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Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

Recruiting
18 years and older
All
Phase 2
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Overview

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

Description

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.

Eligibility

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

Study details
    Hodgkin Lymphoma
    Adult

NCT06984146

National Medical Research Radiological Centre of the Ministry of Health of Russia

15 October 2025

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