Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hodgkin Lymphoma | Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-AVD | Other | — | UNRESOLVED |
| N-EACOPD-14 | Other | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Response-adapted immunochemotherapy (FINISH protocol)
- description
- All 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 If PET remains positive after 4 cycles: patient is withdrawn from the protocol Circulating tumor DNA (ctDNA) is collected at baseline, after 2, 4, and 6 cycles for exploratory molecular response assessment.
- interventionNames
- Drug: Nivolumab
- Other: N-EACOPD-14
- Other: N-AVD
Primary outcomes (3)
- measure
- Proportion of patients achieving complete metabolic response (CMR) after 2 cycles of induction therapy
- timeFrame
- 4 weeks after treatment initiation
- description
- Complete metabolic response is defined as Deauville score 1-3 on PET-CT after two cycles of Nivolumab + EACOPD-14, assessed per LYRIC criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
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