Clinical trial · Interventional
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers
NCT03875235CI-TRIAL-00123965TOPAZ-1active not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Durvalumab + Gemcitabine + Cisplatin
- interventionNames
- Drug: Durvalumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- Placebo + Gemcitabine + Cisplatin
- interventionNames
- Drug: Placebo
Primary outcomes (3)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion 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 1. History of another primary malignancy 2. Brain metastases or spinal cord compression 3. Uncontrolled intercurrent illness 4. Major surgical procedure within 28 days prior to the first dose of IP. 5. Prior locoregional therapy such as radioembolization
References
Publications (7)
- DERIVEDOh DY, He AR, Qin S, Chen LT, Okusaka T, Griffin R, Wang J, Xynos I, Vogel A, Valle JW. Durvalumab Plus Chemotherapy for Advanced Biliary Tract Cancer: A Post Hoc Analysis of the TOPAZ-1 Randomized Clinical Trial. JAMA Oncol. 2026 Jul 9:e262204. doi: 10.1001/jamaoncol.2026.2204. Online ahead of print. PMID 42424063
- DERIVEDAntonuzzo L, Takahashi H, Park JO, Sookprasert A, Gillmore R, Yang SS, Cundom J, Petrova M, Vaccaro G, Holmblad M, Zotkiewicz M, Wang J, Rokutanda N, Oh DY. Immune-mediated adverse events in the randomized phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. Oncologist. 2025 Jul 4;30(7):oyaf148. doi: 10.1093/oncolo/oyaf148. PMID 40622010
- DERIVEDOh DY, He AR, Qin S, Chen LT, Okusaka T, Kim JW, Suksombooncharoen T, Lee MA, Kitano M, Burris HA, Bouattour M, Tanasanvimon S, Zaucha R, Avallone A, Cundom J, Kuzko A, Wang J, Xynos I, Vogel A, Valle JW. Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study. J Hepatol. 2025 Nov;83(5):1092-1101. doi: 10.1016/j.jhep.2025.05.003. Epub 2025 May 15. PMID 40381735
- DERIVEDOh DY, He AR, Bouattour M, Okusaka T, Qin S, Chen LT, Kitano M, Lee CK, Kim JW, Chen MH, Suksombooncharoen T, Ikeda M, Lee MA, Chen JS, Potemski P, Burris HA 3rd, Ostwal V, Tanasanvimon S, Morizane C, Zaucha RE, McNamara MG, Avallone A, Cundom JE, Breder V, Tan B, Shimizu S, Tougeron D, Evesque L, Petrova M, Zhen DB, Gillmore R, Gupta VG, Dayyani F, Park JO, Buchschacher GL Jr, Rey F, Kim H, Wang J, Morgan C, Rokutanda N, Zotkiewicz M, Vogel A, Valle JW. Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):694-704. doi: 10.1016/S2468-1253(24)00095-5. Epub 2024 May 29. PMID 38823398
- DERIVEDBurris HA 3rd, Okusaka T, Vogel A, Lee MA, Takahashi H, Breder V, Blanc JF, Li J, Bachini M, Zotkiewicz M, Abraham J, Patel N, Wang J, Ali M, Rokutanda N, Cohen G, Oh DY. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1): patient-reported outcomes from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2024 May;25(5):626-635. doi: 10.1016/S1470-2045(24)00082-2.