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NCT Number: NCT05445778

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanatorio De La Mujer /ID# 269352, Rosario, Santa Fe Province, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult women >/=18 years old
  • Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
  • Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
  • Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
  • 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

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

Treatment and study plan

Mirvetuximab soravtansine plus Bevacizumab

Drug

Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks

Other names: MIRV

Bevacizumab

Drug

Participants will receive Bevacizumab 15mg/kg every 3 weeks

Primary outcomes

  1. Assess Progression-free survival (PFS)

    Time frame: Up to 4 years

    Progression-free survival defined as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first

Secondary outcomes

  1. Assess Overall survival (OS)

    Time frame: Up to 10 years

    Overall survival (OS), defined as the time from randomization to death

  2. Assess Safety and tolerability

    Time frame: Up to 10 years

    Adverse events (AEs) will be evaluated according to the NCI CTCAE v5

  3. Assess time to second disease progression (PFS2)

    Time frame: Up to 10 years

    Second disease progression (PFS2) defined as the time from date of randomization until second disease progression or death, whichever occurs first

  4. Assess Objective Response Rate (ORR)

    Time frame: Up to 10 years

    Objective response includes best response of complete response (CR) or partial response (PR).

  5. Assess Duration of response (DOR)

    Time frame: Up to 10 years

    DOR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization and achieved a confirmed response of CR or PR after maintenance therapy"

  6. Assess Disease-free survival (DFS)

    Time frame: Up to 10 years

    DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization

  7. CA-125 response

    Time frame: Up to 10 years

    Serum CA-125 response determined using the GCIG criteria

  8. Patient-reported outcome health-related quality of life (HRQoL) of disease-related symptoms using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) DRS-P (disease-related symptom subscale - physical).

    Time frame: Up to 10 years

    A questionnaire assessing the health of patients with ovarian cancer.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • GOG Foundation

Registry information

Official study 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

Acronym: GLORIOSA

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Jul 6, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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