Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-31 @ 5:56 PM
Study NCT ID:
NCT06955169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447941', 'term': 'lutetium Lu 177 dotatate'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D006918', 'term': 'Hydroxyurea'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 153}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Assessed up to 4 years', 'description': 'PFS defined as the time from randomization to date of disease progression per current RANO meningioma criteria or death, whichever occurs first'}], 'secondaryOutcomes': [{'measure': 'Progression free survival at 6 months (PFS-6)', 'timeFrame': '6 months', 'description': 'Proportion of participants alive without progression at 6 months assessed per RANO meningioma criteria'}, {'measure': 'Overall Survival at 12 months (OS-12)', 'timeFrame': '12 months', 'description': 'Proportion of participants alive at 12 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Assessed up to 4 years', 'description': 'Time from randomization to death from any cause'}, {'measure': 'Progression-free Survival after cross-over (PFS2)', 'timeFrame': 'Assessed up to 4 years', 'description': 'Time from cross-over to disease progression per RANO meningioma criteria or death from any cause, whichever occurs first.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Assessed up to 4 years', 'description': 'Proportion of patients achieving complete response, partial response, minor response or stable disease as per RANO meningioma criteria'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Assessed up to 4 years', 'description': 'Proportion of patients achieving complete or partial response as per RANO meningioma criteria.'}, {'measure': 'Number of participants by highest grade treatment-emergent adverse event (TEAE):', 'timeFrame': 'Assessed up to 4 years', 'description': '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).'}, {'measure': 'Number of participants who discontinue treatment due to TEAE', 'timeFrame': 'Assessed up to 4 years', 'description': 'Number of participants who discontinue treatment as a result of treatment-emergent adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MOMENTUM-1', 'Meningioma', 'Advanced Intracranial Meningioma', 'SSTR2', 'Radiopharmaceuticals', 'Theranostics', 'Radioligand Therapy', 'Lu-DOTATATE', 'Lutathera'], 'conditions': ['Intracranial Meningioma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSTEP 1 REGISTRATION\n\n* Aged \\>= 18 years\n* Histologically confirmed diagnosis of WHO grade 1-3 meningioma\n* 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\n* Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as\n\n * ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months, or\n * ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, or\n * Development of a new measurable lesion\n* The following scans must be available for submission for central radiology review:\n\n * Pre-progression gadolinium-enhanced MRI brain scan\n * Progression gadolinium-enhanced MRI brain scan\n\nSTEP 2 REGISTRATION\n\n* Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as\n\n * ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months, or\n * ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, or\n * Development of a new measurable lesion.\n* \\[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.\n* 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.\n* Patients must be willing and able to undergo regular MRI scans of the brain and \\[68Ga\\]Ga-DOTATATE PET-CT imaging during the study.\n* 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).\n* Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration):\n\n * Absolute neutrophil count (ANC) ≥ 1500/mm3\n * Platelet count ≥ 75,000/mm3\n * Hemoglobin ≥ 8 g/dL\n * Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min\n * Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)\n * Potassium within normal limits.\n\nExclusion Criteria:\n\n* Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis.\n* Patients with radiation-associated meningiomas.\n* Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column.\n* Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide.\n* 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.\n* Patients requiring immediate local therapy (e.g. surgical resection).\n* Surgical procedure within the timeframes listed below, prior to step 2 registration.\n\n * 28 days from any prior craniotomy\n * 7 days from stereotactic biopsy Note: There is no limit to the number of prior surgical interventions\n* Treatment within the timeframes specified below, prior to step 2 registration.\n\n * 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\n * 6 weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.\n* 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\n* Peptide receptor radionuclide therapy at any time prior to registration.\n* Known hypersensitivity to somatostatin analogues or any component of the \\[68Ga\\]Ga- DOTATATE or \\[177Lu\\]Lu-DOTATATE formulations.\n* Active infection requiring current use of intravenous therapy with antibiotics.\n* 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.\n* 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.\n* Pregnant and/or breastfeeding patients who are unwilling to discontinue breast feeding.\n* Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry."}, 'identificationModule': {'nctId': 'NCT06955169', 'acronym': 'MOMENTUM-1', 'briefTitle': 'Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment', 'organization': {'class': 'OTHER', 'fullName': 'RTOG Foundation, Inc.'}, 'officialTitle': 'MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma', 'orgStudyIdInfo': {'id': 'RTOG 3523'}, 'secondaryIdInfos': [{'id': 'CAAA601A1US13R', 'type': 'OTHER', 'domain': 'Novartis Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[177Lu]Lu-DOTATATE', 'description': 'Study participants receive \\[177Lu\\]Lu-DOTATATE', 'interventionNames': ['Drug: [177Lu]Lu-DOTATATE']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Study participants receive Local Standard of Care (SOC) Therapy. Control Arm participants crossover to \\[177Lu\\]Lu-DOTATATE at progression', 'interventionNames': ['Other: Standard of Care treatments']}], 'interventions': [{'name': '[177Lu]Lu-DOTATATE', 'type': 'DRUG', 'otherNames': ['Lutathera'], 'description': 'The treatment regimen consists of 4 (+2 optional) administrations of \\[177Lu\\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).', 'armGroupLabels': ['[177Lu]Lu-DOTATATE']}, {'name': 'Standard of Care treatments', 'type': 'OTHER', 'otherNames': ['Avastin (bevacizumab), Afinitor (everolimus), Hydrea (hydroxyurea), Hydroxycarbamide (hydroxyurea), Sutent (sunitinib)'], 'description': '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.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sylvia C Kurz, MD,PhD', 'role': 'CONTACT', 'email': 'Sylvia.Kurz@yale.edu', 'phone': '203-785-5616'}], 'overallOfficials': [{'name': 'Erik P Sulman, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}, {'name': 'Sylvia C Kurz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTOG Foundation, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}