Study on Eye Health During Treatment with Mirvetuximab Soravtansine for Recurrent Ovarian Cancer with High Folate Receptor-Alpha Levels
Sponsor: AbbVie
ClinicalTrials ID:NCT06365853
This clinical trial is examining how often and how severe eye-related side effects occur in patients with recurrent ovarian cancer treated with Mirvetuximab Soravtansine. The study also looks at ways to prevent these side effects in patients with high folate receptor-alpha levels.
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Program Overview
The aim of this study is to find out how often and how severe eye-related side effects are when using Mirvetuximab Soravtansine in patients with recurrent ovarian cancer. The study will also test different strategies to prevent these side effects in patients with high levels of folate receptor-alpha, a protein found in some cancer cells.
Description
Participants in this study will be randomly assigned to one of two groups to test different strategies for preventing eye-related side effects. One group will use steroid eye drops, while the other group will use eye drops that narrow blood vessels. This study focuses on patients with recurrent ovarian cancer who have high levels of folate receptor-alpha, a protein that can be targeted by the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer with high folate receptor-alpha levels.
- Tumor must be positive for folate receptor-alpha, as determined by specific lab tests.
- If there are known BRCA gene mutations, participants must have previously received PARP inhibitors.
- Must have completed previous cancer treatments within specific timeframes:
- At least 5 half-lives or 4 weeks since last systemic cancer treatment, whichever is shorter.
- At least 2 weeks since last focused radiation treatment.
- Must have recovered from any side effects of previous treatments, except for hair loss.
- Women who can become pregnant must use effective birth control during treatment and for at least 7 months after the last dose, and must have a negative pregnancy test within 4 days before starting treatment.
Exclusion Criteria
- Cannot have borderline ovarian tumors or non-epithelial or mixed types of cancer.
- Cannot have disease that did not respond to or worsened within 3 months of the last platinum-based chemotherapy.
- Cannot have more than mild peripheral nerve damage.
- Cannot have significant or ongoing eye problems, such as corneal disorders, history of corneal transplant, or severe eye inflammation.
- Cannot have uncontrolled eye conditions like glaucoma or severe vision loss.
- Cannot be using steroid or vasoconstricting eye drops at the start of the study or within 5 weeks before.
- Cannot have had previous treatment with Mirvetuximab Soravtansine or similar drugs targeting folate receptor-alpha.
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