Effect of Radiotherapy and Nivolumab in Relapsed classical Hodgkin Lymphoma

Abscopal Effect of Radiotherapy and Nivolumab in anti-PD1 Pretreated Relapsed or Refractory classical Hodgkin Lymphoma - An international multicenter Phase II trial - AERN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003334-82-DE

Enrollment

Registered

2019-01-02

Start date

2019-03-11

Completion date

Unknown

Last updated

2024-05-21

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

Conditions

Improvement of efficacy of nivolumab in patients with relapsed or refractory classical Hodgkin Lymphoma who recently progressed on anti-PD1 therapy. 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Relapsed/refractory cHL with progression while treated with an anti-PD1 antibody or Relapsed/refractory cHL with stable disease for > 6 months as best response to ongoing anti-PD1 antibody therapy - At least two distinct FDG-avid HL-lesions with at least 5cm distance between them, and one of them considered eligible for irradiation with 20Gy - One but the irradiated lesion has to be outside the 10% isodose in RT planning confirmed by the Central Response Evaluation Panel (CREP) - Age =18 years, all sexes 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 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Nodular lymphocyte-predominant HL or grey-zone lymphoma - Evidence of active, non-infectious lung disorder with DLCOc 10mg prednisone/d - Any other serious disease or organ dysfunction which might impair protocol treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to show efficacy of the experimental treatment strategy. ;Secondary Objective: Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.;Primary end point(s): Abscopal response rate (ARR-6) with abscopal response centrally confirmed as restaging result after RT to a single lesion and at least four but not more than six nivolumab infusions (RE-6 result);Timepoint(s) of evaluation of this end point: please refer to E.5.1	—

Measure

Time frame

Main Objective: The primary objective of the trial is to show efficacy of the experimental treatment strategy. ;Secondary Objective: Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.;Primary end point(s): Abscopal response rate (ARR-6) with abscopal response centrally confirmed as restaging result after RT to a single lesion and at least four but not more than six nivolumab infusions (RE-6 result);Timepoint(s) of evaluation of this end point: please refer to E.5.1

—

Secondary

Measure	Time frame
Secondary end point(s): Overall abscopal response rate (OARR) Overall response rate (ORR) Duration of response (DOR) Progression-free survival (PFS) Overall survival (OS) Adverse events (AE) Feasibility aspects Quality of life (QoL) and life situation (LS) aspects Correlative studies	—

Countries

Austria, Germany, Netherlands, Norway, United Kingdom

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