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

2 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Bon Secours Hospital Cork	Cork	Ireland
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Hospital Universitario De Jaen	Jaen	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Hopital Prive Des Cotes D’armor	Plerin	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Clinique Victor Hugo	Le Mans	France
Beaumont Hospital	Dublin	Ireland
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ifeltriz Cqeenu Dleqsusllbnegsknd	L'hospitalet De Llobregat	Spain
Oqygqyppmzflpbcqjgxkipxwse	Aalst	Belgium
Iuoglpmnx Odrkyabwjd Dnr Rgqaku Snnv	Barcelona	Spain
Pvgg Ttzek Hkyukajv Ulmptlztzhtd	Sabadell	Spain
Corqqa Huutgzhiids Rqxtesia Ukjrjazmdwqan Dd Tbanc	Tours	France
Ugfttlnjup Oa Aucjjwz	Edegem	Belgium
Ffyednqti Pssw Lk Isvpxdkmmcxnj Blfoerise Dou Hkdqpgkq Uteelyfsuoflo Ln Pml	Madrid	Spain
Hgrzjmsw Votk ddmczged	Barcelona	Spain
Illqimcf Pqjowinbtkqpmfk Cpooxj Cumksv	Marseille	France
Cuxlyf Oxoff Lglwipg	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2024
France	Not recruiting	01.04.2024
Ireland	Not recruiting	01.04.2024
Spain	Not recruiting	01.04.2024

Trial locations

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.

Investigated diseases:

Ovarian cancer

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.

Trial ID:

2023-505617-24-00

Protocol code:

IMGN853-0424

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?