Intracranial MeningiomaPhase 2MOMENTUM-1NCT06955169
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
A Phase 2 study testing [177Lu]Lu-DOTATATE in people with Intracranial Meningioma, run by RTOG Foundation, Inc. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Meningioma
- What is being tested?
- [177Lu]Lu-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 17 sitesUnited States
- Study dates
- 24 Aug 2025to Aug 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Jen Thomas, jennifkt@med.umich.edu
Sean Miller, MD
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30318
Jeff Whorton, BSN,RN, jeff.whorton@piedmont.org
Adam Nowlan, MD, MPH
- Recruiting
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02215
Kathryn Partridge, Kathryn_Partridge@DFCI.HARVARD.EDU
Gilbert Youssef, MD
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Jennifer Cooper, jcoope13@hfhs.org
Tobias Walber, MD, PhD, MPH
- Recruiting
Duke University Medical Center
Durham, North Carolina, 22708
Kelly Moulton, kelly.moulton@duke.edu
Margaret Johnson, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Wathoo Chetna, cwathoo@mdanderson.org
Carlos Kamiya-Matsuoka, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Lauren Perrey-Moore, RN, lperry@iu.edu
Kathryn Nevel, MD
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Kristin West, RN, BSN, kristin-gaimari-varner@uiowa.edu
Kristin Plichta, MD, PhD
- Recruiting
University of California, Irvine
Irvine, California, 92697
Manisha Dandekar, mdandeka@hs.uci.edu
Daniela Bota, MD, PhD
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
CTOinterest@bmcjax.com
Michael Olson, MD PhD
- Recruiting
University of California San Diego - Moores Cancer Center
La Jolla, California, 92093
Mohammad Amjad, mtamjad@health.ucsd.edu
Jona Hattangadi-Gluth, MD
- Recruiting
University of Miami
Miami, Florida, 33146
Lily Friedman, lxf699@med.miami.edu
Marina Kushnirsky, MD
- Recruiting
Baptist Health Medical Group Oncology
Miami, Florida, 33176
Nicolas Morales, nicolas.morales1@baptisthealth.net
Matthew Hall, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Bailee Fritz, bfritz@mcw.edu
Michael Straza, MD
- Recruiting
Yale University
New Haven, Connecticut, 06520
Amy Rodrigues, CCRC, 203-260-9632, amy.rodrigues@yale.edu
Sylvia Kurz, MD, PhD
- Recruiting
NYU Lagone Health
New York, New York, 10016
Olga Garduno-Ortega, Olga.Garduno-Ortega@nyulagone.org
Marissa Barbaro, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33543
Abdullah Abdelkawy, Abdullah.abdelkawy@Moffitt.org
Andre Luiz Beer Furlan, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracranial Meningioma
- Being tested
- [177Lu]Lu-DOTATATE, Standard of Care treatments
- Keywords
- MOMENTUM-1, Meningioma, Advanced Intracranial Meningioma, SSTR2, Radiopharmaceuticals, Theranostics, Radioligand Therapy, Lu-DOTATATE, Lutathera
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-DOTATATEDrug
Also called Lutathera
The treatment regimen consists of 4 (+2 optional) administrations of [177Lu]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).
Standard of Care treatmentsOther
Also called Avastin (bevacizumab), Afinitor (everolimus), Sutent (sunitinib)
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.
| Study group | Role | What they receive |
|---|---|---|
| [177Lu]Lu-DOTATATE | Experimental | Study participants receive [177Lu]Lu-DOTATATE Receives: Drug: [177Lu]Lu-DOTATATE |
| Control | Other | Study participants receive systemic Standard of Care (SOC) Therapy. Control Arm participants crossover to [177Lu]Lu-DOTATATE at progression Receives: Other: Standard of Care treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Proportion of patients alive without disease progression per current RANO meningioma criteria
Measured: Assessed up to 4 years
Secondary outcomes (7)
Progression free survival at 6 months (PFS-6)
Proportion of participants alive without progression at 6 months assessed per RANO meningioma criteria
Measured: 6 months
Overall Survival at 12 months (OS-12)
Proportion of participants alive at 12 months
Measured: 12 months
Overall survival (OS)
Proportion of patients after cross-over alive without disease progression per current RANO meningioma criteria
Measured: 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.
Measured: 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
Measured: Assessed up to 4 years
Objective response rate (ORR)
Proportion of patients achieving complete or partial response as per RANO meningioma criteria.
Measured: Assessed up to 4 years
Number of participants by highest grade treatment-emergent adverse event (TEAE):
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).
Measured: Assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start24 Aug 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTOG Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Erik P Sulman, MD,PhD, Principal investigator, Duke UniversitySylvia C Kurz, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955169
- Sponsor's protocol ID
- RTOG 3523
- Acronym
- MOMENTUM-1
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No