Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 63
Summary
- Conditions
- Cholangiocarcinoma
- Cholangiocarcinoma Non-resectable
- Gall Bladder Carcinoma
- Gallbladder Carcinoma Non-Resectable
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Treatment Arm A: Combination of Durvalumab, Tremelimumab (Regimen 1) and Gemcitabine Treatment Arm B: Combination of Durvalumab, Tremelimumab (Regimen 1), Gemcitabine and Cisplatin Treatment Arm C: Gemcitabine and Cisplatin Treatment Arm D: Combination of Durvalumab, Tremelimumab (Regimen 2), Gemcitabine and Cisplatin Treatment Arm E: Combination of Durvalumab, Gemcitabine and CisplatinMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03473574
- Collaborators
- AstraZeneca
- Investigators
- Principal Investigator: Arndt Vogel, Prof. Dr. Hannover Medical School