Hodgkin Lymphoma, AdultPhase 2NCT06984146
Nivo40-AVD for Advanced Classic Hodgkin Lymphoma
A Phase 2 study testing Nivolumab, Doxorubicin and Vinblastine in people with Hodgkin Lymphoma, Adult, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
Trial summary
The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Adult
- What is being tested?
- Nivolumab, Doxorubicin and Vinblastine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteRussia
- Study dates
- 15 Apr 2025to Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
- No past history of autoimmune disease
- Age > 18 years
- Ejection fraction > 50%
- ECOG 0-4
Who cannot join
- Organ failure (e.g. creatinine > 2x ULN; ALT or AST > 5x ULN; bilirubin > 2x ULN; hemodynamic instability; respiratory failure > Grade 1)
- Uncontrolled infection
- Pregnancy
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation
Moscow
Mobil Akhmedov, MD, PhD, 79261802399, mobilakhmedov@gmail.com
Andrey Kaprin, Prof.
About this study
Official title: Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma
The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma
Read the detailed description
Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.
- Conditions
- Hodgkin Lymphoma, Adult
- Being tested
- Nivolumab, Doxorubicin, Vinblastine, Dacarbazine
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
40 mg day 1 and 15
DoxorubicinDrug
25 mg/m2 day 1 and 15
VinblastineDrug
6 mg/m2 (not exceeding 10 mg) day 1 and 15
DacarbazineDrug
375 mg/m2 day 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| Nivo40-AVD | Experimental | Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15 Receives: Drug: Nivolumab; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 2 years
Secondary outcomes (3)
Overall survival
Measured: 2 years
Complete remission and complete metabolic response
Measured: 2 years
Adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start15 Apr 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma, AdultStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey Kaprin, Study chair, FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984146
- Sponsor's protocol ID
- Nivo40-AVD
- Status last verified
- Nov 2025
- First submitted
- 2 May 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data might not be shared to protect patient privacy and confidentiality. All other information regarding the study will be published in detail
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06984146
- Acronym / sponsor ID
- Nivo40-AVD
- Conditions
- Hodgkin Lymphoma, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 May 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.
The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma
Detailed description
Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivo40-AVD | Experimental | Drug: Nivolumab, Drug: Doxorubicin, Drug: Vinblastine, Drug: DacarbazineNivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
- No past history of autoimmune disease
- Age > 18 years
- Ejection fraction > 50%
- ECOG 0-4
Key exclusion criteria (4 listed)
- Organ failure (e.g. creatinine > 2x ULN; ALT or AST > 5x ULN; bilirubin > 2x ULN; hemodynamic instability; respiratory failure > Grade 1)
- Uncontrolled infection
- Pregnancy
- Inability to sign informed consent
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 |
|---|---|---|
| Nivolumab40 mg day 1 and 15 | Drug | Nivo40-AVD |
| Doxorubicin25 mg/m2 day 1 and 15 | Drug | Nivo40-AVD |
| Vinblastine6 mg/m2 (not exceeding 10 mg) day 1 and 15 | Drug | Nivo40-AVD |
| Dacarbazine375 mg/m2 day 1 and 15 | Drug | Nivo40-AVD |
Primary outcome
Progression-free survival
Time frame: 2 years
3 secondary outcomes
Overall survival
Time frame: 2 years
Complete remission and complete metabolic response
Time frame: 2 years
Adverse events
Time frame: 2 years
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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided. Individual patient data might not be shared to protect patient privacy and confidentiality. All other information regarding the study will be published in detail
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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.
Andrey Kaprin study chair
FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Doxorubicin and Vinblastine in people with Hodgkin Lymphoma, Adult, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site 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 4 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Mobil Akhmedov, MD, PhD (79261802399, mobilakhmedov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). 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 26 Nov 2025.