PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma
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)
National Research Center for Hematology, Russia
30 participants
Jul 29, 2025
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria12
- 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
- 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
Exclusion Criteria16
- 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
- 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
Interventions
Monoclonal antibody targeting PD-1; administered in combination regimens
14-day regimen. Combination of Nivolumab with Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Dacarbazine; given for 2 cycles as initial therapy.
Combination of Nivolumab with Doxorubicin, Vinblastine, and Dacarbazine; used as de-escalated therapy after negative interim PET (2 cycles).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07209059