Pembrolizumab (MK-3475) in Hepatocellular Carcinoma (NCT02940496) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab (MK-3475) in Hepatocellular Carcinoma
United States15 participantsStarted 2016-12-09
Plain-language summary
This will be a Phase II study investigating single agent pembrolizumab (Keytruda®) as a second-line therapy for subjects with hepatocellular carcinoma (HCC) who either progressed on or after sorafenib or did not tolerate sorafenib.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* FOR ARM 1 AND 2: Subjects with advanced hepatocellular carcinoma (HCC) with no curative option; for Arm 2 subjects that are HCV-positive with genotype 1 or 4 virus infection will be enrolled
* Be willing and able to provide written informed consent for the trial; the subject may also provide consent for Future Biomedical Research (FBR); however, the subject may participate in the main trial without participating in FBR.
* Have histologically or cytologically documented HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required; for subjects without cirrhosis histological confirmation is mandatory
* FOR ARM A AND B: Have Barcelona Clinic Liver Cancer (BCLC) stage C disease or BCLC stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
* Have a Child-Pugh A liver score at screening or within 14 days of first dose of study drug
* Have a predicted life expectancy of greater than 3 months
* Have measurable disease based on RECIST 1.1 as confirmed by the blinded MD Anderson radiology; target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions; Note: the same image acquisition and processing parameters should be used throughout the stu…
What they're measuring
1
Correlation of HCC Stiffness to Overall Survival
Timeframe: up to 2 years
2
Correlation of HCC Stiffness to Time To Disease Progression (TTP)
Timeframe: up to 2 years
3
Correlation of HCC Stiffness to the Number of Intratumoral CD3+ T Lymphocytes.
Timeframe: assessed prior to treatment at baseline