Status:

RECRUITING

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

Lead Sponsor:

AbbVie

Collaborating Sponsors:

GOG Foundation

Conditions:

Ovarian Cancer

Peritoneal Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief 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-sensiti...

Detailed Description

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-killin...

Eligibility Criteria

Inclusion Criteria:

  1. Adult women >/=18 years old
  2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  3. Confirmed high FRα 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

Exclusion Criteria:

  1. Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
  2. More than one line of prior chemotherapy before current/planned triplet therapy
  3. PD (progressive disease) while on or following platinum-based therapy
  4. Prior or whole-pelvis or wide-field radiotherapy
  5. > Grade 1 peripheral neuropathy
  6. History of or concurrent ocular disorders
  7. Grade 4 thromboembolic events
  8. Not appropriate for bevacizumab treatment
  9. Requiring use of folate-containing supplements
  10. Prior hypersensitivity to monoclonal antibodies
  11. Pregnant or breatfeeding women
  12. Received prior MIRV or other FRα-targeting agents
  13. Untreated or symptomatic central nervous system metastases
  14. History of other malignancy within 3 years prior to signing study consent

Key Trial Info

Start Date :

March 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2032

Estimated Enrollment :

520 Patients enrolled

Trial Details

Trial ID

NCT05445778

Start Date

March 15 2023

End Date

May 1 2032

Last Update

February 23 2026

Active Locations (264)

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Page 1 of 66 (264 locations)

1

Usa Mitchell Cancer Institute /ID# 269661

Mobile, Alabama, United States, 36604

2

Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987

Phoenix, Arizona, United States, 85016

3

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573

Irvine, California, United States, 92618

4

Moores Cancer Center at UC San Diego /ID# 269564

La Jolla, California, United States, 92093

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