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

Ovarian Cancer | Fallopian Tube Cancer | 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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Participation Requirements

  • Sex:

    FEMALE
  • Eligible Ages:

    18 and up

Participation 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

Study Location

Tom Baker Cancer Centre, Alberta Health Services
Tom Baker Cancer Centre, Alberta Health Services
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Edith-Romy Nsangou

[email protected]
403-521-3784
Juravinski Cancer Centre
Juravinski Cancer Centre
Hamilton, Ontario
Canada

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Primary Contact

Nidhi Kumar-Tyagi, MD

905-387-9495
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Lara deGuerke, MD

[email protected]
514-252-3400
BC Cancer - Vancouver
BC Cancer - Vancouver
Vancouver, British Columbia
Canada

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Primary Contact

Jeff Gardner

1-604-877-6000
Princess Margaret Cancer Centre
Princess Margaret Cancer Centre
Toronto, Ontario
Canada

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CHUS - Hôpital Fleurimont
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec
Canada

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Primary Contact

Paul Bessette, MD

[email protected]
819-821-8000
BC Cancer Surrey
BC Cancer Surrey
Surrey, British Columbia
Canada

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The Ottawa Hospital Cancer Centre
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
Canada

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Primary Contact

Johanne Weberpals, MD

[email protected]
613-737-7700
McGill University Health Centre
McGill University Health Centre
Montreal, Quebec
Canada

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Primary Contact

Mohamed Bakir

[email protected]
5149341934
University of Alberta - Cross Cancer Institute (CCI)
University of Alberta - Cross Cancer Institute (CCI)
Edmonton, Alberta
Canada

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Primary Contact

Shalyn Dafoe

780-391-7686
Kinston Health Sciences Center - KGH Site
Kinston Health Sciences Center - KGH Site
Kingston, Ontario
Canada

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Primary Contact

Julie Holiday

613-549-6666
Centre Hospitalier de L'Universite de Montreal - Centre de Recherche
Centre Hospitalier de L'Universite de Montreal - Centre de Recherche
Montreal, Quebec
Canada

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Cross Cancer Institute /ID# 269392
Cross Cancer Institute /ID# 269392
Edmonton, Alberta
Canada

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Kingston General Hospital /ID# 269397
Kingston General Hospital /ID# 269397
Kingston, Ontario
Canada

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CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269387
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269387
Montreal, Quebec
Canada

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BC Cancer - Vancouver /ID# 269394
BC Cancer - Vancouver /ID# 269394
Vancouver, British Columbia
Canada

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Princess Margaret Cancer Centre /ID# 269390
Princess Margaret Cancer Centre /ID# 269390
Toronto, Ontario
Canada

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CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393
CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393
Sherbrooke, Quebec
Canada

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Arthur J. E. Child Comprehensive Cancer Centre /ID# 269388
Arthur J. E. Child Comprehensive Cancer Centre /ID# 269388
Calgary, Alberta
Canada

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Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396
Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396
Hamilton, Ontario
Canada

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Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 269395
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 269395
Montreal, Quebec
Canada

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Bc Cancer Agency - Fraser Valley Centre /ID# 269398
Bc Cancer Agency - Fraser Valley Centre /ID# 269398
Surrey, British Columbia
Canada

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The Ottawa Hospital - General Campus /ID# 269391
The Ottawa Hospital - General Campus /ID# 269391
Ottawa, Ontario
Canada

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McGill University Health Centre - Glen Site /ID# 269389
McGill University Health Centre - Glen Site /ID# 269389
Montreal, Quebec
Canada

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Study Sponsored By
AbbVie
Participants Required
More Information
Study ID: NCT05445778