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

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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

Based on the provided trial data, I cannot specifically identify any medications or therapies to list, as the source material only mentions "Investigational Therapy" in general terms without specifying particular medications. The trial appears to be studying unspecified targeted treatments based on tumor molecular alterations, but no specific drug names or therapies are provided in the source data. If you have additional information about the specific medications or therapies used in this trial, please provide it, and I will format the descriptions according to the requirements.

What is already known about the treatment

Based on the provided trial data, since no specific medications are listed in the source data (the trial appears to be evaluating unspecified investigational therapies for advanced/metastatic cancers), I cannot provide specific medication descriptions in the requested format. The trial appears to be studying various investigational treatments, but without specific medication names being provided in the source data, I cannot create accurate medication descriptions that would meet the required format and criteria. If you would like medication descriptions, please provide specific medication names from the clinical trial, and I will create appropriate descriptions following the requested format: medication name – description.

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 2 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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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).