This phase II trial studies how well nivolumab and low dose radiation therapy work in treating patients with Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory). 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. Radiation therapy uses high energy x-rays or gamma rays to kill tumor cells and shrink tumors. Giving nivolumab and low dose radiotherapy may work better than nivolumab alone in treating patients with Hodgkin lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03495713.
PRIMARY OBJECTIVES:
I. To determine the overall complete response (CR) rate for the study.
SECONDARY OBJECTIVES:
I. To determine the nivolumab induction CR rate.
II. To determine the post- radiotherapy (RT) + continued nivolumab CR rate.
III. To determine the time to best response.
IV. To determine duration of best response.
V. To estimate progression free survival, overall survival and disease free survival.
VI. To evaluate safety and adverse events.
EXPLORATORY OBJECTIVES:
I. To evaluate baseline levels and post-treatment changes in biomarkers and determine whether biomarker changes are associated with clinical outcomes.
II. To evaluate tumor fludeoxyglucose F-18 (FDG) uptake and determine whether FDG “flare” is associated with clinical outcomes.
OUTLINE:
Patients receive nivolumab intravenously (IV) on day 1 of weeks 0, 4, and 8-12. At weeks 8-12, patients with complete anatomic response continue nivolumab in the absence of disease progression or unacceptable toxicity and patients with less than a complete anatomic response undergo 2 fractions of RT over 2-4 days and continue nivolumab on day 1. At 8-12 weeks post RT, patients with complete anatomic response continue nivolumab in the absence of disease progression or unacceptable toxicity and patients with less than a complete anatomic response may undergo further RT to a new lesion.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJohn P. Plastaras