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

Phase 2

Active, not recruiting

• Conditions: Classical Hodgkin Lymphoma
• Interventions: Other: Nivolumab plus radiotherapy

• Registration Number: NCT03480334
• Lead Sponsor: University of Cologne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-29
• Study Start: 2019-12-05
• Primary Completion: 2024-05-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Study Completion: 2025-05-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Nivolumab plus radiotherapy	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 Outcome Measures

Name	Time	Method
Abscopal response rate (ARR-6)	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)

Trial Locations

Locations (1)

1st Department of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany