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NCT Number: NCT06984146

Nivo40-AVD for 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

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Key information

Conditions

Hodgkin Lymphoma, Adult Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation

Moscow, Russia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nivolumab

Drug

40 mg day 1 and 15

Doxorubicin

Drug

25 mg/m2 day 1 and 15

Vinblastine

Drug

6 mg/m2 (not exceeding 10 mg) day 1 and 15

Dacarbazine

Drug

375 mg/m2 day 1 and 15

Primary outcomes

  1. Progression-free survival

    Time frame: 2 years

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

  2. Complete remission and complete metabolic response

    Time frame: 2 years

  3. Adverse events

    Time frame: 2 years

Interested in participating?

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Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 22, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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