Portfolio – Open Trials

Northern Ireland Cancer Trials Network

Belfast Experimental Cancer Medicine Centre

 TRIALS OPEN TO RECRUITMENT – 

May 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

PROMETCO A real world prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective

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 [ON HOLD]

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)

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

ICON 9 An international phase III randomised study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy

MONITOR-UK Multi-Centre Observational study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK routine clinical practice experience

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  [ON HOLD]

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

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

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)

The Tidal Study A Multicenter, Open-label, single-arm, Phase 2 Study of Zandelisib (ME401) in Subjects with Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies

Multiple Myeloma

 

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]

M16-109 A Phase II Open-Label Study Evaluating Tolerability And Efficacy of Navitoclax Alone or In Combination With Ruxolitinib in Subjects With Myelofibrosis