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

Phase 2Active Not RecruitingNCT03480334

University of Cologne26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Classical Hodgkin Lymphoma

Interventions

Nivolumab plus radiotherapyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Outcomes

Primary Outcomes

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)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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