Classical Hodgkin Lymphoma
Conditions
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.
Interventions
OTHERNivolumab 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.
Sponsors
University of Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany
Outcome results
None listed