Nivolumab with AVD versus PET-adapted BEACOPP-like for advanced classical Hodgkin lymphoma

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

This trial will test whether starting treatment with low-dose nivolumab plus AVD works better than a PET-adapted BEACOPP-like approach for adults (18–60) with advanced classical Hodgkin lymphoma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: St. Petersburg State Pavlov Medical University (other)
• Drugs / interventions: nivolumab
• Locations: 3 sites (Moscow and 2 other locations)
• Trial ID: NCT07234487 on ClinicalTrials.gov

What this trial studies

This prospective multicenter phase II randomized trial enrolls adults with newly diagnosed stage IIB–IV classical Hodgkin lymphoma and randomizes them to one of two first-line strategies. In the experimental arm patients receive two cycles of nivolumab alone followed by nivolumab plus AVD for a total of six cycles. In the standard arm patients start with two cycles of BEACOPP-like chemotherapy and are then managed per PET response after two cycles, either switching to A(B)VD or continuing BEACOPP-like therapy. Whole-body PET/CT is used for staging and on-treatment response assessment, and the study compares disease control and toxicity between the approaches.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–60 with newly diagnosed stage IIB, III, or IV classical Hodgkin lymphoma, ECOG 0–2, adequate organ function, and use of effective contraception as required.

Not a fit: Patients with severe organ failure, uncontrolled infection, active autoimmune disease requiring systemic treatment, pregnancy or breastfeeding, or those outside the specified age or stage criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the regimen could improve cure rates or reduce long-term chemotherapy toxicity by adding PD‑1 blockade to first-line therapy.

How similar studies have performed: PD‑1 inhibitors combined with AVD have shown promising results in prior Hodgkin lymphoma trials and PET‑adapted BEACOPP strategies are well established, so this trial builds on both prior successes.

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

Where this trial is running

Moscow and 2 other locations

• 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)

Study contacts

• Study coordinator: Liudmila Fedorova, MD, PhD

Conditions: Hodgkin Lymphoma, N-AVD, nuvolumab, BEACOPPesc, Low dose nivolumab