RecruitingPhase 1

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

Germany46 participantsStarted 2021-10-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient aged ≥ 18 years at the time of signing the informed consent
. Existing ability to understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
. Patient is at "good risk" ( NCCN guidelines version 1.2021)
. 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
. Existing ability to adhere to the study visit schedule and other protocol requirements
. Existing agreement to refrain from donating blood while on study drug and for 30 days after discontinuation from this study treatment
. Karnofsky performance score \> 50%
. Diagnosis of LMD by CSF and/or MRI (details see Study protocol)

Exclusion criteria

. Women during pregnancy and lactation.
. Previous intrathecal nivolumab application.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Adverse Events for Dose Limiting Toxicities [Safety and Tolerabillity]

Timeframe: up to 4 months after last dose

Trial details

NCT IDNCT05112549

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Ghazaleh Tabatabai, Prof.Dr.

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

View on ClinicalTrials.gov More Leptomeningeal Disease trials