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A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age greater than/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Primary Objective: To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin, vinblastine, dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine). Secondary Objectives: To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups. To compare patient-reported symptoms using selected PRO-CTCAE items between arms stratified by age groups. To compare the safety and tolerability of N-AVD versus that of BV-AVD. Quality of Life Objectives To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of Cycle 3, 4-8 weeks after completion of treatment, and 1 and 3 years after randomization) using the PROMIS-Fatigue, the FACT/GOG-Ntx , and the PROMIS Global, respectively. Banking Objectives To bank specimens for future correlative studies. To bank PET-CT images for future correlative studies.

Phase

III

Recruitment Status

Current Studies