MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma
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.
∙ STEP 1 REGISTRATION
• Aged \>= 18 years
• Histologically confirmed diagnosis of WHO grade 1-3 meningioma
• Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan defined as at least one lesion with two perpendicular diameters measuring ≥10 mm on two or more axial slices (≤ 5 mm interslice thickness, ≤ 1 mm interslice gap) per current RANO meningioma criteria
• Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as
‣ ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months, or
⁃ Development of a new measurable lesion
• The following scans must be available for submission for central radiology review:
‣ Pre-progression gadolinium-enhanced MRI brain scan
⁃ Progression gadolinium-enhanced MRI brain scan
∙ STEP 2 REGISTRATION
• Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as
‣ ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months, or
⁃ Development of a new measurable 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.
• If randomized to the control (standard of care) arm, both the patient and investigator must agree NOT to receive SSTR2-targeted therapy, surgical resection, or radiation therapy.
• Patients must be willing and able to undergo regular MRI scans of the brain and \[68Ga\]Ga-DOTATATE PET-CT imaging during the study.
• Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).
• 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
⁃ 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.