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Evaluation of drug combination therapy (olaparib, nilotinib, tremelimumab, and durvalumab) for patients with advanced or metastatic solid tumors

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 focuses on patients with advanced/metastatic cancers who have already received at least one prior treatment. The study tests several medications including Lynparza (olaparib), Tasigna (nilotinib), Imjudo (tremelimumab), and Imfinzi (durvalumab). These medications are given to patients whose tumors have specific molecular changes that suggest they might respond to these treatments.

The purpose of this study is to evaluate if continuing treatment after an initial period (called maintenance treatment) helps control cancer growth better than stopping treatment. The study is divided into two parts: an initial treatment period and a maintenance period. During the initial period, patients receive one of the study medications. Those who show stable disease or improvement may continue to the maintenance period.

The treatment plan involves taking medications either by mouth as tablets or through intravenous infusion (given directly into a vein). The medications are chosen based on specific features found in each patient's tumor through molecular testing. The study monitors how well the treatment works and how long it can keep the cancer from growing, while also checking for any side effects that may occur during treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period (induction)

    You will receive treatment with one of the following medications based on your specific tumor profile:

    - Lynparza (olaparib) tablets taken by mouth

    - Tasigna (nilotinib) capsules taken by mouth

    - IMJUDO (tremelimumab) given through intravenous infusion

    - IMFINZI (durvalumab) given through intravenous infusion

    The initial treatment period lasts 12 weeks for most treatments, or 52 weeks if receiving immunotherapy

  2. Step 2

    Treatment evaluation

    Your response to treatment will be evaluated through medical imaging (CT scan or MRI)

    If your disease is stable or shows improvement, you may proceed to the maintenance phase

    Treatment effectiveness will be measured by checking if the cancer has grown or spread

  3. Step 3

    Maintenance period

    You will be randomly assigned to one of two groups:

    - Continue receiving the same treatment

    - Stop treatment temporarily

    Regular evaluations will continue to monitor your condition

    Quality of life assessments will be conducted using a standardized questionnaire

  4. Step 4

    Ongoing monitoring

    Regular health checks will assess:

    - How well the treatment is working

    - Any side effects you may experience

    - Your overall health status

    Laboratory tests will be performed to check your organ function and blood counts

Who can join the trial?

19 criteria

  • Must be at least 18 years old
  • Must have received approval for study treatment from the medical staff committee
  • Must have a performance status of 0, 1, or 2 on the ECOG scale (a measure of daily living abilities)
  • For immunotherapy group participants:
    • Must have tumor tissue sample available or a tumor that can be biopsied
    • Must have had no more than 2 previous treatments for advanced cancer
    • Previous cancer treatment side effects must be resolved to mild level or less
    • Must sign informed consent form
    • Must have adequate organ function as shown by blood tests, including:
      • Acceptable white blood cell counts
      • Adequate platelet levels
      • Sufficient hemoglobin levels
      • Proper liver function
      • Adequate kidney function
      • Must have a life expectancy of at least 4 months
      • Must have confirmed advanced cancer that cannot be cured by surgery
      • Must have evidence that disease is getting worse
      • Must have received at least one previous treatment for advanced cancer
      • Must have tumors that can be measured on CT scan or MRI
      • Must have had tumor testing (molecular profiling) with results reviewed by expert panel
      • The recommended treatment must not be currently approved and covered by insurance in France for patient's specific condition

Who cannot join the trial?

15 criteria

  • Previous participation in this clinical trial
  • Active brain metastases (cancer spread to the brain) that are untreated or unstable
  • Pregnant or breastfeeding women
  • Major surgery within 28 days before starting the study treatment
  • Active, uncontrolled infections requiring systemic treatment
  • Known HIV (Human Immunodeficiency Virus) infection
  • Active hepatitis B or hepatitis C infection
  • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Serious heart conditions, including:
    • Heart attack within the last 6 months
    • Unstable angina (chest pain)
    • Heart failure requiring treatment
    • Uncontrolled high blood pressure
    • Any medical condition that, in the investigator's opinion, would make participation unsafe
    • Unable to swallow oral medications
    • Known allergic reactions to components of the study treatment
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Investigated drugs

  • Tremelimumab

    is a type of immunotherapy that works by blocking a protein called CTLA‑4, which can help the immune system recognize and attack cancer cells. In this study, it is given by IV infusion during the induction phase to try to shrink or stop the growth of solid tumors before moving on to the maintenance part of the trial.

  • Nilotinib

    is a targeted oral medication that blocks specific enzymes (tyrosine kinases) that many cancer cells need to grow. Participants take it by mouth as part of the induction treatment, aiming to control tumor growth in cancers that have certain molecular changes.

  • Olaparib

    is an oral tablet that belongs to a class of drugs called PARP inhibitors. It helps stop cancer cells from fixing their DNA damage, which can lead to cell death, especially in tumors with specific genetic defects. In the trial, it is used during the induction period to try to reduce tumor size or keep the disease from getting worse.

  • Durvalumab

    is another immunotherapy given by IV infusion. It works by blocking the PD‑L1 protein, helping the immune system see and attack cancer cells. In this study, it is used as a maintenance therapy after the induction phase, to help keep the cancer from progressing for as long as possible.

What is already known about the treatment

  • Tremelimumab

    Tremelimumab is given by intravenous infusion as a sterile solution that is slowly injected into a vein. It is still an investigational drug and is being studied in clinical trials for cancer treatment. It is aimed at patients with advanced or metastatic solid tumors. The medicine works by blocking a protein called CTLA‑4, which helps the immune system recognize and attack cancer cells; it belongs to the class of immune checkpoint inhibitors.

  • Nilotinib

    Nilotinib is taken orally in hard capsules that are swallowed with water. It is an approved medicine that has been on the market for several years to treat certain blood cancers. It is used mainly for chronic myeloid leukemia and is also studied for other advanced solid cancers. Nilotinib blocks the activity of the BCR‑ABL protein, a type of enzyme that drives cancer cell growth, and is classified as a tyrosine‑kinase inhibitor.

  • Olaparib

    Olaparib comes as film‑coated tablets that are taken by mouth, usually once or twice daily. It is an approved drug for several types of ovarian, breast, pancreatic and prostate cancers that have specific genetic changes. The tablets are used when the cancer has spread or cannot be removed by surgery. Olaparib blocks an enzyme called PARP that helps repair DNA, so cancer cells with faulty DNA repair die; it is known as a PARP inhibitor.

  • Durvalumab

    Durvalumab is administered as an intravenous infusion of a sterile solution delivered directly into a vein. It has received regulatory approval for several lung and bladder cancers and continues to be studied in other solid tumors. The drug is given to patients with advanced or metastatic disease to help keep the cancer from growing. Durvalumab works by attaching to the PD‑L1 protein, preventing it from turning off the immune response, and it is classified as a PD‑L1 immune checkpoint inhibitor.

Investigated diseases

  • Advanced Cancer

    A condition where cancer cells have spread from their original location to other parts of the body. The cancer cells travel through the bloodstream or lymphatic system, forming new tumors in distant organs or tissues. This process, known as metastasis, makes the disease more complex as it affects multiple areas. Advanced cancer typically develops in stages, beginning as a localized tumor that gradually spreads beyond its initial site. The disease can affect various organs and body systems simultaneously, with different patterns of spread depending on the type of original cancer.

  • Metastatic Cancer

    A stage of cancer where malignant cells have spread from the primary tumor to other locations in the body. The cancer cells break away from the original tumor and create new tumors (metastases) in other organs or tissues. These secondary tumors are the same type of cancer as the primary tumor, even though they are growing in a different part of the body. The spreading process can occur through blood vessels, lymph nodes, or by direct extension to nearby tissues.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510566-27-00Protocol codeET-12-081Estimated enrolment900 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

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