carboplatin
DrugIntravenous (IV) infusion
NCT Number: NCT06890338
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 2
University of Alabama at Birmingham (UAB) Hospital /ID# 274793, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous (IV) infusion
Intravenous (IV) infusion
Other names: MIRV, IMGN853, ELAHERE™
Intravenous (IV) infusion (per investigator's discretion)
Time frame: Up to Approximately 3 years
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
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
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
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 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 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
The GCIG CA-125 response was defined as at least 50% reduction in CA-125.
Time frame: Up to Approximately 3 years
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 IDS during the course of the study treatment
Time frame: Up to Approximately 3 years
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
Defined as macroscopically visible residual tumor (≤ 1 cm or > 1cm) at the end of surgery.
Time frame: Up to Approximately 3 years
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).
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06994195
Adnexal Diseases, Carcinoma
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05867251
Adnexal Diseases, Advanced Solid Tumor
New Haven, Connecticut, United States
View Trial DetailsNCT07545460
Adnexal Diseases, Carcinoma
Beijing, Beijing Municipality, China
View Trial DetailsNCT03872947
Adenocarcinoma, Adnexal Diseases
Scottsdale, Arizona, United States
View Trial Details