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

Breast Cancer
SASCIA
Phase III post neoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2 negative breast cancer patients with high relapse risk after standard neoadjuvant treatment
Cancer Centre Lead: Prof Patrick Morris
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

LidERA
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Adjuvant Giredestrant Compared With Physician’s Choice Of Adjuvant Endocrine Monotherapy In Patients With Estrogen Receptor-Positive, Her2-Negative Early Breast Cancer
Cancer Centre Lead: Professor Patrick Morris
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

Colorectal Cancer
Krystal 10
A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy
Cancer Centre Lead: Prof Liam Grogan
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

Gynaecological Cancer

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

INCMOR 0208-301
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Cancer Centre Lead: Dr John Quinn
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

CPD DARA
Phase Ib of Cyclophosphamide, Pomalidomide, Dexamethasone and Daratumumab (CPD-DARA) in patients with relapsed/refractory multiple myeloma. (The CPD-DARA Study)
Cancer Centre Lead: Dr John Quinn
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

Loxo 305
A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Cancer Centre Lead: Dr Philip Murphy
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

HOVON 156
A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy.
Cancer Centre Lead: Dr John Quinn
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

DREAMM14
A Phase 2, Randomized, Parallel, Open-Label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-Agent Belantamab Mafodotin (GSK2857916) in Participants with Relapsed or Refractory Multiple Myeloma
Cancer Centre Lead: Dr John Quinn
Contact: Mr Keith Egan (01) 8092010 keithegan2@beaumont.ie

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 Refractory Multiple Myeloma (RRMM).
Cancer Centre Lead: Dr John Quinn
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

Lung Cancer
KRYSTAL 12
A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation
Cancer Centre Lead: Dr Jarushka Naidoo
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

MK7684A-008
A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer
Cancer Centre Lead: Dr Jarushka Naidoo
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

Krystal 7
A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
Cancer Centre Lead: Dr Jarushka Naidoo
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

CA224104 (Relativity)
A Phase 2 Randomized Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
Cancer Centre Lead: Prof Jarushka Naidoo
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

BRAND: Dynamic changes in breath and plasma: Biomarkers of response to immunotherapy in advanced non-small lung cancer
Cancer Centre Lead: Prof Jarushka Naidoo
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

Urological Cancers
MK6482-022:
A Multi-center, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) plus Pembrolizumab (MK- 3475) Versus Placebo plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy
Cancer Centre Lead: Dr Adrian Murphy
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie

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
Contact: Mr Keith Egan (01)8092010  keithegan2@beaumont.ie
Clinical Trial Results

Presentation and Publication of Recent Trial Activity

The ASCO Post: December 2020:
RxPONDER Study Shows Postmenopausal Patients With Node Positive Breast Cancer May Be Able to Avoid Chemotherapy

JCO Jan 2021:
Pembrolizumab plus Ipilumumab or Placebo for Metastatic Non-Small Cell Lung Cancer with PD-L1 Tumour Proportion Score > 50%: Randomised, Double Blind Phase III KEYNOTE 598 Study

The Lancet Oncology Feb 2021:
Palboclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open label, randomised phase 3 study

Cancers Mar 2021:
Phase 1b Trial of Copanlisib, A Phosphoinositide-3 Kinase (PI3K) Inhibitor, with Trastuzumab in Advanced Pre-Treated HER2-Positive Breast Cancer “Panther”

NEJM Apr 2021:
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer

JCO May 2021:

Palbociclib for Residual High-Risk Invasive HR-Positive and HER2-Negative Early Breast Cancer – The Penelope B Trial