Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Live… (NCT05027425) | Clinical Trial Compass
TerminatedPhase 2
Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant
Stopped: The study is closing due to low enrollment and feasibility of the study.
United States8 participantsStarted 2021-12-07
Plain-language summary
Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Hepatocellular carcinoma, diagnosed either by biopsy or by combination of cirrhosis and imaging criteria (contrast-enhanced CT or MRI).
✓. Tumor confined to liver with no vascular invasion and no evidence of extrahepatic disease.
✓. Patient evaluated by institutional Liver Transplant team and listed for transplant.
✓. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization.
✓. No prior therapy for HCC at any time.
✓. Age ≥18 years at the time of study entry.
✓. ECOG score of 0 or 1
✓. Child-Pugh Score of 5, 6, or 7
Exclusion criteria
✕. Extrahepatic disease.
✕. Variceal bleeding during 3 months prior to registration.
✕. Any autoimmune disease deemed a risk in the setting of immunotherapy per treating physician's judgment.
✕. Any other illness or patient condition deemed a medical or logistical barrier for protocol therapy per treating physician's judgment.
✕
What they're measuring
1
Cellular Rejection Rates
Timeframe: Up to 30 days post transplant. The average time from consent to transplant was 11.88 months.
. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
✕. Participation in another clinical study with an investigational product during the last 12 months Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
✕. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.