This trial evaluates the efficacy and safety of Mirvetuximab soravtansine (IMGN853) plus Carboplatin chemotherapy in FRα high patients with recurrent ovarian cancer who are eligible for platinum-based chemotherapy.
Conditions
Brief summary
Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, whichever occurs earlier.
Detailed description
Overall survival (OS), defined as the time from randomization to death from any cause., Objective Response Rate (ORR), Efficacy regarding PFS, OS and ORR depending on histologic subtype., Time to serological progressive disease according to GCIG criteria., Time to first subsequent treatment (TFST), Time to second subsequent treatment (TSST), Patient-reported outcomes: Quality of Life (EORTC C-30, OV28), Safety and tolerability of the used drugs evaluated by NCI CTCAE v5.0, records of dose reductions, delays, or interruptions.
Interventions
DRUGMIRVETUXIMAB SORAVTANSINE
DRUGLynparza 150 mg film-coated tablets
Sponsors
AGO Research GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, whichever occurs earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the time from randomization to death from any cause., Objective Response Rate (ORR), Efficacy regarding PFS, OS and ORR depending on histologic subtype., Time to serological progressive disease according to GCIG criteria., Time to first subsequent treatment (TFST), Time to second subsequent treatment (TSST), Patient-reported outcomes: Quality of Life (EORTC C-30, OV28), Safety and tolerability of the used drugs evaluated by NCI CTCAE v5.0, records of dose reductions, delays, or interruptions. | — |
Countries
Germany
Outcome results
None listed