Not recruiting

Study on Eye Health During Treatment with Mirvetuximab Soravtansine, Brimonidine Tartrate, and Prednisolone Acetate for Patients with Recurrent Ovarian Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for recurrent ovarian cancer in patients who have a high level of a specific protein called folate receptor-alpha. The treatment being tested is called Mirvetuximab Soravtansine, which is given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The study aims to evaluate the eye-related side effects that might occur during the treatment with Mirvetuximab Soravtansine.

Participants in the study will receive either Mirvetuximab Soravtansine or a placebo. To help manage potential eye side effects, some participants will use eye drops containing either Brimonidine Tartrate or Prednisolone Acetate. Brimonidine Tartrate is a vasoconstrictor, which means it helps narrow blood vessels, while Prednisolone Acetate is a corticosteroid, which helps reduce inflammation. The study will compare the effectiveness of these eye drops in preventing or reducing eye-related side effects.

The study will last for a period of up to 18 weeks, during which participants will undergo regular eye examinations to monitor for any changes or side effects. The goal is to understand how often and how severe these eye-related side effects are, and whether the use of the eye drops can help manage them. This information will help improve the safety and effectiveness of the treatment for patients with recurrent ovarian cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will begin treatment for recurrent ovarian cancer with high folate receptor-alpha expression.
The study aims to evaluate and manage eye-related side effects during treatment with mirvetuximab soravtansine.
Step 2
Initial treatment phase
The patient will receive mirvetuximab soravtansine through an intravenous infusion. This is a method where the medication is delivered directly into the bloodstream.
The treatment will be administered in cycles, with specific intervals between each dose.
Step 3
Eye drop administration
To prevent or reduce eye-related side effects, the patient will use two types of eye drops.
The first type is brimonidine tartrate 0.2% w/v eye drops, which is a solution applied to the eyes.
The second type is prednisolone acetate 1% w/v eye drops suspension, which is a suspension applied to the eyes.
Both eye drops are used for conjunctival application, meaning they are applied to the surface of the eye.
Step 4
Monitoring and assessment
Throughout the study, the patient will undergo regular eye examinations to monitor for any side effects related to the treatment.
The focus is on identifying any changes in the cornea, which is the clear front part of the eye.
Step 5
Completion of treatment cycle
The treatment cycle will continue for up to 18 weeks, or until the 30-day follow-up visit, whichever comes first.
During this period, the patient will be assessed for the severity and frequency of any eye-related side effects.
Step 6
Follow-up and evaluation
After completing the treatment cycle, a follow-up visit will be conducted to evaluate the patient's overall response to the treatment.
The study will also assess the impact of the treatment on the patient's quality of life, particularly focusing on any changes in vision.

Who can join the trial?

26 criteria

Patients must be **18 years or older**.
Patients must have completed any major surgery at least **4 weeks** before the first dose of MIRV and have recovered or stabilized from the side effects of prior surgery.
Patients must have adequate **blood, liver, and kidney functions**. This includes:
- Enough white blood cells and platelets without recent transfusions or growth factors.
- Hemoglobin levels of at least **8.0 g/dL** without recent blood transfusions.
- Kidney function with a creatinine clearance of at least **30 mL/min**.
- Liver enzymes (AST and ALT) should be no more than **3 times** the normal limit.
- Serum bilirubin should be no more than **1.5 times** the normal limit, except for patients with Gilbert syndrome, where it should be less than **3 times** the normal limit.
- Serum albumin should be at least **2 g/dL**.
- Patients must be willing and able to sign the **informed consent form** and follow the study requirements.
- Women of childbearing potential must agree to use **highly effective birth control** methods while on MIRV and for at least **7 months** after the last dose.
- Women of childbearing potential must have a **negative pregnancy test** within **4 days** before the first dose of MIRV.
- For patients who are **HIV positive**:
  - Must be on stable antiretroviral therapy for at least **12 weeks** with a low viral load.
  - Must have a CD4+ T cell count of at least **400 cells/μL**.
  - No serious infections related to AIDS in the past **12 months**.
  - Patients must have an **ECOG Performance Status** of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
  - Patients must have a confirmed diagnosis of **epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer** with high folate receptor-alpha expression.
  - The patient's tumor must be **FRα positive** as defined by specific tests showing high levels of folate receptor-alpha.
  - Patients must have **recurrent ovarian cancer** that is either resistant or sensitive to platinum-based treatments, with specific criteria for each type.
  - Patients with known **BRCA mutations** must have received specific inhibitors called PARPi.
  - Regarding prior cancer treatments:
    
    Neoadjuvant and adjuvant therapies count as one line of therapy.
    Maintenance therapies are part of the preceding line of therapy.
    Therapies changed due to side effects without disease progression are part of the same line.
    Hormonal therapy counts as a separate line unless given as maintenance.
    Patients must have completed prior therapy within specific times:
    
    Systemic therapy at least **5 half-lives or 4 weeks** before the first dose of MIRV.
    Focal radiation at least **2 weeks** before the first dose of MIRV.
    Patients must have recovered or stabilized from all prior therapy-related side effects, except for hair loss.

Who cannot join the trial?

4 criteria

Patients who do not have recurrent ovarian cancer with high folate receptor-alpha expression cannot participate.
Only female patients are eligible; male patients cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are considered part of a vulnerable population may not be eligible. This typically includes groups like children, pregnant women, or those unable to give consent.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario De Jaen
Jaen, Spain
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Mirvetuximab Soravtansine is a medication being studied for its effects on patients with recurrent ovarian cancer. It targets cancer cells that have high levels of a protein called folate receptor-alpha. The study is focused on understanding how this medication might affect the eyes, specifically looking at any potential eye-related side effects.

What is already known about the treatment

Mirvetuximab Soravtansine – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating recurrent ovarian cancer with high folate receptor-alpha expression. It is an investigational drug, meaning it is not yet approved for general medical use but is being evaluated for safety and efficacy. The main therapeutic indication is for ovarian cancer that expresses high levels of folate receptor-alpha. At the molecular level, Mirvetuximab Soravtansine works by targeting and binding to the folate receptor-alpha on cancer cells, delivering a toxic agent directly to the cancer cells to kill them. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic drug.

Investigated diseases

Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expression – This type of ovarian cancer is characterized by the recurrence of cancerous cells in the ovaries, which have a high expression of folate receptor-alpha. The disease often progresses as cancer cells grow and spread beyond the ovaries, potentially affecting other parts of the body. High folate receptor-alpha expression can influence the behavior of the cancer cells, making them more aggressive. This expression is a specific marker that can be targeted for certain therapies. The progression of the disease can vary, with periods of remission and recurrence. Understanding the expression of folate receptor-alpha is crucial in managing and studying this type of cancer.