Advanced Adult Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01010126 -
Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
|
Phase 2 | |
| Completed |
NCT01900002 -
Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
|
Phase 2 | |
| Completed |
NCT01899261 -
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
|
N/A | |
| Completed |
NCT02234986 -
A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma
|
Phase 2 | |
| Completed |
NCT02578602 -
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
|
Phase 1 | |
| Completed |
NCT00608361 -
Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
|
Phase 1 | |
| Completed |
NCT02072486 -
Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
|
N/A | |
| Completed |
NCT01839604 -
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma
|
Phase 1 | |
| Completed |
NCT04576572 -
Comparison of Criteria for Liver Transplantation in Hepatocellular Carcinoma
|
||
| Recruiting |
NCT04022746 -
An Investigational Scan (Magnetic Resonance Elastography) in Detecting Treatment Response in Patients With Advanced Liver Cancer
|
N/A | |
| Completed |
NCT01666756 -
Chinese Herbal Formulation PHY906 and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer
|
Phase 1 | |
| Completed |
NCT02409524 -
An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects
|
Phase 2 | |
| Recruiting |
NCT02418988 -
Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
|
Phase 2 | |
| Terminated |
NCT01405573 -
Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
|
Phase 3 | |
| Completed |
NCT01835223 -
Tivozanib in Treating Patients With Liver Cancer That Is Metastatic or Cannot Be Removed by Surgery
|
Phase 1/Phase 2 | |
| Completed |
NCT01777594 -
Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT01829035 -
A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC
|
Phase 3 | |
| Active, not recruiting |
NCT02042443 -
Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
|
Phase 2 | |
| Completed |
NCT01015833 -
Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
|
Phase 3 | |
| Completed |
NCT01488487 -
Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
|
Phase 2 |