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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05445778
Registration number
NCT05445778
Ethics application status
Date submitted
30/06/2022
Date registered
6/07/2022
Date last updated
22/06/2025
Titles & IDs
Public title
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
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Scientific title
Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRa-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab
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Secondary ID [1]
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2022-501606-35-00
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Secondary ID [2]
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IMGN853-0421
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Universal Trial Number (UTN)
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Trial acronym
GLORIOSA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Peritoneal Cancer
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Fallopian Tube Cancer
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Condition category
Condition code
Cancer
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0
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Womb (Uterine or endometrial cancer)
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Cancer
0
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0
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Stomach
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Inflammatory and Immune System
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mirvetuximab soravtansine plus Bevacizumab
Treatment: Drugs - Bevacizumab
Experimental: Arm 1 - Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
Active comparator: Arm 2 - Bevacizumab monotherapy
Treatment: Drugs: Mirvetuximab soravtansine plus Bevacizumab
Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks
Treatment: Drugs: Bevacizumab
Participants will receive Bevacizumab 15mg/kg every 3 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Assess Progression-free survival (PFS)
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Assessment method [1]
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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
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Timepoint [1]
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Up to 4 years
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Secondary outcome [1]
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Assess Overall survival (OS)
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Assessment method [1]
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Overall survival (OS), defined as the time from randomization to death
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Timepoint [1]
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Up to 10 years
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Secondary outcome [2]
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Assess Safety and tolerability
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Assessment method [2]
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Adverse events (AEs) will be evaluated according to the NCI CTCAE v5
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Timepoint [2]
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Up to 10 years
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Secondary outcome [3]
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Assess time to second disease progression (PFS2)
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Assessment method [3]
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Second disease progression (PFS2) defined as the time from date of randomization until second disease progression or death, whichever occurs first
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Timepoint [3]
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Up to 10 years
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Secondary outcome [4]
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Assess Objective Response Rate (ORR)
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Assessment method [4]
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Objective response includes best response of complete response (CR) or partial response (PR).
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Timepoint [4]
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Up to 10 years
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Secondary outcome [5]
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Assess Duration of response (DOR)
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Assessment method [5]
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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"
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Timepoint [5]
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Up to 10 years
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Secondary outcome [6]
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Assess Disease-free survival (DFS)
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Assessment method [6]
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DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization
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Timepoint [6]
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Up to 10 years
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Secondary outcome [7]
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CA-125 response
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Assessment method [7]
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Serum CA-125 response determined using the GCIG criteria
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Timepoint [7]
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Up to 10 years
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Secondary outcome [8]
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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).
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Assessment method [8]
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A questionnaire assessing the health of patients with ovarian cancer.
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Timepoint [8]
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Up to 10 years
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Eligibility
Key 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 FRa 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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 FRa-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 design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2029
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Actual
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Sample size
Target
520
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital /ID# 269362 - Westmead
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Gold Coast University Hospital /ID# 269365 - Southport
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Ballarat Base Hospital /ID# 269364 - Ballarat
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Monash Health - Monash Medical Centre /ID# 269360 - Clayton
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Cabrini Hospital - Malvern /ID# 269359 - Malvern
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Recruitment hospital [6]
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Peter MacCallum Cancer Centre /ID# 269361 - Melbourne
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Recruitment hospital [7]
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Epworth Hospital /ID# 269363 - Richmond
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Recruitment hospital [8]
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St. John Of God Subiaco Hospital /ID# 269358 - Subiaco
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4215 - Southport
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3350 - Ballarat
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3168 - Clayton
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3144 - Malvern
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Recruitment postcode(s) [6]
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3000 - Melbourne
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Recruitment postcode(s) [7]
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3121 - Richmond
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Recruitment postcode(s) [8]
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6008 - Subiaco
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Recruitment outside Australia
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Ceske Budejovice
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Chiba
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Country [115]
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0
Japan
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State/province [115]
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0
Ehime
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Country [116]
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0
Japan
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State/province [116]
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0
Fukuoka
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Country [117]
0
0
Japan
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State/province [117]
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0
Hokkaido
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Country [118]
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0
Japan
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State/province [118]
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0
Hyogo
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Country [119]
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0
Japan
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State/province [119]
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0
Iwate
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Country [120]
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Japan
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State/province [120]
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Kanagawa
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Country [121]
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Japan
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Miyagi
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Country [122]
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Japan
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State/province [122]
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Niigata
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Country [123]
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0
Japan
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State/province [123]
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0
Okayama
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Country [124]
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0
Japan
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State/province [124]
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Saitama
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Country [125]
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Japan
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State/province [125]
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0
Shizuoka
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Country [126]
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Japan
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State/province [126]
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Tokyo
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Country [127]
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Korea, Republic of
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State/province [127]
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Gyeonggido
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Country [128]
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Korea, Republic of
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State/province [128]
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Gyeongsangbugdo
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Country [129]
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Korea, Republic of
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State/province [129]
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Seoul Teugbyeolsi
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Country [130]
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Philippines
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State/province [130]
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National Capital Region
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Country [131]
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Poland
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State/province [131]
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Mazowieckie
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Country [132]
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Poland
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State/province [132]
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Pomorskie
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Country [133]
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Spain
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State/province [133]
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A Coruna
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Country [134]
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Spain
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State/province [134]
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Barcelona
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Country [135]
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Spain
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State/province [135]
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Navarra
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Country [136]
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Spain
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State/province [136]
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Girona
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Country [137]
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Spain
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Madrid
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Country [138]
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Spain
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Valencia
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Country [139]
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Turkey
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State/province [139]
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Ankara
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Country [140]
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United Kingdom
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State/province [140]
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Gloucestershire
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Country [141]
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United Kingdom
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State/province [141]
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Greater London
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Country [142]
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United Kingdom
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State/province [142]
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Hampshire
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Country [143]
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United Kingdom
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Surrey
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Country [144]
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United Kingdom
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State/province [144]
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Manchester
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Country [145]
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United Kingdom
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State/province [145]
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Other collaborator category [1]
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Other
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Name [1]
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GOG Foundation
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Address [1]
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0
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Country [1]
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0
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Ethics approval
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Summary
Brief 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 (FRa) expression.
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Trial website
https://clinicaltrials.gov/study/NCT05445778
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
ABBVIE INC.
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Address
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AbbVie
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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0
ABBVIE CALL CENTER
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Address
0
0
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Country
0
0
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Phone
0
0
844-663-3742
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05445778
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