To determine the safety of intrathecal (IT) PD1 antibody for Intrathecal application of PD1 antibody in metastatic solid tumors with leptomeningeal disease of solid tumors.
Leptmeningeal disease (LMD) is an aggressive subtype of metastatic disease in the central nervous system (CNS) and has a poor prognosis with a median overall survival of a few months.The IT-PD1 trial group wants to contribute to an improvement of this situation for LMD patients by using an intrathecal application route for the PD1 antibody, i.e. a drug that has shown clinical efficacy in the underlying tumor via the intravenous route.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
Universitätsklinikum Bonn
Bonn, Germany
RECRUITINGUniversity Hospital Freiburg, Neurosurgery
Freiburg im Breisgau, Germany
RECRUITINGAssessment of Adverse Events for Dose Limiting Toxicities [Safety and Tolerabillity]
This trial will investigate the maximum tolerable dose and safety of intrathecal PD1 antibody administration in LMD of metastatic solid tumors with a registered indication for treatment with intravenous PD1 antibody or PD-1L antibody. The safety endpoints will be assessed by a review of adverse events and serious adverse events according to CTCAE up to 4 months days after last dose.Subjects will undergo 6 cycles each 14 days in duration and a safety visit 7 days after the 3th dosage and 7 days after the 6th dosage.The appropriate dose for the expansion phase (Part II) is based on the results in Part I (dose escalation phase) and will define the maximum tolerable fix dose in Part II.
Time frame: up to 4 months after last dose
Overall Survival
The secondary endpoint is overall survival defined as the time interval from the date of first study administration to the date of progression.
Time frame: last follow-up, up to 4 months after last dose
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University Hospital Heidelberg, Neurooncology
Heidelberg, Germany
SLK-Kliniken Heilbronn GmbH Klinik
Heilbronn, Germany
RECRUITINGUniversity Hospital Mannheim, Neurology Clinic
Mannheim, Germany
RECRUITINGKlinikum rechts der Isar/Technische Universität München
München, Germany
RECRUITINGKatharinenhospital Stuttgart
Stuttgart, Germany
RECRUITINGUniversity Hospital Tübingen, Neurooncology
Tübingen, Germany
RECRUITINGUniversity Hospital Ulm, ECTU - Early Clinical Trail Unit
Ulm, Germany
RECRUITING