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Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator’s Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520466-22-00
Enrollment
46
Registered
2026-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-27

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

Conditions

Advanced Platinum-resistant Epithelial Ovarian Cancer

Brief summary

Progression free Survival (PFS): PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.

Detailed description

Overall survival (OS): OS is defined as the time from randomisation until the date of death due to any cause.

Interventions

DRUGMIRVETUXIMAB SORAVTANSINE
DRUGDOXORUBICIN HYDROCHLORIDE
DRUGTOPOTECAN
DRUGPACLITAXEL

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression free Survival (PFS): PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.

Secondary

MeasureTime frame
Overall survival (OS): OS is defined as the time from randomisation until the date of death due to any cause.

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 28, 2026