Not recruiting

Study on Enfortumab Vedotin for Patients with Advanced Neuroendocrine Carcinoma Not Responding to or Ineligible for Platinum Chemotherapy

Verified siteRegistered drugNo placebo

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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 type of cancer known as Neuroendocrine Carcinoma (NEC), which is a group of rare tumors that can occur in various parts of the body. The study is specifically looking at cases where the cancer has advanced and is not responding to standard treatments that include platinum-based chemotherapy. The treatment being tested in this study is a medication called enfortumab vedotin, which is also known by its code names ASG22CE and ASP7465. This medication is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective and safe enfortumab vedotin is when used alone in patients with advanced NEC. Participants in the study will receive the medication over a period of time, and their response to the treatment will be monitored through medical imaging and other assessments. The study will also track how long patients live without the cancer getting worse and how long any positive response to the treatment lasts. Additionally, the study will collect information on any side effects experienced by participants.

This trial is open-label, meaning both the researchers and participants know what treatment is being given. It is a single-arm study, which means all participants receive the same treatment without a comparison group. The study aims to provide valuable information on the potential benefits and risks of using enfortumab vedotin for treating advanced NEC, offering hope for patients who have limited treatment options. The study is expected to continue until 2027, with recruitment starting in late 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
Eligibility criteria include being 18 years or older, having a specific type of neuroendocrine carcinoma, and meeting certain health requirements such as adequate kidney and liver function.
Step 2
Treatment administration
The treatment involves the administration of enfortumab vedotin, a medication given through an infusion. This is a process where the medication is delivered directly into the bloodstream over a period of time.
The specific products used are Padcev 30 mg and Padcev 20 mg powders, which are prepared as a solution for infusion.
Step 3
Treatment schedule
The treatment is administered on a regular schedule. The exact frequency and duration of the treatment will be determined by the study protocol and the patient's response to the medication.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes imaging tests to evaluate the response of the cancer to the treatment.
Patients are monitored for progression-free survival, which is the time during and after treatment that the patient lives with the disease without it getting worse.
Step 5
End of treatment evaluation
At the end of the treatment period, a final evaluation is conducted to determine the overall response to the treatment. This includes assessing the duration of response and overall survival.
The study aims to measure the objective response rate, which is the proportion of patients with a significant reduction in tumor size.

Who can join the trial?

10 criteria

Patients must be **18 years of age or older**.
Women who are not surgically sterile or post-menopausal (for at least one year) and men who have not had a vasectomy must use **highly effective contraception** measures.
Patients must **give informed consent** to participate in the study, meaning they understand and agree to the study's requirements.
Patients must have a **neuroendocrine carcinoma** (a type of cancer) that is poorly differentiated, or a well-differentiated neuroendocrine tumor of grade 3 with a **Ki-67 index** greater than 20%. This means the cancer cells are growing quickly. The cancer can be from any origin except the lung and must have not responded to or be unsuitable for **platinum-based chemotherapy** (a type of cancer treatment).
Patients must have **metastatic** (cancer that has spread) or **locally advanced disease** (cancer that has grown but not spread far) at the start of the study. If they have **brain metastases** (cancer spread to the brain), their symptoms must be controlled, and they must have finished **radiotherapy** (radiation treatment) at least 21 days before starting the study drug.
Patients must have an **ECOG score** of 0-2, which measures their ability to perform daily activities.
Patients must have **evaluable or measurable disease** by a **CT scan** according to **RECIST v1.1**, which is a standard way to measure how well a cancer treatment works.
Patients must have **adequate kidney and liver function** based on local laboratory tests. This includes specific levels for blood cells, kidney function, and liver enzymes.
Patients must have a **life expectancy of at least 12 weeks**.
Women must be **surgically sterile**, post-menopausal (for at least 1 year), or have a **negative pregnancy test**.

Who cannot join the trial?

5 criteria

Patients with **lung** neuroendocrine carcinoma or neuroendocrine tumors are not eligible.
Patients who are eligible for **first-line platinum-based chemotherapy** cannot participate. This means if you can receive a specific type of initial cancer treatment using platinum-based drugs, you are not eligible.
Patients who have already responded well to **first-line platinum-based chemotherapy** are excluded. This means if your cancer has improved with this treatment, you cannot join the study.
Patients with a **Ki-67 index** of 20% or less are not eligible. The Ki-67 index is a measure of how quickly cancer cells are growing.
Patients who are part of a **vulnerable population** are not eligible. This refers to groups of people who might need special protection or care.

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Verified sites

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

Hestia Duran I Reynals
Verified
L'hospitalet De Llobregat, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Enfortumab Vedotin (EV) is being studied as a single-agent treatment for patients with advanced Neuroendocrine Carcinomas (NEC) who are either not responding to or cannot receive platinum-containing chemotherapy. This medication is designed to target and deliver a cancer-fighting agent directly to the cancer cells, potentially helping to reduce the size of tumors or slow their growth. The trial aims to evaluate how effective and safe this treatment is for patients with NEC, excluding those with lung cancer.

Enfortumab Vedotin

What is already known about the treatment

Enfortumab Vedotin – This medication is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced neuroendocrine carcinomas that do not respond to or cannot be treated with standard platinum-based chemotherapy. The main therapeutic use of Enfortumab Vedotin is for patients with these specific types of cancer. At the molecular level, it works by targeting and binding to a protein called Nectin-4 on cancer cells, delivering a toxic agent that helps to kill the cancer cells. It is classified as an antibody-drug conjugate, which combines an antibody with a drug to specifically target and destroy cancer cells.

Investigated diseases

Neuroendocrine Carcinoma – This is a type of cancer that arises from neuroendocrine cells, which have traits similar to nerve cells and hormone-producing cells. It can occur in various parts of the body, excluding the lungs in this context. The disease is characterized by the formation of malignant tumors that can grow and spread to other parts of the body. These tumors are often aggressive and may not respond well to initial treatments. The progression of the disease can vary, with some tumors growing rapidly while others may remain stable for a period. Neuroendocrine carcinoma is often identified by a high Ki-67 index, indicating a high rate of cell proliferation.