NCT04989218

Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC)

An Open-label Window of Opportunity Trial to Evaluate the Activity of Durvalumab (MEDI4736) and Tremelimumab With Platinum-based Chemotherapy (Gemcitabine and Cisplatin) in Intrahepatic Cholangiocarcinoma (ICC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial will be used to assess the activity, safety and feasibility of doublet immunotherapy and platinum-based chemotherapy in resectable intrahepatic cholangiocarcinoma with high risk features. The hypothesis is that the combination of durvalumab/MEDI4736 and tremelimumab (doublet immunotherapy) with platinum-based chemotherapy (gemcitabine and cisplatin) will yield an objective of 52% and improve complete resection rates in intrahepatic cholangiocarcinoma. This will facilitate margin negative resection and ultimately reduce recurrence rates and improve survival. Carrying out this trial in the neoadjuvant setting potentially allows improved overall survival and also provides an opportunity for discovery of biomarkers that may predict response to therapy.

Detailed description

All enrolled participants will receive the study intervention. Patients will receive up to 4 cycles of interventional agents prior to surgical resection. They will undergo imaging scans after the 2nd and 4th cycle (before surgery) of intervention agents. The short interval of scans (6 weeks) allows investigators to identify non responders. These patients may be encouraged to come off study and be treated based on the treating oncologist's choice. Since the investigational agents include 'standard of care' agents, a good argument can be made that these patients would not have benefitted from standard therapy only. Patients with at least stable disease after the 2nd treatment cycle will proceed with study interventions. However, patients with radiologic progression but who remain clinically stable may be allowed to continue treatment if the patient elects to, pending confirmation of progression and after a discussion between the investigator and sponsor-investigator.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Novel combination of chemotherapy and immunotherapy	This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells

Timeline

• Start date: 2023-01-30
• Primary completion: 2024-03-20
• Completion: 2024-05-01
• First posted: 2021-08-04
• Last updated: 2024-11-05
• Results posted: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study