This study is in progress, not accepting new patients

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

a study on Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Neoplasms

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UC Irvine UCLA UCSD
Dates
study started
study ends around
Principal Investigator
by Krishnansu Tewari (uci)
Headshot of Krishnansu Tewari
Krishnansu Tewari

Description

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 (FRα) expression.

Official Title

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

Details

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 (FRα). 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 FRα positivity by the Ventana FOLR1 Assay.

Keywords

Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Platinum-sensitive, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive, High-Grade Ovarian, ADC, Adult, Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms, mirvetuximab soravtansine, Bevacizumab, Mirvetuximab soravtansine plus Bevacizumab

Eligibility

You can join if…

Open to females ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • Moores Cancer Center at UC San Diego /ID# 269564
    La Jolla California 92093 United States
  • University Of California Irvine Medical Center /ID# 269572
    Orange California 92868 United States
  • Olive View-Ucla Medical Center /ID# 269584
    Sylmar California 91342 United States
  • Kaiser Permanente - San Diego Medical Center /ID# 269540
    San Diego California 92123 United States
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573
    Irvine California 92618 United States
  • Kaiser Permanente - Los Angeles Medical Center /ID# 269541
    Los Angeles California 90027 United States
  • Kaiser Permanente Zion Medical Center /ID# 269537
    San Diego California 92120 United States
  • Kaiser Permanente - San Marcos Medical Offices /ID# 269542
    San Marcos California 92069 United States
  • John Muir Health - Walnut Creek Medical Center /ID# 269575
    Walnut Creek California 94598 United States
  • Stanford Women'S Cancer Center /ID# 269552
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Krishnansu Tewari (uci)
    Professor, Obstetrics and Gynecology, School of Medicine. Authored (or co-authored) 268 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT05445778
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 520 people participating
Last Updated