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

Rekrutierend

NCT-Nummer:
NCT03480334

Studienbeginn:
Dezember 2019

Letztes Update:
13.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lymphoma, Hodgkin Disease

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University of Cologne

Collaborator:
-

Studienleiter

Andreas Engert, Prof.
Principal Investigator
University of Cologne, I. Dept. of Medicine

Kontakt

Michael Fuchs
Kontakt:
E-Mail: ghsg@uk-koeln.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

1st Department of Medicine, Cologne University Hospital
Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Michael Fuchs
E-Mail: GHSG@uk-koeln.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Abscopal response rate (ARR-6) (Time Frame - 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)

Geprüfte Regime

Nivolumab 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.

Quelle: ClinicalTrials.gov