Study on Side Effects and Disease Activity Changes with Mirvetuximab Soravtansine Combinations in Adults with Ovarian Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT07059845
This clinical trial is exploring the side effects and changes in disease activity when using the drug mirvetuximab soravtansine in combination with other treatments for ovarian cancer. Participants will be divided into groups to receive different treatment combinations, and the study will take place over approximately 40 months.
Patient Parameters
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Program Overview
Ovarian cancer is a serious disease affecting many people worldwide. This study aims to understand the side effects and effectiveness of a new drug, mirvetuximab soravtansine, when used with other treatments like carboplatin or bevacizumab in patients with ovarian cancer. Participants will be divided into three substudies, each testing different combinations of these drugs. The study will involve about 400 participants across 100 locations globally. Participants will receive the treatments through an IV and will need to attend regular hospital or clinic visits for check-ups, blood tests, and scans.
Eligibility Criteria
Inclusion Criteria
Substudy 1
- Must provide a tumor sample for testing to confirm a specific protein (FRα) is present in the cancer cells.
- Must be in good general health, able to carry out normal activities or light work.
- For first-line treatment: Must have advanced ovarian, peritoneal, or fallopian tube cancer.
- For second-line treatment: Must have cancer that responded to platinum-based chemotherapy but has returned after more than 183 days.
- Must have genetic test results available for certain cancer-related genes.
Substudy 2
- Must provide a tumor sample for testing to confirm a specific protein (FRα) is present in the cancer cells.
- Must be in good general health, able to carry out normal activities or light work.
- Must have advanced ovarian, peritoneal, or fallopian tube cancer.
- Must have cancer that returned after 1 or 2 previous platinum-based chemotherapy treatments.
- Must have cancer that can be measured by scans.
Substudy 3
- Must provide a tumor sample for testing to confirm a specific protein (FRα) is present in the cancer cells.
- Must be in good general health, able to carry out normal activities or light work.
- Must have advanced ovarian, peritoneal, or fallopian tube cancer.
- Must have cancer that returned after 1 or 2 previous platinum-based chemotherapy treatments.
- Must have cancer that can be measured by scans.
Exclusion Criteria
Substudy 1
- Cancer that worsened during or after the last combination treatment before joining the study.
- Received bevacizumab after the last combination treatment before joining the study.
- Previously treated with mirvetuximab soravtansine or similar drugs.
Substudy 2
- More than 2 previous chemotherapy treatments.
- Previously treated with mirvetuximab soravtansine or similar drugs.
Substudy 3
- More than 2 previous chemotherapy treatments.
- Previously treated with mirvetuximab soravtansine or similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC San Diego Health - Moores Cancer Center /ID# 277574 | 92037 | La Jolla | California |
| Sansum Clinic - Solvang /ID# 277712 | 93463 | Solvang | California |
| University of Florida College of Medicine /ID# 278348 | 32610 | Gainesville | Florida |
| Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623 | 32806 | Orlando | Florida |
| Florida Cancer Specialists - North /ID# 278626 | 33705 | St. Petersburg | Florida |
| Florida Cancer Specialists - East /ID# 278605 | 33401 | West Palm Beach | Florida |
| Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440 | 70817 | Baton Rouge | Louisiana |
| Maine Medical Center - Scarborough Campus /ID# 277205 | 04074 | Scarborough | Maine |
| Karmanos Cancer Institute - Detroit /ID# 277085 | 48201 | Detroit | Michigan |
| Intermountain Health - Intermountain Health West End Clinic /ID# 278470 | 59106 | Billings | Montana |
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