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A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Mirvetuximab Soravtansine in Subjects with Ovarian Cancer (FLORENZA)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521606-18-00
Acronym
M25-709
Enrollment
121
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-23

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

Conditions

Ovarian Cancer

Brief summary

Substudy 1 and 2: Number of Participants with TEAEs (any grade, Grade ≥ 3), Substudy 1 and 2: Number of Participants with TEAEs leading to discontinuation, Substudy 1 and 2: Number of Participants with Ocular AEs (any grade, Grade ≥ 2), Substudy 1 and 2: Overall Response (OR) as assessed by the investigator per RECIST v1.1, Substudy 1: Progression free survival (PFS) as assessed by the investigator per RECIST v1.1

Detailed description

Substudy 1 and 2: CA-125 response per Gynecologic Cancer Intergroup (GCIG) Criteria, Substudy 1 and 2: Duration of Response (DOR) as assessed by the investigator per RECIST v1.1, Substudy 1 and 2: Number of Participants with Peripheral neuropathy AEs (any grade, Grade ≥ 2), Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade), Substudy 2: PFS as assessed by the investigator per RECIST v1.1

Interventions

DRUGCARBOPLATIN
DRUGBEVACIZUMAB
DRUGMirvetuximab Soravtansine

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Substudy 1 and 2: Number of Participants with TEAEs (any grade, Grade ≥ 3), Substudy 1 and 2: Number of Participants with TEAEs leading to discontinuation, Substudy 1 and 2: Number of Participants with Ocular AEs (any grade, Grade ≥ 2), Substudy 1 and 2: Overall Response (OR) as assessed by the investigator per RECIST v1.1, Substudy 1: Progression free survival (PFS) as assessed by the investigator per RECIST v1.1—

Secondary

MeasureTime frame
Substudy 1 and 2: CA-125 response per Gynecologic Cancer Intergroup (GCIG) Criteria, Substudy 1 and 2: Duration of Response (DOR) as assessed by the investigator per RECIST v1.1, Substudy 1 and 2: Number of Participants with Peripheral neuropathy AEs (any grade, Grade ≥ 2), Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade), Substudy 2: PFS as assessed by the investigator per RECIST v1.1—

Countries

Belgium, Czechia, Denmark, France, Spain

Outcome results

None listed

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