Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT02658019|
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : November 12, 2020
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab (Keytruda®) in Advanced Hepatocellular Carcinoma (HCC)|
|Actual Study Start Date :||May 6, 2016|
|Actual Primary Completion Date :||November 10, 2019|
|Actual Study Completion Date :||December 17, 2019|
Experimental: Pembrolizumab in Advanced HCC
Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle.
- Disease Control Rate (DCR) in Study Participants [ Time Frame: 8 weeks ]
Disease control rate (DCR) will be calculated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, as the percentage of patients with best overall response to protocol therapy of either complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 8 weeks.
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1)for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Number of Participants With Treatment-Related Adverse Events [ Time Frame: Up to 2 years ]The safety of Pembrolizumab in HCC patients as measured by the incidence of treatment-related adverse events, including serious adverse events (SAEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, per physician discretion. The number of participants experiencing toxicity attributed by treating physician as definitely, probably and possibly-related to study treatment will be reported.
- Progression-Free Survival (PFS) [ Time Frame: Up to 25 months ]Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .
- Overall Survival (OS) [ Time Frame: Up to 25 months ]Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive).
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]Objective response rate (ORR) will be defined as the percentage of the patients with a confirmed complete or partial response (CR or PR),by MRI or CT scan as per RECIST 1.1 criteria. Complete response (CR), Disappearance of all target lesions; Partial response (PR), >=30% decrease in sum of the longest diameter of target lesions; Overall response (OR) = (CR+PR.)Scans and assessments are performed every 9 weeks while on treatment up to 2 years if stable/responding, or up until time of disease progression.
- Duration of Response (DoR) [ Time Frame: Up to 3 Years ]Duration of Response (DoR) will be defined as the elapsed time from documented tumor response to documented disease progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658019
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Lynn Feun, MD||University of Miami|