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Study of Olaparib and Pembrolizumab for Patients with Advanced Cancer with HRRm or HRD Mutations

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 advanced cancers that have specific genetic changes known as Homologous Recombination Repair Mutation (HRRm) and Homologous Recombination Deficiency (HRD). These genetic changes can affect how cancer cells repair themselves, making them more vulnerable to certain treatments. The study involves two medications: Olaparib, which is taken as a film-coated tablet, and Pembrolizumab, also known as Keytruda, which is given as an infusion into a vein. Olaparib is designed to target cancer cells with HRRm and HRD, while Pembrolizumab helps the immune system recognize and attack cancer cells.

The purpose of this study is to evaluate how well the combination of Olaparib and Pembrolizumab works in treating these types of advanced cancers. Participants in the study will receive these medications over a period of up to 24 months. The study will monitor how the cancer responds to the treatment, how long the response lasts, and the overall survival of participants. Additionally, the study will track any side effects experienced by participants and whether any side effects lead to stopping the treatment.

This trial is important for understanding the potential benefits of combining Olaparib and Pembrolizumab for patients with advanced cancers that have HRRm and HRD. By participating in this study, researchers hope to gather valuable information that could lead to improved treatment options for these types of cancer in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    A series of tests may be performed to ensure the presence of specific genetic mutations or deficiencies related to the study.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of olaparib and pembrolizumab.

    Olaparib is taken orally in the form of film-coated tablets. The dosage and frequency will be specified by the study team.

    Pembrolizumab is administered through an intravenous infusion. The dosage and schedule will be provided by the study team.

  3. Step 3

    Ongoing monitoring

    Regular monitoring is conducted to assess the response to treatment. This includes physical examinations and imaging tests.

    Participants are required to attend scheduled visits to track progress and manage any side effects.

  4. Step 4

    Response evaluation

    The effectiveness of the treatment is evaluated using specific criteria to measure changes in the tumor size and overall health.

    The study team will provide updates on the treatment response and any necessary adjustments to the treatment plan.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall outcome.

    Participants may be required to attend follow-up visits to monitor long-term effects and gather additional data.

Who can join the trial?

9 criteria

  • Has a confirmed advanced solid tumor (except breast or ovarian cancers with a specific BRCA mutation) that cannot be cured and for which standard treatments have not worked. The patient must have tried standard treatments that are known to help but did not work or were not tolerated. There is no limit on the number of previous treatments.
  • Has known or suspected harmful mutations in at least one of the specified 15 genes involved in HRR (Homologous Recombination Repair) or confirmed HRD (Homologous Recombination Deficiency) based on a specific test.
  • Has measurable disease according to specific criteria (RECIST 1.1) as assessed by the local investigator and confirmed by an independent review.
  • Has a life expectancy of at least 3 months.
  • Must have had a complete response (CR) or partial response (PR) to previous treatment with cisplatin or carboplatin, or if only treated with oxaliplatin, had CR, PR, or stable disease (SD) during the last treatment. The patient must not have been resistant to previous platinum-based therapy.
  • Has an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, which means the patient is fully active or has some symptoms but does not require bed rest.
  • Male participants must agree to use contraception during the treatment period and for at least 90 days (3 months) after the last dose of olaparib and must not donate sperm during this time.
  • Female participants must not be pregnant or breastfeeding and must meet one of the following conditions: not able to become pregnant or agree to use contraception during the treatment period and for at least 120 days (3 months) after the last dose of pembrolizumab and 180 days (6 months) after the last dose of olaparib. They must have a highly sensitive pregnancy test before starting the study and must not breastfeed during the study and for at least 120 days after the last dose.
  • Has adequate organ function, meaning the organs are working well enough to participate in the study.

Who cannot join the trial?

5 criteria

  • Participants cannot join if they have a different type of cancer that is not HRRm or HRD-positive.
  • Participants who are not within the specified age range cannot participate.
  • Participants who are not part of the specified clinical trial groups are excluded.
  • Participants who are not male or female are excluded.
  • Participants who are considered part of a vulnerable population cannot join the study.
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Investigated drugs

  • Olaparib

    is a medication used in this clinical trial to help treat certain types of advanced cancer. It works by blocking a specific protein in cancer cells, which can help stop the cancer from growing and spreading. This medication is particularly used for cancers that have specific genetic mutations, making it a targeted therapy option for patients with these mutations.

  • Pembrolizumab

    is another medication involved in the trial. It is an immunotherapy drug that helps the body's immune system fight cancer. Pembrolizumab works by blocking a protein that prevents the immune system from attacking cancer cells. By doing this, it helps the immune system recognize and destroy cancer cells more effectively. This medication is used for various types of cancer and is part of a newer class of cancer treatments that harness the power of the immune system.

What is already known about the treatment

  • Olaparib

    Olaparib is administered orally in the form of tablets and is currently being studied in combination with Pembrolizumab for its effectiveness in treating advanced cancers that have specific genetic mutations or deficiencies. It is primarily used for cancers that have homologous recombination repair mutations (HRRm) or homologous recombination deficiency (HRD). At the molecular level, Olaparib works by inhibiting an enzyme called PARP, which helps repair DNA damage in cells, leading to the death of cancer cells. It is classified as a PARP inhibitor in pharmacology.

  • Pembrolizumab

    Pembrolizumab is given as an intravenous infusion and is being tested in combination with Olaparib for its potential to treat advanced cancers with certain genetic profiles. It is mainly indicated for cancers with HRRm and HRD-positive status. Pembrolizumab functions by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It belongs to the class of drugs known as immune checkpoint inhibitors.

Investigated diseases

  • Homologous Recombination Repair Deficiency (HRRm) Cancer

    This type of cancer is characterized by a deficiency in the homologous recombination repair pathway, which is crucial for repairing DNA double-strand breaks. As a result, cells accumulate genetic mutations, leading to cancer development. The progression of HRRm cancer involves the continuous accumulation of DNA damage, which can lead to tumor growth and spread. This condition is often associated with certain genetic mutations, such as BRCA1 and BRCA2. Over time, the inability to repair DNA effectively can result in more aggressive cancer behavior. HRRm cancers can occur in various tissues, including the breast, ovaries, and prostate.

  • Homologous Recombination Deficiency (HRD)-Positive Cancer

    HRD-positive cancer occurs when there is a deficiency in the homologous recombination repair mechanism, similar to HRRm cancer. This deficiency leads to an increased risk of genetic mutations and cancer development. The progression involves the accumulation of unrepaired DNA damage, contributing to tumor growth and potential metastasis. HRD-positive cancers are often linked to specific genetic mutations, such as those in the BRCA genes. As the condition progresses, the cancer may become more aggressive due to the ongoing inability to repair DNA damage. HRD-positive cancers can affect various organs, including the breast, ovaries, and prostate.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503831-17-00Protocol codeMK-7339-007Estimated enrolment425 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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