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

Classical Hodgkin Lymphoma Clinical Trial

— AERN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480334
• Other study ID #: Uni-Koeln 3140
• Status: Recruiting
• Phase: Phase 2
• Start date: December 5, 2019
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: University of Cologne
• Contact: Michael Fuchs
• Email: ghsg[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: December 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	1st Department of Medicine, Cologne University Hospital	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abscopal response rate (ARR-6)	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)	12 weeks