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Cancer clinical trials

Cancer clinical trials

The Cancer Clinical Trials Unit (CCTU) in the Cancer Centre in University Hospital Limerick (UHL) coordinates a wide range of clinical trials in the cancer setting. The CCTU was established in 2001.

UHL is a designated Cancer Centre of Excellence.

The CCTU facilitates all cancer clinical trials for the Midwest region.

The CCTU is involved in medical oncology studies for patients with breast, lung, genitourinary, gastrointestinal and gynaecological cancers and haematology clinical studies.

In 2020 we had 290 patients under our care in Cancer Services participating in 35 Cancer Clinical Trials.

Clinical trials

A clinical trial is a research study designed to test new treatments or a new way of using known treatments. The goal is to find more effective and better ways to treat or prevent cancer. A clinical trial is also known as a clinical study, research study, or medical research.

Clinical Trials may be done to test one of the following:

  • New treatments
  • New ways of using treatments already available
  • New combinations of existing drugs
  • New ways of diagnosing or preventing cancer
  • The psychological effects of the treatment
  • The impact of treatments on Quality of Life (QoL)

Our team

The activity of our CCTU depends on a multidisciplinary team both within the centre and within our hospital community. The CCTU is led by Prof Ruth Clifford, Consultant Haematologist and Director of CCTU.

Our experienced CCTU team consists of the following:

  • 1 Clinical Operations Manager: Maureen O’Grady
  • 5 Clinical Nurse Managers (CNM2)
  • 1 Clinical Trials Pharmacist: Libby Sweeney
  • 1 Project & Finance Manager: Michelle Meade O’Sullivan
  • 1 Administrator
  • 2 Data Managers
  • 11 Consultant Principal Investigators

The Clinical Trials process

During your first visit to Cancer Services at UHL, your consultant may discuss a clinical trial with you.

The research nurse (CNM2) will further explain the details of the procedures involved in participation in the clinical trial.

This will include:

  • what the trial is about
  • what treatment or procedures are involved
  • how you will be treated
  • side effects of treatment
  • what you will have to do to participate in the study

The standard treatment available will also be discussed.

You will receive written information about the clinical trial to take home with you. You can discuss your options with your family or friends.

You can contact the research nurse (CNM2) with more questions during your decision making process.

If you decide to take part in a clinical trial, you have to be fully satisfied with all the information shared with you about all the procedures involved in the clinical trial.

Contact us

For more information on our open clinical trials, please contact our Clinical Trials Unit.

For more information on clinical trials in Ireland see:

Current recruiting clinical trials

Breast

Trial Name: SHAMROCK

Trial No: 2022-002485-32

Patient Profile: Patients with HER2 positive breast Cancer

Purpose: Single arm, phase II trial of neoadjuvant Trastuzumab Deruxecan (T-DXd) with response directed definitive therapy in early stage HER2 positive breast cancer; a cytoxic chemotherapy sparing approach to curative intent treatment.

Principal Investigator (PI): Dr Greg Korpanty

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Trial Name: SASCIA

Trial Number: 20-24

Patient profile: Her 2 - breast cancer patients in post neoadjuvant setting

Purpose: Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2- negative breast cancer patients with high relapse risk after standard neoadjuvant treatment’

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Trial Name:lidERA / G042784 / TRIO 045

Trial Number: 21-04

Patient Profile: Breast Cancer patients with medium-and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Purpose: To evaluate the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice

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Trial Name:Destiny – Breast05

Trial Number: 21-15

Patient Profile: HER2-positive primary breast cancer who do not achieve complete response after appropriate neoadjuvant therapy and are at higher risk of disease recurrence.

Purpose: This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

Lymphoma and blood cancers

Trial Name: MajesTEC-4

Trial No: 2021-002531-27

Patient Profile: Patients with multiple myeloma

Purpose: A phase III of Teclistamab in combination with Lenalidomide and Teclistamab alone versus Lenalidomide alone in newly diagnosed MM as maintenance following autologous stem cell transplant.

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Trial Name: MK1026-003

Trial No: 2020-002324-36

Patient Profile: Participants with CLL, Richet’s transformation, non-Hodgkin lymphoma and Waldenstrom’s macroglobulinaemia

Purpose: A phase II study to evaluate the safety and efficacy of ML1026-003 in participants with haematologic malignancies

PI: Professor Ruth Clifford

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Trial Name: ANT-007

Trial No: 2021-003026-14

Patient Profile: Patients with cancer associated VTE (ASTER)

Purpose: A multicentre, randomised, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

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Trial Name: ANT-008

Trial No: 2021-003085-12

Patient Profile: Abelacimab versus dalteparin in the treatment of GI/GU cancer and associated VTE

Purpose: A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

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Trial Name: Isa-RVD

Trial Number: 19-34

Patient Profile: The target population for this study are patients with newly diagnosed multiple myeloma for high dose therapy and autologous stem cell transplant. Patients will have a confirmed diagnosis of multiple myeloma, based on standard IMWG criteria.

Purpose: This study is a Phase II, multi-centre, single-arm, open-label study to evaluate the efficacy and safety of the combination regimen Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in patients with newly diagnosed multiple myeloma.

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Trial name: BCBI (Blood Cancer Biobank Ireland) sample collection

Trial number: n/a

Patient profile: Suspected or newly diagnosed or relapsed but not on treating patients with CLL, AML or Multiple Myeloma.

Purpose: Collection of bone marrow or peripheral blood samples to be stored in a biobank for use in current or future research.

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Trial name: The Impact of Genetic Expression Profile on Depth of Response and Survival in Myeloma (MRD Study)

Trial number: n/a

Patient profile: Patients who have been diagnosed with multiple myeloma and are potentially eligible for autologous stem cell transplant.

Purpose: Prospective, non-interventional, observational study to evaluate the combined assessment of gene expression profiling and MRD analysis to determine impact of genetic risk on achievement of MRD negativity and PFS in newly diagnosed transplant eligible patientswith Multiple Myeloma receiving standard of care regimens

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Trial name: Natural and Vaccine-induced Immunity to COVID-19 in Haematological Malignancies

Trial number: n/a

Patient profile: Patients with blood cancers who are undertaking the COVID-19 Vaccine or who have had a COVID-19 infection to understand if there is a response to the vaccine/infection.

Purpose: This is a study on the immune response of patients with blood cancers who are undertaking the COVID-19 vaccine or who have had a COVID-19 infection to understand if there is a response to the vaccine/infection. We know that not all patients with blood cancers will have a normal response to vaccines such as the influenza vaccine.

For this reason, more information is needed to understand the immune response of patients with blood cancers. We will be studying blood samples taken ideally before and after vaccination and testing different parts of the immune system to see if, compared to people without blood cancer, the immune response is different.

Please remember, that these are research tests and their results will not impact your treatment, but we hope that this project will help us to understand how patients will respond to COVID-19 infection and vaccination. This may lead to improved protective measures against COVID-19 in the future for patients.

Lung

Trial Name: ADEPPT

Trial No: 2022-002736-31

Patient Profile: Patients with Non-Small Cell Lung Cancer

Purpose: A multicentre, single-arm phase II trial of Adagrasib in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status

Principal Investigator: Dr Greg Korpanty

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Trial Name: Latify

Trial No: 2022-000493-26

Patient Profile: Lung cancer

Purpose: A Phase III, open-label, randomised, multicentre study of Ceralasertib plus Durvalumab versus Docetaxel in patients with advanced or metastatic non-small cell lung cancer without actionable genomic alterations, and whose disease has progressed on or after prior Anti-PD-(L) Therapy and platinum-based chemotherapy.

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Trial Name: Plan Study – Translational Study

Trial No: 006/2023

Patient Profile: Plasma Genomic testing in patients with advanced non-small cell lung cancer

Purpose: To establish the feasibility of liquid biopsies for genomic diagnosis and targeted therapy selection in patients with advanced lung cancer.

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Trial Name: Krystal -12

Trial No: CTRIAL-IE 21 13

Patient Profile: Previously treated metastatic NSCLC with a KRAS G12C mutation.

Purpose: To evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

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