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

NCT ID: NCT03480334

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-05
• Study Completion Date: 2025-05-04

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.

Conditions

Classical Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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.

Group Type: EXPERIMENTAL

Nivolumab plus radiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Dr. Paul Broeckelmann

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Engert, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, I. Dept. of Medicine

Locations

1st Department of Medicine, Cologne University Hospital

Cologne, , Germany

Countries

Germany

Other Identifiers

Uni-Koeln 3140

Identifier Type: -

Identifier Source: org_study_id