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Study on Durvalumab with Radiochemotherapy for Patients with Locally-Advanced Anal Cancer

Fast replyRegistered 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 called locally-advanced anal carcinoma, which includes stages II and III of anal cancer. The study is exploring the effects of adding a medication called durvalumab to the standard treatment for this cancer. Durvalumab, also known by its code name MEDI4736, is a type of drug known as an immune checkpoint inhibitor. It is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if adding durvalumab to the usual treatment can improve the time patients live without the cancer coming back, known as disease-free survival. The usual treatment involves a combination of chemotherapy and radiation therapy, referred to as radiochemotherapy. In this study, some patients will receive the standard treatment with durvalumab, while others will receive the standard treatment without it. A placebo may be used in the group not receiving durvalumab to help compare the results.

Participants in the study will undergo regular check-ups and tests, including imaging scans like MRI and procedures like proctoscopy, to monitor their response to the treatment. The study will also look at other factors such as the safety of the treatment, how well patients stick to the treatment plan, and the overall survival rate. Additionally, the study will assess the quality of life of participants and explore the use of different MRI techniques to predict and monitor treatment response. The trial is expected to continue until the end of 2026.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, the patient is randomly assigned to one of two groups: the control group or the experimental group. This process is called randomization and ensures that each participant has an equal chance of receiving the standard treatment or the new treatment being tested.

  2. Step 2

    Treatment initiation

    The patient begins treatment for locally-advanced anal carcinoma. The standard treatment involves radiochemotherapy, which combines radiation therapy with chemotherapy drugs, specifically mitomycin C (MMC) and 5-fluorouracil (5-FU).

    If assigned to the experimental group, the patient also receives an additional medication called durvalumab. Durvalumab is administered as an intravenous infusion, which means it is given directly into the bloodstream through a vein. The dosage is 50 mg/mL, and it is provided as a solution for infusion.

  3. Step 3

    Treatment duration

    The treatment with radiochemotherapy, with or without durvalumab, continues for a specified period. The exact duration of the treatment phase is determined by the study protocol and the patient's response to the therapy.

  4. Step 4

    Restaging and assessment

    Approximately 26 weeks after starting the treatment, the patient undergoes a restaging process. This involves imaging tests such as MRI and proctoscopy, which may include biopsies of any suspicious areas. The purpose is to assess the response to the treatment and determine if there is a complete clinical response.

  5. Step 5

    Follow-up

    After the initial treatment phase, the patient enters a follow-up period. During this time, regular check-ups and assessments are conducted to monitor the patient's health and detect any signs of cancer recurrence or progression.

    The follow-up period is crucial for evaluating the long-term effectiveness of the treatment and ensuring the patient's well-being.

  6. Step 6

    Study completion

    The study is expected to conclude by December 31, 2026. At this point, all data collected from the participants will be analyzed to determine the overall outcomes and effectiveness of the treatment strategies tested in the trial.

Who can join the trial?

20 criteria

  • The patient must have a confirmed diagnosis of **ASCC** (Anal Squamous Cell Carcinoma) in the anal canal or anal margin.
  • The patient must have a **leukocyte** count greater than 3.5 x 109/l. Leukocytes are white blood cells that help fight infections.
  • The patient must have an **absolute neutrophil count (ANC)** of at least 1.5 x 109/l. Neutrophils are a type of white blood cell important for fighting infections.
  • The patient must have a **platelet count** of at least 100 x 109/l. Platelets help with blood clotting.
  • The patient's **serum bilirubin** must be less than or equal to 1.5 times the normal upper limit. Bilirubin is a substance made by the liver.
  • The patient's **AST (SGOT)**, **ALT (SGPT)**, and **AP** levels must be less than or equal to 3 times the normal upper limit. These are liver enzymes.
  • The patient must have a **creatinine clearance** greater than 40 mL/min. This measures how well the kidneys are working.
  • Female patients who can have children must have a negative pregnancy test within 72 hours before the first dose of the study drug.
  • Female patients who can have children must agree to use effective birth control during the study and for 90 days after the last dose of the study drug.
  • Male patients who can have children must agree to use effective birth control during the study and for 90 days after the last dose of the study drug.
  • The patient must be willing and able to follow the study rules, including attending treatment sessions and follow-up visits.
  • The patient must have a cancer stage of **IIB-IIIC** according to specific medical tests done within 30 days before joining the study.
  • HIV-positive patients must be on **combined antiretroviral therapy (CART)** and have an undetectable HIV viral load.
  • The patient must be at least 18 years old, with no upper age limit.
  • The patient must have an **ECOG-Performance score** of 0-1, which measures daily living abilities.
  • The patient must have a medical history and physical examination within 30 days before joining the study.
  • The patient must provide written informed consent and any required local authorizations before any study procedures.
  • The patient must have a life expectancy of more than 12 months.
  • The patient must weigh more than 30 kg.
  • The patient must have a **hemoglobin** level of at least 9.0 g/dl. Hemoglobin is a protein in red blood cells that carries oxygen.

Who cannot join the trial?

16 criteria

  • Patients who have had another type of cancer in the past, except for certain skin cancers that have been treated.
  • Patients who have a serious infection that is not controlled or treated.
  • Patients who have a condition that affects their immune system, like HIV or AIDS.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an organ transplant.
  • Patients who are taking certain medications that affect the immune system.
  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients who have a serious heart condition.
  • Patients who have a serious lung condition.
  • Patients who have a serious liver condition.
  • Patients who have a serious kidney condition.
  • Patients who have a mental health condition that is not stable or controlled.
  • Patients who are participating in another clinical trial.
  • Patients who have had a recent surgery that has not fully healed.
  • Patients who have a history of drug or alcohol abuse that is not controlled.
  • Patients who are unable to follow the study procedures or instructions.
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Investigated drugs

  • Durvalumab

    is an immune checkpoint inhibitor that helps the body's immune system recognize and attack cancer cells. In this trial, it is being tested to see if it can improve disease-free survival when added to the standard treatment for locally-advanced anal carcinoma.

  • Radiochemotherapy (RCT)

    is a combination of radiation therapy and chemotherapy used to treat cancer. In this trial, it serves as the standard treatment for patients with locally-advanced anal carcinoma. The chemotherapy part of this treatment includes the use of two drugs, mitomycin C and 5-fluorouracil, which work together to kill cancer cells and enhance the effects of radiation therapy.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating locally-advanced anal carcinoma, specifically stages II and III. The main therapeutic indication for durvalumab in this context is to improve disease-free survival when added to standard chemoradiotherapy. At the molecular level, durvalumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses against cancer.

Investigated diseases

Anal Carcinoma – Anal carcinoma is a type of cancer that occurs in the tissues of the anus. It is often classified into stages, with stage II and III indicating more advanced disease where the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. The progression of anal carcinoma can involve local growth and potential spread to nearby lymph nodes. Symptoms may include bleeding, pain, or a lump near the anus. The disease is often associated with certain risk factors, including human papillomavirus (HPV) infection. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513914-36-00Protocol codeRADIANCEEstimated enrolment188 patientsSponsorGoethe University Frankfurt

sourced from the EU Clinical Trials Register and site verification

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