Evaluation of the Relationship Between Therapeutical Antibody Exposure and Tumor VOLUME in Patients Treated for Conventional HODgkin's Lymphoma

Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumor VOLUME in Patients Treated for Conventional HODgkin's Lymphoma - REVOLUMHOD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001856-16-FR

Enrollment

Registered

2020-07-10

Start date

2020-09-08

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Hodgkin Lymphoma MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: OPDIVO Product Name: OPDIVO Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion Trade Name: KEYTRUDA Product Name: KEYTRUDA Pharmaceutical Form: Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - More than 18 years old - Patient for whom treatment with anti-PD-1 antibodies (nivolumab or pembrolizumab) is administered as monotherapy for relapsed or refractory classical Hodgkin's lymphoma within the scope of the WMA - Patient for whom a PET/CT scan for evaluation of TMTV is available within 30 days prior to the first dose of treatment without intercurrent antitumor therapy between the last PET-CT and the start of anti-PD1 therapy - Signed consent form - Patient with a Health insurance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to give their consent - Patient with a contraindication to treatment with OPDIVO or KEYTRUDA - Patient treated with anti-PD1 in combination with other antitumor therapy - Patient included in another interventional clinical study

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the correlation between pre-treatment tumor volume and early exposure to anti-PD-1 in patients treated for Hodgkin Lymphoma.;Secondary Objective: a.Assess the correlation between anti-PD-1 exposure during treatment and initial tumour volume (TMTV). b.Evaluate the correlation between anti-PD-1 exposure and tumor volume (TMTV) at 3 months (for Deauville 4-5) c.Assess the correlation between anti-PD-1 exposure and metabolic response at 3 months of treatment initiation. d.Assess the correlation between anti-PD-1 exposure and residual tumour disease (ctDNA) at 3 months from the start of treatment (12). e.Determine the relationship between anti-PD-1 exposure and the expression of target molecules (PD-1, PDL-1 and PDL-2) in tumour and plasma at 3 months from the start of treatment. f.Determine the relationship between anti-PD-1 exposure and the occurrence of immunological adverse events (irAE) at 3 months from the start of treatment. g.Assess the relationship between anti-PD-1 exposure and medium- and long-term therapeutic efficacy (PFS and OS).;Primary end point(s): Linear relationship, using Pearson's correlation, between the initial TMTV evaluated according to Meignan et al. (13) and the area under the curve (AUC) of anti-PD-1 at the first treatment.;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: Evaluate the correlation between pre-treatment tumor volume and early exposure to anti-PD-1 in patients treated for Hodgkin Lymphoma.;Secondary Objective: a.Assess the correlation between anti-PD-1 exposure during treatment and initial tumour volume (TMTV). b.Evaluate the correlation between anti-PD-1 exposure and tumor volume (TMTV) at 3 months (for Deauville 4-5) c.Assess the correlation between anti-PD-1 exposure and metabolic response at 3 months of treatment initiation. d.Assess the correlation between anti-PD-1 exposure and residual tumour disease (ctDNA) at 3 months from the start of treatment (12). e.Determine the relationship between anti-PD-1 exposure and the expression of target molecules (PD-1, PDL-1 and PDL-2) in tumour and plasma at 3 months from the start of treatment. f.Determine the relationship between anti-PD-1 exposure and the occurrence of immunological adverse events (irAE) at 3 months from the start of treatment. g.Assess the relationship between anti-PD-1 exposure and medium- and long-term therapeutic efficacy (PFS and OS).;Primary end point(s): Linear relationship, using Pearson's correlation, between the initial TMTV evaluated according to Meignan et al. (13) and the area under the curve (AUC) of anti-PD-1 at the first treatment.;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): a. Assess the correlation between anti-PD-1 exposure during treatment and initial tumour volume (TMTV). b. Evaluate the correlation between anti-PD-1 exposure and tumor volume (TMTV) at 3 months (for Deauville 4-5) c. Assess the correlation between anti-PD-1 exposure and metabolic response at 3 months of treatment initiation. d. Assess the correlation between anti-PD-1 exposure and residual tumour disease (cfDNA) at 3 months from the start of treatment (14). e. Determine the relationship between anti-PD-1 exposure and the expression of the target molecules (PD-1, PDL-1 and PDL-2) in the tumour prior to treatment and in the plasma prior to treatment and during the first 3 months of treatment. f. Determine the relationship between anti-PD-1 exposure and the occurrence of immunological adverse events (irAE) within 3 months of treatment initiation. g. Assess the relationship between anti-PD-1 exposure and survival (PFS and OS).;Timepoint(s) of evaluation of this end point: a. 3 months b. 3 months c. 3 months d. 3 months e. 3 months f. 3 months g. 12 months	—

Measure

Time frame

Secondary end point(s): a. Assess the correlation between anti-PD-1 exposure during treatment and initial tumour volume (TMTV). b. Evaluate the correlation between anti-PD-1 exposure and tumor volume (TMTV) at 3 months (for Deauville 4-5) c. Assess the correlation between anti-PD-1 exposure and metabolic response at 3 months of treatment initiation. d. Assess the correlation between anti-PD-1 exposure and residual tumour disease (cfDNA) at 3 months from the start of treatment (14). e. Determine the relationship between anti-PD-1 exposure and the expression of the target molecules (PD-1, PDL-1 and PDL-2) in the tumour prior to treatment and in the plasma prior to treatment and during the first 3 months of treatment. f. Determine the relationship between anti-PD-1 exposure and the occurrence of immunological adverse events (irAE) within 3 months of treatment initiation. g. Assess the relationship between anti-PD-1 exposure and survival (PFS and OS).;Timepoint(s) of evaluation of this end point: a. 3 months b. 3 months c. 3 months d. 3 months e. 3 months f. 3 months g. 12 months

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Countries

France

Contacts

Public ContactSponsor

Rennes University Hospital

dri@chu-rennes.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026