Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

3 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Ezabenlimab

    Ezabenlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating squamous cell anal carcinoma. It is an investigational medication, meaning it is not yet approved for general medical use. The main therapeutic indication is for patients with stage III squamous cell anal carcinoma. Ezabenlimab works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

  • Docetaxel

    Docetaxel is given through an intravenous infusion and is used in combination with other drugs in clinical trials for squamous cell anal carcinoma. It is an established chemotherapy medication used to treat various cancers. The main therapeutic indication is to inhibit cancer cell growth by interfering with cell division. Docetaxel belongs to the pharmacological class of taxanes, which work by stabilizing microtubules and preventing cell division.

  • Cisplatin

    Cisplatin is administered intravenously and is part of the chemotherapy regimen being tested in clinical trials for squamous cell anal carcinoma. It is a well-known chemotherapy drug used to treat different types of cancer. The main therapeutic indication is to damage the DNA of cancer cells, leading to cell death. Cisplatin is classified as a platinum-based chemotherapy agent, which forms cross-links in DNA, disrupting the replication process.

  • 5-Fluorouracil

    5-Fluorouracil is given intravenously and is included in the chemotherapy combination for squamous cell anal carcinoma in clinical trials. It is a widely used chemotherapy medication for various cancers. The main therapeutic indication is to inhibit the synthesis of DNA in cancer cells, preventing their growth and division. 5-Fluorouracil is classified as an antimetabolite, which interferes with the normal metabolism of cells, particularly affecting rapidly dividing cancer cells.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514083-31-00Estimated enrolment55 patientsSponsorCentre Hospitalier Regional Universitaire

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).