Northern Ireland Cancer Trials Network
Belfast Experimental Cancer Medicine Centre
TRIALS OPEN TO RECRUITMENT –
April 2021
COVID-19 update: NICTN is currently working to re-activate recruitment to studies, where this is feasible and safe. Anyone who wishes to consider participation in a cancer clinical trial should discuss this with their own doctor.
THE NICTN OPEN CLINICAL TRIALS LIST
Biliary Tract Cancer
MK3475-966 A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma
Bowel Cancer
BALLAD UK A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma
CReST 2 Colorectal Stenting Trial 2 – Uncovered and Covered Endoluminal Stenting in the acute management of obstructing colorectal cancer in the palliative setting
ADD ASPIRIN A Phase III, Double-Blind, Placebo-Controlled Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival after Primary Therapy in Common Non-Metastatic Solid Tumours
CHALLENGE A phase III study of the impact of a physical activity programme on disease-free survival in patients with high risk stage II or stage III colon cancer: A randomised controlled trial
ALLEGRO A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery [ON HOLD]
ANICCA A phase II trial assessing nivolumab in strong class II expressing microsatellite stable colorectal cancer
Brain Tumours
Breast Cancer
POSNOC POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes
OPTIMA Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis
ADD ASPIRIN A Phase III, Double-Blind, Placebo-Controlled Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival after Primary Therapy in Common Non-Metastatic Solid Tumours
PIONEER Randomised Phase II clinical trial PIONEER- A Pre-operative wIndOw study of Letrozole plus PR agonist (Megestrol Acetate) versus Letrozole aloNE in post-menopausal patients with ER-positive breast cancer
PRIMETIME Post-operative avoidance of radiotherapy in minimal risk women: patient selection using biomarkers
ROSCO Response To Optimal Selection Of Neo-Adjuvant Chemotherapy In Operable Breast Cancer
PEARL A window of opportunity study to assess the biological effects of progesterone in premenopausal ER-positive, PgR-positive early breast cancer
SMALL A Phase III, randomised, multi-centre trial addressing overtreatment of small screen-detected breast cancer by comparing standard surgery versus minimally invasive vacuum-assisted excision
KEYLYNK-009 An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC)
PIK3CA Registry A descriptive study of PIK3CA mutations in patients with HR+/Her2- advanced breast cancer
Cervical Cancer
INTERLACE A phase III multicentre trial of weekly induction chemotherapy followed by standard chemoradiation versus standard chemoradiation alone in patients with locally advanced cervical cancer
RANGO Rare Neoplasms of Gynaecological Origin
Children’s Cancers (Royal Belfast Hospital for Sick Children)
UMBRELLA A SIOP Renal Tumours Study Group Prospective Clinical Study. Improving Population Outcomes for Renal Tumours of Childhood
rEECur International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma
Ewings PK 2013 Study Pilot study to investigate the early prediction of toxicity following induction chemotherapy in Ewing’s sarcoma by blood-borne biomarkers and correlation with age-dependent pharmacokinetic variation
Myechild01 International Randomised Phase III Clinical Trial in Children with Acute Myeloid Leukaemia – Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination with Induction Chemotherapy
SIOP Ependymoma II An International clinical program for the diagnosis and treatment of children, adolescents and young adults with ependymoma
Relapse in UK Neuroblastoma Clinical and Biological factors associated with relapse and length of survival following relapse in UK neuroblastomas
IMAT Neuroblastoma A randomised phase I/II study of Intensity Modulated Arc Therapy techniques in abdominal neuroblastoma
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis
PHITT Paediatric Hepatic International Tumour Trial
SMP Paeds: Stratified Medicine Paediatrics: Genomic Characterisation Of Relapsed Paediatric Cancers For Diagnostics And Stratified Therapy
Endometrial (Womb) Cancer
RANGO Rare Neoplasms of Gynaecological Origin
Germ Cell Tumours
UK P3BEP A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours
Head and Neck Cancer
iNATT The interNational Anaplastic Thyroid Cancer Tissue Bank and Database Project
COMPARE Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer
Haematological Cancers (see below)
Liver Cancer
MK3475-937 A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937)
Lung Cancer
Stratified Medicine Programme 2 Cancer Research UK Stratified Medicine Programme 2
National Lung Matrix Trial National Lung Matrix Trial: Multi-drug, genetic marker-directed, non-comparative, multi-centre, multi-arm phase II trial in non-small cell lung cancer
SYSTEMS-2 A Randomised Phase II Trial of Standard Versus Dose Escalated Radiotherapy in the Treatment of Pain in Malignant Pleural Mesothelioma
HALT Lung cancer “Targeted therapy with or without dose intensified radiotherapy for oligo-progressive disease in oncogene-addicted lung tumours”
FAK-PD1 A Phase I/IIA Study to Assess Safety, Tolerability and Preliminary Activity of FAK (defactinib) and PD-1 (Pembrolizumab) Inhibition in Patients with Advanced Solid Malignancies (including non-small cell lung cancer)
Melanoma
DANTE A randomised phase III trial to evaluate the Duration of ANti-PD1 monoclonal antibody Treatment in patients with metastatic mElanoma
CA045-001 A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or metastatic Melanoma
Oesophageal Cancer
OCCAMS Multicentre Study to determine Predictive and Prognostic Biomarkers and Therapeutic Targets for Oesophageal and Junctional Adenocarcinoma including whole genome sequencing [ON HOLD]
ADD ASPIRIN A Phase III, Double-Blind, Placebo-Controlled Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival after Primary Therapy in Common Non-Metastatic Solid Tumours
SCOPE 2 A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemo-radiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET)
PLATFORM PLAnning Treatment For Oesophago-Gastric Cancer: a Randomised Maintenance Therapy Trial [ON HOLD]
ICHOR Investigation of Circulating Haematological Biomarkers in Cancer [ON HOLD]
Ovarian Cancer
RANGO Rare Neoplasms of Gynaecological Origin
Protector Preventing Ovarian Cancer through Early Excision of Tubes and late Ovarian Removal
Pancreatic Cancer
PIONEER A Phase I Study of Olaparib in combination with Chemo-radiation in Locally Advanced Pancreatic Cancer
Precision-Panc Master Protocol Personalising Treatment For Pancreatic Cancer
PRIMUS-001 An adaptive phase II study of FOLFOX-A (FOLFOX and nab-paclitaxel) versus AG (nab-paclitaxel and gemcitabine) in patients with metastatic pancreatic cancer, with integrated biomarker evaluation
Prostate Cancer
Stampede Systemic Therapy in Advancing or Metastatic Prostate cancer – Evaluation of Drug Efficacy [ON HOLD]
UKGPC UK Genetics Prostate Cancer Study
SPORT High-Risk Trial A Randomised Feasibility Study Evaluating Stereotactic Prostate Radio Therapy In High-Risk Localised Prostate Cancer With Or Without Elective Nodal Irradiation
Immune gene expression and tumour microenvironment in prostate cancer How does radiotherapy affect immune gene expression and the tumour microenvironment in men with localised prostate cancer? [ON HOLD]
ADD ASPIRIN A Phase III, Double-Blind, Placebo-Controlled Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival after Primary Therapy in Common Non-Metastatic Solid Tumours
ACE Proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer
INTERVAL (GAP 4) Intense Exercise For Survival Among Men with Metastatic Castrate-Resistant Prostate Cancer (Interval-MCRPC): A Multicentre, Randomised, Controlled III Study [ON HOLD]
Lantern Pharma Biomarker analysis using fresh biopsy tissue [ON HOLD]
Pivotal Boost A Phase III Randomised Controlled Trial of Prostate and Pelvis Versus Prostate Alone Radiotherapy With Or Without Prostate Boost
PACE-C (Prostate Advances in Comparative Evidence) International randomised study of prostatectomy vs stereotactic body radiotherapy (SBRT) and conventional radiotherapy vs SBRT for organ-confined prostate cancer
Sarcoma
Stomach/Gastro-oesophageal junction Cancer
ADD ASPIRIN A Phase III, Double-Blind, Placebo-Controlled Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival after Primary Therapy in Common Non-Metastatic Solid Tumours
PLATFORM PLAnning Treatment For Oesophago-Gastric Cancer: a Randomised Maintenance Therapy Trial [ON HOLD]
Vulval Cancer
RANGO Rare Neoplasms of Gynaecological Origin
Studies not specific to one particular type of cancer
CaPP3 A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme
ADD ASPIRIN A Phase III, Double-Blind, Placebo-Controlled Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival after Primary Therapy in Common Non-Metastatic Solid Tumours
A Phase I trial of LY3143921 hydrate in solid tumours A Cancer Research UK phase I trial of LY3143921 hydrate (a CDC7 inhibitor) given orally once daily in adult patients with advanced solid tumours
CellCentric CCS1477-01 An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination in patients with advanced solid/metastatic tumours
UK P3BEP A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours
Haematological Clinical Trials
Leukaemia
UKALL 14 A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia
AML19 Adults with Acute Leukaemia or High Risk Myelodysplastic Syndrome
AML 18 A Trial For Older Patients With Acute Myeloid Leukaemia And High Risk Myelodysplastic Syndrome
PACE Patients with AML and COVID-19 Epidemiology
Lymphoma
FLAIR Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab
MaPLe Molecular Profiling for Lymphoma Study [ON HOLD]
ENRICH A randomised, open label study of rituximab + ibrutinib (IR) vs rituximab + chemotherapy (R-Chemo) in older patients with untreated mantle cell lymphoma. Primary objective is to assess whether IR is superior to R-Chemo in terms of progression-free survival (PFS)
ME-401 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies
Multiple Myeloma
C16021 A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation [ON HOLD]
CC-5013-MM-034 A prospective non-interventional post-authorization safety study (PASS) of lenalidomide in previously untreated adult multiple myeloma patients who are not eligible for transplant (“transplant noneligible” [TNE]) (“Revlimid® TNE NDMM PASS”)
Other Haematological
AML 18 A Trial For Older Patients With Acute Myeloid Leukaemia And High Risk Myelodysplastic Syndrome
Idiopathic Cytopenia Improving diagnosis in idiopathic cytopenia using gene sequencing
Manifest A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Haematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 with and without Ruxolitinib in Patients with Myelofibrosis)
MOSAICC MyeloprOliferative NeoplasmS An In-Depth Case-Control Study: A Case-Control Study Of Patients With Myeloproliferative Neoplasms And Non-Blood Relative/Friend Controls [ON HOLD]
