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)

September 2, 2026 updated by: RTOG Foundation, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Daniela Bota, MD, PhD
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego - Moores Cancer Center
        • Principal Investigator:
          • Jona Hattangadi-Gluth, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Sylvia Kurz, MD, PhD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Principal Investigator:
          • Michael Olson, MD PhD
        • Contact:
        • Sub-Investigator:
          • Andre Alvarez, MD PhD
      • Miami, Florida, United States, 33146
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Marina Kushnirsky, MD
      • Miami, Florida, United States, 33176
      • Tampa, Florida, United States, 33543
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Andre Luiz Beer Furlan, MD, PhD
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Piedmont Healthcare
        • Contact:
        • Principal Investigator:
          • Adam Nowlan, MD, MPH
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Kathryn Nevel, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
        • Contact:
        • Principal Investigator:
          • Kristin Plichta, MD, PhD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center
        • Contact:
        • Principal Investigator:
          • Sean Miller, MD
    • New York
      • New York, New York, United States, 10016
    • North Carolina
      • Durham, North Carolina, United States, 22708
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Margaret Johnson, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Carlos Kamiya-Matsuoka, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Michael Straza, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

STEP 1 REGISTRATION

  • Aged >= 18 years
  • Histologically confirmed diagnosis of WHO grade 1-3 meningioma
  • Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation.
  • The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation.
  • 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 (196 days), or
  • ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), 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 no older than 12 months (379 days) that serves as a reference for evaluation of radiographic disease progression
  • 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 (196 days), or
  • ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), 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.
  • Both the patient and investigator must agree that the patient will NOT receive SSTR2-targeted therapy, surgical resection, or radiation therapy until progression of disease while on study treatment.
  • 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
  • AST (SGOT) and ALT (SGPT) ≤ 3 x the laboratory upper limit of normal (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.

Exclusion Criteria:

  • Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis.
  • Patients with radiation-associated meningiomas.
  • Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column. Meningiomas invading the skull base or orbits are not excluded.
  • Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies.
  • Unstable neurological symptoms requiring steroids to control symptoms at a dose of >2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration.
  • Patients requiring immediate local therapy (e.g. surgical resection).
  • Surgical procedure within the timeframes listed below, prior to step 2 registration.
  • 28 days from any prior craniotomy
  • 7 days from stereotactic biopsy Note: There is no limit to the number of prior surgical interventions
  • Treatment within the timeframes specified below, prior to step 2 registration.
  • 28 days (or 5 half-lives, whichever is longer) for cytotoxic chemotherapy, biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma
  • 6 weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.
  • A target lesion is excluded if it has received any of the following:
  • More than 2 total prior courses of radiation
  • More than 1 prior course of standard fractionated external beam radiation therapy (EBRT)
  • Radiation treatment to the target lesion completed <24 weeks (168 days) before Step 2 registration.

For purposes of this criterion, one course of EBRT counts as one course regardless of duration, and each course of stereotactic radiation (1-5 fractions) counts as one course. Accordingly, a target lesion may have received at most one prior course of EBRT plus one prior course of stereotactic radiation, or two prior courses of stereotactic radiation. Prior radiation history must be evaluated on a lesion-by-lesion basis, including radiation delivered before any subsequent surgical resection.

  • All types of radioligand therapy at any time prior to registration. Radioligands received for diagnostic purposes are not exclusionary.
  • Known hypersensitivity to somatostatin analogues or any component of the [68Ga]Ga- DOTATATE or [177Lu]Lu-DOTATATE formulations.
  • Active infection requiring current use of intravenous therapy with antibiotics.
  • Active cardiovascular disease: cerebral vascular accident/stroke (≤ 6 months prior to registration), myocardial infarction (≤ 6 months prior to registration), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.
  • An active malignancy ≤ 3 years. Note: Patients with a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Pregnant and/or breastfeeding patients who are unwilling to discontinue breast feeding.
  • Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [177Lu]Lu-DOTATATE
Study participants receive [177Lu]Lu-DOTATATE
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).
Other Names:
  • Lutathera
Other: Control
Study participants receive systemic Standard of Care (SOC) Therapy. Control Arm participants crossover to [177Lu]Lu-DOTATATE at progression
Other: Standard 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.
Other Names:
  • Avastin (bevacizumab), Afinitor (everolimus), Sutent (sunitinib)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Assessed up to 4 years
Proportion of patients alive without disease progression per current RANO meningioma criteria
Assessed up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival at 6 months (PFS-6)
Time Frame: 6 months
Proportion of participants alive without progression at 6 months assessed per RANO meningioma criteria
6 months
Overall Survival at 12 months (OS-12)
Time Frame: 12 months
Proportion of participants alive at 12 months
12 months
Progression-free Survival after cross-over (PFS2)
Time Frame: Assessed up to 4 years
Time from cross-over to disease progression per RANO meningioma criteria or death from any cause, whichever occurs first.
Assessed up to 4 years
Disease Control Rate (DCR)
Time Frame: Assessed up to 4 years
Proportion of patients achieving complete response, partial response, minor response or stable disease as per RANO meningioma criteria
Assessed up to 4 years
Objective response rate (ORR)
Time Frame: Assessed up to 4 years
Proportion of patients achieving complete or partial response as per RANO meningioma criteria.
Assessed up to 4 years
Number of participants by highest grade treatment-emergent adverse event (TEAE):
Time Frame: Assessed up to 4 years
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).
Assessed up to 4 years
Overall survival (OS)
Time Frame: Assessed up to 4 years
Proportion of patients after cross-over alive without disease progression per current RANO meningioma criteria
Assessed up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTOG Foundation, Inc.

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Sylvia C Kurz, MD, PhD, Yale University
  • Principal Investigator: Erik P Sulman, MD,PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG 3523
  • CAAA601A1US13R (Other Identifier: Novartis Pharmaceuticals, Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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