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Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
Study details:
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. .
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-12-27
Primary completion: 2027-03-01
Study completion finish: 2029-04-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05445778
Intervention or treatment
DRUG: Mirvetuximab soravtansine plus Bevacizumab
DRUG: Bevacizumab
Conditions
- • Ovarian Cancer
- • Fallopian Tube Cancer
- • Peritoneal Cancer
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
Westmead Hospital
Westmead, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Grampians Health Service
Ballarat, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm 1
| DRUG: Mirvetuximab soravtansine plus Bevacizumab
|
ACTIVE_COMPARATOR: Arm 2
| DRUG: Bevacizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Assess Progression-free survival (PFS) | Progression-free survival defined as the time from date of randomization until investigator-assessed progressive disease (PD) or death, whichever occurs first. | Up to 4 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Assess Overall survival (OS) | Overall survival (OS), defined as the time from randomization to death | Up to 7 years |
Assess Safety and tolerability | Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0 | Up to 7 years |
Assess second disease progression (PFS2) | Second disease progression (PFS2)defined as the time from date of randomization until second disease progression or death, whichever occurs first | Up to 7 years |
Assess Objective Response Rate (ORR) | Objective response includes best response of complete response (CR) or partial response (PR). | Up to 7 years |
Assess Duration of response (DOR) | Measured only in patients who achieved a confirmed best overall response of CR or PR upon completion of platinum-based combination chemotherapy with bevacizumab (triplet therapy) | Up to 7 years |
Assess Disease-free survival (DFS) | Measured only in patients who have no measurable disease per RECIST v1.1 at randomization | Up to 7 years |
CA-125 response | Serum CA-125 response determined using the GCIG criteria | Up to 7 years |
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). | A questionnaire assessing the health of patients with ovarian cancer. | Up to 7 years |
Frequently Asked Questions
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