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Study on Ceralasertib and Durvalumab for Patients with Advanced Melanoma Resistant to PD-(L)1 Therapy

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 treatments for unresectable or advanced melanoma, a type of skin cancer that cannot be removed by surgery or has spread to other parts of the body. The study is testing two treatments: ceralasertib alone and ceralasertib combined with durvalumab (also known as MEDI4736). The purpose of the study is to evaluate how effective these treatments are in patients whose melanoma has not responded to previous treatments that target a protein called PD-(L)1.

Participants in the study will receive either ceralasertib by itself or ceralasertib together with durvalumab. Ceralasertib is taken as a tablet, while durvalumab is given through an infusion, which means it is delivered directly into the bloodstream. The study will last for up to 22 months, during which time the response of the cancer to the treatments will be monitored. Some participants may also be part of a sub-study that involves taking small samples of their tumor tissue to see how the treatments affect certain immune cells.

The trial aims to understand the changes in the tumor and the immune system caused by the treatments. This includes looking at how many patients show a reduction in tumor size and how long any positive effects last. The study will also measure the presence of certain immune cells, like CD8+ T cells, in the tumor before and after treatment. This research could provide valuable insights into new ways to treat melanoma that has not responded to other therapies.

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

    Joining the study

    Upon joining the study, a diagnosis of unresectable or advanced melanoma must be confirmed. This includes melanoma of cutaneous, acral, or mucosal subtype.

    A fresh tumor biopsy and an archival tumor sample are required at the start of the study.

  2. Step 2

    Initial treatment phase

    The treatment involves the use of ceralasertib and durvalumab. Ceralasertib is administered orally in the form of film-coated tablets.

    Durvalumab is given as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Biopsy sub-study

    Participation in a biopsy sub-study is required. This involves three mandatory tumor biopsies: at baseline, during ceralasertib treatment, and after ceralasertib treatment.

    The same tumor lesion is preferred for all biopsies, but if not possible, different lesions from the same tissue type may be used.

  4. Step 4

    Ongoing assessments

    Regular assessments will be conducted to measure the response to treatment. This includes evaluating tumor size and progression.

    The primary measure is the objective response rate (ORR) for each treatment arm. Secondary measures include duration of response (DoR) and progression-free survival (PFS).

  5. Step 5

    End of treatment

    The study is estimated to conclude by April 30, 2026. Final assessments will be conducted to evaluate the overall survival (OS) and other outcomes.

    The concentration of ceralasertib in plasma will be measured, and changes in tumor characteristics will be assessed.

Who can join the trial?

12 criteria

  • The patient must have a confirmed diagnosis of **unresectable** or **metastatic melanoma**. This means the melanoma cannot be removed by surgery or has spread to other parts of the body.
  • For the **Biopsy Sub-Study**, lesions used for biopsy can have had prior radiation therapy only if there is proof that the lesion got worse after the radiation treatment.
  • The patient must provide a sample of their tumor from the past and a new tumor biopsy taken during the screening process.
  • The patient must have received at least one prior **immunotherapy** treatment, which is a type of cancer treatment that helps the immune system fight cancer. This should include treatment with a **PD-(L)1 inhibitor** with or without a **CTLA-4 inhibitor** for at least 6 weeks, but not more than two different treatments in the metastatic setting. The patient must have shown progression during treatment with a PD-(L)1 inhibitor, with or without a CTLA-4 inhibitor.
  • No other treatments, such as experimental therapies, are allowed between the PD-(L)1 therapy and the study treatment.
  • The **BRAF V600E** or **V600K mutation status** must be known at the time of screening. These are specific changes in the BRAF gene that can affect cancer growth.
  • The patient must have measurable disease according to **RECIST 1.1**, which is a set of guidelines used to measure how well a cancer treatment is working.
  • For the **Biopsy Sub-Study**, the patient must agree to provide three mandatory tumor biopsies.
  • For the **Biopsy Sub-Study**, the patient must have at least one tumor lesion that can be accessed for three biopsies: at the start, during, and after treatment with **ceralasertib**. Accessible lesions are those that can be biopsied unless it is not safe or the patient decides not to continue. It is preferred to use the same lesion for each biopsy, but if not possible, the patient can still participate if they have more than one lesion suitable for biopsy from the same tissue type, like three skin lesions.
  • For the **Biopsy Sub-Study**, lesions used for biopsy should be different from those used to measure the disease unless there are no other suitable lesions for biopsy.
  • Both male and female patients can participate.
  • The study includes patients from vulnerable populations.

Who cannot join the trial?

7 criteria

  • Patients who have a type of skin cancer called melanoma that cannot be removed by surgery or is in an advanced stage.
  • Patients who have not shown resistance to a type of treatment called PD-(L)1 inhibitor, which is a medication that helps the immune system fight cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to provide informed consent or are part of a vulnerable population that requires special protection.
  • Patients who have other medical conditions or are taking medications that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

  • Ceralasertib

    is a medication being studied for its potential to treat patients with advanced melanoma that cannot be surgically removed. It is being tested to see if it can help patients who have not responded to other treatments that target a specific protein involved in cancer growth. Ceralasertib is being used alone in some parts of the study to see how effective it is by itself.

  • Durvalumab

    is another medication used in this study, combined with ceralasertib. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. The combination of durvalumab with ceralasertib is being tested to see if it can improve the treatment outcomes for patients with advanced melanoma who have not responded to previous therapies.

What is already known about the treatment

  • Ceralasertib

    Ceralasertib is administered orally and is currently being studied in clinical trials for its effectiveness in treating unresectable or advanced melanoma, particularly in patients who have shown resistance to PD-(L)1 inhibitors. It is classified as a kinase inhibitor, specifically targeting the ATR protein, which plays a role in DNA damage repair. By inhibiting ATR, ceralasertib disrupts the repair of damaged DNA in cancer cells, potentially leading to their death. This medication is still under investigation, and its full potential and safety profile are being evaluated in ongoing studies.

  • Durvalumab

    Durvalumab is administered via intravenous infusion and is being evaluated in combination with ceralasertib for treating unresectable or advanced melanoma with resistance to PD-(L)1 inhibitors. It is an immune checkpoint inhibitor that targets the PD-L1 protein, helping to enhance the body's immune response against cancer cells. By blocking PD-L1, durvalumab allows T cells to better recognize and attack cancer cells. This medication is part of ongoing research to determine its effectiveness and safety in combination therapies.

Investigated diseases

Unresectable or Advanced Melanoma – This is a type of skin cancer that has progressed to a stage where it cannot be removed through surgery. It often spreads to other parts of the body, making it more challenging to manage. The disease originates in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As it advances, melanoma can invade deeper layers of the skin and potentially reach lymph nodes or distant organs. Patients with this condition may experience changes in existing moles or the appearance of new, unusual growths on the skin. The progression of the disease can vary, with some cases remaining stable for extended periods while others may progress more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512378-91-00Protocol codeD533AC00001Estimated enrolment291 patientsSponsorAstraZeneca AB

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