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

University of Cologne

Status and phase: Active, not recruiting; Phase 2

Conditions: Classical Hodgkin Lymphoma

Treatments: Other: Nivolumab plus radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03480334

Uni-Koeln 3140

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Arm A

Experimental group

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.

Treatment:

Other: Nivolumab plus radiotherapy