Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
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 (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
- Adult women ">/=18 years old
- Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
- Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
- Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
- 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
- Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
- More than one line of prior chemotherapy before current/planned triplet therapy
- PD (progressive disease) while on or following platinum-based therapy
- Prior or whole-pelvis or wide-field radiotherapy
- > Grade 1 peripheral neuropathy
- History of or concurrent ocular disorders
- Grade 4 thromboembolic events
- Not appropriate for bevacizumab treatment
- Requiring use of folate-containing supplements
- Prior hypersensitivity to monoclonal antibodies
- Pregnant or breatfeeding women
- Received prior MIRV or other FRα-targeting agents
- Untreated or symptomatic central nervous system metastases
- History of other malignancy within 3 years prior to signing study consent
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: FEMALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT05445778
Intervention or treatment
DRUG: Mirvetuximab soravtansine plus Bevacizumab
DRUG: Bevacizumab
Conditions
- Ovarian Cancer
- Peritoneal Cancer
- Fallopian Tube Cancer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Westmead Hospital /ID# 269362
Select from list below to view details:
Westmead Hospital /ID# 269362
Westmead, New South Wales, Australia
Gold Coast University Hospital /ID# 269365
Southport, Queensland, Australia
Ballarat Base Hospital /ID# 269364
Ballarat, Victoria, Australia
Monash Health - Monash Medical Centre /ID# 269360
Clayton, Victoria, Australia
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Who is running the clinical trial?
AbbVie
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
| Measure | Description | Time Frame |
|---|---|---|
| Assess Progression-free survival (PFS) | 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 | Up to 4 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Assess Overall survival (OS) | Overall survival (OS), defined as the time from randomization to death | Up to 10 years |
| Assess Safety and tolerability | Adverse events (AEs) will be evaluated according to the NCI CTCAE v5 | Up to 10 years |
| Assess time to 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 10 years |
| Assess Objective Response Rate (ORR) | Objective response includes best response of complete response (CR) or partial response (PR). | Up to 10 years |
| Assess Duration of response (DOR) | 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" | Up to 10 years |
| Assess Disease-free survival (DFS) | DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization | Up to 10 years |
| CA-125 response | Serum CA-125 response determined using the GCIG criteria | Up to 10 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 10 years |
References
Clinical Trials Gov: Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal CancerOther trials to consider
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