Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Ovarian Cancer | Fallopian Tube Cancer | Peritoneal CancerGLORIOSA 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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Conditions de participation
-
Sexe:
FEMALE -
Âges admissibles:
18 and up
Critères de participation
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
Lieu de l'étude
Tom Baker Cancer Centre, Alberta Health Services
Tom Baker Cancer Centre, Alberta Health ServicesCalgary, Alberta
Canada
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Juravinski Cancer Centre
Juravinski Cancer CentreHamilton, Ontario
Canada
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Nidhi Kumar-Tyagi, MD
905-387-9495Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)Montreal, Quebec
Canada
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BC Cancer - Vancouver
BC Cancer - VancouverVancouver, British Columbia
Canada
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Jeff Gardner
1-604-877-6000Princess Margaret Cancer Centre
Princess Margaret Cancer CentreToronto, Ontario
Canada
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CHUS - Hôpital Fleurimont
CHUS - Hôpital FleurimontSherbrooke, Quebec
Canada
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BC Cancer Surrey
BC Cancer SurreySurrey, British Columbia
Canada
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The Ottawa Hospital Cancer Centre
The Ottawa Hospital Cancer CentreOttawa, Ontario
Canada
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McGill University Health Centre
McGill University Health CentreMontreal, Quebec
Canada
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University of Alberta - Cross Cancer Institute (CCI)
University of Alberta - Cross Cancer Institute (CCI)Edmonton, Alberta
Canada
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Shalyn Dafoe
780-391-7686Kinston Health Sciences Center - KGH Site
Kinston Health Sciences Center - KGH SiteKingston, Ontario
Canada
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Julie Holiday
613-549-6666Centre Hospitalier de L'Universite de Montreal - Centre de Recherche
Centre Hospitalier de L'Universite de Montreal - Centre de RechercheMontreal, Quebec
Canada
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Cross Cancer Institute /ID# 269392
Cross Cancer Institute /ID# 269392Edmonton, Alberta
Canada
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Kingston General Hospital /ID# 269397
Kingston General Hospital /ID# 269397Kingston, 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# 269387Montreal, Quebec
Canada
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BC Cancer - Vancouver /ID# 269394
BC Cancer - Vancouver /ID# 269394Vancouver, British Columbia
Canada
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Princess Margaret Cancer Centre /ID# 269390
Princess Margaret Cancer Centre /ID# 269390Toronto, Ontario
Canada
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CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393
CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393Sherbrooke, Quebec
Canada
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Arthur J. E. Child Comprehensive Cancer Centre /ID# 269388
Arthur J. E. Child Comprehensive Cancer Centre /ID# 269388Calgary, Alberta
Canada
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Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396
Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396Hamilton, Ontario
Canada
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Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 269395
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 269395Montreal, Quebec
Canada
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Bc Cancer Agency - Fraser Valley Centre /ID# 269398
Bc Cancer Agency - Fraser Valley Centre /ID# 269398Surrey, British Columbia
Canada
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The Ottawa Hospital - General Campus /ID# 269391
The Ottawa Hospital - General Campus /ID# 269391Ottawa, Ontario
Canada
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McGill University Health Centre - Glen Site /ID# 269389
McGill University Health Centre - Glen Site /ID# 269389Montreal, Quebec
Canada
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- Étude parrainée par
- AbbVie
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05445778