Multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501220-14-00

Acronym

IMGN853-0420

Enrollment

Registered

2023-04-26

Start date

2023-10-17

Completion date

Unknown

Last updated

2025-12-10

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

Conditions

epithelial ovarian, primary peritoneal, or fallopian tube cancer

Brief summary

ORR following carboplatin plus MIRV combination as measured by the investigator and assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as the proportion of confirmed responders among patients with FRα expression of ≥ 50% of tumor cells with PS2+ staining intensity who have measurable disease per RECIST v1.1 at inclusion

Detailed description

ORR, defined as the proportion of confirmed responders (CR or PR) following carboplatin plus MIRV combination, as measured by the investigator and assessed according to the RECIST v1.1, among patients with FRα expression of ≥ 25% of tumor cells with PS2+ staining intensity who have measurable disease per RECIST v1.1 at inclusion o ORR will also be measured by a BICR, as a sensitivity analysis, in the same patient population.

Interventions

DRUGMirvetuximab Soravtansine

DRUGPred Forte 1% w/v

DRUGEye Drops Suspension

DRUGCarboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

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

DRUGCarboplatin 10 mg/ml Intravenous Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR following carboplatin plus MIRV combination as measured by the investigator and assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as the proportion of confirmed responders among patients with FRα expression of ≥ 50% of tumor cells with PS2+ staining intensity who have measurable disease per RECIST v1.1 at inclusion	—

Secondary

Measure	Time frame
ORR, defined as the proportion of confirmed responders (CR or PR) following carboplatin plus MIRV combination, as measured by the investigator and assessed according to the RECIST v1.1, among patients with FRα expression of ≥ 25% of tumor cells with PS2+ staining intensity who have measurable disease per RECIST v1.1 at inclusion o ORR will also be measured by a BICR, as a sensitivity analysis, in the same patient population.	—

Measure

Time frame

—

Countries

Belgium, Ireland, Spain

Outcome results

None listed

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