PET-guided first-line nivolumab plus chemotherapy 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)
This pilot trial tests whether adding nivolumab to initial chemotherapy and changing treatment based on an early PET scan helps adults with advanced classical Hodgkin lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | National Research Center for Hematology, Russia Research network |
| Drugs / interventions | nivolumab, chemotherapy, immunotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07209059 on ClinicalTrials.gov |
What this trial studies
The FINISH protocol gives all newly diagnosed patients with advanced or bulky classical Hodgkin lymphoma induction immunochemotherapy including nivolumab plus EACOPD-14, then uses an interim PET-CT after two cycles to guide next steps. Patients with a good PET response receive de-escalated consolidation with Nivo-AVD followed by nivolumab alone, while those with incomplete responses receive continued or intensified therapy according to further PET results. The study also collects blood for circulating tumor DNA (ctDNA) analysis at set time points to compare molecular response with PET findings and explore early residual disease detection. Primary goals are to maintain or improve efficacy while reducing long-term toxicity through PET-guided de-escalation and early checkpoint inhibitor integration.
Who should consider this trial
Good fit: Ideal candidates are adults age 18–60 with newly diagnosed classical Hodgkin lymphoma stage IIB (bulky), III, or IV, ECOG 0–2, measurable disease, adequate organ function, and no prior lymphoma therapy.
Not a fit: Patients with early-stage disease, active viral infections (HBV/HCV, HIV), uncontrolled autoimmune disease, pregnancy or breastfeeding, or prior lymphoma treatment are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could maintain or improve cure rates while reducing long-term chemotherapy toxicity by using early PET scans to tailor treatment and integrating nivolumab up front.
How similar studies have performed: Checkpoint inhibitors have shown strong activity in relapsed/refractory classical Hodgkin lymphoma and PET-adapted de-escalation has been successful in other settings, but combining front-line nivolumab with PET-guided adaptation is relatively novel and only preliminarily explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Moscow
- National Medical Research Center for Hematology — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Anna A Kravtsova, MD
- Email: kravtsovaanna95@gmail.com
- Phone: +74956122361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.