Clinical ResearchNavigation

Clinical research is undertaken across the breath of cancer diseases. Phase I, IIa, IIb and III trials are led by consultant medical oncologists, radiation oncologists, surgeons and haematologists. Patients treated on clinical trials receive experimental therapy in the Cancer Centre either with or in lieu of other standard systemic anticancer therapy. Recent advances in cancer treatment are the direct result of high quality, prospective research and so clinical trials are consistently seen as a core component of the optimal management of patients with cancer. The importance of this is recognised in the National Cancer Strategy (2017-2026).

Cancer Clinical Trials and Research Unit

The Cancer Clinical Trials and Research Unit (CCTU), Beaumont Hospital conducts clinical, translational and outcomes research in patients with cancer across the Dublin North – North East region. A key aim of the work is to learn more about the pathophysiology of malignancy and to deliver new therapies to improve quality-of-life and cancer survival, by conducting high quality research in compliance with EU, national and international regulations. Clinical trials are routinely sponsored by pharmaceutical companies or Cancer Trials Ireland. In addition to providing funding to conduct the trials, the Sponsor plays a key role in research governance to ensure that all trials are carried out in accordance with National and International standards and applicable laws, including as defined under “Good Clinical Practice” (GCP), the international ethical, scientific and practical standard to which all clinical research is conducted.

Research is led by consultant medical oncologists and haematologists and patients treated on clinical trials receive experimental therapy in Beaumont Hospital either with or in lieu of other standard systemic anticancer therapy (SACT). Recent advances in cancer treatment are the direct result of high quality, prospective research and so clinical trials are consistently seen as a core component of the optimal management of patients with cancer. The importance of this is recognised in the National Cancer Strategy (2017-2026).
Open Clinical Trials

For further information about any of our clinical trials contact Cancer Clinical Trials Unit Programme Manager Mr Keith Egan

Tel: (01) 8092010 Email: keithegan2@beaumont.ie

Breast Cancer

Shamrock: Single arm phase 2 trial of neoadjuvant trastuzumab deruxtecan (T-DXd) with response-directed definitive therapy in early stage HER2-positive breast cancer: a standard chemotherapy-sparing approach to curative-intent treatment – SHAMROCK study Recruitment on hold August 2024

Cancer Centre Lead: Prof Bryan Hennessy

EMBER 4: A Randomized, Open-Label, Phase III Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Cancer Centre Lead: Prof Patrick Morris

DESTINY-Breast15: A Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (BC)

Cancer Centre Lead: Prof Patrick Morris

CAMBRIA 2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Cancer Centre Lead: Prof Patrick Morris

Colorectal Cancer

Mountaineer-03: An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer

Cancer Centre Lead: Prof Adrian Murphy

Haematological Malignancies

MajesTEC-4 (EMN30): Phase 3 Study of Teclistamab in Combination with Lenalidomide and Teclistamab Alone versus Lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation

Cancer Centre Lead: Prof Siobhán Glavey

Lung Cancer

BRAND: Dynamic changes in breath and plasma: Biomarkers of response to immunotherapy in advanced non-small lung cancer

Cancer Centre Lead: Prof Jarushka Naidoo

Neo-Coast 2: A Phase II, Open-label, multicentre, randomised study of neoadjuvant and adjuvant treatment in patients with resectable, early-stage (II to IIIB) non-small cell lung cancer Recruitment on hold August 2024

Cancer Centre Lead: Prof Jarushka Naidoo

KRYSTAL 7: A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

Cancer Centre Lead: Prof Jarushka Naidoo

HARMONi-3 (SMT112-3003) A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non Small Cell Lung Cancer

Cancer Centre Lead: Prof Jarushka Naidoo

Skin Cancer

Upper Gastro Intestinal Cancer

Gynaecological Cancer

GLORIOSA: Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with

FRα-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab

Cancer Centre Lead: Prof Patrick Morris

IMGN853-0424: A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment with Mirvetuximab Soravtansine in Patients with Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expression

Cancer Centre Lead: Prof Patrick Morris

Rare Cancers (Basket Studies, Immuno-Oncology, Sarcoma)

Immunofertility: A prospective observational study investigating the impact of immune checkpoint inhibitors for cancer on fertility in males and females of childbearing age (Immuno-fertility)

Cancer Centre Lead: Prof Jarushka Naidoo

Aster (ANT-007): A multicenter, randomized, 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)

Cancer Centre Lead: Dr Karl Ewins

Magnolia (ANT-008): 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)

Cancer Centre Lead: Dr Karl Ewins

Gut Microbiome: A prospective observational study investigating the impact of the gut microbiome constitution on the response to neo-adjuvant chemotherapy and neo-adjuvant chemo-radiation in early-stage breast cancers and early-stage gastrointestinal cancers

Cancer Centre Lead: Prof Bryan Hennessy

Bellwave 003: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies.

Cancer Centre Lead: Prof Patrick Thornton

GAMBIT: Genomic, Acquired Immunologic and Microbial Biomarkers of Immunotherapy Response and Toxicity to Immunotherapy in Cancer

Cancer Centre Lead: Prof Jarushka Naidoo