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

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Biliary Tract Neoplasms

Treatments: Drug: Durvalumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03875235

2023-507405-34-00 (Registry Identifier)

2018-004688-30 (EudraCT Number)

D933AC00001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 810 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

810 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Description:

Durvalumab + Gemcitabine + Cisplatin

Treatment:

Drug: Durvalumab

Placebo Arm

Placebo Comparator group

Description:

Placebo + Gemcitabine + Cisplatin

Treatment:

Drug: Placebo