OncoMatch/Clinical Trials/NCT05112549
Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26)
Is NCT05112549 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Nivolumab [Opdivo] for leptomeningeal disease.
Treatment: Nivolumab [Opdivo] — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Biomarker criteria
Allowed: PDCD1 any tested
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.
Allowed: PD-L1 (CD274) any tested
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.
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: intrathecal nivolumab (nivolumab)
Previous intrathecal nivolumab application.
Cannot have received: live or attenuated vaccine therapy
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
Lab requirements
Blood counts
Existence of abnormal laboratory values for the following values in hematology, coagulation parameters, liver and renal function (details see study protocol)
Kidney function
Existence of abnormal laboratory values for the following values in hematology, coagulation parameters, liver and renal function (details see study protocol)
Liver function
Existence of abnormal laboratory values for the following values in hematology, coagulation parameters, liver and renal function (details see study protocol)
Existence of abnormal laboratory values for the following values in hematology, coagulation parameters, liver and renal function (details see study protocol)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05112549 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior intrathecal nivolumab, live or attenuated vaccine therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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