GLORIOSA
Research type
Research Study
Full title
Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum based chemotherapy plus bevacizumab (GLORIOSA)
IRAS ID
1007431
Contact name
Anna Berkenblit
Contact email
Sponsor organisation
Immunogen, Inc.
Research summary
MIRV (study drug) is being develop by ImmunoGen, Inc. as a potential treatment for high grade ovarian, peritoneal and fallopian tube cancers. This study involve patients in which cancer has come back after their first round of treatment and tumour has tested positive for high levels of a tumour-associated protein called folate receptor alpha (FRα). The study involves pre-screening of patients to test the FRα in tumour tissue as MIRV targets FRα. The study will look at whether MIRV is effective in a maintenance setting to prevent or delay the cancer from returning when administered in combination with Bevacizumab (BEV). Researchers hope MIRV will cause the cancer cells to stop growing and spreading. This drug is designed to selectively kill tumours. The antibody (protein) part of MIRV targets tumours by delivering a cell-killing drug to the tumour cells carrying FRα. BEV is an approved maintenance treatment. About 418 people and about 250 study sites are expected to participate in this study worldwide. Patients will undergo physical exams, vital signs, blood/ urine sampling, heart examinations, eye examinations, tumour assessments and other assessments. MIRV and BEV will be given by needle into one of the veins. This is called infusion which may take up to 6 hours depending on the treatment assigned. Participants will receive infusions every 3 weeks. They can stay on the study as long as they will are doing well, and their cancer will not get worse. Participants will be followed up every 4 months for the first 2 years then every 6 months after that.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0049
Date of REC Opinion
1 Sep 2023
REC opinion
Further Information Favourable Opinion