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진보적 인 두개 내 등급 1-3 수막종을 가진 성인의 [177lu] lu-dotatate에 대한 연구 (MOMENTUM-1)

2026년 10월 1일 업데이트: RTOG Foundation, Inc.

Momentum-1 : 진보적 인 두개 내 등급 1-3 수막종을 가진 성인에서 [177lu] lu-dotatate에 대한 다기관, 무작위, 오픈 라벨, 2 상 연구.

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

130

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: [177Lu]Lu-DOTATATE

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

다른 이름들:
  • 루타테라
다른: Control

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

다른 이름들:
  • Avastin (bevacizumab), Afinitor (everolimus), Sutent (sunitinib)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: Assessed up to 4 years

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

2차 결과 측정

결과 측정
측정값 설명
기간
Progression free survival at 6 months (PFS-6)
기간: 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)
기간: 12 months

Proportion of participants alive at 12 months
12 months
Overall survival (OS)
기간: 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)
기간: 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)
기간: 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)
기간: 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):
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

RTOG Foundation, Inc.

협력자

Novartis Pharmaceuticals

수사관

  • 수석 연구원: Sylvia C Kurz, MD, PhD, Yale University
  • 수석 연구원: Erik P Sulman, MD,PhD, Duke University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 24일

기본 완료 (추정된)

2029년 8월 1일

연구 완료 (추정된)

2030년 8월 1일

연구 등록 날짜

최초 제출

2025년 4월 22일

QC 기준을 충족하는 최초 제출

2025년 4월 30일

처음 게시됨 (실제)

2025년 5월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 1일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RTOG 3523

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다