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Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05445778
Protocol IDs
IMGN853-0421 (primary)
NCI-2023-00369
Study Sponsor
Abbvie

Summary

GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and
efficacy of mirvetuximab Soravtansine + Bevacizumab as maintenance therapy in
participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube
cancers with high folate receptor-alpha (FRa) expression.

Objectives

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed
to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by
delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein
called folate receptor alpha (FRa). It is being developed as maintenance therapy for the
treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian,
primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.
Patients must have confirmation of FRa positivity by the Ventana FOLR1 Assay.

Eligibility

  1. Adult women >/=18 years old
  2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  3. Confirmed high FRa expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
  4. Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
  5. Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
  6. Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.