Summary
Cancer happens when cells in the body grow and spread in an uncontrolled way.
This study is testing a medicine called mirvetuximab soravtansine (also called MIRV) in people with certain types of ovarian cancer that have come back or stopped responding to treatment with platinum-based chemotherapy.
MIRV is an investigational targeted treatment known as an antibody-drug conjugate. This means it is designed to find cancer cells using a specific marker (FRα) and deliver a chemotherapy drug directly into those cells to destroy them.
Who can take part?
This trial is for people with:
- advanced ovarian, fallopian tube, or primary peritoneal cancer
- cancer that has stopped responding to platinum treatment
- tumours that have a high level of a protein called folate receptor alpha (FRα)
How the study works
There are two parts (cohorts) in this study.
- Randomised phase 2 group
- Participants are randomly placed (by chance) into 1 of 2 groups
- Both groups receive MIRV, but on different schedules:
- Once every 3 weeks, or
- Twice every 4 weeks
- Liver function group
- This group is for people with moderate liver problems
- It aims to find the safest starting dose of MIRV for these patients
What does taking part involve?
If you join this trial, you will have regular visits to a hospital or clinic, receive the study treatment (MIRV), and have check-ups such as blood tests, scans, and other assessments.
Taking part may involve more visits and tests than standard care, which could increase the time and effort required.
The study will enrol around 110 people around the world, and is expected to run for about 2 years.
Conditions
This trial is treating people with high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have progressed on prior platinum-based therapy