CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab

  • STATUS
    Recruiting
  • End date
    Nov 17, 2023
  • participants needed
    30
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 17 March 2022
ascites
measurable disease
TACE
durvalumab
chemoembolization

Summary

The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.

Details
Condition Intermediate Stage of Hepatocellular Carcinoma, Hepatocellular Carcinoma
Treatment durvalumab, Tremelimumab 300mg, Tremelimumab 75mg, Tremelimumab (Cohort A dose), Tremelimumab (Cohort B dose)
Clinical Study IdentifierNCT03638141
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on17 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent form
Age 18-75 years
Newly diagnosed with hepatocellular carcinoma
Have measurable disease
Have disease that responds to DEB-TACE
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Body weight >30 kg
Evidence of clinical or radiographic ascites with a score < 7
Patients must have adequate organ function defined by study-specified laboratory tests
Evidence of post-menopausal status or negative pregnancy test
Willing and able to comply with study procedures
Willing to undergo a liver biopsy

Exclusion Criteria

Anyone involved with the planning and/or conduct of the study
Has participated in another investigational study during the last 6 months
Any concurrent anticancer therapy or received therapy ≤30 days prior to study
Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of IP
Have a diffuse HCC (Hepatocellular Carcinoma), vascular invasion or extrahepatic tumor
Main portal vein thrombosis present on imaging
History of hepatic encephalopathy within past 12 months or require medications to prevent or control encephalopathy
Ascites within 6 weeks prior to study treatment
Any contraindications for embolization
Has an active infection such as TB, HIV, hepatitis B or C
History of another primary malignancy
History of leptomeningeal carcinomatosis
History of active primary immunodeficiency
Any unresolved toxicities from previous anticancer therapy
Grade ≥2 neuropathy
History of bleeding disorder
History or current use of immunosuppressive medications within 14 days prior to study medications
Has an active known or suspected autoimmune disease
Patients with hypothyroidism
Any active skin conditions
History of allogenic organ transplantation
Significant heart disease
Patients weighing < 30 kg
Patients with celiac disease not controlled by diet alone
Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Have received a live vaccine within 30 days prior to study drug
Woman who are pregnant or breastfeeding
Known allergy or hypersensitivity to the study drug
Have received durvalumab, tremelimumab, anti-PD-1, anti-PD-L1 or anti-CTLA-4 in a prior study
Unwilling or unable to follow the study schedule for any reason
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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