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New treatment option for Ovarian Cancer
Official title A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer
ClinicalTrials.gov ID: NCT07059845
What this study is testing
What is Mirvetuximab Soravtansine?
Mirvetuximab Soravtansine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Substudy 1
- Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a...
- Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial...
- Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with...
You likely can't join if
- Substudy 1
- Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before...
- Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
- Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor...
- More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
- Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen...
See the full eligibility criteria
- Substudy 1
- Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC)...
- Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. 2L participants must...
- Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available...
- Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC)...
- Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
- Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline. Substudy 3
- Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC)...
- Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
- Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.
- Substudy 1
- Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.
- Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
- Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi). Substudy 2
- More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
- Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
- Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).
- If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy
- Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
- Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents. Substudy 3
- More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
- Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
- Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).
- If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy
- Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
- Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Solvang, California, United States
- Gainesville, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Baton Rouge, Louisiana, United States
- Scarborough, Maine, United States
- Detroit, Michigan, United States
- Billings, Montana, United States
- Camden, New Jersey, United States
- Syracuse, New York, United States
- Pinehurst, North Carolina, United States
- Hilliard, Ohio, United States
- Eugene, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Knoxville, Tennessee, United States
- Abilene, Texas, United States
- Fort Worth, Texas, United States
+ 52 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Solvang, California, United States; Gainesville, Florida, United States; Orlando, Florida, United States; St. Petersburg, Florida, United States; West Palm Beach, Florida, United States and 66 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.