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.

Korábbi kezelés

• 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).

Más betegség

• 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.

Egyéb

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

• 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.