RECRUITING

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

Description

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 (FRα) expression.

Conditions

Ovarian CancerPeritoneal CancerFallopian Tube Cancer
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Related Conditions:

Ovarian CancerPeritoneal CancerFallopian Tube Cancer

Study Overview

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Study Details

Study overview

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 (FRα) expression.

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

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

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Mobile

Usa Mitchell Cancer Institute /ID# 269661, Mobile, Alabama, United States, 36604

Phoenix

Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987, Phoenix, Arizona, United States, 85016

Irvine

City of Hope Orange County Lennar Foundation Cancer Center /ID# 269573, Irvine, California, United States, 92618

La Jolla

Moores Cancer Center at UC San Diego /ID# 269564, La Jolla, California, United States, 92093

Orange

University Of California Irvine Medical Center /ID# 269572, Orange, California, United States, 92868

Palo Alto

Stanford Women'S Cancer Center /ID# 269552, Palo Alto, California, United States, 94304

San Diego

Kaiser Permanente Zion Medical Center /ID# 269537, San Diego, California, United States, 92120

San Diego

Kaiser Permanente - San Diego Medical Center /ID# 269540, San Diego, California, United States, 92123

San Marcos

Kaiser Permanente - San Marcos Medical Offices /ID# 269542, San Marcos, California, United States, 92069

Sylmar

Olive View-Ucla Medical Center /ID# 269584, Sylmar, California, United States, 91342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2029-04