Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

NCT06984146 | Recruiting Phase 2

• 1 other identifier: Nivo40-AVD
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hodgkin Lymphoma, Adult

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2 years

Secondary Outcomes (3)

• Overall survival

  2 years

• Complete remission and complete metabolic response

  2 years

• Adverse events

  2 years

Study Arms (1)

Nivo40-AVD

EXPERIMENTAL

Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15

Drug: Nivolumab; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine

Interventions

Nivolumab DRUG

40 mg day 1 and 15

Nivo40-AVD

Doxorubicin DRUG

25 mg/m2 day 1 and 15

Nivo40-AVD

Vinblastine DRUG

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

Nivo40-AVD

Dacarbazine DRUG

375 mg/m2 day 1 and 15

Nivo40-AVD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Medical Research Radiological Centre of the Ministry of Health of Russia: lead

Study Sites (1)

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

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab; Doxorubicin; Vinblastine; Dacarbazine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Andrey Kaprin

  FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation

  STUDY CHAIR

Central Study Contacts

Mobil Akhmedov, MD, PhD

CONTACT

79261802399; mobilakhmedov@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 22, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

RU (1)