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Un estudio para evaluar la actividad antitumoral del carboplatino infundido intravenoso (IV) con la soravtansina de mirvetuximab en participantes con receptor de folato alfa (FRα) recién diagnosticado que expresa ovario epitelial seroso de estadio avanzado, tubo de Falopio o cáncer peritoneal primario.

19 de octubre de 2026 actualizado por: AbbVie

Un estudio de fase de un solo brazo de la fase 2 de carboplatino neoadyuvante y soravtansina de mirvetuximab en sujetos con cáncer de ovario epitelial seroso, de Falopio o cáncer peritoneal primario que expresa en etapa avanzada que expresa

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Mirvetuximab Soravtansine

Intravenous (IV) infusion

Otros nombres:
  • IMGN853
  • MIRV
  • Elahere ™
Droga: Carboplatin

Intravenous (IV) infusion

Droga: Bevacizumab

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response (OR) by Independent Central Review (ICR)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants with Adverse Events (AE)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AbbVie

Colaboradores

GOG Foundation

Investigadores

  • Director de estudio: ABBVIE INC., AbbVie

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de noviembre de 2025

Finalización primaria (Estimado)

1 de febrero de 2030

Finalización del estudio (Estimado)

1 de febrero de 2030

Fechas de registro del estudio

Enviado por primera vez

20 de marzo de 2025

Primero enviado que cumplió con los criterios de control de calidad

20 de marzo de 2025

Publicado por primera vez (Actual)

24 de marzo de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • M25-231
  • GOG-3115 (Otro identificador: GOG)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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