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NCT Number: NCT07234487

Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL

Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens

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Key information

Conditions

Hodgkin Lymphoma 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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;
  • Patients with evidence of lesion extent assessed by whole-body PET/CT;
  • Patients aged 18-60 years;
  • ECOG 0-2;
  • Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug;

Exclusion criteria

  • Severe organ failure: creatinine > 2 norms; alanine aminotransferase, aspartate aminotransferase > 5 norms; bilirubin> 1.5 norms;
  • Respiratory failure > grade 1 at the time of enrollment
  • Requirement for vasopressor support at the time of enrollment
  • Uncontrolled bacterial or fungal infection at the time of enrollment
  • Active or prior documented autoimmune disease requiring systemic treatment
  • Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
  • Hypersensitivity or allergy to study drugs
  • Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
  • Simultaneous use of drugs or medical devices studied in other clinical trials

Treatment and study plan

Nivo-AVD

Drug
  • Monotherapy phase - Nivolumab - 40 mg every 14 days x 2 cycles
  • Combination therapy phase - Nivo-AVD x 6 cycles Nivolumab - 40 mg every 14 days; Doxorubicin 25 mg/m2 in D1 and 15; Vinblastine 6 mg/m2 (no more than 10 mg) in D 1 and 15; Dacarbazine 375 mg/m2 in D 1 and 15;

BEACOPP-like

Drug
  • BEACOPP-like regimens x 2 cycles + BEACOPP-like regimens x 4 (for patients with PR, SD by PET/CT after 2 cycles)
  • BEACOPP-like regimens x 2 + A(B)VD x 4 cycles (for patients with CR by PET/CT after 2 cycles)

Primary outcomes

  1. Incidence of adverse events

    Time frame: Up to 24 months from thetreatment start

    To compare the safety of therapy use in the Nivo-AVD and Standard cohorts: analysis of the incidence, severity and spectrum of adverse events (according to CTCAE v5.0 criteria)

Secondary outcomes

  1. Progression-free survival

    Time frame: 12, 24 and 36 months after completion of therapy

    To compare progression-free survival in the Nivo-AVD and Standard cohorts

  2. Response rates

    Time frame: after 2 cycles of nivo and 2 cycles of Nivo-AVD (3 months from therapy initiation) and at the end of treatment (7 months from therapy initiation) and, in Standard cohorts, after 2 cycles and EOT of BEACOPPesc (2 and 6 months)

    To compare the rates of objective response, complete and partial responses after 2 and 6 courses of therapy in the Nivo-AVD and Standard cohorts by whole-body PET-CT (according to Lugano criteria for chemotherapy and LYRIC criteria for immunochemotherapy)

  3. Overall survival

    Time frame: 12, 24, and 36 months after completion of therapy

    • To compare overall survival at 12, 24, and 36 months after completion of therapy in the Nivo-AVD and Standard cohorts.

Study contacts

Contact information is provided by the study sponsor or research team.

Liudmila Fedorova, MD, PhD

CONTACT

[email protected]

+78123386265

Polina Kotseliabina, MD

CONTACT

[email protected]

+78123386265

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 18, 2025
Registry last updated
Apr 1, 2026

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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