Active — Not RecruitingPhase 3

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

United States, Argentina, Bulgaria810 participantsStarted 2019-04-16

Plain-language summary

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

Who can participate

Age range

18 Years – 130 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
. 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.
. WHO/ECOG PS of 0 or 1

Exclusion criteria

. History of another primary malignancy
. Brain metastases or spinal cord compression
. Uncontrolled intercurrent illness
. Major surgical procedure within 28 days prior to the first dose of IP.
. Prior locoregional therapy such as radioembolization

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial comparing durvalumab plus gemcitabine and cisplatin against a placebo plus the same chemotherapy — can you tell me what the latest survival data from this study shows, and whether it might change how you'd approach my treatment?
2Since the trial is no longer actively enrolling, am I able to access durvalumab through any other route, such as expanded access, compassionate use, or standard approval based on results from this study?
3The trial specifically measures overall survival at 18 and 24 months — based on what's been published so far, does adding durvalumab to gemcitabine and cisplatin appear to meaningfully improve survival for someone with my specific type of biliary tract cancer?
4Gemcitabine and cisplatin together are already an intensive chemotherapy regimen — how does adding an immunotherapy like durvalumab change the side effect profile, and do you think I could handle that combination given my current health?
5Would you recommend I start with standard gemcitabine and cisplatin chemotherapy now, or does the data from this trial make you think a durvalumab combination should be part of my first-line treatment plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival (OS)

Timeframe: From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)

Overall Survival (OS) Rate at 18 Months

Timeframe: From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.

Overall Survival (OS) Rate at 24 Months

Timeframe: From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.

Trial details

NCT IDNCT03875235

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-11

Results submitted2022-08-10

View on ClinicalTrials.gov More Biliary Tract Neoplasms trials