Study of Ezabenlimab and Drug Combination for Stage III Anal Cancer Treatment

2 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of squamous cell anal cancer, a type of cancer that affects the anal canal. The study involves a combination of medications and treatments. The main treatment being tested is Ezabenlimab (also known as BI 754091), which is a type of medication called a monoclonal antibody. This is used alongside a combination of chemotherapy drugs known as mDCF, which includes docetaxel, cisplatin, and 5-fluorouracil. These drugs are used to help stop the growth of cancer cells. The purpose of the study is to evaluate how well this combination of treatments works in achieving a complete response, meaning no signs of cancer, by week 40 from the start of the treatment.

The study will begin with the administration of the mDCF chemotherapy regimen, followed by treatment with Ezabenlimab. After this, patients will receive chemoradiotherapy, which is a combination of chemotherapy and radiation therapy. This approach aims to enhance the effectiveness of the treatment by using different methods to target the cancer cells. The study will monitor patients over a period to assess the response to the treatment and any side effects that may occur.

Throughout the study, various assessments will be conducted to evaluate the effectiveness of the treatment. These include imaging tests like MRI and PET scans to check for any remaining cancer. The study will also look at the overall survival of patients, which is the time from the start of treatment until death from any cause, and progression-free survival, which is the time during which the cancer does not get worse. Additionally, the study will assess the quality of life of patients during and after the treatment. Safety will be closely monitored by checking for any adverse effects or changes in health status.

1 initiation of treatment

The treatment begins with the administration of ezabenlimab and a combination of docetaxel, cisplatin, and fluorouracil. This combination is referred to as mDCF.

Ezabenlimab is given as a solution for infusion. Docetaxel and cisplatin are administered intravenously, while fluorouracil is also given intravenously.

2 chemoradiotherapy

Following the initial treatment phase, chemoradiotherapy is administered. This involves the use of chemotherapy in conjunction with radiation therapy to target cancer cells more effectively.

The specific schedule and dosage of chemoradiotherapy will be determined by the healthcare provider based on individual patient needs.

3 evaluation of response

The primary objective is to evaluate the clinical complete response (cCR) rate at week 40 from the first DCF cycle. This means checking for any remaining signs of cancer through clinical and radiological assessments.

The best time to evaluate the local response is at 26 weeks from the start of standard chemoradiotherapy.

4 monitoring and follow-up

Throughout the trial, regular monitoring will occur to assess the patient’s health and response to treatment. This includes evaluating adverse events, conducting laboratory tests, and performing physical examinations.

Health-related quality of life will be assessed at various points, including baseline, evaluation visits, the end of treatment, and follow-up visits.

5 completion of trial

The trial is expected to conclude by January 4, 2027. At the end of the trial, a final assessment will be conducted to determine the overall effectiveness of the treatment and any long-term effects.

Who Can Join the Study?

You must sign and date an informed consent form, which is a document that explains the study and confirms your agreement to participate.
You need to be at least 18 years old.
You should be able to follow the study plan according to the doctor’s judgment.
Your physical condition should be good, with a performance status of ECOG-WHO 1 or less. This means you should be able to carry out daily activities with little or no help.
You must have a confirmed diagnosis of squamous cell anal carcinoma, a type of cancer.
Your disease should be locally advanced, which means it has spread to nearby areas but not to distant parts of the body. This includes specific stages and conditions of lymph nodes, which are small glands that help fight infection.
You should be eligible for the mDCF regimen, which is a specific treatment plan.
A CT scan (a detailed imaging test) must be done within 30 days before joining the study.
An MRI (a type of scan that uses magnets and radio waves to create images of the inside of the body) of the pelvis must be done within 30 days before joining the study.
A PET scan (a test that helps show how your tissues and organs are functioning) must be done within 30 days before joining the study.
Your blood and organ functions should be adequate, as shown by specific lab test results taken within 7 days before starting the study treatment.
Your serum albumin level, a protein in your blood, should be at least 25 g/L (2.5 g/dL).
If you are not on blood-thinning medication, your blood clotting tests (INR or PTT) should be 1.5 times the upper limit of normal or less.
You must be part of or have benefits from the French social security health insurance system.

Who Cannot Join the Study?

Patients who have a different type of cancer than squamous cell anal carcinoma cannot participate. This is a specific type of cancer that affects the anal area.
Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut Sainte Catherine	Avignon	France
Hopital Prive Jean Mermoz	Lyon	France
Centre Hospitalier Regional Universitaire	Besançon	France
Hopital Nord Franche-Comte	Belfort	France
Cjfaic Lpce Bajcjd	Lyon	France
Chfwvc Hznjevzjejj Uslnaslnbqtvf Ruwye	Reims	France
Amvnjkbrwx Poidzoae Haamawfn Dt Pkluz	Paris	France
Aicvnkxfij Pmzwhjka Hqdasazi Dp Mfxfrlwer	Marseille	France
Cueuyj Onxby Lxbseyu	Lille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	04.01.2022

Trial locations

Investigated drugs:

Ezabenlimab (BI 754091) is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with other treatments to see if it can improve outcomes for patients with stage III squamous cell anal carcinoma.

Docetaxel is a type of chemotherapy that works by stopping cancer cells from growing and dividing. It is used in combination with other medications to treat various types of cancer, including anal carcinoma.

Cisplatin is another chemotherapy drug that helps kill cancer cells by damaging their DNA. It is often used in combination with other chemotherapy drugs to enhance its effectiveness against cancer.

5-Fluorouracil is a chemotherapy medication that interferes with the growth of cancer cells. It is commonly used in combination with other drugs to treat different types of cancer, including anal carcinoma.

Chemoradiotherapy is a treatment that combines chemotherapy and radiation therapy. This approach aims to increase the effectiveness of treatment by using chemotherapy to make cancer cells more sensitive to radiation, thereby improving the chances of destroying the cancer.

Investigated diseases:

Anal squamous cell carcinoma

Squamous Cell Anal Carcinoma – This is a type of cancer that begins in the squamous cells lining the anal canal. It typically develops slowly, starting as a precancerous condition known as anal intraepithelial neoplasia. Over time, these abnormal cells can become cancerous and invade deeper layers of tissue. The disease may initially present with symptoms such as bleeding, pain, or a mass in the anal area. As it progresses, it can spread to nearby lymph nodes and other parts of the body. Early detection and monitoring are crucial for managing its progression.

Trial ID:

2024-514083-31-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Ezabenlimab and Drug Combination for Stage III Anal Cancer Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?