A Phase 2 study of mirvetuximab soravtansine

• Research type

  Research Study

• Full title

  A randomized Phase 2, open-label study of mirvetuximab soravtansine in patients with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression testing 2 schedules of administration for dose optimization, with a separate cohort to determine starting dose in patients with moderate hepatic impairment

• IRAS ID

  1011000

• Contact name

  Bernhard Dodell

• Contact email

  global-clinical-trials@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2024-517184-23

• Clinicaltrials.gov Identifier

  NCT06682988

• Research summary

  The study drug, mirvetuximab soravtansine (MIRV) is already approved by the FDA and EMA for treating patients with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha (FRα) expression. The main purpose of this study is to determine whether MIRV is safe, well-tolerated and whether it is effective in treating this patient population when given as an alternative schedule of administration rather than the schedule already approved by the FDA. This would potentially improve the risk-benefit profile of this study drug to patients. An additional purpose of this study is to try and determine a starting dose of the study drug in patients with moderate hepatic impairment.
  Approximately 110 participants are expected to take part in the study globally. The maximum amount of time participants will be in this study is 2 years. The research study procedures include screening for eligibility and study treatment including evaluations and follow-up visits.
  Participants will be enrolled into one of two cohorts (treatment groups):
  Randomised cohort – Participants who do not have moderate liver impairment will be assigned to this cohort. The cohort will be split into 2 arms which have different doses and schedules of the study drug. Participants will be assigned randomly (by chance, like tossing a coin) to one of the two treatment arms.
  Hepatic impairment cohort – Participants with moderate liver impairment will be assigned to this cohort. Participants will receive increasing doses of the study drug depending on how well it is tolerated.

• REC name

  Wales REC 5

• REC reference

  25/WA/0116

• Date of REC Opinion

  19 May 2025

• REC opinion

  Further Information Favourable Opinion