Regorafenib + Durvalumab for Biliary Tract Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to measure how effective combining Durvalumab and Regorafenib will be for participants with advance stage biliary track carcinoma who have received one line of prior treatment
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot use other investigational agents or certain cancer treatments while participating. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Regorafenib and Durvalumab for treating biliary tract cancer?
Is the combination of Regorafenib and Durvalumab safe for humans?
Durvalumab has been studied for safety in various cancers, including biliary tract cancer, and is generally considered safe, though liver injury has been noted as a potential side effect. Regorafenib has shown clinical activity in biliary tract cancers, and while specific safety data for the combination with Durvalumab is not detailed, both drugs have been evaluated for safety in other settings.12367
How is the drug combination of Regorafenib and Durvalumab unique for treating biliary tract cancer?
The combination of Regorafenib and Durvalumab is unique because it combines a drug that modulates the immune system (Regorafenib) with an immune checkpoint inhibitor (Durvalumab), potentially enhancing the body's ability to fight cancer by boosting immune response, which is different from standard chemotherapy treatments.12345
Research Team
Raed Al-Rajabi
Principal Investigator
University of Kansas Medical Center
Eligibility Criteria
This trial is for adults with advanced biliary tract cancers that have worsened after one prior treatment. Participants must be able to swallow pills, have a life expectancy of at least 3 months, and an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory). They should not have had cancer therapy within the last 21 days and must use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Finding
3 + 3 design with two dose levels of 80 mg and 120 mg to discover the Maximum Tolerated Dose (MTD) for regorafenib
Treatment
Participants receive Regorafenib and Durvalumab; each cycle is 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Regorafenib
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor