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New treatment option for Leptomeningeal Disease
Official title Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26)
ClinicalTrials.gov ID: NCT05112549
What this study is testing
What is Nivolumab [Opdivo]?
Nivolumab [Opdivo] is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leptomeningeal disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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 \&...
You likely can't join if
- Women during pregnancy and lactation.
- Previous intrathecal nivolumab application.
- Patient at "poor risk" (NCCN guidelines version 1.2021)
- The following differential diagnoses to LMD are exclusion criteria: a. Aseptic, meningitis b. Viral meningitis, c. Bacterial meningitis
- History of hypersensitivity to monoclonal antibodies
- 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...
See the full eligibility criteria
- Main
- 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...
- 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)
- 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
- Neurological examination (NANO scale) acc. Nayak et al., 2017 performed
- MRI assessment at screening is based on the LANO scorecard acc. to Le Rhun et al., 2019
- Existing ability to undergo intrathecal therapy via an intraventricular catheter (e.g. Ommaya reservoir)
- 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.
- 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...
- Women during pregnancy and lactation.
- Previous intrathecal nivolumab application.
- Patient at "poor risk" (NCCN guidelines version 1.2021)
- The following differential diagnoses to LMD are exclusion criteria: a. Aseptic, meningitis b. Viral meningitis, c. Bacterial meningitis
- History of hypersensitivity to monoclonal antibodies
- 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...
- 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...
- 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
- Patient with confirmed history of current autoimmune disease
- Patients with any disease resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
- Existence of clinically significant active infection (details see study protocol)
- Inability to undergo MRI with contrast agent
- 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...
- Existence of abnormal laboratory values for the following values in hematology, coagulation parameters, liver and renal function (details see study protocol)
- 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
- Patients requiring chronic systemic corticosteroid therapy (\> 10 mg prednisone or equivalent per day) or any other immunosuppressive therapies (including anti-TNF-a therapies)
The study team makes the final eligibility decision.
Where it's taking place
- Bonn, Germany
- Freiburg im Breisgau, Germany
- Heidelberg, Germany
- Heilbronn, Germany
- Mannheim, Germany
- München, Germany
- Stuttgart, Germany
- Tübingen, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bonn, Germany; Freiburg im Breisgau, Germany; Heidelberg, Germany; Heilbronn, Germany; Mannheim, Germany; München, Germany and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.