Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26)

PHASE1RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

October 12, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

September 30, 2027

Conditions
Leptomeningeal Disease
Interventions
DRUG

Nivolumab [Opdivo]

Nivolumab (OPDIVO®) is a marketed pharmaceuticals material authorized in the European Union. This study uses an off-label route of administration of nivolumab. Subjects with leptomeningeal disease in solid tumours with an approved indication for intravenous treatment with the PD1 antibody will receive an intrathecal application of nivolumab. A total of six i.th. applications will be performed every 14 days. The intrathecal administration will be performed via an Ommaya reservoir or another intraventricular catheter.

Trial Locations (9)

68167

RECRUITING

University Hospital Mannheim, Neurology Clinic, Mannheim

69120

NOT_YET_RECRUITING

University Hospital Heidelberg, Neurooncology, Heidelberg

70565

RECRUITING

Katharinenhospital Stuttgart, Stuttgart

72076

RECRUITING

University Hospital Tübingen, Neurooncology, Tübingen

74078

RECRUITING

SLK-Kliniken Heilbronn GmbH Klinik, Heilbronn

79106

RECRUITING

University Hospital Freiburg, Neurosurgery, Freiburg im Breisgau

81675

RECRUITING

Klinikum rechts der Isar/Technische Universität München, München

89081

RECRUITING

University Hospital Ulm, ECTU - Early Clinical Trail Unit, Ulm

753127

RECRUITING

Universitätsklinikum Bonn, Bonn

All Listed Sponsors
lead

University Hospital Tuebingen

OTHER