OncoMatch/Clinical Trials/NCT06955169
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
Official title: MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma
Is NCT06955169 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies [177Lu]Lu-DOTATATE for intracranial meningioma.
Treatment: [177Lu]Lu-DOTATATE — This is an open-label, multicenter, randomized, phase 2 clinical study to evaluate the efficacy of \[177Lu\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Cancer type
Meningioma
Biomarker criteria
Required: SSTR2 expression (uptake at least as high as liver in at least one target lesion)
[68Ga]Ga-DOTATATE uptake on PET-CT. Positive uptake is defined as uptake at least as high as liver, based on the uptake in at least one target lesion.
Performance status
WHO 0–1
Prior therapy
Must have received: surgical intervention
Disease progression following at least one prior surgical intervention (biopsy or resection)
Must have received: radiation therapy
Disease progression following...at least one prior course of radiation
Cannot have received: SSTR2-targeted therapy (Somatostatin LAR, short-acting Octreotide)
Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies.
Cannot have received: radioligand therapy
Exception: Radioligands received for diagnostic purposes are not exclusionary.
All types of radioligand therapy at any time prior to registration. Radioligands received for diagnostic purposes are not exclusionary.
Lab requirements
Blood counts
ANC ≥ 1500/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 8 g/dL
Kidney function
Creatinine clearance (Cockroft-Gault) ≥40mL/min
Liver function
AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; total serum bilirubin ≤ 3 x ULN (except Gilbert's Syndrome ≤ 5 x ULN)
Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration): Absolute neutrophil count (ANC) ≥ 1500/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 8 g/dL; Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min; AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN); Potassium within normal limits.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, Irvine · Irvine, California
- University of California San Diego - Moores Cancer Center · La Jolla, California
- Yale University · New Haven, Connecticut
- Baptist MD Anderson Cancer Center · Jacksonville, Florida
- University of Miami · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06955169 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior SSTR2-targeted therapy, radioligand therapy disqualifies patients from enrollment.
Does this trial require SSTR2?
Yes, SSTR2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages