Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma

The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.

Inclusion Criteria:

1. Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
2. No past history of autoimmune disease
3. Age > 18 years
4. Ejection fraction > 50%
5. ECOG 0-4

Exclusion Criteria:

1. Organ failure (e.g. creatinine > 2x ULN; ALT or AST > 5x ULN; bilirubin > 2x ULN; hemodynamic instability; respiratory failure > Grade 1)
2. Uncontrolled infection
3. Pregnancy
4. Inability to sign informed consent