Study on Treatment for Recurrent Platinum-Sensitive Ovarian, Peritoneal, or Fallopian Tube Cancer Using Carboplatin and Mirvetuximab Soravtansine in Eligible Patients

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What is this study about?

This clinical trial is focused on studying the treatment of certain types of cancer, specifically epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. These are cancers that affect the ovaries, the lining of the abdomen, and the fallopian tubes, respectively. The study involves a combination of two treatments: Carboplatin, a chemotherapy drug, and Mirvetuximab Soravtansine, a type of medication known as a monoclonal antibody-drug conjugate. This combination is being tested in patients whose cancer has returned after initial treatment with platinum-based chemotherapy and who have a specific protein called folate receptor-alpha on their cancer cells.

The purpose of the study is to evaluate how well the combination of Carboplatin and Mirvetuximab Soravtansine works in treating these cancers. Initially, patients will receive both Carboplatin and Mirvetuximab Soravtansine together. After this phase, patients will continue treatment with Mirvetuximab Soravtansine alone. The study aims to see if this treatment approach can help control the cancer in patients who have shown sensitivity to platinum-based chemotherapy in the past.

Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the response of the cancer to the treatment over time. This trial is open-label, meaning both the researchers and participants know which treatments are being administered. The study will help determine the effectiveness of this treatment combination in managing these specific types of cancer.

1 initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a physical examination.

You will need to provide a sample of your tumor tissue for testing. This is to confirm that your cancer expresses a protein called folate receptor-alpha at a certain level.

2 treatment phase 1

In the first phase of treatment, you will receive two medications: carboplatin and mirvetuximab soravtansine. Both are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.

The exact dosage and frequency will be determined by the study team based on your specific condition and response to treatment.

3 treatment phase 2

After completing the initial combination treatment, you will continue to receive mirvetuximab soravtansine alone. This phase is designed to evaluate the ongoing effectiveness of the treatment.

The duration of this phase will depend on your response to the medication and any side effects you may experience.

4 regular monitoring

Throughout the trial, you will have regular appointments to monitor your health and the effects of the treatment. This includes blood tests, imaging scans, and other assessments as needed.

These appointments are important to ensure your safety and to gather data on the effectiveness of the treatment.

5 end of trial

At the end of the trial, you will have a final assessment to evaluate your overall response to the treatment.

The study team will discuss the results with you and provide guidance on any further treatment options if necessary.

Who Can Join the Study?

Patients must be 18 years of age or older.
Patients must have completed any major surgery at least 4 weeks before the first dose of the study drugs and have recovered or stabilized from the side effects of prior surgery.
Patients must have adequate blood, liver, and kidney functions, which means:
- Absolute neutrophil count (a type of white blood cell) must be at least 1500 per microliter without recent use of certain growth factors.
- Platelet count (cells that help with blood clotting) must be at least 100,000 per microliter without recent transfusion.
- Hemoglobin (a protein in red blood cells) must be at least 9.0 grams per deciliter without recent blood transfusion.
- Serum creatinine (a measure of kidney function) must be within normal limits.
- Aspartate aminotransferase and alanine aminotransferase (liver enzymes) must be within normal limits.
- Serum bilirubin (a substance made by the liver) must be within normal limits, with some exceptions for certain conditions.
- Serum albumin (a protein in the blood) must be at least 2 grams per deciliter.
Patients must be willing and able to sign the informed consent form and follow the study requirements.
Females of childbearing potential must agree to use highly effective birth control methods while on study medication and for a specified time after the last dose.
Females of childbearing potential must have a negative pregnancy test within 4 days before starting the study drugs.
Patients must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Patients must have relapsed after 1 prior line of platinum-based chemotherapy.
Patients must have platinum-sensitive disease, meaning the cancer progressed more than 6 months after the last dose of platinum-based chemotherapy.
Prior BRCA testing on the tumor or genetic testing is required. If not done before, it will need to be done at study entry. Patients with BRCA-positive results must have received prior treatment with a PARP inhibitor.
Patients must have at least one lesion that can be measured by imaging tests.
Patients must provide a tumor sample for testing or undergo a procedure to obtain a new biopsy to confirm FRα positivity (a specific protein expression in the tumor).
Patients must have recovered from all prior therapy-related side effects (except hair loss) and have stopped any maintenance therapy at least 4 weeks before starting the study drugs.

Who Cannot Join the Study?

Patients with any other type of cancer besides epithelial ovarian, primary peritoneal, or fallopian tube cancer cannot participate.
Patients who have not shown a response to platinum-based chemotherapy in the past are excluded. This means if the cancer did not shrink or go away after treatment with drugs containing platinum, they cannot join.
Patients whose cancer does not have at least 50% of tumor cells with folate receptor-alpha (FRα) expression at a 2+ intensity level cannot participate. This is a specific characteristic of the cancer cells that is required for the study.
Only female patients are eligible for this study. Male patients cannot participate.
Patients who are considered part of a vulnerable population are not allowed to join. 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
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Centre hospitalier universitaire de Liege	Liege	Belgium
Hopital De Libramont	Libramont-Chevigny	Belgium
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Bon Secours Hospital Cork	Cork	Ireland
Beaumont Hospital	Dublin	Ireland
Clbjuxhvg Uwkpflcjnhofiw Sbcmfmcbl	Woluwe-Saint-Lambert	Belgium
Iajtartw Csigmb Deqadnutquovcfezd	L'hospitalet De Llobregat	Spain
Hpnhjmpe Ujmxkgieuffni Dq Bcupqhg	Badajoz	Spain
Hbfdvoim Vrta dfcedqnl	Barcelona	Spain
Hltbhyjp Uuizcmwjuhkzw dz A Czzpmb	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.12.2022
Ireland	Not recruiting	30.12.2022
Spain	Not recruiting	30.12.2022

Trial locations

Investigated drugs:

Carboplatin is a type of chemotherapy medication used to treat various forms of cancer, including ovarian cancer. It works by interfering with the DNA in cancer cells, which prevents them from growing and dividing. In this clinical trial, carboplatin is used in combination with another medication to help shrink tumors and slow the progression of the disease.

Mirvetuximab soravtansine is a targeted therapy designed to treat certain types of cancer cells that have a specific protein called folate receptor-alpha on their surface. This medication combines an antibody that specifically targets these cancer cells with a powerful anti-cancer drug. The antibody helps deliver the drug directly to the cancer cells, which can help reduce side effects on healthy cells and improve the effectiveness of the treatment. In this trial, mirvetuximab soravtansine is used both in combination with carboplatin and on its own to continue treatment after the initial combination therapy.

Investigated diseases:

Epithelial Ovarian Cancer – Epithelial ovarian cancer is a type of cancer that begins in the layer of cells covering the ovaries. It is the most common form of ovarian cancer. The disease often progresses silently, with symptoms appearing only in advanced stages. As it advances, the cancer can spread to nearby tissues and organs within the pelvis and abdomen. The progression may involve the formation of tumors on the surface of the ovaries and the peritoneum. Over time, it can lead to the accumulation of fluid in the abdomen, known as ascites.

Primary Peritoneal Cancer – Primary peritoneal cancer is a rare cancer that starts in the peritoneum, the thin layer of tissue lining the abdomen. It behaves similarly to epithelial ovarian cancer and is often treated as such. The disease progresses by spreading across the peritoneal surface, affecting abdominal organs. Symptoms may be vague and include abdominal discomfort and bloating. As the cancer advances, it can lead to the buildup of fluid in the abdomen. The disease can also spread to other parts of the body.

Fallopian Tube Cancer – Fallopian tube cancer is a rare type of cancer that originates in the fallopian tubes, which connect the ovaries to the uterus. It is similar in behavior and progression to epithelial ovarian cancer. The disease often progresses with few symptoms until it reaches an advanced stage. It can spread to nearby organs and tissues within the pelvis and abdomen. As it advances, it may cause symptoms such as pelvic pain and abnormal vaginal bleeding. The cancer can also lead to the accumulation of fluid in the abdomen.

Trial ID:

2022-501220-14-00

Protocol code:

IMGN853-0420

NCT ID:

NCT05456685

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Treatment for Recurrent Platinum-Sensitive Ovarian, Peritoneal, or Fallopian Tube Cancer Using Carboplatin and Mirvetuximab Soravtansine in Eligible Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?