For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 781-895-0600Email iconEmail Study Center

Study Details


Contition

Ovarian Cancer,Peritoneal Cancer,Fallopian Tube Cancer

Age

18+

Phase

PHASE3

Participants Needed

520

Est. Completion Date

Apr 30, 2029

Treatment Type

INTERVENTIONAL


Sponsor

AbbVie

ClinicalTrials.gov NCT Identifier

NCT05445778

Study Number

IMGN853-0421

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