Clinical Trial 23765

• Overview

  Study Title:

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

  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.

  Objective:

  Primary Objective: *To evaluate the efficacy of [177Lu]Lu-DOTA-TATE (177Lu-Dotatate) measured by progression-free survival (PFS), as compared to local SOC therapy in adult patients with progressive WHO grade 1-3 meningioma that demonstrate sufficient uptake by [68Ga]Ga-DOTA-TATE (68Ga-Dotatate) PET Secondary Objectives: *To evaluate the efficacy of l 77Lu-Dotatate as compared to local SOC treatment by additional survival outcome measures. *To evaluate treatment response assessed in patients receiving l77Lu-Dotatate as compared to local SOC. *To evaluate the overall safety and tolerability of 177Lu-Dotatate as compared to local SOC.

• Treatments

  Therapies:

  A somatostatin analogue, latches onto somatostatin receptors; Chemotherapy (NOS); Small molecule, tyrosine kinase inhibitor (TKI); mTOR inhibitor; monoclonal antibody

  Medications:

  Avastin (Bevacizumab); Bevacizumab (); Hydroxyurea (Droxia); Lu-Dotatate (); Sunitinib (); everolimus (RAD001)

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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 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.
  • If randomized to the control (standard of care) arm, both the patient and investigator must agree NOT to receive SSTR2-targeted therapy, surgical resection, or radiation therapy.
  • 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.

• Exclusion Criteria

  Key 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.
  • 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: 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.
  • Prior external beam radiation, interstitial brachytherapy or stereotactic radiosurgery cumulative radiation dose of > 70 Gy or the last dose of radiotherapy > 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.
  • 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.

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