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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
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 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
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Adverse Events that occur
Investigate the safety and tolerability of 14-day cycles of nivolumab plus bevacizumab. Adverse events will be collected for each subject that received the study treatment combination.
Time frame: Every 14 day cycle for up to 2 years - Patients are expected to be on treatment for an average of 6 months
Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D). Dose Limiting Toxicities (DLT) will define subsequent subject accrual and dose escalation
Time frame: The DLT period will begin at Cycle 1 Day 1 and continue through Cycle 1 Day 28 for each patient
Progression Free Survival (PFS)
To examine the effect of the study treatment combination on the rate of progression-free survival (PFS). Subjects will have regular imaging scans to measure disease status and response will be defined by RECIST1.1.
Time frame: 3 years after treatment stops
Overall Survival
To examine the effect of the study treatment combination on the rate of overall survival.
Time frame: 3 years after treatment stops
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