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

NCT ID: NCT07234487

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-14
• Study Completion Date: 2030-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivo-AVD

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

Group Type: EXPERIMENTAL

Nivo-AVD

Intervention Type: 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;

BEACOPP-like regimes - Standard cohort

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)

Group Type: ACTIVE_COMPARATOR

BEACOPP-like

Intervention Type: 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)

Interventions

Nivo-AVD

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;

Intervention Type: DRUG

BEACOPP-like

• 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ivan S Moiseev

Vice-director of RM Gorbacheva Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalia Mikhailova, MD, PhD

Role: STUDY_CHAIR

St. Petersburg State Pavlov Medical University

Locations

St. Petersburg State Pavlov Medical University

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Liudmila Fedorova, MD, PhD

Role: CONTACT

md.FedorovaL@gmail.com

+78123386265

Polina Kotseliabina, MD

Role: CONTACT

polina.kotselyabina.med@gmail.com

+78123386265

Facility Contacts

Polina Kotseliabina, MD

Role: primary

polina.kotselyabina.med@gmail.com

+78123386265

Role: backup

+78123386265

Other Identifiers

28/24-н

Identifier Type: -

Identifier Source: org_study_id