Back to resultsAbscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy (AERN)
Primary Purpose
Classical Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Nivolumab plus radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Classical Hodgkin Lymphoma
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
Sites / Locations
- 1st Department of Medicine, Cologne University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm A
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03480334
First Posted
March 21, 2018
Last Updated
September 12, 2023
Sponsor
University of Cologne
1. Study Identification
Unique Protocol Identification Number
NCT03480334
Brief Title
Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy
Acronym
AERN
Official Title
Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Nivolumab plus radiotherapy
Intervention Description
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 Measure Information:
Title
Abscopal response rate (ARR-6)
Description
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)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Fuchs
Email
ghsg@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof.
Organizational Affiliation
University of Cologne, I. Dept. of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Medicine, Cologne University Hospital
City
Cologne
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Fuchs
Email
GHSG@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Andreas Engert, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy
We'll reach out to this number within 24 hrs