drugset / Trial / NCT03473574

Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients

NCT03473574 ↗

Phase 2 Completed 128 enrolled AIO-Studien-gGmbH AstraZeneca · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

To determine the efficacy in terms of objective response rate (ORR) of the combination of durvalumab and tremelimumab in addition with gemcitabine or in addition with gemcitabine and cisplatin in treatment-naïve patients with advanced, unresectable and/or metastatic cholangio- and gallbladder carcinoma (CCA).

Timeline

Start
2018-05-02
Primary completion
2022-03-15
Completion
2022-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified — —
Subject Durvalumab Monoclonal antibody — —
Subject Gemcitabine Small molecule — —
Subject Tremelimumab Monoclonal antibody — —