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
130
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. Systemic SOC therapy with one of the following agents: bevacizumab, everolimus, or sunitinib.
University of California, Irvine
Irvine, California, United States
RECRUITINGUniversity of California San Diego - Moores Cancer Center
Progression Free Survival (PFS)
Proportion of patients alive without disease progression per current RANO meningioma criteria
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)
Proportion of patients after cross-over alive without disease progression per current RANO meningioma criteria
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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La Jolla, California, United States
Yale University
New Haven, Connecticut, United States
RECRUITINGBaptist MD Anderson Cancer Center
Jacksonville, Florida, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGBaptist Health Medical Group Oncology
Miami, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGPiedmont Healthcare
Atlanta, Georgia, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa Health Care
Iowa City, Iowa, United States
RECRUITING...and 6 more locations
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