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

NCT07234487 | Recruiting Phase 2

• 1 other identifier: 28/24-н
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma; N-AVD; nuvolumab; BEACOPPesc; Low dose nivolumab

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  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)

  Up to 24 months from thetreatment start

Secondary Outcomes (3)

• Progression-free survival

  12, 24 and 36 months after completion of therapy

• Response rates

  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)

• Overall survival

  12, 24, and 36 months after completion of therapy

Study Arms (2)

Nivo-AVD

EXPERIMENTAL

Nivo-AVD cohort patients will receive 2 cycles of nivolumab monotherapy (40 mg) followed by Nivo-AVD combination therapy (6 cycles total)

Drug: Nivo-AVD

BEACOPP-like regimes - Standard cohort

ACTIVE COMPARATOR

In the Standard cohort, patients will receive therapy according to current clinical guidelines 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 an A(B)VD regimen (when achieving CR by PET/CT) or continuing therapy with BEACOPP-like regimens (when achieving PR,SD by PET/CT)

Drug: BEACOPP-like

Interventions

Nivo-AVD DRUG

1. Monotherapy phase - Nivolumab - 40 mg every 14 days x 2 cycles 2. 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;

Nivo-AVD

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)

BEACOPP-like regimes - Standard cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (3)

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

Moscow, Russia

RECRUITING

National Medical and Surgical Center named after N.I. Pirogov

Moscow, Russia

RECRUITING

St. Petersburg State Pavlov Medical University

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Natalia Mikhailova, MD, PhD

  St. Petersburg State Pavlov Medical University

  STUDY CHAIR

Central Study Contacts

Liudmila Fedorova, MD, PhD

CONTACT

+78123386265; md.FedorovaL@gmail.com

Polina Kotseliabina, MD

CONTACT

+78123386265; polina.kotselyabina.med@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director of RM Gorbacheva Research Institute

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: November 18, 2025
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 1, 2026

Record last verified: 2025-04

Locations

RU (3)