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.
Study participants will be randomized by a 2:1 ratio to receive either \[177Lu\]Lu-DOTATATE or standard of care therapy as deemed appropriate by the local investigator. At time of progression, participants on the standard of care arm may cross-over to the \[177Lu\]Lu-DOTATATE alternative treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).
Treatments will occur at the discretion and based on clinical judgement of the local and treating investigator. Local SOC therapy with one of the following agents: bevacizumab, everolimus, hydroxyurea, or sunitinib.
Piedmont Healthcare
Atlanta, Georgia, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGProgression Free Survival (PFS)
PFS defined as the time from randomization to date of disease progression per current RANO meningioma criteria or death, whichever occurs first
Time frame: Assessed up to 4 years
Progression free survival at 6 months (PFS-6)
Proportion of participants alive without progression at 6 months assessed per RANO meningioma criteria
Time frame: 6 months
Overall Survival at 12 months (OS-12)
Proportion of participants alive at 12 months
Time frame: 12 months
Overall survival (OS)
Time from randomization to death from any cause
Time frame: Assessed up to 4 years
Progression-free Survival after cross-over (PFS2)
Time from cross-over to disease progression per RANO meningioma criteria or death from any cause, whichever occurs first.
Time frame: Assessed up to 4 years
Disease Control Rate (DCR)
Proportion of patients achieving complete response, partial response, minor response or stable disease as per RANO meningioma criteria
Time frame: Assessed up to 4 years
Objective response rate (ORR)
Proportion of patients achieving complete or partial response as per RANO meningioma criteria.
Time frame: Assessed up to 4 years
Number of participants by highest grade treatment-emergent adverse event (TEAE):
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Number of participants experiencing the highest grade TEAE, graded according to CTCAE version 5.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death related to adverse event).
Time frame: Assessed up to 4 years
Number of participants who discontinue treatment due to TEAE
Number of participants who discontinue treatment as a result of treatment-emergent adverse events.
Time frame: Assessed up to 4 years