Ovarian Cancer study: Mirvetuximab soravtansine
Official title Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer
ClinicalTrials.gov ID: NCT04606914
What this study is testing
What is mirvetuximab soravtansine?
an investigational antibody‑drug conjugate being studied as a potential treatment for advanced ovarian cancer. is designed to bind the folate receptor α on tumor cells and deliver a cytotoxic maytansinoid payload to kill those cells.
Also referred to as IMGN853, MIRV.
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
- This study checks if adding a targeted drug to standard chemotherapy is safe and workable for patients with advanced ovarian cancer.
- Who it's for
- People with newly diagnosed, advanced-stage ovarian, fallopian tube, or primary peritoneal cancer that has a specific protein marker on the tumor cells.
- What's involved
- Participants receive chemotherapy and the new drug for several months, have surgery to remove tumors, and then continue the drug mix for a few more months.
- Time commitment
- The treatment plan lasts about 7 months, with regular visits for infusions and one major surgery.
- 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
- Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.
- Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy
- Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically...
- Patients must have a performance status of 0 or 1.
- Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \>75% of cells
You likely can't join if
- Patients who have previously been treated with a systemic anti-cancer therapy
- Patients with low-grade serous, endometrioid, clear cell, or mucinous histology
- Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing...
- History of hepatitis B or C infection (whether or not on active antiviral therapy)
- History of human immunodeficiency virus (HIV) infection
- Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
See the full eligibility criteria
- Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.
- Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy
- Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα...
- Patients must have a performance status of 0 or 1.
- Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \>75% of cells
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL)
- Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion in the prior 10 days
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN)
- Serum albumin ≥ 2 g/dL
- Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
- Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4 months after the last dose
- WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV
- Patients who have previously been treated with a systemic anti-cancer therapy
- Patients with low-grade serous, endometrioid, clear cell, or mucinous histology
- Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular...
- History of hepatitis B or C infection (whether or not on active antiviral therapy)
- History of human immunodeficiency virus (HIV) infection
- Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
- Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
- Myocardial infarction ≤ 6 months prior to first dose
- Unstable angina pectoris
- Uncontrolled congestive heart failure (New York Heart Association \> class II)
- Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
- Uncontrolled cardiac arrhythmias
- Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
- Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
- Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
- Patients requiring use of folate-containing supplements (eg, folate deficiency)
- Patients with prior hypersensitivity to monoclonal antibodies (mAb)
- Women who are pregnant or breastfeeding
- Patients who received prior treatment with MIRV or other FRα-targeting agents
- Patients with untreated or symptomatic central nervous system (CNS) metastases
- Patients with a history of other malignancy within 3 years prior to enrollment Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Oxford, Mississippi, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
- Richmond, Virginia, United States
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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; San Francisco, California, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States; Oxford, Mississippi, United States; Columbus, Ohio, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.