Research Ethics Committee Reference Number

Research Ethics Committee Reference Number

Minimum Maximum Total Number Number Of Number Of Target Date To Research Ethics Integrated Research Date Agreed to Of Patients Date That The Total Number Of Target Number Of Patients Agreed Patients Agreed Recruit Reason For Closure Committee Application System Name of Trial recruit target Recruited At Trial Closed To Study Participants Patients Agreed? (Enter Same In (Enter Same In Patients Of Trial Reference Number Number number of patients The Agreed Recruitment Recruited Both If Only One Both If Only One Agreed? Target Date Number) Number) Not Available / Not Withdrawn By 15/LO/0834 172183 WO29522 (Impassion-130) Date Agreed 31/07/2017 3 05/06/2017 3 Agreed Sponsor Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to Standard-of-Care 16/LO/0595 198560 Chemotherapy of Physician’s Choice plus Trastuzumab in Number Agreed 6 6 Date Agreed 31/12/2018 7 02/02/2018 7 Recruitment Finished Women with HR+, HER2+ Locally Advanced or Metastatic Breast Cancer A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO- CONTROLLED PHASE II STUDY OF THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE IN COMBINATION WITH 16/EM/0320 208246 ATEZOLIZUMAB OR ATEZOLIZUMAB-PLACEBO IN PATIENTS Number Agreed 2 2 Date Agreed 30/06/2017 3 28/07/2017 3 Recruitment Finished WITH HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE RECEIVED PRIOR TRASTUZUMAB AND TAXANE BASED THERAPY. An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and postmenopausal women with 16/EE/0463 214371 Range Agreed 8 12 Date Agreed 31/12/2019 10 16/10/2017 10 Recruitment Finished hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (ABC) with no prior hormonal therapy for advanced disease A phase 1, open-label, non-randomized, dose escalating safety, tolerability, harmacokinetic, and pharmacodynamic study of tas- Withdrawn By 14/LO/1081 156436 Number Agreed 50 50 Date Agreed 31/01/2017 18 31/10/2017 25 119, as monotherapy and in combination with docetaxel, in Sponsor patients with advanced solid tumours DOSE-ESCALATING SAFETY TRIAL OF TISSUE FACTOR SPECIFIC ANTIBODY DRUG CONJUGATE (HUMAX®-TF-ADC) IN PATIENTS 15/LO/1284 179637 Number Agreed 26 26 Date Agreed 01/10/2016 3 14/06/2017 6 Recruitment Finished WITH LOCALLY ADVANCED AND/OR METASTATIC SOLID TUMORS KNOWN TO EXPRESS TISSUE FACTOR 16/ES/0004 192492 D081KC00001 (MEDIOLA) Advanced Solid Tumours Number Agreed 5 5 Date Agreed 30/09/2017 5 29/05/2017 5 Recruitment Finished A phase Ib, Open-Label, Dose Escalation and Expansion Study of Demcizumab Plus Pembrolizumab and Demcizumab plus Withdrawn By 16/LO/0397 191752 Number Agreed 10 10 Date Agreed 31/03/2017 5 10/04/2017 5 Pembrolizumab, Pemetrexed and Carboplatin in Patients with Sponsor Locally Advanced or Metastatic Solid Tumors A phase I open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical Withdrawn By 14/LO/0044 139567 Number Agreed 25 25 Date Agreed 01/03/2015 2 19/06/2017 16 activity of GSK2816126 in subjects with relapsed/refractory Sponsor diffuse large B cell and transformed follicular lymphoma An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-970 as a 14/LO/0372 148591 Number Agreed 40 40 Date Agreed 31/10/2015 31 27/09/2017 71 Recruitment Finished Single Agent and in Combination With Carboplatin in Subjects With Advanced Solid Tumors IMPALA - Evaluation of an immunomodulatory maintenance 14/SC/0295 154130 treatment in patients with metastatic colorectal cancer with Number Agreed 10 10 Date Agreed 01/10/2019 23 11/05/2017 23 Recruitment Finished tumour reduction during induction treatment 15/LO/1246 180129 CARRIE Range Agreed 2 6 Date Agreed 29/10/2015 3 05/05/2017 3 Recruitment Finished GAST-4466 - GS-US-296-1080, A Study to evaluate the 16/LO/0334 193988 Number Agreed 3 3 Date Agreed 31/07/2018 5 12/05/2017 5 Recruitment Finished efficacy&safety of GS-5745 Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo plus Cisplatin and Gemcitabine as First- 16/NW/0379 200426 Number Agreed 6 6 Date Agreed 30/05/2017 1 28/07/2017 2 Recruitment Finished Line Treatment in Patients with Advanced or Mmetastatic Biliary Tract Cancer A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined with Nivolumab 16/EM/0408 211983 versus Nivolumab Alone in Subjects with Unresectable or Range Agreed 1 4 Date Agreed 01/03/2018 14 10/04/2017 14 Recruitment Finished Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus 15/WS/0174 182797 Range Agreed 1 5 Date Agreed 30/04/2019 0 03/05/2017 0 Recruitment Finished Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma A Novel Phase I/IIa Open-label Study of IMM-101 in Withdrawn By 16/LO/1784 211244 Combination with Selected Standard of Care (SOC) Regimens in Range Agreed 1 40 Date Agreed 31/03/2019 0 31/07/2017 0 Sponsor Patients with Metastatic or Unresectable Cancer at Study Entry RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY EVALUATING 15/LO/2100 192155 Range Agreed 1 4 Date Agreed 01/12/2017 4 30/11/2017 4 Recruitment Finished TAS-102 PLUS ElevatION:CRC-101: A Phase Ib study of PDR001 in combination Not Available / 17/EM/0272 228700 with bevacizumab and mFOLFOX6 as first line therapy in Number Agreed 3 3 08/11/2017 1 Recruitment Finished Not Agreed patients with metastatic MSS colorectal cancer 16/NE/0027 187317 Javelin Ovarian 200 B9991009 Number Agreed 6 6 Date Agreed 30/06/2017 15 19/04/2017 13 Recruitment Finished A PHASE 3 OPEN-LABEL RANDOMIZED STUDY OF QUIZARTINIB (AC220) MONOTHERAPY VERSUS SALVAGE CHEMOTHERAPY IN SUBJECTS WITH FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA 14/EM/0130 149751 Number Agreed 5 5 Date Agreed 29/05/2015 10 01/09/2017 11 Recruitment Finished (AML) REFRACTORY TO OR RELAPSED AFTER FIRST-LINE TREATMENT WITH OR WITHOUT HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) CONSOLIDATION A randomized, multicenter, open label, non-inferiority, phase 3 Not Available / Not Not Available / 15/NW/0492 181246 study of ACP-196 versus Ibrutinib in previously treated subjects 31/10/2017 3 Recruitment Finished Agreed Not Agreed with high risk chronic lymphocytic leukaemia 16/SC/0068 196245 Fusion MDS-001 Range Agreed 1 4 Date Agreed 15/07/2017 4 06/11/2017 7 Recruitment Finished KEYNOTE 048 - A Phase 3 Clinical Trial of Pembrolizumab (MK- 16/LO/1133 203679 3475) in First Line Treatment of Recurrent/Metastatic Head and Range Agreed 6 11 Date Agreed 22/12/2016 11 12/04/2017 12 Recruitment Finished Neck Squamous Cell Carcinoma An Open-Label, Single-Arm, Multicenter, Phase 2 Trial of Withdrawn By 16/LO/1799 199959 Number Agreed 3 3 Date Agreed 25/07/2018 2 10/10/2017 2 Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC) Sponsor 15/EM/0312 141696 Ascend 7: Novartis Brain Mets study - new lung study Number Agreed 2 2 Date Agreed 01/07/2018 2 15/09/2017 2 Recruitment Finished An Open-Label, Randomized Phase 3 Trial of Nivolumab and Nivolumab plus Ipilimumab versus Platinum Doublet Withdrawn By 15/SC/0475 174852 Number Agreed 6 6 Date Agreed 31/08/2019 4 17/08/2017 4 Chemotherapy in Patients with Chemotherapy-Naïve Stage IV or Sponsor Recurrent Non-Small Cell Lung Cancer (NSCLC) CheckMate 451: CHECKpoint pathway and nivolumab clinical 15/EE/0418 188945 Number Agreed 4 4 Date Agreed 14/10/2017 3 11/09/2017 3 Recruitment Finished Trial Evaluation 451 A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Withdrawn By 16/LO/1032 199608 Maintenance Treatment after Induction with Nab-Paclitaxel plus Range Agreed 2 10 Date Agreed 31/05/2017 1 02/06/2017 1 Sponsor Carboplatin in Subjects with Squamous Cell Non-Small Cell Lung Cancer (NSCLC) A Phase 2, Multicenter Study of the EZH2 Inhibitor Tazemetostat 16/SC/0341 204761 in Adult Subjects with Relapsed or Refractory Malignant Range Agreed 5 6 Date Agreed 31/05/2018 6 18/05/2017 6 Recruitment Finished Mesothelioma with BAP1 Loss of Function A Phase 3 Multicenter Open-label Study of Brigatinib versus 16/EM/0165 203281 Range Agreed 1 3 Date Agreed 31/07/2017 1 28/07/2017 1 Recruitment Finished Crizotinib A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide 15/LO/1950 184545 in Subjects with Newly Diagnosed Glioblastoma (GBM) with Range Agreed 4 10 Date Agreed 30/03/2018 4 15/12/2017 4 Recruitment Finished Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1) A Phase 1/2 multicenter, open-label, dose-finding study to assess the safety, tolerability and preliminary efficacy of weekly 13/LO/1272 133720 Number Agreed 5 5 Date Agreed 30/07/2016 9 18/10/2017 9 Recruitment Finished paclitaxel in paediatric patients with recurrent or refractory solid tumours PROSPER: A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Not Available / 13/LO/1081 132715 Number Agreed 25 25 14/04/2017 8 Recruitment Finished Patients With Nonmetastatic Castration-Resistant Prostate Not Agreed Cancer CheckMate 401: CHECKpoint pathway and nivoluMAb clinical 15/EE/0448 189797 Range Agreed 1 5 Date

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