This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and pembrolizumab may work better in treating patients with liver cancer.
PRIMARY OBJECTIVES: I. To assess the overall response rate (ORR) related to the combination of sorafenib tosylate (sorafenib) + pembrolizumab in advanced hepatocellular carcinoma patients. SECONDARY OBJECTIVES: I. To assess time to tumor progression in patients who received the combination therapy of sorafenib + pembrolizumab compared to historical data on sorafenib only treatment in patients with advanced hepatocellular carcinoma. TERTIARY OBJECTIVES: I. To obtain data on changes in immune cell function and in the tumor microenvironment pre- and post-treatment to screen for potential biomarkers that may be able to predict clinical benefit. \- All patients will be followed for survival OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days -28 to -1 and 1-21. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months for up to 1 year, then every 6 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Overall Response Rate Defined as Partial or Complete Response Per Immune-related Response Evaluation Criteria in Solid Tumors
The response rate will be estimated as the binomial proportion of responders among evaluable patients, and supported by Jeffreys? 95% confidence interval.
Time frame: Up to 6 months
Overall Survival
Will be estimated using the Kaplan-Meier method.
Time frame: From the date of study enrollment to the time of death from any cause, assessed up to 3 year
Time to Tumor Progression
Will be estimated using the Kaplan-Meier method, where the median will be estimated with a 95% confidence interval.
Time frame: From the date of study enrollment to the first observation of progressive disease, assessed up to 3 years
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