NCT03473574

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

A Randomized Phase II Trial of Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine and Cisplatin Compared to Gemcitabine and Cisplatin in Treatment-naïve Patients With Cholangio- and Gallbladder Carcinoma (IMMUCHEC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients with CCA have poor outcomes, as a consequence of the very aggressive nature of the disease, and the limited treatment options. Thus there is a significant unmet medical need for additional treatment options for use in this patient population. As in most other tumor entities however, only a fraction of patients respond to immunotherapy alone. Evidence suggests that those patients might preferentially have tumors that have favorable mutational landscapes, express the PD-L1 and/ or contain preexisting tumor-infiltrating CD8+ T cells that are inhibited locally, e.g., by PD-1 engagement. In order to increase the proportion of patients who could ultimately benefit from immunotherapies, it is important to develop strategies that can be employed for converting tumor microenvironments lacking T cell infiltration to ones displaying antitumor T-cell immunity and therefore to sensitize tumors to checkpoint inhibition therapy. Therefore, the aim of this study is to determine 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.

Conditions

• Cholangiocarcinoma
• Gall Bladder Carcinoma
• Cholangiocarcinoma Non-resectable
• Gallbladder Carcinoma Non-Resectable

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	immune checkpoint inhibitor
DRUG	Gemcitabine	standard chemotherapy
DRUG	Cisplatin	standard chemotherapy
BIOLOGICAL	Tremelimumab	immune checkpoint inhibitor

Timeline

• Start date: 2018-05-02
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2018-03-22
• Last updated: 2023-06-15

Locations

1 site across 1 country: Germany