Status:
RECRUITING
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.
Lead Sponsor:
AbbVie
Collaborating Sponsors:
GOG Foundation
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 mirvetuxim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06890338
Start Date
November 21 2025
End Date
February 1 2030
Last Update
January 5 2026
Active Locations (39)
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1
University of Alabama at Birmingham (UAB) Hospital /ID# 274793
Birmingham, Alabama, United States, 35294
2
Usa Mitchell Cancer Institute /ID# 276022
Mobile, Alabama, United States, 36604
3
California Pacific Medical Center /ID# 275329
San Francisco, California, United States, 94109
4
Ridley Tree Cancer Center /ID# 275219
Santa Barbara, California, United States, 93105