Mirvetuximab Soravtansine + Carboplatin for Ovarian Cancer
Trial Summary
What is the purpose of this trial?
IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have stabilized or recovered from all prior therapy-related side effects and have discontinued any maintenance therapy at least 4 weeks before starting the trial treatment.
What data supports the effectiveness of the drug Mirvetuximab Soravtansine combined with Carboplatin for ovarian cancer?
Mirvetuximab Soravtansine has shown promising results in treating ovarian cancer, particularly in patients with platinum-resistant disease, with a 32.4% response rate and a median response duration of 6.9 months. Additionally, when combined with another drug, bevacizumab, it demonstrated a 64% response rate, indicating its potential effectiveness in combination therapies.12345
Is the combination of Mirvetuximab Soravtansine and Carboplatin safe for humans?
The combination of Mirvetuximab Soravtansine and Carboplatin has been studied for safety in ovarian cancer patients. Mirvetuximab Soravtansine can cause low-grade eye and stomach-related side effects, which are generally manageable. Corticosteroid eye drops have been used to help manage eye-related side effects.12367
What makes the drug Mirvetuximab Soravtansine + Carboplatin unique for treating ovarian cancer?
This drug combination is unique because Mirvetuximab Soravtansine is an antibody-drug conjugate that specifically targets the folate receptor alpha, which is often present in ovarian cancer cells, allowing for targeted delivery of the chemotherapy agent DM4. This targeted approach aims to improve effectiveness and reduce side effects compared to traditional chemotherapy.12368
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for adults with high-grade ovarian, primary peritoneal, or fallopian tube cancer that's sensitive to platinum-based chemo and has returned after one treatment round. Participants must have a certain level of tumor cell positivity for FRα, be in good physical condition (ECOG 0-1), and not pregnant. They can't join if they've had more than one chemo round, severe eye conditions, prior MIRV treatments, certain other cancers within the last three years or serious health issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive carboplatin plus mirvetuximab soravtansine for 6 cycles, followed by continuation with mirvetuximab soravtansine alone
Continuation
Participants continue with single-agent mirvetuximab soravtansine if they have stable disease, complete response, or partial response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Mirvetuximab soravtansine
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
ImmunoGen, Inc.
Lead Sponsor