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.

Launched by ABBVIE · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate the safety and effectiveness of a combination treatment using two drugs, carboplatin and mirvetuximab soravtansine (often called MIRV), for women with advanced-stage serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that expresses a specific protein called folate receptor alpha (FRα). The study will enroll around 140 participants who will receive treatment through intravenous infusions every 21 days for up to 9 cycles, with the total study lasting about three years.

To be eligible for this trial, participants need to be women aged 65 to 74 with a confirmed diagnosis of high-grade serous cancer that is stage III or IV and shows a significant level of FRα expression. They should also be in good health overall, with a good performance status (which measures their ability to carry out daily activities). Participants can expect to have regular visits to a hospital or clinic for assessments, blood tests, and scans, as this may involve more treatment and monitoring than standard care. It’s important to note that this trial is not yet recruiting patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • 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, 27 and
• • Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of ≥ 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining by the AbbVie specified vendor with the Ventana Folate Receptor Alpha (FOLR1) assay, 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 (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent that has resolved per investigator or resolution of the radiologic findings).
• • 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 better eye worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in both eyes).
• • 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.