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Étude de [177lu] lu-dotaté chez les adultes atteints de méningiome intracrânien progressif (MOMENTUM-1)

5 novembre 2026 mis à jour par: RTOG Foundation, Inc.

Momentum-1: une étude multicentrique, randomisée et ouverte, de phase II de [177lu] lu-dotaté chez les adultes atteints de méningiome intracrânien progressif 1-3

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

130

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Irvine, California, États-Unis, 92697
        • Recrutement
        • University of California, Irvine
        • Chercheur principal:
          • Daniela Bota, MD, PhD
        • Contact:
      • La Jolla, California, États-Unis, 92093
        • Recrutement
        • University of California San Diego - Moores Cancer Center
        • Chercheur principal:
          • Jona Hattangadi-Gluth, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06520
        • Recrutement
        • Yale University
        • Chercheur principal:
          • Sylvia Kurz, MD, PhD
        • Contact:
    • Florida
      • Jacksonville, Florida, États-Unis, 32207
        • Recrutement
        • Baptist MD Anderson Cancer Center
        • Chercheur principal:
          • Michael Olson, MD PhD
        • Contact:
        • Sous-enquêteur:
          • Andre Alvarez, MD PhD
      • Miami, Florida, États-Unis, 33146
        • Recrutement
        • University of Miami
        • Contact:
        • Chercheur principal:
          • Marina Kushnirsky, MD
      • Miami, Florida, États-Unis, 33176
      • Tampa, Florida, États-Unis, 33543
        • Recrutement
        • Moffitt Cancer Center
        • Contact:
        • Chercheur principal:
          • Andre Luiz Beer Furlan, MD, PhD
    • Georgia
      • Atlanta, Georgia, États-Unis, 30318
        • Recrutement
        • Piedmont Healthcare
        • Contact:
        • Chercheur principal:
          • Adam Nowlan, MD, MPH
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • Recrutement
        • Indiana University
        • Chercheur principal:
          • Kathryn Nevel, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, États-Unis, 52242
        • Recrutement
        • University of Iowa Health Care
        • Contact:
        • Chercheur principal:
          • Kristin Plichta, MD, PhD
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • Recrutement
        • University of Michigan Rogel Cancer Center
        • Contact:
        • Chercheur principal:
          • Sean Miller, MD
      • Detroit, Michigan, États-Unis, 48202
        • Recrutement
        • Henry Ford Hospital
        • Contact:
        • Chercheur principal:
          • Tobias Walber, MD, PhD, MPH
    • New York
      • New York, New York, États-Unis, 10016
    • North Carolina
      • Durham, North Carolina, États-Unis, 22708
        • Recrutement
        • Duke University Medical Center
        • Chercheur principal:
          • Margaret Johnson, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19107
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • MD Anderson Cancer Center
        • Contact:
        • Chercheur principal:
          • Carlos Kamiya-Matsuoka, MD
    • Wisconsin
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Recrutement
        • Medical College of Wisconsin
        • Contact:
        • Chercheur principal:
          • Michael Straza, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: [177Lu]Lu-DOTATATE

Study participants receive [177Lu]Lu-DOTATATE
Médicament: [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).

Autres noms:
  • Lutathera
Autre: Control

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

Autres noms:
  • Avastin (bevacizumab), Afinitor (everolimus), Sutent (sunitinib)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival (PFS)
Délai: Assessed up to 4 years

Proportion of patients alive without disease progression per current RANO meningioma criteria
Assessed up to 4 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Progression free survival at 6 months (PFS-6)
Délai: 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)
Délai: 12 months

Proportion of participants alive at 12 months
12 months
Overall survival (OS)
Délai: 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
Progression-free Survival after cross-over (PFS2)
Délai: 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)
Délai: 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)
Délai: 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):
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

RTOG Foundation, Inc.

Collaborateurs

Novartis Pharmaceuticals

Les enquêteurs

  • Chercheur principal: Sylvia C Kurz, MD, PhD, Yale University
  • Chercheur principal: Erik P Sulman, MD,PhD, Duke University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 août 2025

Achèvement primaire (Estimé)

1 août 2029

Achèvement de l'étude (Estimé)

1 août 2030

Dates d'inscription aux études

Première soumission

22 avril 2025

Première soumission répondant aux critères de contrôle qualité

30 avril 2025

Première publication (Réel)

2 mai 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RTOG 3523

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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