Study of mirvetuximab soravtansine dosing schedules for patients with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer with high folate receptor expression

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What is this study about?

This study focuses on patients with platinum-resistant advanced high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The research evaluates a medication called mirvetuximab soravtansine, which is given as a solution through intravenous infusion. The study aims to test different dosing schedules of this medication to determine which one works best while causing the least side effects.

The study involves two main groups of patients. The first group will receive the medication according to different dosing schedules, while patients with moderate liver problems will be studied separately to find the right starting dose for them. During treatment, patients will receive the medication every three weeks as part of a 21-day cycle. The study will also use prednisolone acetate eye drops and lubricating eye drops as supportive care.

The research team will monitor patients for treatment effectiveness and any side effects, particularly paying attention to eye-related effects. They will track how the cancer responds to treatment through regular medical examinations and imaging tests. The study will also measure how long the treatment keeps working and how long patients survive after starting the treatment.

1 Initial evaluation

You will undergo evaluation to confirm that your tumor is positive for FRα expression using a special test (Ventana FOLR1 assay)

Your doctor will check if you have measurable tumors using imaging scans

Laboratory tests will be performed to check your blood counts, liver, and kidney function

2 Treatment assignment

You will be randomly assigned to one of two treatment schedules with mirvetuximab soravtansine

The medication will be given through an intravenous infusion

The standard dose is 6 mg/kg given once every 3 weeks in a 21-day cycle

3 Treatment period

You will receive the medication through an intravenous infusion according to your assigned schedule

Regular monitoring of your condition will include blood tests and imaging scans

Your doctor will check for any side effects, particularly those affecting your eyes

Treatment will continue as long as it is beneficial and you do not experience serious side effects

4 Follow-up assessments

Regular scans will be performed to measure how your tumors are responding to treatment

Blood tests will include monitoring of CA-125 tumor marker levels

Your doctor will monitor your overall health and any side effects throughout the study

The study is expected to continue until March 2028

Who Can Join the Study?

  • Must be 18 years or older
  • Must be female with confirmed diagnosis of high-grade ovarian, peritoneal, or fallopian tube cancer
  • Must have disease that has progressed (gotten worse) after most recent treatment, confirmed by imaging
  • Must have received 1-3 previous cancer treatments
  • Must be willing to provide tumor tissue sample or undergo a biopsy procedure
  • Must have tumors that test positive for a specific protein called FRα at required levels
  • Must have at least one tumor that can be measured by imaging scans
  • Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
  • Must have adequate blood cell counts, liver function, and kidney function
  • Must have completed previous cancer treatments within specific timeframes:
    • At least 4 weeks since last cancer medication
    • At least 2 weeks since last radiation treatment
    • At least 4 weeks since major surgery
  • Must have recovered from side effects of previous treatments
  • If able to become pregnant, must:
    • Use effective birth control during study and for 7 months after
    • Have negative pregnancy test within 4 days before starting treatment
  • Must be willing and able to provide informed consent
  • Must have cancer that has become resistant to platinum-based chemotherapy within specific timeframes

Who Cannot Join the Study?

  • Male patients (study is only for female participants)
  • Patients under 18 years of age
  • Patients with severe liver problems (the study only accepts patients with moderate liver impairment)
  • Patients who have not previously received platinum-based chemotherapy (a type of cancer treatment)
  • Patients who do not have high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is resistant to platinum treatment
  • Patients who are part of vulnerable populations (such as persons with mental disabilities, prisoners, or other protected groups)
  • Patients who cannot receive the study medication every 3 weeks according to the prescribed schedule
  • Patients who cannot be accurately weighed to determine the correct medication dose

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hospital Universitario Hm Sanchinarro Madrid Spain
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
Hospital Universitario De Jaen Jaen Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Virgen del Rocío University Hospital Sevilla Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hopital Prive Des Cotes D’armor Plerin France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Francois Baclesse Caen France
Clhdbvyqw Uxukdtypfnpulo Skvwrbklo Woluwe-Saint-Lambert Belgium
Udyxwdumgpnqc Soazfab Kunimqvtk Nj 2 Prx W Sshxsiqnip Szczecin Poland
Ucnhvladybxlbd Ccealnq Kqiaxajgf Gdansk Poland
Icsmhvex Cjfckd Djatryxcczexcqavi L'hospitalet De Llobregat Spain
Hfhamcju Vepa dytazegw Barcelona Spain
Cnnayh Oawwd Luxkvkg Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.06.2025
France France
Recruiting
01.06.2025
Poland Poland
Recruiting
01.06.2025
Spain Spain
Recruiting
01.06.2025

Trial locations

Mirvetuximab soravtansine is a medication used to treat patients with certain types of ovarian, peritoneal, or fallopian tube cancers. It specifically targets cancer cells that have high levels of a protein called folate receptor-alpha on their surface. This medication works by delivering an anti-cancer drug directly to these cancer cells, which helps to destroy them while potentially reducing effects on healthy cells. The medication is given through an intravenous infusion (IV drip into a vein).

Epithelial Ovarian Cancer – A cancer that begins in the cells that cover the ovaries. It starts in the outer layer of the ovaries and can spread to nearby tissues. The disease typically develops gradually, with cancer cells multiplying and forming tumors in the ovaries.

Primary Peritoneal Cancer – A rare cancer that forms in the peritoneum, the thin layer of tissue that lines the inside of the abdomen. It develops in the cells of the peritoneum and shares many similarities with ovarian cancer. The cancer can spread throughout the abdominal cavity.

Fallopian Tube Cancer – A cancer that develops in the fallopian tubes, which connect the ovaries to the uterus. The cancer begins in the cells lining the fallopian tubes. It can grow within the tubes and spread to nearby organs.

Trial ID:
2024-517184-23-00
Protocol code:
IMGN853-0425
NCT ID:
NCT06682988
Trial Phase:
Therapeutic exploratory (Phase II)

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