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AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer

NCT07218809 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2026-01-16

No results posted yet for this study

Summary

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

Conditions

  • Epithelial Ovarian Cancer

Interventions

DRUG

AZD5335

antibody drug conjugate

DRUG

Mirvetuximab Soravtansine (MIRV)

antibody drug conjugate

DRUG

Paclitaxel

chemotherapy

DRUG

Pegylated liposomal Doxorubicin (PLD)

chemotherapy

DRUG

Topotecan

chemotherapy

Sponsors & Collaborators

  • European Network of Gynecological Oncological Trial Groups (ENGOT)

    collaborator UNKNOWN

  • GOG Foundation, Inc. (GOG Foundation)

    collaborator UNKNOWN

  • Ventana Medical Systems, Inc

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-29
Primary Completion
2028-11-17
Completion
2030-05-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218809 on ClinicalTrials.gov