The aim of this study is to improve the chance of cure for people with higher risk Hodgkin lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose of this Phase II study is to test whether including nivolumab in treatment for untreated Hodgkin lymphoma can improve the chance of cure for patients with abnormal PET scans after 2 cycles of ABVD.
The phase II portion of cohort A will enroll patients with untreated stage III or IV Hodgkin lymphoma. All patients will begin with 2 cycles of ABVD as standard of care treatment. A PET scan will be performed after 2 cycles of ABVD. Enrollment at MSK may occur at any point during the first two cycles of ABVD treatment. Enrollment at non-MSK locations will occur after the PET scan is performed. MSK patients with a PET-negative response (defined by Deauville 1, 2 or 3) will proceed with 4 additional cycles of ABVD or AVD (per treating physician preference) on-study. Non-MSK patients with a PET-negative response are not eligible for this study. Patients with a PET-positive response (Deauville 4 or 5) will proceed with 4 cycles of AVD plus nivolumab on-study. Non-MSK patients must have a PET-positive response to enroll on this study
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Doxorubicin: 25 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Bleomycin: 10 units/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Vinblastine: 6 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
number of patients who have dose limiting toxicity
For this objective, the standard 3+3 scheme will be used. Initially, 3 patients will enroll onto dose level 1. If no patients experience DLT, enrollment will proceed to the next dose level. If 1 DLT is observed, 3 additional patients will enroll onto dose level 1. If 1 or fewer patients out of 6 experience DLT, enrollment will proceed to the next dose level. If 2 or more DLTs are observed at a given dose level, the previous dose will be declared the MTD. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, will be used.
Time frame: 2 years
Phase II- progression free survival
The updated response criteria entitled "The Lugano Classification" system will be applied to define complete response, partial response, and progression of disease in this study.
Time frame: 2 year
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Dacarbazine (DTIC): 375 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.
nivolumab 240mg q14 days
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
BC Cancer (Data Collection Only)
Vancouver, Canada