Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer (NCT03211416) | Clinical Trial Compass
CompletedPhase 1/2
Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer
United States37 participantsStarted 2017-12-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant must have histologically or radiographically confirmed hepatocellular cancer (HCC) that is advanced or metastatic and if archival tissue is available, have archival tissue submitted for PD-L1, PD-L2 testing
* Participants with measurable disease that has progressed are eligible if prior surgery or locoregional therapy occurred \> 28 days prior to enrollment
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky \>= 60%)
* Child-Pugh class-A liver function
* Absolute neutrophil count (ANC) \>= 1,500/ mcL
* Hemoglobin \>= 8.5 g/dL
* Platelets \>= 75,000/ mcL
* Total bilirubin =\< 2.0 mg/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 X ULN
* Serum Creatinine \<= 1.5 upper limit of normal (ULN)or Creatinine clearance \> 50 mL/minute if serum creatinine is elevated above 1.5 X ULN
* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
* Ability to swallow and retain oral medication
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/In…
What they're measuring
1
Overall Response Rate Defined as Partial or Complete Response Per Immune-related Response Evaluation Criteria in Solid Tumors