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

ASCENT 05: A Randomized, Open-label, Ph 3 Study of Adj Sacituzumab Govitecan and Pembro vs Tx of
Physician’s Choice in Pts With Triple -ve Breast Ca Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Cancer Centre Lead: Prof Patrick Morris

Fourlight 3: An Open-Label Randomized Phase 3 Study of PF-07220060 + Letrozole Compared To CDK4/6 Inhibitor + Letrozole In Pts With HR+ve, Her2-ve, First Line Advanced /Metastatic Breast Cancer Recruitment on hold

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

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

Colorectal Cancer

Mountaineer-03:

A clinical trial for patients with colon or rectal cancer that has spread around the body. Tumours must test positive for HER2. Patients cannot have received any systemic therapy (e.g. chemotherapy) for advanced disease. Patients are randomised to receive either 2 anti-HER2 therapies (tucatinib and trastuzumab) with chemotherapy (FOLFOX) or trastuzumab with FOLFOX.

Additional information is available here: MOUNTAINEER-03 EU info

Cancer Centre Lead: Prof Adrian Murphy

Haematological Malignancies

CLL18/MOIRAI: A phase 3 multicenter, randomised, prospective, open-label trial of fixed-duration (12 cycles) veneto-clax/ obinutuzumab vs. fixed-duration (15 cycles) venetoclax/ pirtobrutinib vs. MRD-guided ve-netoclax/ pirtobrutinib in patients with previously untreated chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL) aiming to establish measurement of individual residual disease for adjustment of treatment duration to improve outcomes.

Cancer Centre Lead: Prof Patrick Thornton

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

RENEW (KER-050-D301): Phase 3, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion- Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS)

Additional information is available here: RENEW (KER-050-D301)

Cancer Centre Lead: Prof Philip Murphy

HOVON 177: Randomised study to assess revumenib in combination with azacitidine & yenetoclax in adult patients with newly diagnosed NMP1-mutated or KMT2-rearranged AML ineligible for intensice chemptherapy.

Cancer Centre Lead: Prof John Quinn

Additional information is available here : https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-512733-32-00

Lung Cancer

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

KRYSTAL-4 (CA239-0004): A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation.

Additional information is available here: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-515698-85-00

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

TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer

(NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and

chemotherapy.

Cancer Centre Lead: Prof Jarushka Naidoo

ABBIL1TY NSCLC-06: A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab

Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a

PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy

Cancer Centre Lead: Prof Jarushka Naidoo

ETOP ADOPT:

An open-label randomised ph III trial to evaluate the benefit of adding adjuvant durvalumab after

neoadjuvant chemotherapy plus durvalumab in patients with stage IIB-IIIB (N2) resectable NSCLC.

For additional information click here: http://6. https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-508773-82-00

RASolve 301 :

Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients

with Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

Additional Information can be found here : https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-518154-16-00

ARTEMIDE Lung-04:

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients with PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

Cancer Centre Lead: Prof Jarushka Naidoo

Skin Cancer

Upper Gastro Intestinal Cancer

Gynaecological Cancer

Urological Cancers

CA071-1000 rechARge:

A Ph 3 Randomized, Open-label Study Comparing BMS-986365 vs Investigator’s Choice of Therapy in Pts with

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Cancer Centre Lead: Dr Min Yuen Teo

Additonal information can be found here : http://6. https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-517422-25-00

SGNDV001

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

Cancer Centre Lead: Dr Min Yuen Teo

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

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