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NCT04989218 · ClinicalTrials.gov registry record · Phase 1
Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC)
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04989218 is a Phase 1 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 1 participants.
The verdict
NCT04989218, a Phase 1 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study 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.
Interventions
- DRUG Novel combination of chemotherapy and immunotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-01-30 |
| Est. Completion | 2024-05-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04989218
The ClinicalTrials.gov registry entry for NCT04989218 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Novel combination of chemotherapy and immunotherapy is the first listed.
NCT04989218 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04989218 about?
NCT04989218 is a clinical study titled "Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC)". 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 immunot...
What is the current status of trial NCT04989218?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2023-01-30. Estimated completion is 2024-05-01.
What interventions are being tested in trial NCT04989218?
The interventions under investigation include: Novel combination of chemotherapy and immunotherapy (DRUG).
Who is sponsoring clinical trial NCT04989218?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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