Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy

The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of patients suffers from progressive disease. Localized RT induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Classical Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Progression of refractory or relapsed cHL during treatment with an anti-PD1 agent
At least two distinct FDG-avid HL-lesions with at least 5 cm distance between them, and one of them considered eligible for irradiation with 20Gy based on localization and prior RT exposure
Age at registration ≥ 18 years

Exclusion criteria

Nodular-lymphocyte predominant HL (NLPHL) or composite/greyzone lymphoma
Lymphoma involving the central nervous system
Naïve to treatment with anti-PD1 targeting antibodies

Treatment and study plan

Nivolumab plus radiotherapy

Other

Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity.

Primary outcomes

Abscopal response rate (ARR-6)

Time frame: 12 weeks

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)

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: AERN

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2025
First posted: Mar 29, 2018
Registry last updated: Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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