Nivolumab and AVD in earlystage unfavorable classical Hodgkin lymphoma

Nivolumab and AVD in earlystage unfavorable classical Hodgkin lymphoma - A GHSG randomized, multicenter phase II trial - NIVAHL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002626-37-DE

Enrollment

110

Registered

2016-11-28

Start date

2017-03-10

Completion date

Unknown

Last updated

2023-09-04

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

Conditions

Improvement of first-line treatment for early-stage unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab in combincation with a truncated standard chemotherapy (AVD). 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: Nivolumab Pharmaceutical Form: Lyophilisate for solution for infusion Trade Name: Adrimedac Product Name: Adrimedac Pharmaceutical Form: Lyophilisate for solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically proven classical HL - First diagnosis, no previous treatment - Age: 18-60 years - Stage I, IIA with risk factors a-d, IIB with RF c-d: a) large mediastinal mass b) extranodal lesions c) elevated ESR d) = 3 nodal areas confirmed by central review. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Composite lymphoma or nodular lymphocytepredominant Hodgkin lymphoma (NLPHL) - History of other malignancy = 5 years - Prior chemotherapy or radiation therapy - Concurrent disease precluding protocol treatment - Pregnancy, lactation - Non-compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate efficacy and quality of life measures of the two experimental treatment strategies.;Secondary Objective: Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.;Primary end point(s): Complete remission (CR) rate at the end of treatment, assessed by central review.;Timepoint(s) of evaluation of this end point: please refer to E.5.1.	—

Measure

Time frame

Main Objective: The primary objective is to evaluate efficacy and quality of life measures of the two experimental treatment strategies.;Secondary Objective: Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.;Primary end point(s): Complete remission (CR) rate at the end of treatment, assessed by central review.;Timepoint(s) of evaluation of this end point: please refer to E.5.1.

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary endpoint: - Treatment-related morbidity (TRMorbidity) Further secondary endpoints: - 1- and 3-year progression-free survival (PFS) - 1- and 3-year overall survival (OS) - Quality of life including the prevalence of severe long-term fatigue - Objective response rate (ORR; proportion of patients with complete or partial remission) at the end of treatment - Proportion of patients with negative PET/CT after four infusions of Nivolumab Secondary exploratory endpoints: - Correlative studies including biomarker analyses;Timepoint(s) of evaluation of this end point: Please refer to E.5.2.1.	—

Measure

Time frame

Secondary end point(s): Key secondary endpoint: - Treatment-related morbidity (TRMorbidity) Further secondary endpoints: - 1- and 3-year progression-free survival (PFS) - 1- and 3-year overall survival (OS) - Quality of life including the prevalence of severe long-term fatigue - Objective response rate (ORR; proportion of patients with complete or partial remission) at the end of treatment - Proportion of patients with negative PET/CT after four infusions of Nivolumab Secondary exploratory endpoints: - Correlative studies including biomarker analyses;Timepoint(s) of evaluation of this end point: Please refer to E.5.2.1.

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Countries

Germany

Contacts

Public ContactTrial Coordination Center

German Hodgkin Study Group

ghsg@uk-koeln.de004922147888200

Outcome results

None listed

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