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

Cancer Centre Lead: Prof Bryan Hennessy

EPIK-B5: A Phase III, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HRpositive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed on or after aromatase inhibitor and a CDK4/6 inhibitor

Cancer Centre Lead: Prof Patrick Morris

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

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

Isa-RVD: 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

Cancer Centre Lead: Prof Siobhán Glavey

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

HOVON 150: A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy.

Cancer Centre Lead: Dr Philip Murphy

Excaliber-RRMM: A Phase 3, Two-Stage, randomized, Multicenter, open-label study comparing Iberdomide, Dartumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib and Dexamethasone (DVD) in subjects with relapsed or efractory Multiple Myeloma (RRMM).

Cancer Centre Lead: Dr John Quinn

AFFIRM-AL: A Phase 3, randomized, multicentre, double-blind, placebo-controlled, efficacy and safety study of Birtamimab plus Standard of Care versus placebo plus standard of care in mayo stage IV subjects (AL) amyloidosis

Cancer Centre Lead: Dr John Quinn

Lung Cancer

ADEPPT: A multicentre, single-arm phase II trial of Adagrasib in patients with KRAS G12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status

Cancer Centre Lead: Prof Jarushka Naidoo

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

Cancer Centre Lead: Prof Jarushka Naidoo

PLAN: Plasma genomic testing in Patients with Advanced Non-Small Cell Lung Cancer: The PLAN study

Centre Lead: Prof Jarushka Naidoo

DeLLphi-304: A Randomized, Open-label, Phase 3 Study of Tarlatamab compared with standard of care in subjects with relapsed small cell lung cancer after platinum-based first-line chemotherapy (DeLLphi-304)

Centre Lead: Prof Jarushka Naidoo

Skin Cancer

R3767-ONC-2055: A Phase 3 Trial of Fianlimab (anti-LAG-3) and Cemiplimab versus Pembrolizumab in the Adjuvant Setting in Patients with Completely Resected High-risk Melanoma

Cancer Centre Lead: Prof Jarushka Naidoo

Upper Gastro Intestinal Cancer

Destiny Gastric 04: A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study Of Trastuzumab Deruxtecan In Subjects With Her2-Positive Metastatic And/Or Unresectable Gastric Or Gastro-Esophageal Junction (Gej) Adenocarcinoma Subjects Who Have Progressed On Or After A Trastuzumab-Containing Regimen

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