PICCOLO/Mirvetuximab Soravtansine Monotherapy in Epithelial, Peritoneal, and Fallopian Tube Cancers
Research type
Research Study
Full title
PICCOLO: A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
IRAS ID
1005290
Contact name
Michael Method
Contact email
Sponsor organisation
ImmunoGen, Inc.
Eudract number
2021-003592-34
ISRCTN Number
ISRCTN12633596
Clinicaltrials.gov Identifier
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 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 tumor tissue as MIRV mainly targets the FRα. The study will look at the following:
• If the study drug works (called efficacy)
• what the study drug does to the body (called pharmacodynamics).
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.
About 75 people and about 75 study sites are expected to participate in this study worldwide. Patients will undergo physical exams, vital signs, blood/ urine sampling, heart examinations, eye examinations and other assessments. MIRV will be given by needle into one of the veins. This is called infusion which may take 15 minutes to 4 hours depending on the drug dose. Participants will receive infusions every 3 weeks. They can stay on the study as long as you will be doing well, and their cancer will not get worse. The total duration of participation for an individual participant is approximately 30 months including follow ups.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0155
Date of REC Opinion
22 Aug 2022
REC opinion
Further Information Favourable Opinion