Research Ethics Committee Reference Number Integrated Research Application System Number Submission Type Name of Trial Date of Receipt of Date of Valid Research Application First Patient Recruited? Date of First Date Study Patient Recruited Initiated Date Site Invited Date Site Selected HRA Approval Date Date Site Date Site Confirmed By Confirmed Sponsor Non- Confirmation Status Date Site Ready To Start A - s delayed/denied B - Suspended C - Closed by by sponsor sponsor D - Sponsor Delays E - Staff availability issues F - No patients G - No seen patients consented H - Contracting I - Rare delays diseases J - Other Reasons for delay correspond to: Multi-drug, genetic marker- 14/SC/1346 151280 directed, non-comparative, multi-centre, multi-arm phase II trial in non-small cell lung cancer 23/06/2015 01/07/2015 Yes 24/08/2015 A Phase II Clinical Trial of 15/LO/0236 170073 Pembrolizumab (MK-3475) in Subjects with Advanced/Unresectable or Metastatic Urothelial Cancer 23/06/2015 02/07/2015 Yes 03/12/2015 Y Neither A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as 15/LO/0171 138557 second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy. 18/06/2015 07/07/2015 Yes 12/08/2015 12/LO/1319 95993 14/LO/2181 154300 A Phase 2 study for older adults with Acute Lymphoblastic Leukaemia RIO - Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer 23/06/2015 08/07/2015 No Y Neither 14/05/2015 14/07/2015 Yes Sponsor 05/08/2015 Y Y An open label, phase Ib/2 study 15/YH/0125 165426 of ACP-196 in subjects with Waldenstrom Macroglobulinemia 17/06/2015 20/07/2015 Yes 20/11/2015 Y Y Y Neither A Randomised Phase II Study of Nintedanib (BIBF1120) 13/ES/0123 119188 Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium 16/07/2015 20/07/2015 Yes 27/10/2015 Y Neither UNIRAD: Randomized, doubleblind, multicentre phase III trial evaluating the safety and benefit of adding everolimus to 14/SS/1043 142447 adjuvant hormone therapy in women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after at least 1 year of adjuvant hormone therapy 17/07/2015 27/07/2015 No Y Sponsor A RANDOMIZED, OPEN LABEL, PHASE 2 STUDY OF THE SELECTIVE INHIBITOR OF NUCLEAR EXPORT (SINE) SELINEXOR (KPT330) VERSUS 14/NW/1358 158383 SPECIFIED PHYSICIAN?S CHOICE IN PATIENTS = 60 YEARS OLD WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY AND/OR TRANSPLANTATION 17/07/2015 29/07/2015 Yes 01/06/2016 Y Y Neither A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, 15/LO/0710 177905 Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy 27/07/2015 29/07/2015 Yes 17/02/2016 Y Neither TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Singleagent Cytotoxic Chemotherapy 15/LO/0182 171587 in Patients with Mutant EGFR Non-small Cell Lung Cancer (NSCLC) after Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy 29/07/2015 30/07/2015 Yes 21/08/2015
Phase I open label, dose escalation trial to determine the MTD, safety, PK and efficacy of Afatinib Monotherapy in 15/LO/0605 161395 children aged 2 years to <18 years with recurrent/refractory Neuroectodermal tumours, Rhabdomyosarcoma and/or other solid tumours with known ErbB pathway deregulation regardless of tumour histology. 23/07/2015 31/07/2015 Yes 13/08/2015 Phase II randomised placebo controlled Neoadjuvant 13/NW/0134 105317 chemotherapy study of Nintedanib with Gemcitabine and Cisplatin in locally advanced muscle invasive bladder cancer 23/07/2015 31/07/2015 Yes 29/09/2015 Prostate Adenocarcinoma: TransCutaneous Hormones. A 05/Q1206/168 32077 randomised-controlled trial of transcutaneous oestrogen patches versus LHRH analogues in prostate cancer. 10/06/2015 03/08/2015 Yes 11/08/2015 15/LO/1003 173560 MINSTREL - Mri IN STaging REctal cancer planes 24/07/2015 13/08/2015 Yes 11/09/2015 A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and 15/LO/0448 171812 Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL) 11/08/2015 14/08/2015 Yes 18/09/2015 International randomised controlled trial of 14/NW/1110 149572 chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma 12/08/2015 18/08/2015 Yes 05/10/2015 A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin 15/EE/0126 173629 Compared to Investigator?s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non- Adjuvant Chemotherapy 14/08/2015 19/08/2015 Yes 12/10/2015 ARMOR3-SV: A PHASE 3, RANDOMIZED, OPEN LABEL, MULTICENTER, CONTROLLED STUDY OF GALETERONE 15/LO/0564 173148 COMPARED TO ENZALUTAMIDE IN MEN EXPRESSING ANDROGEN RECEPTOR SPLICE VARIANT-7 mrna (AR-V7) METASTATIC (M1) CASTRATE RESISTANT PROSTATE CANCER (CRPC) 03/08/2015 19/08/2015 Yes 15/03/2016 Y Sponsor Phase I study of oral BAY 15/LO/1016 178348 1143269 given alone or in combination with intravenous docetaxel. 19/08/2015 07/09/2015 Yes 22/09/2015 A Randomised phase II trial of Adaptive Image guided 15/LO/0539 166304 standard or Dose Escalated tumour boost Radiotherapy in the treatment of transitional cell carcinoma of the bladder 25/08/2015 22/09/2015 Yes 20/10/2015 A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, 15/LO/1118 180199 pharmacodynamics and clinical activity of GSK525762 in subjects with NUT midline carcinoma (NMC) and other cancers. 15/09/2015 22/09/2015 Yes 14/10/2015
IMMotion 151 - A Phase III, Open-Label, Randomized Study 15/LO/0897 171318 Of MPDL3280A (Anti-PD-L1 Antibody) In Combination With Bevacizumab Versus Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma 08/09/2015 24/09/2015 Yes 04/03/2016 Y Neither A phase III, double blind, placebo controlled, randomised 14/SC/0171 120104 trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumours 17/09/2015 25/09/2015 Yes 20/10/2015 LungTech Stereotactic Body 15/NW/0076 163097 Radiotherapy (SBRT) of Inoperable Centrally Located Non-Small Cell Lung Cancer (NSCLC): A Phase II Study 02/09/2015 29/09/2015 Yes 02/12/2015 Y Sponsor 15/SC/0406 182571 15/WM/0102 172463 15/LO/0984 171246 15/EM/0385 174324 15/EM/0312 141696 14/LO/1568 148036 15/LO/1014 166974 12/LO/1078 97486 15/NW/0382 174771 15/WS/0011 122822 15/WS/0182 167556 15/NW/0416 167060 15/SC/0552 184105 15/NW/0431 177346 15/LO/1284 179637 15/LO/0114 160295 15/LO/1246 180129 15/LO/1282 183773 15/LO/1117 181901 15/LO/0302 172756 15/NW/0627 181538 15/LO/0924 173624 15/SC/0456 174561 15/LO/1302 169660 14/WM/0083 125950 15/LO/0290 151495 15/SC/0306 176881 15/LO/0159 169996 11/LO/2036 95258 velumab combined with axitinib in 30/09/2015 01/10/2015 Yes 15/10/2015 Daratumumab Dose Schedules in 24/09/2015 02/10/2015 Yes 31/03/2016 Y Neither CORAIL 24/09/2015 05/10/2015 Yes 21/10/2015 Checkmate - 171 18/09/2015 05/10/2015 Yes 03/11/2015 Novartis Brain Mets study - new 18/09/2015 14/10/2015 Yes 14/03/2016 Y Y Neither TIER 21/09/2015 16/10/2015 No Y Y Neither n aromatherapy intervention on s 13/10/2015 19/10/2015 Yes 11/12/2015 MUK five 09/10/2015 22/10/2015 Yes 18/11/2015 Paclitaxel in 2L Subjects with Adva 21/10/2015 23/10/2015 Yes 22/12/2015 BALLAD 09/10/2015 26/10/2015 Yes 12/02/2016 Y Y Neither d acceptability of closed-face and 15/10/2015 27/10/2015 Yes 12/11/2015 MUK8 21/10/2015 03/11/2015 No Y Y Sponsor rointestinal Stromal Tumors (GIST 16/10/2015 03/11/2015 Yes 11/01/2016 Y Sponsor e II trial with a pan-fgfr Tyrosine 04/11/2015 06/11/2015 Yes 05/01/2016 MAX?-TF-ADC) IN PATIENTS WITH 27/10/2015 12/11/2015 Yes 03/03/2016 Y Neither ass chimeric IgE antibody against 05/11/2015 12/11/2015 No Sponsor Y CARRIE 09/11/2015 12/11/2015 No Y Sponsor mab plus Pembrolizumab in differ 03/11/2015 12/11/2015 Yes 17/11/2015 oride in combination with paclitax 05/11/2015 19/11/2015 Yes 02/12/2015 Millennium C34001 Study 18/11/2015 20/11/2015 Yes 10/02/2016 Y Sponsor MACODYNAMICS OF AXITINIB (AG 25/11/2015 26/11/2015 No Neither Y nd Randomised Study of Orally Ad 30/10/2015 27/11/2015 No Y Y Neither -L1 Antibody (MPDL3280A) in Ped 23/11/2015 30/11/2015 Yes 28/01/2016 OCTOPUS 18/11/2015 01/12/2015 Yes 30/12/2015 LORIS 20/08/2015 03/12/2015 Yes 25/02/2016 Y Y Sponsor METformin And Longevity (METAL 17/11/2015 09/12/2015 Yes 11/02/2016 Y Sponsor RANGE 08/12/2015 11/12/2015 Yes 15/03/2016 Neither Y Y SelPac 16/12/2015 18/12/2015 Yes 22/12/2015, PK & Efficacy Study of Oral Ruca 18/11/2015 21/12/2015 Yes 18/02/2016 Y Sponsor INtegratioN of trastuzumab, with or without pertuzumab, 15/LO/0954 177557 into perioperative chemotherapy of HER-2 positive stomach cancer: the INNOVATION-TRIAL 01/12/2015 04/01/2016 No Y Y Neither Dose Optimization Study of 15/YH/0434 185622 Idelalisib in Follicular Lymphoma and Small Lymphocytic Lymphoma 16/12/2015 06/01/2016 No Y Sponsor An Open-label Phase 1b 15/LO/1825 191886 QT/QTc Study of JNJ-56021927 (ARN-509) in Subjects With Castration-Resistant Prostate Cancer. 21/12/2015 13/01/2016 Yes 21/04/2016 Y Neither
PRADA -Neoadjuvant 15/LO/1071 154616 Chemotherapy and Radiotherapy before Mastectomy & DIEP Reconstruction 22/12/2015 14/01/2016 Yes 25/01/2016 A Phase I, Open-Label, Multicentre Study to Assess the 14/NW/0069 144974 Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages >6 Months to <18 Years Receiving Treatment with Opioids 16/12/2015 18/01/2016 No Y Y Neither ANNOUNCE - A Randomized, Double-Blind, Placebo- 15/SC/0676 186964 Controlled, Phase 3 Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma 18/12/2015 20/01/2016 Yes 01/02/2016 Adults with Acute Myeloid 14/WA/1056 154468 Leukaemia or High-Risk Myelodysplastic Syndrome (AML19) 04/01/2016 21/01/2016 Yes 08/02/2016 UK Multicentre Study of 13/LO/0706 119677 Children with Opsoclonus Myoclonus Syndrome (UMSCOM) 22/01/2016 26/01/2016 No Y Y Neither A randomized, multicenter, open label, non-inferiority, 15/NW/0492 181246 phase 3 study of ACP-196 versus Ibrutinib in previously treated subjects with high risk chronic lymphocytic leukaemia 22/12/2015 27/01/2016 Yes 21/04/2016 Y Y Neither Phase 1b/2 Study of Carfilzomib in Combination with Dexamethasone, Mitoxantrone, 15/LO/1226 163213 PEG-asparaginase, and Vincristine (UK R3 Induction Backbone) in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia 25/01/2016 27/01/2016 No Y Y Neither A Phase 2 Open Label, Multi- Center, Multinational, Randomized, Parallel Design 15/NW/0713 171836 Study Investigating The Efficacy and Safety Of GTx-024 On Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women 22/01/2016 29/01/2016 Yes 23/02/2016 Open-label, Non-randomized Phase 2 Study With Safety Run- 15/SC/0009 170938 in Evaluating Efficacy and Safety of PQR309 in Patients With Relapsed or Refractory Lymphoma 17/12/2015 29/01/2016 Yes 12/05/2016 Y Y Sponsor An explorative phase II study of 15/LO/0640 166391 Anti-PD-1 (Pembrolizumab) therapy in metastatic melanoma (ADAPTeM) 15/01/2016 29/01/2016 No Y Y Sponsor Randomized, placebocontrolled, double-blind phase 2 study of Patritumab (U3-15/LO/1670 188788 1287) in combination with cetuximab plus platinum-based therapy in first line setting in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck 21/01/2016 02/02/2016 Yes 04/02/2016 Adjuvant immunotherapy with anti-pd-1 monoclonal antibody Pembrolizumab (MK-3475) 15/NW/0690 177116 versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double- blind Phase 3 trial of the EORTC Melanoma Group 08/01/2016 02/02/2016 Yes 24/02/2016
A randomized, multicenter, double-blind, placebocontrolled, Phase 2/3 study of the Bruton?s Tyrosine Kinase inhibitor ibrutinib in 15/EE/0353 187464 combination with nab-paclitaxel and gemcitabine versus placebo in combination with nabpaclitaxel and gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma 02/02/2016 03/02/2016 Yes 09/03/2016 A Phase I, Open-Label,Two- 15/NE/0375 191513 Part, Safety and Tolerability Study of U3-1784 in Patients with Advanced Solid Tumours 04/02/2016 04/02/2016 Yes 11/05/2016 Y Sponsor A Clinical Trial of Pembrolizumab (MK-3475) 15/LO/2073 192537 Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158) 01/02/2016 05/02/2016 Yes 14/03/2016 A Trial for Older Patients with 13/WA/0205 127379 Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome 13/01/2016 11/02/2016 Yes 04/05/2016 Y Neither A Phase 3, Randomized, Placebo-Controlled, Double- Blind Study of Oral Ixazomib 15/NE/0167 171524 Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation 09/02/2016 15/02/2016 No Y Y Neither A randomized, phase 3 trial with anti-pd-1 monoclonal antibody pembrolizumab (MK- 15/LO/1419 183975 3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS) 29/01/2016 17/02/2016 No Y Neither An Open-Label, Randomized Phase 3 Trial of Nivolumab and Nivolumab plus Ipilimumab 15/SC/0475 174852 versus Platinum Doublet Chemotherapy in Patients with Chemotherapy-Na?ve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) 09/02/2016 18/02/2016 Yes 24/03/2016 A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent 15/LO/1950 184545 Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1) 15/02/2016 22/02/2016 No Y Y Neither Randomised phase 3 trial of 14/LO/2218 161762 enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer : ENZAMET 15/02/2016 25/02/2016 Yes 16/06/2016 Y Neither TRIGGER - Magnetic Resonance Tumour Regression Grade (mrtrg) As A Novel Biomarker 15/LO/1836 156408 To Stratify The Management Of Good And Poor Responders To Chemoradiotherapy: A Rectal Cancer Multicentre Randomised Control Trial 08/02/2016 26/02/2016 Yes 16/03/2016 A PHASE 1, OPEN-LABEL, NON- RANDOMIZED, SAFETY, 15/LO/2028 191408 TOLERABILITY, AND PHARMACOKINETIC STUDY OF TAS3681 IN PATIENTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER 16/02/2016 29/02/2016 Yes 30/03/2016 15/EM/0546 194511 15/LO/1904 173980 MEDI4736 or in combo with Tremelimumab vs SOC in 1st 25/02/2016 29/02/2016 Yes 29/02/2016 line SCCHN cancer MROC: MR in Ovarian Cancer 25/02/2016 04/03/2016 Yes 17/05/2016 Y Neither
A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single 15/LO/1990 185316 Agent Chemotherapy per Physician?s Choice for Metastatic Triple Negative Breast Cancer (mtnbc)? (KEYNOTE-119) 04/03/2016 07/03/2016 Yes 14/03/2016 15/EE/0421 191851 Pomalidomide in relapsed and refractory multiple myeloma (RRMM) 02/03/2016 10/03/2016 Yes 06/04/2016 A phase III, open label, multicentre randomised clinical study comparing Acelarin (NUC- 15/EM/0095 166503 1031) with Gemcitabine in patients with metastatic pancreatic carcinoma (ACELARATE: Acelarin first line randomised pancreatic study) 04/02/2016 14/03/2016 Yes 28/04/2016 Y Y Sponsor Evaluation of CanADVICE+? M- 15/LO/1849 174504 health system to support cancer patients receiving oral anticancer drugs: Proof of concept 04/02/2016 16/03/2016 Yes 02/05/2016 Y Neither A RANDOMIZED PHASE II/III STUDY TO ASSESS THE EFFICACY OF TRAMETINIB (GSK 14/ES/1064 148489 1120212) IN PATIENTS WITH RECURRENT OR PROGRESSIVE LOW-GRADE SEROUS OVARIAN CANCER OR PERITONEAL CANCER. NCT #NCT02101788 (07/28/14) - LOGS Study 07/03/2016 22/03/2016 No Y Sponsor A study to determine if it is feasible to recruit into a randomised trial comparing 13/LO/1481 132746 (extended) pleurectomy decortication versus no pleurectomy decortication in the multimodality management of patients with malignant pleural mesothelioma 11/03/2016 23/03/2016 Yes 04/07/2016 Y Neither 16/NW/0034 194828 on Therapy in Newly Diagnosed A 23/03/2016 05/04/2016 No Y Y Neither 15/SC/0437 177789 18F) PET/CT in biochemical recurr 29/03/2016 05/04/2016 Yes 13/07/2016 Y Y Sponsor 15/LO/1595 183040 PRISM 29/03/2016 07/04/2016 Yes 01/06/2016 15/LO/1807 187302 Checkmate 331 30/03/2016 08/04/2016 Yes 26/05/2016 14/YH/0076 141623 BALANCED 04/03/2016 12/04/2016 Yes 04/05/2016 13/SC/0467 136379 scalation of LTX-315 in transderma 07/04/2016 19/04/2016 Yes 19/05/2016 Controlled Phase 3 Adaptive Trial 30/03/2016 19/04/2016 No 15/EM/0543 176792 Y Neither 16/ES/0004 192492 00001 (MEDIOLA) Advanced Solid 22/04/2016 22/04/2016 No 15/LO/1478 170857 ve radiotherapy with anti-pd1 ant 29/04/2016 03/05/2016 Yes 07/06/2016 PLUMMB 01/03/2016 04/05/2016 No 15/SC/0414 164334 Y Sponsor 15/SC/0679 157131 Combination with Dabrafenib in C 23/03/2016 11/05/2016 No Y Y Sponsor point pathway and nivolumab clin 21/03/2016 18/05/2016 Yes 16/SC/0137 198815 27/05/2016 15/WS/0248 164622 udy of IMRT in primary bone and s 29/03/2016 09/06/2016 Yes 27/06/2016 Y Both 14/NW/1097 121982 3397 c?kit in advanced acral and 24/03/2016 27/06/2016 No Y Y Sponsor Phase 1B/2 study of avelumab HRA Approval in patients with advanced Y Sponsor 16/SC/0139 184651 22/10/2015 02/03/2016 26/04/2016 24/05/2016 25/05/2016 25/05/2016 Y malignancies 15/EE/0442 181302 HRA Approval CANC - 5173 24/03/2016 23/03/2016 23/03/2016 22/04/2016 18/07/2016 18/07/2016 18/07/2016 Y Sponsor 14/LO/1486 159398 HRA Approval T-Vec - MASTERKEY-265 30/03/2016 09/05/2014 07/04/2016 07/04/2016 Y Y Sponsor A Phase 1b/2 Study of Ibrutinib Combination Therapy in 16/LO/0685 199044 HRA Approval Selected Advanced Gastrointestinal And Genitourinary Tumors MK-8628 Haematologic 16/LO/0676 200558 HRA Approval Malignancy Trial KEYNOTE-199 - Phase II Trial of MK-3475 in Subjects with 16/LO/1034 205702 HRA Approval mcrpc with Prior Chemotherapy 11/04/2016 21/04/2016 Y Y Sponsor 29/01/2016 22/04/2016 31/05/2016 01/04/2016 01/06/2016 16/NE/0142 202233 HRA Approval Javelin Ovarian 100 B9991010 03/06/2016
Three versus five years of adjuvant imatinib as treatment 16/EE/0234 194284 HRA Approval of patients with operable GIST with a high risk for recurrence: A randomised phase III study 14/06/2016 14/06/2016 16/NE/0166 200316 HRA Approval Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab In Patients With Follicular Non- Hodgkin's Lymphoma 16/06/2016 28/06/2016 A Phase 1B/2A Multicenter, Open-Label, Dose-Escalation Study to Determine the Maximum tolerated Dose, 16/NE/0159 205953 HRA Approval Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of CC- 220 Monotherapy... Evaluating TAS-116 in Patients 16/LO/0708 200170 HRA Approval with Advanced Solid Tumors 11/04/2016 21/06/2016 09/03/2016 06/06/2016 30/06/2016