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

NCT06955169 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: RTOG 3523CAAA601A1US13R
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Intracranial Meningioma

Keywords

MOMENTUM-1; Meningioma; Advanced Intracranial Meningioma; SSTR2; Radiopharmaceuticals; Theranostics; Radioligand Therapy; Lu-DOTATATE; Lutathera

Outcome Measures

Primary Outcomes (1)

• Progression 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

  Assessed up to 4 years

Secondary Outcomes (8)

• Progression free survival at 6 months (PFS-6)

  6 months

• Overall Survival at 12 months (OS-12)

  12 months

• Overall survival (OS)

  Assessed up to 4 years

• Progression-free Survival after cross-over (PFS2)

  Assessed up to 4 years

• Disease Control Rate (DCR)

  Assessed up to 4 years

Study Arms (2)

[177Lu]Lu-DOTATATE

EXPERIMENTAL

Study participants receive \[177Lu\]Lu-DOTATATE

Drug: [177Lu]Lu-DOTATATE

Control

OTHER

Study participants receive Local Standard of Care (SOC) Therapy. Control Arm participants crossover to \[177Lu\]Lu-DOTATATE at progression

Other: Standard of Care treatments

Interventions

[177Lu]Lu-DOTATATE DRUG

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

Also known as: Lutathera

[177Lu]Lu-DOTATATE

Standard of Care treatments OTHER

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.

Also known as: Avastin (bevacizumab), Afinitor (everolimus), Hydrea (hydroxyurea), Hydroxycarbamide (hydroxyurea), Sutent (sunitinib)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEP 1 REGISTRATION
• Aged \>= 18 years
• Histologically confirmed diagnosis of WHO grade 1-3 meningioma
• 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, or
• ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, 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
• 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, or
• ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, or

You may not qualify if:

• 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.
• Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide.
• 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.
• days from any prior craniotomy
• 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.
• 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
• weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.
• Prior external beam radiation, interstitial brachytherapy or stereotactic radiosurgery cumulative radiation dose of \> 70 Gy or the last dose of radiotherapy \< 24 weeks (6 months) prior to step 2 registration
• Peptide receptor radionuclide therapy at any time prior to registration.
• Known hypersensitivity to somatostatin analogues or any component of the \[68Ga\]Ga- DOTATATE or \[177Lu\]Lu-DOTATATE formulations.

Sponsors & Collaborators

• RTOG Foundation, Inc.: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (11)

University of California San Diego - Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

RECRUITING

University of Miami

Miami, Florida, 33146, United States

RECRUITING

Baptist Health Medical Group Oncology

Miami, Florida, 33176, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30318, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Dana-Farber/Harvard Cancer Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 22708, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

lutetium Lu 177 dotatate; Bevacizumab; Everolimus; Hydroxyurea; Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sirolimus; Macrolides; Lactones; Organic Chemicals; Urea; Amides; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Erik P Sulman, MD,PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Sylvia C Kurz, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvia C Kurz, MD,PhD

CONTACT

203-785-5616; Sylvia.Kurz@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 2, 2025
• Study Start: December 24, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (11)