Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)
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|ClinicalTrials.gov Identifier: NCT05445778|
Recruitment Status : Recruiting
First Posted : July 6, 2022
Last Update Posted : November 24, 2023
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer||Drug: Mirvetuximab soravtansine plus Bevacizumab Drug: Bevacizumab||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||418 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)|
|Actual Study Start Date :||December 27, 2022|
|Estimated Primary Completion Date :||March 2027|
|Estimated Study Completion Date :||April 2029|
Experimental: Arm 1
Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
Drug: Mirvetuximab soravtansine plus Bevacizumab
Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks
Other Name: MIRV
Active Comparator: Arm 2
Participants will receive Bevacizumab 15mg/kg every 3 weeks
- Assess Progression-free survival (PFS) [ Time Frame: Up to 4 years ]Progression-free survival defined as the time from date of randomization until investigator-assessed progressive disease (PD) or death, whichever occurs first.
- Assess Overall survival (OS) [ Time Frame: Up to 7 years ]Overall survival (OS), defined as the time from randomization to death
- Assess Safety and tolerability [ Time Frame: Up to 7 years ]Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0
- Assess second disease progression (PFS2) [ Time Frame: Up to 7 years ]Second disease progression (PFS2)defined as the time from date of randomization until second disease progression or death, whichever occurs first
- Assess Objective Response Rate (ORR) [ Time Frame: Up to 7 years ]Objective response includes best response of complete response (CR) or partial response (PR).
- Assess Duration of response (DOR) [ Time Frame: Up to 7 years ]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)
- Assess Disease-free survival (DFS) [ Time Frame: Up to 7 years ]Measured only in patients who have no measurable disease per RECIST v1.1 at randomization
- CA-125 response [ Time Frame: Up to 7 years ]Serum CA-125 response determined using the GCIG criteria
- 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). [ Time Frame: Up to 7 years ]A questionnaire assessing the health of patients with ovarian cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05445778
|Contact: ImmunoGen, Inc.||email@example.com|