Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05112549

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

Led by University Hospital Tuebingen · Updated on 2025-04-03

46

Participants Needed

9

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Main

  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
  11. MRI assessment at screening is based on the LANO scorecard acc. to Le Rhun et al., 2019
  12. Existing ability to undergo intrathecal therapy via an intraventricular catheter (e.g. Ommaya reservoir)
  13. Primary tumor tissue for the assessment of PD-1 and PD-L1 is optional at the timepoint of inclusion and enrollment but does need to be shipped before end of the trial.
  14. Existing willingness of female patient of childbearing potential and male patient with female partner of childbearing potential to use highly effective contraceptive methods during treatment and for 150 days (male or female, see SmPC) after the last dose (details see Study protocol)

Main

Not Eligible

You will not qualify if you...

  1. Women during pregnancy and lactation.
  2. Previous intrathecal nivolumab application.
  3. Patient at "poor risk" (NCCN guidelines version 1.2021)
  4. The following differential diagnoses to LMD are exclusion criteria: a. Aseptic, meningitis b. Viral meningitis, c. Bacterial meningitis
  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)
  12. Inability to undergo MRI with contrast agent
  13. The underlying primary tumor has not a registered and authorized indication in the European Union for intravenous treatment with Nivolumab, Pembrolizumab or Atezolizumab (details see study protocol). In addition, leptomeningeal disease of solid tumors with a high tumor mutational burden is also eligible.
  14. Existence of abnormal laboratory values for the following values in hematology, coagulation parameters, liver and renal function (details see study protocol)
  15. Patients who have received live or attenuated vaccine therapy used for prevention of infectious disease within 4 weeks of the first IT application of nivolumab
  16. Patients requiring chronic systemic corticosteroid therapy (> 10 mg prednisone or equivalent per day) or any other immunosuppressive therapies (including anti-TNF-a therapies)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 9 locations

1

Universitätsklinikum Bonn

Bonn, Germany, 753127

Actively Recruiting

2

University Hospital Freiburg, Neurosurgery

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

3

University Hospital Heidelberg, Neurooncology

Heidelberg, Germany, 69120

Not Yet Recruiting

4

SLK-Kliniken Heilbronn GmbH Klinik

Heilbronn, Germany, 74078

Actively Recruiting

5

University Hospital Mannheim, Neurology Clinic

Mannheim, Germany, 68167

Actively Recruiting

6

Klinikum rechts der Isar/Technische Universität München

München, Germany, 81675

Actively Recruiting

7

Katharinenhospital Stuttgart

Stuttgart, Germany, 70565

Actively Recruiting

8

University Hospital Tübingen, Neurooncology

Tübingen, Germany, 72076

Actively Recruiting

9

University Hospital Ulm, ECTU - Early Clinical Trail Unit

Ulm, Germany, 89081

Actively Recruiting

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Research Team

G

Ghazaleh Tabatabai, Prof.Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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