이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

고급 단계의 상피 난소, 나팔관 또는 1 차 복막 암을 발현하는 새로 진단 된 엽산 수용체 알파 (FRα)가있는 참가자에서 miRVetuximab 소라 바타 신과 정맥 내 (IV) 주입 카보 플라틴의 항 종양 활성을 평가하기위한 연구.

2026년 10월 19일 업데이트: AbbVie

FRα- 발현 장부 상피 난소, 나팔관 또는 1 차 복막 암을 갖는 대상체에서 Neoadjuvant Carboplatin 및 Mirvetuximab Soravtansine의 단일 암, 2 상 연구

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.

Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

140

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
    • Alabama
      • Birmingham, Alabama, 미국, 35294
        • 모병
        • University of Alabama at Birmingham (UAB) Hospital /ID# 274793
      • Mobile, Alabama, 미국, 36604
        • 모병
        • Usa Mitchell Cancer Institute /ID# 276022
    • California
      • Irvine, California, 미국, 92618
        • 모병
        • Kaiser Permanente - Irvine /ID# 276924
      • Los Angeles, California, 미국, 90095
        • 모병
        • UCLA - University of California Los Angeles Medical Center /ID# 274566
      • San Diego, California, 미국, 92103
        • 모병
        • Scripps Md Anderson - Prebys Cancer Center /ID# 276891
      • San Francisco, California, 미국, 94109
        • 모병
        • California Pacific Medical Center - Van Ness Campus /ID# 275329
      • Santa Barbara, California, 미국, 93105
        • 모집하지 않고 적극적으로
        • Ridley Tree Cancer Center /ID# 275219
    • Connecticut
      • Danbury, Connecticut, 미국, 06810
        • 모병
        • Danbury Hospital, Western Connecticut Health Network /ID# 274783
      • New Haven, Connecticut, 미국, 06510
        • 모병
        • Yale University School of Medicine /ID# 275794
      • Norwalk, Connecticut, 미국, 06856
        • 모병
        • Norwalk Hospital /ID# 274561
    • Florida
      • Jupiter, Florida, 미국, 33458
        • 모병
        • Jupiter Medical Center /ID# 276616
      • Miami Beach, Florida, 미국, 33140
        • 완전한
        • Mount Sinai Medical Center /ID# 274868
    • Illinois
      • Chicago, Illinois, 미국, 60607
        • 모병
        • Rush Md Anderson Cancer Center /ID# 274926
      • Chicago, Illinois, 미국, 60637
        • 모병
        • University of Chicago Medical Center /ID# 274796
      • Peoria, Illinois, 미국, 61637-0001
        • 모병
        • OSF St. Francis Medical Center /ID# 274752
      • Urbana, Illinois, 미국, 61801
        • 모병
        • Carle Foundation Hospital /ID# 276470
    • Indiana
      • Fort Wayne, Indiana, 미국, 46845
        • 모병
        • Parkview Research Center /ID# 274338
      • Indianapolis, Indiana, 미국, 46202
        • 모병
        • Indiana University Melvin and Bren Simon Cancer Center /ID# 275492
    • Kentucky
      • Lexington, Kentucky, 미국, 40503
        • 모병
        • Baptist Health Lexington /ID# 275218
      • Louisville, Kentucky, 미국, 40207
        • 모병
        • Norton Cancer Institute - St. Matthews /ID# 276173
    • Louisiana
      • Covington, Louisiana, 미국, 70433
        • 모병
        • Women'S Cancer Care /ID# 276469
      • New Orleans, Louisiana, 미국, 70112
        • 모병
        • University Medical Center New Orleans /ID# 274755
      • Shreveport, Louisiana, 미국, 71103
        • 모병
        • Willis-Knighton Medical Center /ID# 274310
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • 모병
        • University of Maryland, Baltimore /ID# 275308
      • Silver Spring, Maryland, 미국, 20910
        • 모병
        • Holy Cross Hospital /ID# 275872
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455-0341
        • 모병
        • University of Minnesota - Minneapolis /ID# 275718
      • Saint Louis Park, Minnesota, 미국, 55416
        • 모병
        • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
    • Mississippi
      • Jackson, Mississippi, 미국, 39216
        • 모병
        • University Of Mississippi Medical Center /ID# 276342
    • Missouri
      • Springfield, Missouri, 미국, 65807
        • 모병
        • Cox Medical Center South /ID# 274826
      • St Louis, Missouri, 미국, 63141
        • 모병
        • Mercy David C. Pratt Cancer Center /ID# 275655
    • Nevada
      • Reno, Nevada, 미국, 89511
        • 모병
        • The Center Of Hope /ID# 274313
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • 모병
        • Dartmouth-Hitchcock Medical Center /ID# 274676
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • 모병
        • John Theurer Cancer Center /ID# 275756
      • New Brunswick, New Jersey, 미국, 08901
        • 모병
        • Rutgers Cancer Institute of New Jersey /ID# 274358
      • Teaneck, New Jersey, 미국, 07666
        • 모병
        • Holy Name Medical Center /ID# 276240
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87109
        • 모병
        • Optimum Clinical Research Group /ID# 274583
    • New York
      • Bay Shore, New York, 미국, 11706
        • 모병
        • Imbert Cancer Center /ID# 275634
      • Greenlawn, New York, 미국, 11740
        • 모병
        • Northwell Health Cancer Institute At Huntington /ID# 276814
      • Lake Success, New York, 미국, 11042
        • 모병
        • Northwell Health Center for Advanced Medicine. /ID# 275641
      • New York, New York, 미국, 10032
        • 모병
        • Columbia University Irving Medical Center /ID# 276156
      • Rego Park, New York, 미국, 11374
        • 모병
        • Northwell Health Queens Cancer Center /ID# 274850
      • West Islip, New York, 미국, 11795
        • 모병
        • Good Samaritan Hospital Medical Center /ID# 274938
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • 모병
        • University of North Carolina Medical Center /ID# 275307
      • Charlotte, North Carolina, 미국, 28204
        • 모병
        • Atrium Health Levine Cancer Institute /ID# 274557
      • Greenville, North Carolina, 미국, 27834
        • 모병
        • East Carolina University - Brody School of Medicine /ID# 275770
      • Winston-Salem, North Carolina, 미국, 27157
        • 모병
        • Atrium Health Wake Forest Baptist Medical Center /ID# 276952
    • North Dakota
      • Fargo, North Dakota, 미국, 58102
        • 모병
        • Sanford Fargo Medical Center - Fargo /ID# 275489
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • 모병
        • Cleveland Clinic - Cleveland /ID# 276133
      • Cleveland, Ohio, 미국, 44195
        • 모병
        • Cleveland Clinic - Cleveland /ID# 278273
      • Cleveland, Ohio, 미국, 44195
        • 모병
        • Cleveland Clinic - Cleveland /ID# 278274
      • Cleveland, Ohio, 미국, 44109
        • 모병
        • Metrohealth Medical Center - Cleveland /ID# 276664
      • Columbus, Ohio, 미국, 43219
        • 모병
        • The Mark H Zangmeister Center /ID# 275106
      • Kettering, Ohio, 미국, 45429
        • 모병
        • Kettering Medical Center /ID# 274365
    • Oregon
      • Eugene, Oregon, 미국, 97401
        • 모병
        • Oncology Associates of Oregon, P.C. /ID# 275006
      • Tigard, Oregon, 미국, 97223
        • 모병
        • Compass Oncology - West - Tigard /ID# 275101
        • 연락하다:
          • Site Coordinator
          • 전화번호: (971) 708-7600
    • Pennsylvania
      • Bethlehem, Pennsylvania, 미국, 18015
        • 모병
        • St. Lukes University Hospital /ID# 274362
      • Philadelphia, Pennsylvania, 미국, 19104
        • 모병
        • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612
      • Pittsburgh, Pennsylvania, 미국, 15224
        • 모병
        • West Penn Hospital /ID# 276028
    • Rhode Island
      • Providence, Rhode Island, 미국, 02905
        • 모병
        • Women & Infants Hospital /ID# 274716
    • South Dakota
      • Sioux Falls, South Dakota, 미국, 57105
        • 모병
        • Avera Cancer Institute - Sioux Falls /ID# 276226
      • Sioux Falls, South Dakota, 미국, 57104
        • 모병
        • Sanford Cancer Center /ID# 274901
    • Texas
      • Austin, Texas, 미국, 78731
        • 모병
        • Texas Oncology - Austin Central /ID# 275046
      • Fort Worth, Texas, 미국, 76104
        • 모병
        • Texas Oncology - Fort Worth Cancer Center /ID# 275043
      • Houston, Texas, 미국, 77030
        • 모병
        • Houston Methodist Hospital /ID# 274568
        • 연락하다:
          • Site Coordinator
          • 전화번호: 713.441.3250
      • San Antonio, Texas, 미국, 78240
        • 모병
        • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
      • The Woodlands, Texas, 미국, 77380
        • 모병
        • Texas Oncology - The Woodlands /ID# 275015
      • Tyler, Texas, 미국, 75702
        • 모병
        • Texas Oncology - Northeast Texas /ID# 275057
    • Virginia
      • Charlottesville, Virginia, 미국, 22903
        • 모병
        • UVA Health University Hospital /ID# 275309
      • Fairfax, Virginia, 미국, 22031
        • 모병
        • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456
      • Norfolk, Virginia, 미국, 23502-2800
        • 모병
        • Virginia Oncology Associates- Norfolk (Brock) /ID# 275227
      • Roanoke, Virginia, 미국, 24014
        • 모병
        • Carilion Roanoke Memorial Hospital /ID# 274684
    • Washington
      • Spokane, Washington, 미국, 99204
        • 모병
        • Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
    • West Virginia
      • Morgantown, West Virginia, 미국, 26506
        • 모병
        • West Virginia University School of Medicine /ID# 274556

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

여성

설명

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

  • Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.

  • Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.

  • Participant meets the following disease criteria:

    • Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and
    • Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of >= 75% of viable tumor cells with moderate >= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and
    • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.

Exclusion Criteria:

  • Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.

  • Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.

  • Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin

  • Participants with the following ocular history and/or concurrent disorders:

    • History of corneal transplantation;
    • Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;
    • Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;
    • Active or chronic clinically significant (>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);
    • Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment;
    • Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).

  • History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Carboplatin + Mirvetuximab Soravtansine

Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.
의약품: Mirvetuximab Soravtansine

Intravenous (IV) infusion

다른 이름들:
  • IMGN853
  • 미르브
  • Elahere ™
의약품: Carboplatin

Intravenous (IV) infusion

의약품: Bevacizumab

Intravenous (IV) infusion (per investigator's discretion)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response (OR) by Independent Central Review (ICR)
기간: Up to Approximately 3 years

OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).
Up to Approximately 3 years

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants with Adverse Events (AE)
기간: Up to Approximately 3 years

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Up to Approximately 3 years
Percentage of Participants with AEs leading to study drug discontinuation or dose modification
기간: Up to Approximately 3 years

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Up to Approximately 3 years
Objective Response (OR) by Investigator
기간: Up to Approximately 3 years

OR is defined as the best overall response of radiographic CR or PR as assessed by investigator using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including IDS.
Up to Approximately 3 years
Disease Control by ICR
기간: Up to Approximately 3 years

Disease control defined as CR, PR, or stable disease (SD) as assessed by ICR per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.
Up to Approximately 3 years
Disease control by Investigator
기간: Up to Approximately 3 years

Disease control defined as CR, PR, or stable disease (SD) as assessed by investigator per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.
Up to Approximately 3 years
Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
기간: Up to Approximately 3 years

The GCIG CA-125 response was defined as at least 50% reduction in CA-125.
Up to Approximately 3 years
Progression-Free Survival (PFS) by investigator
기간: Up to Approximately 3 years

PFS by investigator, defined as the time from the date of C1D1 until PD per RECIST v1.1 as assessed by investigator or death from any cause, whichever occurs first.
Up to Approximately 3 years
Percentage of Participants that Underwent Interval debulking surgery (IDS)
기간: Up to Approximately 3 years

Percentage of participants that underwent IDS during the course of the study treatment
Up to Approximately 3 years
Percentage of participants with complete tumor cytoreduction at IDS
기간: Up to Approximately 3 years

Complete tumor cytoreduction is defined as the absence of macroscopically visible residual disease at the end of the surgery
Up to Approximately 3 years
Percentage of participants with Incomplete Tumor Cytoreduction at IDS
기간: Up to Approximately 3 years

Defined as macroscopically visible residual tumor (≤ 1 cm or > 1cm) at the end of surgery.
Up to Approximately 3 years
Change from baseline in disease-related symptoms as measured by the NCCN-FACT Ovarian Symptom Index (NFOSI-18) disease symptom subscale - physical (DRS-P)
기간: Up to Approximately 3 years

The NFOSI-18 provides a total score that sums all 18 items, plus 2 multi-item scales that assess physical disease-related symptoms (DRS-P; 9 items) and general function/well-being (F/WB; 3 items).
Up to Approximately 3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AbbVie

협력자

GOG Foundation

수사관

  • 연구 책임자: ABBVIE INC., AbbVie

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 11월 21일

기본 완료 (추정된)

2030년 2월 1일

연구 완료 (추정된)

2030년 2월 1일

연구 등록 날짜

최초 제출

2025년 3월 20일

QC 기준을 충족하는 최초 제출

2025년 3월 20일

처음 게시됨 (실제)

2025년 3월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 19일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • M25-231
  • GOG-3115 (기타 식별자: GOG)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD 공유 기간

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD 공유 액세스 기준

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

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