Study on Mirvetuximab Soravtansine with Bevacizumab vs. Bevacizumab for Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)
Sponsor: AbbVie
ClinicalTrials ID:NCT05445778
This clinical trial is testing whether adding the drug Mirvetuximab Soravtansine to Bevacizumab can improve treatment outcomes for patients with platinum-sensitive ovarian, fallopian tube, or peritoneal cancer that have high levels of a specific protein called folate receptor-alpha.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The GLORIOSA study is a Phase 3 trial conducted at multiple centers to evaluate the safety and effectiveness of Mirvetuximab Soravtansine as a maintenance treatment for patients with platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancers that express high levels of folate receptor-alpha (FRα).
Description
Mirvetuximab Soravtansine (MIRV) is an experimental drug designed to target and kill cancer cells. It works by attaching to a protein called folate receptor alpha (FRα) found on certain tumor cells and delivering a cell-killing drug directly to them. This study is exploring its use as a maintenance therapy for patients with recurrent platinum-sensitive high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers that have high FRα expression. To participate, patients must have their FRα levels confirmed by a specific test called the Ventana FOLR1 Assay.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Must provide a tumor sample for testing to confirm high levels of FRα.
- Must have had BRCA genetic testing, and if positive, must have received prior treatment with a PARP inhibitor.
- Cancer must have returned after one line of platinum-based chemotherapy and be sensitive to platinum, meaning it has not progressed for more than 6 months after the last treatment.
- Must have completed a specific number of cycles of platinum-based chemotherapy with bevacizumab in the second line of treatment.
- Must have achieved a complete response, partial response, or stable disease after second-line treatment.
- Must have adequate blood counts and organ function.
- Must agree to use effective contraception if of childbearing potential and have a negative pregnancy test before starting treatment.
Exclusion Criteria
- Have certain types of ovarian cancer, such as endometrioid, clear cell, or mucinous.
- Have had more than one line of chemotherapy before the current treatment.
- Have disease progression while on or after platinum-based therapy.
- Have received certain treatments like wide-field radiotherapy affecting bone marrow.
- Have significant peripheral neuropathy or eye conditions.
- Have active infections like hepatitis B, C, or HIV.
- Have significant heart disease or recent stroke.
- Have a history of severe lung disease or bowel obstruction.
- Have significant protein in urine or history of severe blood clots.
- Are not suitable for bevacizumab treatment.
- Are pregnant or breastfeeding.
- Have received prior treatment with MIRV or similar drugs.
- Have untreated or symptomatic brain metastases.
- Have had another cancer within the last 3 years, except for certain low-risk cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USA Mitchell Cancer Institute | 36604 | Mobile | Alabama |
| Honor Health Cancer Care, Biltmore, 2222 E. Highland Ave, #400 | 85016 | Phoenix | Arizona |
| John Muir Health | 94520 | Concord | California |
| City of Hope | 92618 | Irvine | California |
| Kaiser Permanente Irvine Medical Center, 6650 Alton Pkwy | 92618 | Irvine | California |
| UC San Diego Health - Moores Cancer Center | 92093 | La Jolla | California |
| Kaiser Permanente Los Angeles Medical Center, 4950 Sunset Blvd., 6th Floor | 90027 | Los Angeles | California |
| UCI Health- Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Stanford University | 94304 | Palo Alto | California |
| Kaiser Permanente Riverside Medical Center, 10800 Magnolia Ave | 92505 | Riverside | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.