Nivolumab and Bevacizumab in Patients With Advanced and or Metastatic Hepatocellular Carcinoma

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor: University of Utah
Study ID: NCT03382886
Phase: PHASE1
Status: Terminated

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Nivolumab — DRUG
Nivolumab will be administered as a 240mg IV infusion given once every two weeks (+/- 3 days). Subjects will remain on study treatment for up to two years or until progression or excessive toxicity
Bevacizumab — DRUG
Bevacizumab will be administered as an IV infusion from 1-10mg/kg in accordance with the appropriate subject cohort being examined as described below: Dose level 1: 5 mg/kg intravenously once every two weeks Dose level 2: 10 mg/kg intravenously once every two weeks Dose level -1: 1 mg/kg intravenously once every two weeks Dosing is based on actual body weight. There is no dose adjustment for obese or frail individuals. Dosing is recalculated if patient weight changes by more than 10% as reviewed by the principal investigator. Subjects will remain on study treatment for up to two years or until progression or excessive toxicity

Study Details

This is an open label, phase I study to test for maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of the combination of nivolumab and bevacizumab. The study will use a 3+3 phase I study design using a fixed dose of nivolumab (240mg) and escalating doses of bevacizumab (1-10mg).