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Hodgkin LymphomaPhase 2FINISH-HLNCT07209059

PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma

A Phase 2 study testing Nivolumab, N-EACOPD-14 and N-AVD in people with Hodgkin Lymphoma and Hodgkin Disease, run by National Research Center for Hematology, Russia at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-center, open-label, phase 2 pilot study evaluating the efficacy and safety of a response-adapted first-line treatment strategy for patients with classical Hodgkin lymphoma (cHL) and unfavorable prognostic factors. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Nivolumab, N-EACOPD-14 and N-AVD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteRussia
Study dates
29 Jul 2025to Dec 2028
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

  • Signed written informed consent prior to any study-specific procedures
  • Histologically confirmed classical Hodgkin lymphoma (cHL)
  • Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV
  • At least one measurable lesion ≥15 mm in the longest diameter (by CT)
  • Age between 18 and 60 years (inclusive)
  • ECOG performance status 0-2
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  • PET-CT performed at baseline
  • No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
  • Adequate organ function, including:
  • Serum creatinine ≤ 0.2 mmol/L
  • Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction
  • Ability to comply with the study protocol and scheduled visits

Who cannot join

  • Active hepatitis B or C infection
  • Positive test for HIV
  • Pregnancy or breastfeeding
  • Prior or active autoimmune disease requiring systemic therapy
  • Vaccination with a live vaccine within 30 days prior to first nivolumab dose
  • History of non-infectious pneumonitis requiring corticosteroids
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  • Prior malignancy (except for adequately treated basal cell carcinoma or cervical carcinoma in situ)
  • Congestive heart failure, unstable angina, recent myocardial infarction, or severe cardiac arrhythmias
  • Severe renal impairment (serum creatinine > 0.2 mmol/L), unless lymphoma-related
  • Severe hepatic dysfunction, unless directly related to lymphoma
  • Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days
  • Sepsis or hemodynamic instability
  • Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)
  • Cachexia (total serum protein < 35 g/L), unless due to lymphoma-related liver damage
  • Decompensated diabetes mellitus
  • Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna A Kravtsova, MD contact

+74956122361

kravtsovaanna95@gmail.com

Yana K Mangasarova, MD contact

+74956122361

v.k.jana@mail.ru

Russia1 site, 1 recruiting

  • National Medical Research Center for Hematology

    Moscow, 125167

    Anna A Kravtsova, MD, kravtsovaanna95@gmail.com

    Recruiting

Other trials in Russia

About this study

Official title: A Single-Center Pilot Study Evaluating the Efficacy and Safety of First-Line Immunochemotherapy With Nivolumab Guided by Interim PET for Stratification and Hazard Minimization in Patients With Advanced Classical Hodgkin Lymphoma (FINISH-HL)

This is a single-center, open-label, phase 2 pilot study evaluating the efficacy and safety of a response-adapted first-line treatment strategy for patients with classical Hodgkin lymphoma (cHL) and unfavorable prognostic factors. The FINISH protocol (First-line Immuno-chemotherapy Navigated by Interim PET for Stratification and Hazard minimization In Hodgkin lymphoma) integrates nivolumab into induction therapy and tailors subsequent treatment based on interim PET-CT response. The study also includes exploratory monitoring of circulating tumor DNA (ctDNA) to investigate its role in early response assessment and residual disease detection.

Read the detailed description

The FINISH study (First-line Immuno-chemotherapy Navigated by Interim PET for Stratification and Hazard minimization In Hodgkin lymphoma) is designed to evaluate a novel personalized treatment strategy for newly diagnosed patients with classical Hodgkin lymphoma (cHL) and advanced-stage or bulky disease. All participants receive initial immunochemotherapy with nivolumab plus EACOPD-14. Treatment is then adapted based on interim PET-CT after two cycles. Patients with a complete metabolic response (Deauville score 1-3) receive de-escalated consolidation with Nivo-AVD followed by nivolumab monotherapy. Patients with inadequate metabolic response undergo continued or intensified therapy based on further PET response.

In addition to clinical and imaging-based endpoints, the study incorporates exploratory monitoring of circulating tumor DNA (ctDNA) at predefined time points. This includes analysis of ctDNA kinetics and correlation with PET response, aiming to develop a molecular framework for response stratification and early detection of residual disease.

The primary goal is to increase treatment efficacy while minimizing long-term toxicity through PET-guided de-escalation and early immunotherapy integration. Safety, feasibility, and molecular response patterns will be analyzed to inform future trials.

Being tested
Nivolumab, N-EACOPD-14, N-AVD
Keywords
Classical Hodgkin Lymphoma, Hodgkin Disease, Nivolumab, Immunotherapy, First-line treatment, PET-adapted therapy, Checkpoint inhibitors, ctDNA, Response-adapted treatment, EACOPD, AVD, PD-1 blockade, Circulating tumor DNA
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

    Also called Opdivo

    Monoclonal antibody targeting PD-1; administered in combination regimens

  • N-EACOPD-14Other

    Also called Nivolumab + EACOPD

    14-day regimen. Combination of Nivolumab with Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Dacarbazine; given for 2 cycles as initial therapy.

  • N-AVDOther

    Also called Nivolumab + AVD

    Combination of Nivolumab with Doxorubicin, Vinblastine, and Dacarbazine; used as de-escalated therapy after negative interim PET (2 cycles).

Study groups in NCT07209059
Study groupRoleWhat they receive
Response-adapted immunochemotherapy (FINISH protocol)ExperimentalAll participants receive induction immunochemotherapy with nivolumab and EACOPD-14 (2 cycles). Based on interim PET-CT after 2 cycles: 1. PET-negative (Deauville 1-3): de-escalated consolidation with Nivolumab + AVD ×2, followed by nivolumab monotherapy ×2 2. PET-positive (Deauville ≥4): continuation of Nivo-EACOPD-14 ×2 (total 4 cycles). 2.1. If PET becomes negative after 4 cycles: consolidation with Nivo-EACOPD-14 ×2 2.2. If PET remains positive after 4 cycles: patient is withdrawn from the protocol Circulating tumor DNA (ctDNA) is collected at baseline, after 2, 4, and 6 cycles for exploratory molecular response assessment.
Receives: Drug: Nivolumab; Other: N-EACOPD-14; Other: N-AVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving complete metabolic response (CMR) after 2 cycles of induction therapy

    Complete metabolic response is defined as Deauville score 1-3 on PET-CT after two cycles of Nivolumab + EACOPD-14, assessed per LYRIC criteria.

    Measured: 4 weeks after treatment initiation

  2. Time to CMR

    Time from first dose of study treatment to the first documentation of complete metabolic response (Deauville 1-3) by PET-CT. If CMR is not achieved, patients are censored at last PET assessment.

    Measured: Up to 6 cycles (approximately 12-14 weeks)

  3. Proportion of patients achieving CMR at PET-2, PET-4, and PET-6

    Rate of complete metabolic response (Deauville 1-3) assessed at interim and end-of-treatment PET-CT scans after 2, 4, and 6 cycles of therapy.

    Measured: Up to 18 weeks after first dose

Secondary outcomes (6)

  1. Overall Survival (OS)

    Time from the first dose of study treatment to death from any cause. Patients alive at the time of analysis will be censored at the date of last follow-up.

    Measured: Up to 24 months

  2. Progression-Free Survival (PFS)

    Time from first dose of treatment to documented disease progression or death, whichever occurs first. Progression is defined according to LYRIC criteria.

    Measured: Up to 24 months

  3. Event-Free Survival (EFS)

    Time from start of therapy to first documented disease progression, relapse, treatment discontinuation for any reason, or death.

    Measured: Up to 24 months

  4. Duration of metabolic response

    Time from first PET-defined complete metabolic response (Deauville 1-3) to documented disease progression or relapse.

    Measured: Up to 24 months

  5. Overall Response Rate (ORR) at PET-2, PET-4, and PET-6

    Proportion of patients with complete or partial metabolic response according to LYRIC and Deauville criteria at each time point.

    Measured: PET-2 (Week 4), PET-4 (Week 8), PET-6 (Week 12-14)

  6. Incidence and severity of treatment-emergent adverse events

    Number and grade of adverse events according to CTCAE v5.0, including immune-related adverse events, reported throughout treatment.

    Measured: From first dose until 90 days after last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study start29 Jul 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Model description
Single-arm, response-adapted treatment model. All participants receive the same initial induction therapy (Nivolumab + EACOPD-14), followed by PET-guided stratification into de-escalated, continued, or intensified therapy paths. There is no randomization or comparator group.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07209059
Sponsor's protocol ID
HL-2025
Acronym
FINISH-HL
Status last verified
Sep 2025
First submitted
3 Jul 2025
Last updated
6 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, N-EACOPD-14 and N-AVD in people with Hodgkin Lymphoma and Hodgkin Disease, run by National Research Center for Hematology, 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 12 inclusion and 16 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 6 Oct 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 Anna A Kravtsova, MD (+74956122361, kravtsovaanna95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving complete metabolic response (CMR) after 2 cycles of induction therapy (time frame: 4 weeks after treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07209059.

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 6 Oct 2025.

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