Fallopian tube cancer metastatic Trials in Disease

Study on Mirvetuximab Soravtansine and Carboplatin for Patients with Recurrent Ovarian Cancer Eligible for Platinum-Based Chemotherapy

This clinical trial is studying a new treatment approach for patients whose cancer has returned after initial treatment. The trial is being conducted in Germany and focuses on patients with epithelial cancer of the ovary, fallopian tube, or peritoneum.

Main inclusion criteria:

• Patients must have confirmed epithelial cancer of the ovary, fallopian tube, or peritoneum that has returned after previous treatment
• Must be female and at least 18 years old
• The cancer must have stayed away for more than 3 months after previous platinum-based chemotherapy treatment
• Patients must have high levels of a protein called folate receptor alpha (FRα) in their tumor cells
• Must be able to carry out daily activities with little or no symptoms (ECOG performance status of 0 or 1)
• Must have had at least one previous chemotherapy treatment that included 4 or more cycles of platinum-based chemotherapy with good results
• Women who can become pregnant must use effective birth control during the study and for at least 8 months after treatment ends
• Must have adequate blood counts and proper liver, heart, and kidney function

Main exclusion criteria:

• Patients who are not eligible for platinum-based chemotherapy
• Patients whose tumors do not have high levels of the folate receptor alpha protein
• Male patients
• Patients who belong to vulnerable populations that may require special protection

Focus and goal of the trial:

The study aims to evaluate whether combining a new targeted medication called Mirvetuximab soravtansine with the chemotherapy drug Carboplatin is effective and safe for treating recurrent disease. The trial will compare this combination to standard treatment options, which may include drugs like Gemcitabine, Paclitaxel, Doxorubicin, or PARP inhibitors such as Rucaparib, Olaparib, or Niraparib. Some participants may receive a placebo.

The main goal is to measure progression-free survival, which is the time patients live without their disease getting worse. Researchers will also look at overall survival and how well the cancer responds to treatment. Patients will receive treatment in cycles that repeat every three weeks, and they will be closely monitored with regular health assessments and imaging tests throughout the study.

Investigational drug:

The main drug being tested is Mirvetuximab soravtansine (also known as IMGN853). This medication is designed to target cancer cells that have high levels of folate receptor alpha protein on their surface. It works like a guided missile – it finds the cancer cells by attaching to this specific protein, then delivers a toxic substance directly to the cancer cells to destroy them. This targeted approach aims to kill cancer cells while potentially reducing harm to healthy cells. The medication is given as an intravenous injection in combination with Carboplatin chemotherapy.