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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
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
Secondary ID [1] 0 0
2022-501606-35-00
Secondary ID [2] 0 0
IMGN853-0421
Universal Trial Number (UTN)
Trial acronym
GLORIOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Peritoneal Cancer 0 0
Fallopian Tube Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess Progression-free survival (PFS)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Assess Overall survival (OS)
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Assess Safety and tolerability
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Assess time to second disease progression (PFS2)
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [4] 0 0
Assess Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to 10 years
Secondary outcome [5] 0 0
Assess Duration of response (DOR)
Timepoint [5] 0 0
Up to 10 years
Secondary outcome [6] 0 0
Assess Disease-free survival (DFS)
Timepoint [6] 0 0
Up to 10 years
Secondary outcome [7] 0 0
CA-125 response
Timepoint [7] 0 0
Up to 10 years
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
Up to 10 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital /ID# 269362 - Westmead
Recruitment hospital [2] 0 0
Gold Coast University Hospital /ID# 269365 - Southport
Recruitment hospital [3] 0 0
Ballarat Base Hospital /ID# 269364 - Ballarat
Recruitment hospital [4] 0 0
Monash Health - Monash Medical Centre /ID# 269360 - Clayton
Recruitment hospital [5] 0 0
Cabrini Hospital - Malvern /ID# 269359 - Malvern
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre /ID# 269361 - Melbourne
Recruitment hospital [7] 0 0
Epworth Hospital /ID# 269363 - Richmond
Recruitment hospital [8] 0 0
St. John Of God Subiaco Hospital /ID# 269358 - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3350 - Ballarat
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment postcode(s) [8] 0 0
6008 - Subiaco
Recruitment outside Australia
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Iwate
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Miyagi
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Niigata
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Okayama
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Saitama
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Gyeongsangbugdo
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Seoul Teugbyeolsi
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Philippines
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National Capital Region
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Poland
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Mazowieckie
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Pomorskie
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A Coruna
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Barcelona
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Madrid
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Spain
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Valencia
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Turkey
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Ankara
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United Kingdom
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Gloucestershire
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Greater London
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Hampshire
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Surrey
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Manchester
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
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.