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AERN-Studie

AcronymISRCTNEudraCTClinicaltrials.govDRKS
2017-003334-82NCT03480334

Abscopal Effect of Radiotherapy and Nivolumab in Relapsed HL after anti-PD1 Therapy

Status: Active

Purpose / Objectives

Primary Outcome

  • 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 Outcomes

  • Overall abscopal response rate (OARR)
  • Overall response rate (ORR)
  • Duration of response (DOR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Adverse events (AE)
  • Feasibility aspects
  • Quality of life (QoL) and life situation (LS) aspects
  • Correlative studies on tumor and blood samples

Diagnosis

Patient attributes

Stage

1, 2

Age

18-99

Inclusion criteria

  • Relapsed/refractory cHL with histopathologically confirmed progression while treated with an anti-PD1 agent
  • At least two distinct FDG-avid HL-lesions with at least 5cm distance between them, and one of them considered eligible for irradiation with 20Gy
  • One but the irradiated lesion has to be outside the 10% isodose in RT planning confirmed by the Central Response Evaluation Panel (CREP)
  • [...]

Exclusion criteria

  • Nodular lymphocyte-predominant HL or grey-zone lymphoma
  • Evidence of active, non-infectious lung disorder with DLCOc <50%
  • History of long-term or ongoing ingestion of immunosuppressive agents >10mg prednisone/d
  • Any other serious disease or organ dysfunction which might impair protocol treatment
  • [...]

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

  • Nivolumab 240 mg i.v. at 2-weekly intervals until disease progression or unacceptable toxicity combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion

Documents (password protected)

Responsibilities in overall trial

Universität zu Köln

  • Tel. +49 (0)221 478 0

National Coordinating Investigator

Univ.-Prof. Dr. med. Andreas Engert

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Univ.-Prof. Dr. med. Andreas Engert

Deputy of Principal Investigator

  • Dr. med. Dennis Eichenauer

Subinvestigator

  • Dr. Christian Baues
  • Dr. med. Paul Bröckelmann
  • Dr. med. Sarah Gillessen
  • PD Dr. Stefan Haneder
  • Dr. med. Anja Jühling
  • Dr. Stefanie Kreissl
  • Prof. Dr. med. Christian Pallasch
  • Johanna Prinz
  • Dr. med. Armin Tuchscherer
  • Univ.-Prof. Dr. med. Dr. rer.-nat. Roland Ullrich
  • PD Dr. med. Thomas Zander

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