BRENTUXIMAB VEDOTIN IN COMBINATION WITH NIVOLUMAB, DOXORUBICIN, AND DACARBAZINE IN NEWLY DIAGNOSED PATIENTS WITH ADVANCED HODGKIN LYMPHOMA (SGN35‐027, TRIAL IN PROGRESS)

last treatment in cycle 2 (cycle 3 or 4 if receiving brentuximab vedotin)).Patients with autoimmune disorders, colitis, inflammatory bowel disorders or pneumonitis are excluded.Trial treatment eligibility, assessments and patient progress are shown in Fig 1.The primary endpoint is ORR by PET after 4-8 cycles of nivolumab.The study is powered to exclude an ORR <40% for which we require 30 nivolumab-treated patients (A'Hern single arm design, 80% power and a one-sided 0.1 alpha).We expect to register 75-120 patients during salvage treatment.Secondary endpoints are: safety and tolerability of nivolumab (including safety of subsequent allogeneic transplant); progression free survival and overall survival at one year.Exploratory endpoints include: correlating disease response with baseline PD-1 copy number, PD-1 expression by IHC, immune profiling of tumour and peripheral blood by flow and gene expression profiling; and assessment of whether response assessment can be improved by combining PET with serum biomarkers e.g.TARC.Since December 2018, 38 patients have been registered, of whom 16 have been PET positive at the end of their current salvage therapy and eligible for nivolumab.Clinical trials.govNo. NCT03337919