Study of Farletuzumab Ecteribulin vs. Chemotherapy for Women with Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as platinum-resistant high-grade serous ovarian cancer, which can also affect the primary peritoneal or fallopian tube areas. The study is testing a new treatment called farletuzumab ecteribulin, also known by its code name MORAb-202. This treatment is a special kind of medicine called an antibody-drug conjugate, which is designed to target cancer cells more precisely. The trial will compare this new treatment to other chemotherapy options chosen by the doctors involved in the study.

The purpose of the study is to see how well MORAb-202 works compared to the other chemotherapy treatments. Participants in the study will receive either the new treatment or one of the standard chemotherapy options, which may include drugs like Caelyx (containing doxorubicin hydrochloride), paclitaxel, or topotecan. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The study will follow participants over a period of time to monitor their response to the treatment and any side effects they may experience. The main goal is to determine the effectiveness of MORAb-202 in treating this type of cancer and to assess the safety of the treatment. Participants will be closely monitored by healthcare professionals throughout the study to ensure their well-being and to gather important information about the treatment’s impact on their cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis, and previous treatments.

A formalin-fixed, paraffin-embedded tissue sample or a new biopsy is required for assessment before randomization.

2 randomization

Participants are randomly assigned to receive either the investigational drug farletuzumab ecteribulin or a chemotherapy treatment chosen by the investigator.

3 treatment administration

The investigational drug farletuzumab ecteribulin is administered through an intravenous infusion.

If assigned to chemotherapy, options include doxorubicin hydrochloride, paclitaxel, or topotecan, all given intravenously.

4 monitoring and evaluation

Participants are monitored for treatment response and any adverse effects.

The primary focus is on the objective response rate and any treatment-related adverse events that may lead to discontinuation.

5 follow-up

Regular follow-up visits are scheduled to assess the duration of response and progression-free survival.

Participants are evaluated using criteria to measure tumor response and progression.

Who Can Join the Study?

Participants must be at least 18 years old or the age of majority in their area when they sign the consent form.
Participants must be women with a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. This means the cancer has been identified through a tissue sample.
The cancer must be platinum-resistant, which means it has not responded well to platinum-based treatments. Specifically, if they had one round of platinum treatment, the cancer came back between 1 and 6 months after the last dose. If they had two or three rounds, it came back within 6 months after the last dose.
Participants should have had at least one but no more than three previous treatments with drugs that go through the whole body. They should be suitable for a single-drug treatment next. They must have had a treatment with bevacizumab (a type of cancer drug) or be unable to take it for medical reasons, or they refused or couldn’t access it. If they had chemotherapy before surgery or after surgery, it counts as one treatment. Maintenance therapy, like bevacizumab or PARP inhibitors (drugs that help repair DNA), is part of the previous treatment. Changing therapy without the cancer getting worse is still part of the same treatment.
The cancer must have gotten worse according to a specific method called RECIST v1.1, which is a way to measure cancer growth, and there must be at least one tumor that can be measured after the last treatment.
A sample of the cancer tissue must be available for a test called FRα assessment before the study starts. This can be from an older sample or a new biopsy.
Participants must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means they are fully active or have some symptoms but can still do light work.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied cannot participate.
Patients who are not female cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who have had certain treatments or medications that might interfere with the study cannot participate.
Patients who have other serious health conditions that could affect their safety or the study results cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
MD Anderson Cancer Center	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA	Valencia	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Clftrtoyc Usoknfuuzziljg Sidfmvhtz	Woluwe-Saint-Lambert	Belgium
Amtadqj Urkid Smkezdjyi Lqovme Dz Biklbdw	Bologna	Italy
Iyyjtqan Ccsylt Dwlutxhurljlvlyzi	L'hospitalet De Llobregat	Spain
Flextkilf Pars Ln Iiwbnhchwcjqd Brijuiilr Dwi Hnsljmpd Usneobxmrjild Lm Pvw	Madrid	Spain
Hqnqtath Vxzp dqhalxjf	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.03.2023
Italy	Not recruiting	30.03.2023
Spain	Not recruiting	30.03.2023

Trial locations

Investigated drugs:

Farletuzumab Ecteribulin (MORAb-202) is an experimental medication being tested in this clinical trial. It is a type of treatment known as an antibody-drug conjugate. This means it combines an antibody, which can specifically target cancer cells, with a drug that can kill these cells. In this trial, it is designed to target a protein called folate receptor alpha, which is often found on the surface of certain cancer cells, including those in ovarian, primary peritoneal, or fallopian tube cancer. The goal is to deliver the drug directly to the cancer cells, minimizing damage to healthy cells.

Investigator’s Choice Chemotherapy refers to a selection of standard chemotherapy treatments that the doctor in charge of the trial can choose from for each participant. These treatments are commonly used to treat ovarian, primary peritoneal, or fallopian tube cancer and work by killing rapidly dividing cells, including cancer cells. The specific chemotherapy drugs used can vary, but they are chosen based on the participant’s individual needs and the doctor’s judgment.

Investigated diseases:

Platinum-resistant High-grade Serous Ovarian Cancer – This type of cancer originates in the ovaries and is characterized by its resistance to platinum-based chemotherapy, which is a common treatment. It is a high-grade serous carcinoma, meaning it is an aggressive form of cancer that tends to grow and spread quickly. The disease often presents with symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. As it progresses, it may spread to other parts of the abdomen and pelvis. The resistance to platinum-based treatments makes managing the disease more challenging, requiring alternative therapeutic approaches.

Primary Peritoneal Cancer – This cancer develops in the peritoneum, a thin layer of tissue lining the abdomen. It is similar to ovarian cancer in terms of symptoms, progression, and treatment, often presenting with abdominal discomfort, bloating, and digestive issues. The disease can spread within the abdominal cavity, affecting other organs. It is often diagnosed at an advanced stage due to its subtle early symptoms. The progression of primary peritoneal cancer is similar to that of ovarian cancer, with a tendency to spread rapidly.

Fallopian Tube Cancer – This rare cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It shares many characteristics with ovarian cancer, including symptoms like pelvic pain, abnormal vaginal discharge, and bloating. The disease can spread to nearby organs and tissues, often being detected at a later stage. Its progression is similar to other gynecological cancers, with a potential for rapid growth and spread. Early detection is challenging due to the non-specific nature of its symptoms.

Trial ID:

2023-504111-33-00

Protocol code:

CA116-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Farletuzumab Ecteribulin vs. Chemotherapy for Women with Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?