Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastati… (NCT03439891) | Clinical Trial Compass
CompletedPhase 2
Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver Cancer
United States16 participantsStarted 2018-04-16
Plain-language summary
This phase II trial studies the best dose and side effects of sorafenib tosylate and nivolumab in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and nivolumab may work better in treating patients with liver cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologic or cytologic diagnosis of unresectable, locally advanced and/or metastatic hepatocellular carcinoma (HCC) not amenable to curative surgery, transplantation, or ablative therapies based upon assessment of treating investigator.
✓. Radiographically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in at least one site not previously treated with chemoembolization, radioembolization, radiation, or other local/liver-directed procedures (i.e. must have at least one measurable target lesion, either within the liver or in a measurable metastatic site); a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable.
✓. Untreated/pretreatment archival tumor tissue must be available for correlative analyses
✓. Age at least 18 years at enrollment.
✓. Eastern Cooperative Oncology Group (ECOG) 0 or 1 at enrollment
✓. At least 4 weeks after any prior chemoembolization, radioembolization, local ablative therapies, or hepatic radiation and recovery to =\< grade 1 treatment-related toxicity.
✓. At least 6 weeks after any major surgery including prior hepatic resection and recovery to =\< grade 1 treatment-related toxicity.
✓
What they're measuring
1
Maximum Tolerated Dose (MTD) (Part 1 Only)
Timeframe: 28 days
2
Proportion of Participants With Grade 3 or Higher Treatment-related Adverse Events (Part 2 Only)
. At least 7 days after minor surgery (such as central venous access) or biopsy and recovery to =\< grade 1 treatment-related toxicity
Exclusion criteria
✕. Any prior systemic therapy for HCC.
✕. Known fibrolamellar or mixed HCC-cholangiocarcinoma histology.
✕. Requirement for paracentesis to control ascites within 6 months before enrollment.
✕. Symptomatic hepatic encephalopathy requiring medication (such as lactulose or rifaximin) (Part 1) or any hospitalization for encephalopathy within 6 months before enrollment (Part 1 or 2).
✕. Hepatic encephalopathy that is adequately controlled on stable doses of lactulose and/or rifaximin per assessment of treating investigator is allowed in Part 2, provided no hospitalization for encephalopathy within 6 months before enrollment.
✕. Medications such as lactulose used for other indications (e.g. constipation) are allowed in both Part 1 and 2.
✕. History of upper gastrointestinal (GI) bleeding from esophageal and/or gastric varices within 12 months before enrollment.
✕. Requirement for systemic corticosteroids unless used for adrenal replacement, acute therapy for asthma or bronchitis exacerbation (=\< 2 weeks), or premedication for contrast allergy.