A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

Официальное название

A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Обзор

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.

Вмешательства

• Препарат Carboplatin
  Intravenous (IV) infusion
• Препарат Mirvetuximab Soravtansine
  Intravenous (IV) infusion
• Препарат Bevacizumab
  Intravenous (IV) infusion (per investigator's discretion)

Первичные конечные точки

• Objective Response (OR) by Independent Central Review (ICR) [Срок оценки: Up to Approximately 3 years]

Вторичные конечные точки (11)

• Percentage of Participants with Adverse Events (AE) [Срок оценки: Up to Approximately 3 years]
• Percentage of Participants with AEs leading to study drug discontinuation or dose modification [Срок оценки: Up to Approximately 3 years]
• Objective Response (OR) by Investigator [Срок оценки: Up to Approximately 3 years]
• Disease Control by ICR [Срок оценки: Up to Approximately 3 years]
• Disease control by Investigator [Срок оценки: Up to Approximately 3 years]
• Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria [Срок оценки: Up to Approximately 3 years]
• Progression-Free Survival (PFS) by investigator [Срок оценки: Up to Approximately 3 years]
• Percentage of Participants that Underwent Interval debulking surgery (IDS) [Срок оценки: Up to Approximately 3 years]
• Percentage of participants with complete tumor cytoreduction at IDS [Срок оценки: Up to Approximately 3 years]
• Percentage of participants with Incomplete Tumor Cytoreduction at IDS [Срок оценки: 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) [Срок оценки: Up to Approximately 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 67 центров

• University of Alabama at Birmingham (UAB) Hospital /ID# 274793 — Birmingham
• Usa Mitchell Cancer Institute /ID# 276022 — Mobile
• University of California Los Angeles Medical Center /ID# 274566 — Los Angeles
• Scripps Md Anderson - Prebys Cancer Center /ID# 276891 — San Diego
• California Pacific Medical Center - Van Ness Campus /ID# 275329 — San Francisco
• Ridley Tree Cancer Center /ID# 275219 — Santa Barbara
• Danbury Hospital, Western Connecticut Health Network /ID# 274783 — Danbury
• Yale University School of Medicine /ID# 275794 — New Haven
• … и ещё 59 центров

Идентификаторы

NCT: NCT06890338 · M25-231 · GOG-3115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗