This is a multi-center, randomized, two-arm, open-label, comparative phase II trial of Mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα) high recurrent ovarian cancer eligible for platinum-based chemotherapy.
136 patients will be randomized into the follow-ing two treatment arms as specified below: Arm A: Control arm Platinum-based chemotherapy Arm B: Carboplatin + Mirvetuximab soravtansine (IMGN853)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Carboplatin will administered by intravenous route
PLD will be administered by intravenous route
Gemcitabine will be administered by intravenous route
Charite - Universitätsmedizin Berlin
Berlin, Germany
Städtisches Klinikum Dessau
Dessau, Germany
Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, whichever occurs earlier. PD is based on investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
PD is based on investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Time frame: Up to 2.5 years. From date of randomization until date of progressive disease (PD) or death, whichever occurs earlier.
OS
Overall survival
Time frame: Up to 2.5 years. From date of randomization until date of death from any cause.
ORR
Objective response rate
Time frame: Up to 2.5 years. From date of randomization to date of death death from any cause.
Efficacy regarding PFS
Efficacy regarding Progression Free Survival depending on histologic subtype
Time frame: Up to 2.5 years. From date of randomization to date of death from any cause.
Efficacy regarding OS
Efficacy regarding Overall Survival depending on histologic subtype
Time frame: Up to 2.5 years. From date of randomization to date of death from any cause.
Efficacy regarding ORR
Efficacy regarding Objective Response Rate depending on histologic subtype
Time frame: Up to 2.5 years. From date of randomization to date of death from any cause.
Serological progressive disease
Time to serological progressive disease according to GCIG criteria
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Paclitaxel will be administered by intravenous route
Mirvetuximab Soravtansine will be administered by intravenous route
Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden
Dresden, Germany
Evangelische Kliniken-Essen-Mitte
Essen, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Germany
St. Elisabeth-Krankenhaus GmbH
Köln-Hohenlind, Germany
...and 9 more locations
Time frame: Up to 2.5 years. From date of randomization to date of death death from any cause.
Time to first subsequent treatment (TFST)
Time to first subsequent treatment (TFST)
Time frame: Up to 2.5 years. From date of randomization to date of death from any cause.
Time to second subsequent treatment (TSST)
Time to second subsequent treatment (TSST)
Time frame: Up to 2.5 years. From date of randomization until date of death from any cause.
Patient-reported outcomes
Quality of Life (EORTC C-30)
Time frame: Up to 2.5 years. From date of randomization until date of death from any cause.
Patient-reported outcomes
Quality of Life (EORTC OV28)
Time frame: Up to 2.5 years. From date of randomization until date of death from any cause.
Safety and tolerability
Safety and tolerability of the used drugs evaluated by NCI CTCAE v5.0
Time frame: Up to 2.5 years. From date of randomization until date of death from any cause through study completion.