NCT07234487

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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;
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)

Timeline

• Start date: 2024-10-14
• Primary completion: 2029-10-01
• Completion: 2030-10-01
• First posted: 2025-11-18
• Last updated: 2026-04-01

Locations

3 sites across 1 country: Russia