A Phase 2 interventional study of Carboplatin and Mirvetuximab Soravtansine in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer, sponsored by AbbVie. Recruiting at 70 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
Participant meets the following disease criteria:
Exclusion Criteria:
Participants with the following ocular history and/or concurrent disorders:
Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.
Drug: Carboplatin · Drug: Mirvetuximab Soravtansine · Drug: Bevacizumab
Intravenous (IV) infusion
Intravenous (IV) infusion
Also known as: MIRV, IMGN853, ELAHERE™
Intravenous (IV) infusion (per investigator's discretion)
Objective Response (OR) by Independent Central Review (ICR)
OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).
Time frame: Up to Approximately 3 years
Percentage of Participants with Adverse Events (AE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time frame: Up to Approximately 3 years
Percentage of Participants with AEs leading to study drug discontinuation or dose modification
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time frame: Up to Approximately 3 years
Objective Response (OR) by Investigator
OR is defined as the best overall response of radiographic CR or PR as assessed by investigator using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including IDS.
Time frame: Up to Approximately 3 years
Disease Control by ICR
Disease control defined as CR, PR, or stable disease (SD) as assessed by ICR per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.
Time frame: Up to Approximately 3 years
Disease control by Investigator
Disease control defined as CR, PR, or stable disease (SD) as assessed by investigator per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.
Time frame: Up to Approximately 3 years
Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
The GCIG CA-125 response was defined as at least 50% reduction in CA-125.
Time frame: Up to Approximately 3 years
Progression-Free Survival (PFS) by investigator
PFS by investigator, defined as the time from the date of C1D1 until PD per RECIST v1.1 as assessed by investigator or death from any cause, whichever occurs first.
Time frame: Up to Approximately 3 years
Percentage of Participants that Underwent Interval debulking surgery (IDS)
Percentage of participants that underwent IDS during the course of the study treatment
Time frame: Up to Approximately 3 years
Percentage of participants with complete tumor cytoreduction at IDS
Complete tumor cytoreduction is defined as the absence of macroscopically visible residual disease at the end of the surgery
Time frame: Up to Approximately 3 years
Percentage of participants with Incomplete Tumor Cytoreduction at IDS
Defined as macroscopically visible residual tumor (≤ 1 cm or \> 1cm) at the end of surgery.
Time frame: 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)
The NFOSI-18 provides a total score that sums all 18 items, plus 2 multi-item scales that assess physical disease-related symptoms (DRS-P; 9 items) and general function/well-being (F/WB; 3 items).
Time frame: Up to Approximately 3 years
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
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Carcinoma, Ovarian Epithelial→
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