Clinical trial · Interventional
Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumour VOLUME in Patients Treated for Classical HODgkin's Lymphoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of eligible patients
Summary
Brief summary (as posted)
Anti-PD-1antibodies (iPD-1) are indicated as monotherapy in the treatment of adult patients with classical LH. The recommended dosage in LH is based on solid tumour experience and no dose-concentration-effect studies have been conducted. According to the literature, therapeutic efficacy appears to be highly variable, and could be related to differences in treatment exposure. Since Total metabolic tumor volume (TMTV) is a prognostic factor in LH and the clearance of iPD-1, and thus exposure to iPD-1, is related to clinical efficacy, we hypothesize that TMTV influences the exposure to iPD-1 and thus its therapeutic efficacy. The aim of this study is to evaluate the relationship between TMTV and anti-PD-1 exposure in refractory or relapsed LH.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients
- interventionNames
- Other: blood samples
Primary outcomes (1)
- measure
- Pearson's correlation between the initial Tumour Metabolic Total Volume and the area under the curve of iPD-1 .
- timeFrame
- 1 month
- description
- linear relationship, using Pearson's correlation, between the initial Tumour Metabolic Total Volume and the area under the curve (AUC) of iPD-1 during the first treatment.
Secondary outcomes (8)
- measure
- Correlation between treatment exposure and initial TMTV for each cycle
- timeFrame
- 3 months
- description
- Degree of correlation between AUC, peak concentration (Cmax), residual concentration (Cmin) measured at each treatment cycle of the first 3 months, and initial TMTV (tumour Metabolic Total Volume)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient at least 18 years of age * Patient for whom anti-PD-1 antibody therapy (nivolumab or pembrolizumab) is given as monotherapy for relapsed or refractory classical Hodgkin's lymphoma within the scope of the WMA. * Patient for whom a PET-CT for the evaluation of TMTV is available within 30 days prior to the first treatment without intercurrent antitumour therapy between the last PET-CT and the start of anti-PD1 treatment. * For women of childbearing age, use of effective contraception * Patient with free, informed and written consent * Patient affiliated to a social security scheme Exclusion Criteria: * Persons of full age subject to legal protection (judicial protection, guardianship, trusteeship), persons deprived of their liberty, pregnant or breastfeeding women, persons unable to give consent * Patient with a contraindication to NIV or PEM treatment * Patient previously treated with anti-PD1 regardless of indication * Patient treated with anti-PD1 in combination with other anti-tumour treatment * Patient participating in another interventional clinical study
References
Publications (0)
Data not yet available