2022-501606-35-00 – Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA).

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501606-35-01

Acronym

IMGN853-0421

Enrollment

110

Registered

2023-11-06

Start date

2024-02-21

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers

Brief summary

PFS, as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first. PFS as assessed by the investigator, as a sensitivity analysis, in the same patient population

Detailed description

OS defined as the time from randomization to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive., Treatment-emergent adverse events (TEAEs) and laboratory test results, physical examination (PE) findings, and vital signs, PFS2 as assessed by the investigator, defined as the time from date of randomization until second disease progression or death due to any cause, whichever occurs first, ORR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization, DOR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization and achieved a confirmed response of CR or PR after maintenance therapy, DFS as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization, CA-125 response rate per GCIG criteria, HRQoL/PRO measured by NFOSI-18 DRS-P

Interventions

DRUGCaelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCarboplatin Accord

DRUG10 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji

DRUGGemcitabin AqVida 38 mg/ml Pulver zur Herstellung einer Infusionslösung

DRUGGemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPaclitaxel AqVida 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPaclitaxel Bendalis 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGMVASI 25 mg/mL concentrate for solution for infusion

DRUGBendacitabin 38 mg/ml Pulver zur Herstellung einer Infusionslösung

DRUGRibocarbo®-L 10 mg/ml – Konzentrat zur Herstellung einer Infusionslösung

DRUGZirabev 25 mg/ml concentrate for solution for infusion.

DRUGAlymsys 25mg/mL concentrate for solution for infusion.

DRUGPROPYLENE GLYCOL

DRUGMirvetuximab Soravtansine

DRUGCarboplatin Accord 10 mg/ml koncentratas infuziniam tirpalui

DRUGPred Forte 1% w/v

DRUGEye Drops Suspension

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS, as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first. PFS as assessed by the investigator, as a sensitivity analysis, in the same patient population	—

Secondary

Measure	Time frame
OS defined as the time from randomization to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive., Treatment-emergent adverse events (TEAEs) and laboratory test results, physical examination (PE) findings, and vital signs, PFS2 as assessed by the investigator, defined as the time from date of randomization until second disease progression or death due to any cause, whichever occurs first, ORR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization, DOR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization and achieved a confirmed response of CR or PR after maintenance therapy, DFS as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization, CA-125 response rate per GCIG criteria, HRQoL/PRO measured by NFOSI-18 DRS-P	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026