Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice
Research type
Research Study
Full title
MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression.
IRAS ID
276634
Contact name
Susana Banerjee
Contact email
Sponsor organisation
ImmunoGen, Inc
Eudract number
2019-003509-80
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Research Summary:
Epithelial Ovarian Cancer (EOC) is the most common type of ovarian cancer. It is a lethal disease with 22,530 new cases and 13,930 deaths expected in 2019 in the US. The estimated number of new EOC cases in the EU (EU27) in 2012 was 44,149 with 29,758 deaths. The overall 5-year survival for EOC patients is only 44% . EOC means the cancer started in the surface layer covering the ovary. There are different types of epithelial ovarian cancer.
Current management of advanced stage disease includes surgical tumour debulking, followed by post-surgery platinum- and taxane-based chemotherapy. Chemotherapy uses anti-cancer drugs to destroy cancer cells. However, the disease will come back (relapse) in the majority of the patients. Patients with relapsed platinum sensitive disease are often treated with carboplatin alone or as part of a combination regimen, whereas those with platinum-resistant disease may be treated with a variety of agents.
An experimental study drug called mirvetuximab soravtansine is being studied as a possible treatment for EOC. MIRV is designed to selectively kill tumours. The antibody (protein) part of MIRV is designed to target tumours by delivering a cell-killing drug to the tumour cells carrying a tumour-associated protein called FRα. Researchers hope mirvetuximab soravtansine will cause the cancer cells to stop growing and stop the cancer cells from spreading.
The purpose of this study is to compare mirvetuximab soravtansine, an experimental drug made by ImmunoGen, Inc. (the Sponsor of this clinical research study), to standard chemotherapy. The term “experimental” means that the study drug has not been approved by any Health Authority that regulates new medicines.
This is a multicentre study and about 430 people are expected to participate in this study worldwide.
Summary of results:
The Summary of Results and corresponding Lay Summary of Study Results will be available in the EU Clinical Trials Register (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Feuclinicaltrials.eu%2F&data=05%7C02%7Charrow.rec%40hra.nhs.uk%7C06b00c023db74c1f8e1108dd62dc0ce9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638775419426674131%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=3R0audDMzqZmGFdYk3d28SP0U5%2FtrT6YdaWPBK%2BWTck%3D&reserved=0) within the timeframe required for posting of trial results. Clinicaltrials.gov (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclinicaltrials.gov%2F&data=05%7C02%7Charrow.rec%40hra.nhs.uk%7C06b00c023db74c1f8e1108dd62dc0ce9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638775419426686777%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=hc1Ur960L5Uz5bKp7%2FEk052Fi0vNVbbRR%2FinTe0Q0Eo%3D&reserved=0) will also be updated with results information in accordance with the applicable requirements.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/0957
Date of REC Opinion
30 Oct 2020
REC opinion
Further Information Favourable Opinion