TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexFemale
- Healthy volunteersNo
You may be able to join if
- 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.
You cannot join if
- 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.