major surgical procedure within 28 days prior to the first dose of IP.
9. Prior locoregional therapy such as radioembolization

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (126 Sites)

• Research Site — Los Angeles, California
• Research Site — Orange, California
• Research Site — Washington D.C., District of Columbia
• Research Site — Fort Myers, Florida
• Research Site — St. Petersburg, Florida
• Research Site — Westwood, Kansas
• Research Site — Louisville, Kentucky
• Research Site — Burlington, Massachusetts
• Research Site — St Louis, Missouri
• Research Site — Chapel Hill, North Carolina
• Research Site — Portland, Oregon
• Research Site — Philadelphia, Pennsylvania
• Research Site — Chattanooga, Tennessee
• Research Site — Nashville, Tennessee
• Research Site — Seattle, Washington
• Research Site — Buenos Aires,
• Research Site — CABA,
• Research Site — CABA,
• Research Site — Ciudad de Buenos Aires,
• Research Site — Ciudad de Buenos Aires,
• Research Site — Rosario,
• Research Site — San Salvador de Jujuy,
• Research Site — Burgas,
• Research Site — Sofia,
• Research Site — Sofia,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.