Perfomance in Delivering (Commercial Trials)

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1 Perfomance in Delivering (Commercial Trials) REC Ref IRAS ID Name of Trial Target Of? Minimum Of Maximum Of Target Date To Recruit? Total Date Of to recruit target number Recruited At of patients The Target Date Date That The Trial Closed To Total Of Study Participants Recruited Reason For Closure Of Trial Comments 17/LO/ A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study 1 1 Date 30/09/ /01/ The proposed patient due to roll over to the extension was later found to be ineligible and it was only after this time that a substantial amendment reopened recruitment to patients rolling over from another trial running at Mount Vernon Cancer Centre. 16/NE/ A Randomized, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Avelumab (MSB C) in Combination with and/or Following Chemotherapy in with Previously Untreated Epithelial Ovarian Cancer 5 5 Date 31/07/ /01/ Global recruitment target reached. 16/LO/ A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Balloon PTA Catheter for Treatment of Dysfunctional AV Fistulae 5 10 Date 31/10/ /02/ Sponsor reached target enrolment.

2 16/EM/ An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention 8 8 Date 31/05/ /04/ /SC/ Prospective,single-arm, multicentre, observational registry Not Available to further validate safety and / Not efficacy of the ultimaster DES in real-world patients. Not Available / Not 03/05/ /WM/ A phase 3 randomized, openlabel (sponsor-blind), activecontrolled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa Date 30/04/ /06/ Less eligible patients seen during the recruitment period than expected. 1 patient was successfully randomised into the study and there was 1 screen fail. 17/LO/ A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab soravtansine (IMGN853) Versus Investigator s Choice of Chemotherapy in Women with Folate Receptor a- positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer 3 3 Date 21/06/ /04/ patients recruited to the study. Unfortunatley 1 patient signed the prescreening consent but passed away before results came back to determine if they were eligible to go on to the study or not.

3 16/EM/ SINGLE ARM STUDY OF ALXN1210 IN COMPLEMENT INHIBITOR TREATMENT-NAÃ VE ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (ahus) 1 1 Date 31/05/ /05/ This study was difficult to recruit to due to the rare cohort of patients and strict inclusion/exclusion criteria. 17/LO/ A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma 1 1 Date 31/12/ /06/ finished 17/YH/ A Randomized Phase 3 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Alone or with Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in with Metastatic Non-Small Cell Lung Cancer 3 3 Date 31/07/ /07/ Sponsor suspended recruitment and closed the open label pembrolizumab + epacadostat arm. As a result we were unable to reach our target. 17/YH/ A multi-center, double-blind, randomized, placebocontrolled study to assess the pharmacodynamics, pharmacokinetics, tolerability, and safety of a single subcutaneous injection of ACT in adults with stable coronary artery disease 2 13 Date /07/2018 4

4 16/LO/ A Randomised, Double-blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Admitted for Acute Heart Failure (AFFIRM-AHF) 2 10 Date 30/06/ /09/ /EE/ A RANDOMIZED, DOUBLE- BLIND, PLACEBOCONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-α INHIBITORS 3 3 Date 31/05/ /08/ patient screen failed and study closed early to recruitment due to not being feasible. 17/LO/ A PHASE III, RANDOMIZED, MULTICENTER, DOUBLE- BLIND, PLACEBO- CONTROLLED CLINICAL TRIAL OF OMALIZUMAB IN PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS 2 6 Date 26/09/ /08/ patients screen failed and study closed to recruitment due to study target being met. 17/LO/ A Phase III Randomized, Double-Blind, Placebocontrolled Trial of Pembrolizumab (MK 3475/SCH900475) in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the Firstline Treatment of Subjects with Extensive Stage Small Cell Lung Cancer (KEYNOTE- 604) 4 4 Date 05/03/ /07/ patient recruited and 1 patient screen failed. was more difficult than expected.

5 18/NW/ Effect and safety of semaglutide 2.4 mg onceweekly in subjects with overweight or obesity and type 2 diabetes 8 8 Date 19/11/ /11/ /EM/ A Phase III, double-blind, randomized placebocontrolled study to evaluate the effectsof dalcetrapib on cardiovascular (CV) Risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal- GenE trial 6 6 Date 30/11/ /12/ /YH/ A Phase 1/2, open-label, multicentre, dose escalation and dose expansion study of NKTR-214 and Nivolumab in patients with select locally advanced or metastatic solid tumor malignancies 5 5 Date 31/07/ /11/ Withdrawn By Sponsor Sponsor (NEKTAR) decided to close our site for the PIVOT-02 study. There were 4 cohorts open and 3 of them closed before we could recruit. With regards to the last cohort left open, we didn t have any suitable patients for it. 17/LO/ Phase 3, Randomized, Open- Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE CONVERSION) 4 4 Date 31/01/ /12/ Sponsor met their global recruitment target and closed us as a site, therefore we did not meet our recruitment target.