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

NCT03480334 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: Uni-Koeln 3140
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm A

EXPERIMENTAL

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.

Other: Nivolumab plus radiotherapy

Interventions

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.

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Location

MeSH Terms

Interventions

Nivolumab; Radiotherapy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Andreas Engert, Prof.

  University of Cologne, I. Dept. of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: December 5, 2019
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

DE (1)