This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to evaluate the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Phase I: Ruxolitinib at assigned dose\* twice daily by mouth begin Day 1 and continuing daily until study treatment stop. * Dose Levels: 1. (starting) : 10mg twice daily 2: 15mg twice daily 3: 20mg: twice daily Phase II: Ruxolitinib 20mg twice daily by mouth begin Day 1 and continuing daily until study treatment stop.
Nivolumab 480 mg IV every 4 weeks (Day 1) Until disease progression, unacceptable toxicity, patient refusal or a maximum of 2 years
University of Illinois Cancer Center
Chicago, Illinois, United States
COMPLETEDIndiana Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
WITHDRAWNUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Maximum Tolerated Dose
To assess the maximum tolerated dose (MTD) of ruxolitinib in combination with nivolumab in patients with relapsed/refractory Hodgkin lymphoma. (Phase I Only)
Time frame: 24 months
Overall Disease Control
To evaluate the best Overall Disease Control (CR+PR+SD) at 3 months of nivolumab in combination with ruxolitinib at MTD in patients with relapsed/refractory Hodgkin lymphoma using the modified Lugano Classification "lymphoma response criteria to immunomodulatory therapy criteria" (LYRIC)1 (Phase II Only)
Time frame: 24 months
Overall Response Rate
To characterize the Best Overall Response Rate (CR+PR) at 6 months of nivolumab in combination with ruxolitinib in patients with relapsed/refractory classical Hodgkin lymphoma (cHL).
Time frame: 24 months
Progression Free Survival
To evaluate progression free survival (PFS) at 2 years for nivolumab in combination with ruxolitinib in patients with relapsed/refractory Hodgkin lymphoma using the modified Lugano Classification "lymphoma response criteria to immunomodulatory therapy criteria" (LYRIC)
Time frame: 24 months
Duration of Response
To evaluate duration of response (DOR) at 2 years for nivolumab in combination with ruxolitinib in patients with relapsed/refractory Hodgkin lymphoma using the modified Lugano Classification "lymphoma response criteria to immunomodulatory therapy criteria" (LYRIC)
Time frame: 24 months
Overall Survival
To evaluate overall survival (OS) at 2 years for nivolumab in combination with ruxolitinib in patients with relapsed/refractory Hodgkin lymphoma using the modified Lugano Classification "lymphoma response criteria to immunomodulatory therapy criteria" (LYRIC)
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University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGUniversity of Wisconsin
Madison, Wisconsin, United States
RECRUITINGTime frame: 24 months
Frequency and Severity of Adverse Events as assessed by CTCAE v4.0
To characterize he safety and tolerability of nivolumab in combination with ruxolitinib as determined by the frequency and severity of adverse events (AEs) as defined by the NCI's Common Terminology Criteria for Adverse Events version 4 (CTCAE v4)
Time frame: 24 months