RecruitingPhase 2NCT06955169

Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment

MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma


Sponsor

RTOG Foundation, Inc.

Enrollment

130 participants

Start Date

Aug 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard of Care treatments and a drug called [177Lu]Lu-DOTATATE for people with intracranial meningioma. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[177Lu]Lu-DOTATATE

The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).

OTHERStandard of Care treatments

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.


Locations(16)

University of California, Irvine

Irvine, California, United States

University of California San Diego - Moores Cancer Center

La Jolla, California, United States

Yale University

New Haven, Connecticut, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Baptist Health Medical Group Oncology

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa Health Care

Iowa City, Iowa, United States

Dana-Farber/Harvard Cancer Center

Boston, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

NYU Lagone Health

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06955169


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