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Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05112549•University Hospital Tuebingen

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient aged ≥ 18 years at the time of signing the informed consent
•2. Existing ability to understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
•3. Patient is at "good risk" ( NCCN guidelines version 1.2021)
•4. Existence of the following Tumor board protocol confirmations: clinical recommendation for intrathecal therapy and evaluation of trial enrolment \& statement on the potential necessity of additional systemic treatment of metastatic tumor outside the CNS
•5. Existing ability to adhere to the study visit schedule and other protocol requirements
•6. Existing agreement to refrain from donating blood while on study drug and for 30 days after discontinuation from this study treatment
•7. Karnofsky performance score \> 50%
•8. Diagnosis of LMD by CSF and/or MRI (details see Study protocol)
•9. If radiation therapy was performed please confirm: Participants eligible for IT-PD1 should have completed their radiation therapy due to clinical indication \> 2 weeks prior to enrollment into the trial
•10. Neurological examination (NANO scale) acc. Nayak et al., 2017 performed
+4 more criteria

Exclusion Criteria

•1. Women during pregnancy and lactation.
•2. Previous intrathecal nivolumab application.
•3. Patient at "poor risk" (NCCN guidelines version 1.2021)
•5. History of hypersensitivity to monoclonal antibodies
•6. Participation in other clinical AMG or MDR trials or observation period of competing trials or if there is otherwise a high risk of insurance law issues intervening between two studies and if the participation affects the primary endpoint of the IT-PD1 study. In case of uncertainty, competing insurances must be contacted prior to participation
•7. A clinical condition that in the opinion of the investigator would interfere with the evaluation or interpretation of patient safety or trial results or that would prohibit the understanding of informed consent and compliance with the requirements of the protocol
•8. Any treatment-related toxicities from prior systemic anti-tumor or immune therapy not having resolved to CTCAE version 5.0 grade 1, with the exception of alopecia
•9. Patient with confirmed history of current autoimmune disease
•10. Patients with any disease resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
•11. Existence of clinically significant active infection (details see study protocol)
+5 more criteria

Locations (9)

Universitätsklinikum Bonn

Bonn, Germany

University Hospital Freiburg, Neurosurgery

Freiburg im Breisgau, Germany

University Hospital Heidelberg, Neurooncology

Heidelberg, Germany

SLK-Kliniken Heilbronn GmbH Klinik

Heilbronn, Germany

University Hospital Mannheim, Neurology Clinic

Mannheim, Germany

Klinikum rechts der Isar/Technische Universität München

München, Germany

Katharinenhospital Stuttgart

Stuttgart, Germany

University Hospital Tübingen, Neurooncology

Tübingen, Germany

University Hospital Ulm, ECTU - Early Clinical Trail Unit

Ulm, Germany

Key Dates

Start Date

October 12, 2021

Primary Completion Date

December 31, 2026

Completion Date

September 30, 2027

Last Updated

April 3, 2025

Enrollment

ESTIMATED participants

Conditions

Leptomeningeal Disease

Interventions

Nivolumab [Opdivo]

DRUG

Contacts

Ghazaleh Tabatabai, Prof.Dr.

CONTACT

+49 (0) 7071 - 2985018 ghazaleh.tabatabai@uni-tuebingen.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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