Hodgkin LymphomaPhase 2NCT07234487
Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
A Phase 2 study testing Nivo-AVD and BEACOPP-like in people with Hodgkin Lymphoma, run by St. Petersburg State Pavlov Medical University at 3 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Nivo-AVD and BEACOPP-like
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesRussia
- Study dates
- 14 Oct 2024to Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia3 sites, 3 recruiting
- Recruiting
A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health
Moscow
Olga Mukhortova, MD, PhD, olgamukhortova@yandex.ru
Maria Metelkina, MD, metelkina.masha@yandex.ru
- Recruiting
National Medical and Surgical Center named after N.I. Pirogov
Moscow
Vladislav Sarzhevskiy, MD, PhD, vladislavsarzhevsky@yandex.ru
- Recruiting
St. Petersburg State Pavlov Medical University
Saint Petersburg
Polina Kotseliabina, MD, +78123386265, polina.kotselyabina.med@gmail.com
+78123386265
About this study
Official 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
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
- Being tested
- Nivo-AVD, BEACOPP-like
- Keywords
- Hodgkin Lymphoma, N-AVD, nuvolumab, BEACOPPesc, Low dose nivolumab
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivo-AVDDrug
- 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-likeDrug
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: BEACOPP-like |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 24 months from thetreatment start
Secondary outcomes (3)
Progression-free survival
To compare progression-free survival in the Nivo-AVD and Standard cohorts
Measured: 12, 24 and 36 months after completion of therapy
Response rates
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)
Measured: 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
- To compare overall survival at 12, 24, and 36 months after completion of therapy in the Nivo-AVD and Standard cohorts.
Measured: 12, 24, and 36 months after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start14 Oct 2024
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
- Investigators
- Natalia Mikhailova, MD, PhD, Study chair, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234487
- Sponsor's protocol ID
- 28/24-н
- Status last verified
- Apr 2025
- First submitted
- 3 Feb 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07234487
- Acronym / sponsor ID
- 28/24-н
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin Lymphoma, N-AVD, nuvolumab, BEACOPPesc, Low dose nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivo-AVD | Experimental | Drug: Nivo-AVDNivo-AVD cohort patients will receive 2 cycles of nivolumab monotherapy (40 mg) followed by Nivo-AVD combination therapy (6 cycles total) |
| BEACOPP-like regimes - Standard cohort | Active comparator | Drug: BEACOPP-likeIn 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivo-AVD1. 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 | Nivo-AVD |
| 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) | Drug | BEACOPP-like regimes - Standard cohort |
Primary outcome
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)
3 secondary outcomes
Progression-free survival
Time frame: 12, 24 and 36 months after completion of therapy
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)
Overall survival
Time frame: 12, 24, and 36 months after completion of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalia Mikhailova, MD, PhD study chair
St. Petersburg State Pavlov Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivo-AVD and BEACOPP-like in people with Hodgkin Lymphoma, run by St. Petersburg State Pavlov Medical University at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liudmila Fedorova, MD, PhD (+78123386265, md.FedorovaL@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 24 months from thetreatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.