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.
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.
Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and
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
History of corneal transplantation;
Single group
Carboplatin
DrugIntravenous (IV) infusion
Mirvetuximab Soravtansine
DrugIntravenous (IV) infusion
Bevacizumab
DrugIntravenous (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).
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.
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.
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.
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.
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AbbVie
Lead sponsor
GOG Foundation
Collaborator
