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NCT02087085	9.1.3	Severity	9.1.3 Severity A clinical determination will be made of the intensity of an adverse event. The severity assessment for a clinical adverse event must be completed using the following definitions as guidelines: Mild Awareness of sign or symptom, but easily tolerated. Moderate Discomfort enough to cause interference with ...	[]
NCT02087085	9.1.4	Relationship to Study Drug or Study Procedure	9.1.4 Relationship to Study Drug or Study Procedure A determination will be made of the relationship (if any) between an adverse event and the study drug or study procedure, as applicable. A causal relationship is present if a determination is made that there is a reasonable possibility that the adverse event may have ...	[]
NCT02087085	9.2	Procedures for Reporting Adverse Events	9.2 Procedures for Reporting Adverse Events Any adverse event must be recorded on the appropriate CRF. All adverse events that are drug-related and unexpected (not listed as treatment-related in the current Investigator's Brochure) must be reported to the governing Institutional Review Board/Independent Ethics Committe...	[]
NCT02087085	9.3	Procedures for Reporting a Serious Adverse Event	9.3 Procedures for Reporting a Serious Adverse Event Any serious adverse event occurring during the study period (beginning with informed consent) and any serious ocular adverse event occurring within 4 months after the last dose of study treatment must be immediately reported but no later than 24 hours after learning ...	[]
NCT02087085	9.4	Procedures for Unmasking of Study Medication	9.4 Procedures for Unmasking of Study Medication When necessary for the safety and proper treatment of the patient, the investigator can unmask the patient's treatment assignment to determine which treatment has been assigned and institute appropriate follow-up care. When possible, the Allergan Medical Safety Physician...	[]
NCT02087085	10	Administrative Items	10 Administrative Items This protocol is to be conducted in accordance with the applicable Good Clinical Practice (GCP) regulations and guidelines, eg, the International Conference on Harmonisation (ICH) Guideline on GCP.	[]
NCT02087085	10.1	Protection of Human Patients	10.1 Protection of Human Patients	[]
NCT02087085	10.1.1	Compliance With Informed Consent Regulations (US 21 CFR Part 50) and Relevant Country Regulations	10.1.1 Compliance With Informed Consent Regulations (US 21 CFR Part 50) and Relevant Country Regulations Written informed consent is to be obtained from each patient prior to any study-related activities or procedures in the study, and/or from the patient's legally authorized representative. If the patient is under the...	[]
NCT02087085	10.1.2	Compliance With IRB or IEC Regulations	10.1.2 Compliance With IRB or IEC Regulations This study is to be conducted in accordance with IRB regulations (US 21 CFR Part 56.103) or applicable IEC regulations. The investigator must obtain approval from a properly constituted IRB/IEC prior to initiating the study and re-approval or review at least annually. Aller...	[]
NCT02087085	10.1.3	Compliance With Good Clinical Practice	10.1.3 Compliance With Good Clinical Practice This protocol is to be conducted in accordance with the applicable GCP regulations and guidelines.	[]
NCT02087085	10.1.4	Compliance With Electronic Records; Electronic Signatures Regulations (US 21 CFR Part 11)	10.1.4 Compliance With Electronic Records; Electronic Signatures Regulations (US 21 CFR Part 11) This study is to be conducted in compliance with the regulations on electronic records and electronic signature.	[]
NCT02087085	10.2	Changes to the Protocol	10.2 Changes to the Protocol The investigator must not implement any deviation from or changes to the protocol without approval by Allergan and prior review and documented approval/favorable opinion from the IRB/IEC of a protocol amendment, except where necessary to eliminate immediate hazards to study patients, or whe...	[]
NCT02087085	10.3	Patient Confidentiality	10.3 Patient Confidentiality A report of the results of this study may be published or sent to the appropriate health authorities in any country in which the study drug may ultimately be marketed, but the patient's name will not be disclosed in these documents. The patient's name may be disclosed to the sponsor of the ...	[]
NCT02087085	10.3.1	Patient Privacy	10.3.1 Patient Privacy Written authorization (US sites only), data protection consent (European sites only), and other documentation in accordance with the relevant country and local privacy requirements (where applicable) are to be obtained from each patient prior to enrollment into the study. These authorizations are...	[]
NCT02087085	10.4	Documentation	10.4 Documentation	[]
NCT02087085	10.4.1	Source Documents	10.4.1 Source Documents Source documents may include a patient's medical records, hospital charts, clinic charts, the investigator's patient study files, as well as the results of diagnostic tests such as X-rays, laboratory tests, and electrocardiograms. The investigator's copy of the CRFs serves as part of the investi...	[]
NCT02087085	10.4.2	Case Report Form Completion	10.4.2 Case Report Form Completion The investigator is responsible for ensuring that data are properly recorded on each patient's CRFs and related documents. An investigator who has signed the protocol signature page should personally sign for the CRFs (as indicated in the CRFs) to ensure that the observations and find...	[]
NCT02087085	10.4.3	Study Summary	10.4.3 Study Summary An investigator's summary will be provided to Allergan within a short time after the completion of the study, or as designated by Allergan. A summary is also to be provided to the responsible IRB/IEC.	[]
NCT02087085	10.4.4	Retention of Documentation	10.4.4 Retention of Documentation All study related correspondence, patient records, consent forms, patient privacy documentation, records of the distribution and use of all investigational products, and copies of CRFs should be maintained on file. For countries falling within the scope of the ICH guidelines, the Aller...	[]
NCT02087085	10.5	Labeling, Packaging, and Return or Disposal of Study Medications/Treatments	10.5 Labeling, Packaging, and Return or Disposal of Study Medications/Treatments	[]
NCT02087085	10.5.1	Labeling/Packaging	10.5.1 Labeling/Packaging Study medication will be packaged, labeled, and supplied by Allergan. The assembled Brimo DDS Applicator System is individually packaged in foil pouches with desiccant and sealed. The entire foil pouch package is sterilized. Each foil pouch is packaged in a carton with a single-panel label and...	[]
NCT02087085	10.5.2	Clinical Supply Inventory	10.5.2 Clinical Supply Inventory The investigator must keep an accurate accounting of the number of investigational units received from Allergan, dispensed to the patients, and the number of units returned to Allergan during and at the completion of the study. A detailed inventory must be completed for the study medica...	[]
NCT02087085	10.5.3	Return or Disposal of Study Medications/Treatments	10.5.3 Return or Disposal of Study Medications/Treatments All used applicators shall be disposed of on-site by unmasked site personnel, using a standard syringe sharps container, and destroyed according to the site's sharps disposal procedures. All unused investigational product kits, attributed or not attributed to pa...	[]
NCT02087085	10.6	Monitoring by the Sponsor	10.6 Monitoring by the Sponsor A representative of Allergan will monitor the study on a periodic basis. The determination of the extent and nature of monitoring will be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the study. Authorized representatives of A...	[]
NCT02087085	10.7	Handling of Biological Specimens	10.7 Handling of Biological Specimens Samples of blood and urine for evaluation of hematology, chemistries, and urinalysis will be analyzed at a centralized clinical laboratory with certification from a recognized accreditation agency (eg, College of American Pathology [CAP] or Clinical Laboratory Improvement Amendment...	[]
NCT02087085	10.8	Publications	10.8 Publications Allergan as the sponsor, has proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between multiple investigators and sites and Allergan personnel. Authorship will be established prior to the writing of the manuscript. As this study involves multiple ...	[]
NCT02087085	10.9	Coordinating Investigator	10.9 Coordinating Investigator A signatory Coordinating Investigator will be designated prior to the writing of the Clinical Study Report.	[]
NCT02087085	11	References	11 References AREDS Research Group. Change in area of geographic atrophy in the Age-Related Eye Disease Study. Arch Ophthalmol. 2009;127:1168-1174. Bindewald A, Bird AC, Dandekar SS, Dolar-Szczasny J, Dreyhaupt J, Fitzke FW, et al. Classification of fundus autofluorescence patterns in early age-related macular disease....	[]
NCT02087085	12	Attachments	12 Attachments	[]
NCT02087085	12.1	Glossary of Terms and Abbreviations	12.1 Glossary of Terms and Abbreviations \| Term/Abbreviation \| Definition \| \|-------------------\|-----------------------------------------------------\| \| AMD \| age-related macular degeneration \| \| AREDS \| Age-Related Eye Disease Study \| \| ARMS2 \| age related maculopathy susceptibility 2 [locus] \| \| BCVA \| best correcte...	[]
NCT02087085	12.2	Protocol Amendment Summary Amendment 1	12.2 Protocol Amendment Summary Amendment 1 Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration Protocol 190342-038 Amendment 1 Date of Amendment: March 2014 Amendment Summary This summary includes changes ma...	[ "Amendment Summary" ]
NCT02087085	12.3	Protocol Amendment Summary Amendment 2	12.3 Protocol Amendment Summary Amendment 2 Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration Protocol 190342-038 Amendment 2 Date of Amendment: August 2014 Amendment Summary This summary includes changes m...	[ "Amendment Summary", "Section Revision Rationale Summary; Sections 6.4.10.4, 7.3.4, 8.3.1, 8.3.3 to 8.3.14, and 10.4.1 Updated complete ophthalmic examinations to include: external examination of the eye and adnexa, screening for eyelid/pupil responsiveness, slit-lamp biomicroscopy, indirect ophthalmoscopy, dilat...
NCT02087085	12.4	Protocol Amendment Summary Amendment 3	12.4 Protocol Amendment Summary Amendment 3 Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration Protocol 190342-038 Amendment 3 Date of Amendment: September 2014 Amendment Summary This summary includes change...	[ "Amendment Summary" ]
NCT02087085	12.5	Protocol Amendment Summary Amendment 4	12.5 Protocol Amendment Summary Amendment 4 Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration Protocol 190342-038 Amendment 4 Date of Amendment: October 2014 Amendment Summary This summary includes changes ...	[ "Amendment Summary" ]
NCT02087085	12.6	Protocol Amendment Summary Amendment 5	12.6 Protocol Amendment Summary Amendment 5 Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration Protocol 190342-038 Amendment 5 Date of Amendment: January 2015 Amendment Summary This summary includes changes ...	[ "Amendment Summary" ]
NCT02087085	12.7	Protocol Amendment Summary Amendment 6	12.7 Protocol Amendment Summary Amendment 6 Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration Protocol 190342-038 Amendment 6 Date of Amendment: May 2015 Amendment Summary This summary includes changes made...	[ "Amendment Summary", "Section Revision Rationale" ]
NCT02087085	12.8	Protocol Amendment Summary Amendment 7	12.8 Protocol Amendment Summary Amendment 7 Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration Protocol 190342-038 Amendment 7 Date of Amendment: May 2017 Amendment Summary This summary includes changes made...	[ "Amendment Summary", "ALLERGAN" ]
NCT02125461	1	INTRODUCTION	1. INTRODUCTION Investigators should be familiar with the MEDI4736 Investigator's Brochure (IB).	[]
NCT02125461	1.1	Background	1.1 Background	[]
NCT02125461	1.1.1	Non-small cell lung cancer	1.1.1 Non-small cell lung cancer Lung cancer has been the most common cancer in the world for several decades, and by 2008, there were an estimated 1.61 million new cases, representing 12.7% of all new cancers. It was also the most common cause of death from cancer, with 1.38 million deaths (18.2% of the total) (GLOBOC...	[]
NCT02125461	1.1.2	Immunotherapies	1.1.2 Immunotherapies The immune system can identify tumour-associated antigens and eliminate the cancerous cells expressing them and thus plays an important role in preventing and combating the growth of tumours. This process of tumour immune surveillance is believed to result in a co-evolution of the tumour and immun...	[ "Clinical data for agents targeting PD-1 and PD-L1" ]
NCT02125461	1.1.3	MEDI4736	1.1.3 MEDI4736 MEDI4736 is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MED...	[]
NCT02125461	1.1.4	Non-clinical experience with MEDI4736	1.1.4 Non-clinical experience with MEDI4736 For full details of the non-clinical information, please refer to the current IB. MEDI4736 binds with high affinity and specificity to human PD-L1 and blocks its interaction with PD-1 and CD80. In vitro studies demonstrate that MEDI4736 antagonizes the inhibitory effect of PD...	[]
NCT02125461	1.1.5	Clinical experience with MEDI4736	1.1.5 Clinical experience with MEDI4736 For full details of the clinical information, please refer to the current IB. MEDI4736 has been given to humans as part of ongoing studies where it is given either as a single drug or in combination with other drugs. The majority of the safety data currently available for MEDI473...	[]
NCT02125461	1.1.6	Safety pharmacology summary	1.1.6 Safety pharmacology summary Refer to the latest version of the IB for the latest information on identified and potential risks associated with MEDI4736. There are a number of potential/possible risks based on the mechanism of action of MEDI4736 and related molecules including immune-mediated reactions such as ent...	[]
NCT02125461	1.1.7	Genetic data	1.1.7 Genetic data The pharmacogenetic (PGx) research elements of this study (relating to DNA) are optional. Refer to Appendix D.	[]
NCT02125461	1.2	Research hypothesis	1.2 Research hypothesis The research hypothesis for this study is: MEDI4736 (10 mg/kg Q2W via iv infusion) will show improved efficacy compared with placebo when given as sequential therapy to patients with locally advanced, unresectable NSCLC (Stage III) who have not progressed following definitive, platinum-based, co...	[]
NCT02125461	1.3	Rationale for conducting this study	1.3 Rationale for conducting this study The rationale for combining chemotherapy and radiotherapy is to combine the benefits of radiotherapy in terms of local regional control with the benefits of chemotherapy in terms of reducing the risks of metastatic disease. With concurrent chemoradiation (cCTRT) there is the pote...	[]
NCT02125461	1.4	Benefit/risk and ethical assessment	1.4 Benefit/risk and ethical assessment Refer to the IB for information on the potential benefits of MEDI4736 and an assessment of the potential and known risks.	[]
NCT02125461	1.4.1	Unmet need and potential role of immunotherapies in NSCLC	1.4.1 Unmet need and potential role of immunotherapies in NSCLC Non-small cell lung cancer (NSCLC) represents approximately 80% to 85% of all lung cancers and 30% of patients present with Stage III disease. Standard treatment for patients with a good performance status and unresectable Stage III NSCLC is platinum-based...	[]
NCT02125461	1.4.2	Summary of MEDI4736 data and potential benefits and risks	1.4.2 Summary of MEDI4736 data and potential benefits and risks MEDI4736, a human monoclonal antibody directed against human PD-L1, may offer benefit to this patient population. MEDI4736 has a high affinity for human PD-L1 and is able to completely block the interaction of recombinant human PD-L1 with both recombinant ...	[]
NCT02125461	1.4.3	Summary of potential benefits and risks of other immunotherapy agents	1.4.3 Summary of potential benefits and risks of other immunotherapy agents Other monoclonal antibodies targeting the PD-1/PD-L1 pathway are currently in clinical development. Among the most frequent treatment-related AEs noted in these antibodies are fatigue, rash, diarrhoea and pruritus. Immune-PHGLDWHG\$(VRI\UDGHUHS...	[]
NCT02125461	1.4.4	Summary benefit: risk statement	1.4.4 Summary benefit: risk statement In summary, the potential for clinical benefit associated with inhibition of the PD-1/PD-L1 pathway, supported by objective responses observed in earlier studies in patients with NSCLC, outweighs the known and potential risks based on the AEs reported in patients treated with MEDI4...	[]
NCT02125461	2	STUDY OBJECTIVES	2. STUDY OBJECTIVES	[]
NCT02125461	2.1	Primary objective	2.1 Primary objective \| Primary Objective: \| Outcome Measure: \| \|----------------------------------------------------------------------------------------------\|--------------------------------------------------------------\| \| To assess the efficacy of MEDI4736 treatmentcompared with placebo in terms of OS and PFS \| OSP...	[]
NCT02125461	2.2	Secondary objectives	2.2 Secondary objectives \| Secondary Objective: \| Outcome Measure: \| \|-----------------------------------------------------------------------------------------------------------------------------------------------------\|----------------------------------------------------------------------------------------------------...	[]
NCT02125461	2.3	Exploratory objectives	2.3 Exploratory objectives \| Exploratory Objective: \| Outcome Measure: \| \|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------...	[]
NCT02125461	3	STUDY PLAN AND PROCEDURES	3. STUDY PLAN AND PROCEDURES This Clinical Study Protocol has been subject to a peer review according to AstraZeneca standard procedures.	[]
NCT02125461	3.1	Overall study design and flow chart	3.1 Overall study design and flow chart This study is a Phase III, randomised, double-blind, placebo-controlled, multi-centre study assessing the efficacy and safety of MEDI4736 compared with placebo as sequential therapy in male and female patients with locally advanced, unresectable NSCLC (Stage III) who have not pro...	[ "Independent Data Monitoring Committee" ]
NCT02125461	3.2	Rationale for study design, doses and control groups	3.2 Rationale for study design, doses and control groups	[]
NCT02125461	3.2.1	Unmet need and potential role of immunotherapies in NSCLC	3.2.1 Unmet need and potential role of immunotherapies in NSCLC For patients with unresectable Stage IIIA or Stage IIIB disease combined modality therapy (chemoradiation) is superior to radiation alone and cCTRT is superior to sequential therapy (NCCN Guidelines 2014). Concurrent chemoradiation regimens that may be use...	[]
NCT02125461	3.2.2	Potential role for MEDI4736 in the treatment of NSCLC	3.2.2 Potential role for MEDI4736 in the treatment of NSCLC Currently available data from the MEDI4736 FTIH study (Section 1.1.5 and MEDI4736 IB), indicates encouraging response rates and DoR, with a manageable safety profile in patients with a variety of solid malignancies, including patients with NSCLC. These are adv...	[]
NCT02125461	3.2.3	Study design rationale	3.2.3 Study design rationale Timing of treatment with MEDI4736 relative to concurrent chemoradiation therapy Non-clinical data shows that both chemotherapy and ionising radiation up-regulate PD-L1 expression (Deng et al 2014, Zhang et al 2008b). In addition chemotherapy and radiotherapy both release new antigens leavi...	[ "Timing of treatment with MEDI4736 relative to concurrent chemoradiation therapy", "Dose justification", "Predictive biomarkers and rationale for an unselected population in Study D4191C00001", "Rationale for study endpoints (efficacy)", "Rationale for study endpoints (other exploratory endpoints)", "Rati...
NCT02125461	4	PATIENT SELECTION CRITERIA	4. PATIENT SELECTION CRITERIA The patient population should be selected without bias. Investigator(s) should keep a record, the patient screening log, of patients who entered pre-study screening. Each patient should meet all of the inclusion criteria and none of the exclusion criteria for this study. Under no circumsta...	[]
NCT02125461	4.1	Inclusion criteria	4.1 Inclusion criteria For inclusion in the study patients should fulfil the following criteria: - 1. Provision of signed, written and dated informed consent prior to any study specific procedures - 2. Male or female aged 18 years or older - 3. Patients must have histologically- or cytologically-documented NSCLC who pr...	[ "Genetics research study (optional)" ]
NCT02125461	4.2	Exclusion criteria	4.2 Exclusion criteria Patients should not enter the study if any of the following exclusion criteria are fulfilled: - 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/MedImmune staff and/or staff at the study site). - 2. Either: x Previous drug assignment in the present study or ...	[ "Genetics research study (optional)" ]
NCT02125461	4.3	Criteria for treatment through progression of disease and retreatment	4.3 Criteria for treatment through progression of disease and retreatment Patients with rapid tumour progression or with symptomatic progression that requires urgent medical intervention (eg, central nervous system metastasis, respiratory failure due to tumour compression, spinal cord compression) will not be eligible ...	[]
NCT02125461	5	STUDY CONDUCT	5. STUDY CONDUCT	[]
NCT02125461	5.1	Restrictions during the study	5.1 Restrictions during the study - 1. Females of childbearing potential who are sexually active with a nonsterilised male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of study drug; cessation of birth control af...	[]
NCT02125461	5.2	Patient enrolment and randomisation	5.2 Patient enrolment and randomisation At Visit 1 (Screening), the Principal Investigator, or suitably trained delegate, will: - 1. Obtain signed informed consent (main study) from the potential patient before any study specific procedures are performed. Procedures that are part of standard of care may occur before in...	[]
NCT02125461	5.2.1	Procedures for randomisation	5.2.1 Procedures for randomisation Patients must not be randomised unless all eligibility criteria have been met. At Visit 2, patients who satisfy all the entry criteria will be centrally assigned to study drug by the IVRS/IWRS, according to the randomisation scheme generated by the Biostatistics Group, AstraZeneca, or...	[]
NCT02125461	5.3	Procedures for handling patients incorrectly enrolled or randomised or initiated on study drug	5.3 Procedures for handling patients incorrectly enrolled or randomised or initiated on study drug Patients who fail to meet the inclusion/exclusion criteria should not, under any circumstances, be enrolled or receive study medication. There can be no exceptions to this rule. Where patients that do not meet the inclusi...	[]
NCT02125461	5.4	Blinding and procedures for unblinding the study	5.4 Blinding and procedures for unblinding the study	[]
NCT02125461	5.4.1	Methods for ensuring blinding	5.4.1 Methods for ensuring blinding The study will be conducted in a double-blind manner. The reconstituted MEDI4736 solution and its matching placebo will be identical in colour and the iv bags used for administration will be identical with regards to size. All study drug will be blinded using an opaque sleeve, fasten...	[]
NCT02125461	5.4.2	Methods for unblinding the study	5.4.2 Methods for unblinding the study Individual treatment codes, indicating the treatment randomisation for each randomised patient, will be available to the Investigator(s) or pharmacists at the study centre from the IVRS/IWRS. Routines for this will be described in the IVRS/IWRS user manual that will be provided to...	[]
NCT02125461	5.5	Treatments	5.5 Treatments	[]
NCT02125461	5.5.1	Identity of investigational product(s)	5.5.1 Identity of investigational product(s) The Investigational Products Supply section of AstraZeneca/MedImmune will supply MEDI4736 to the Investigator as a lyophilised powder for reconstitution.The saline solution for the matching placebo will be sourced locally. \| Investigationalproduct \| Dosage form and strength ...	[ "Product preparation of MEDI4736", "Reconstitution of investigational product", "Preparation of MEDI4736 doses for administration with an iv bag", "Dose calculation" ]
NCT02125461	5.5.2	Doses and treatment regimens	5.5.2 Doses and treatment regimens Patients enrolled in the study will receive either MEDI4736 10 mg/kg or placebo via iv infusion Q2W ±3 days. Administration of study drug will commence on Day 1 following randomisation to MEDI4736 or placebo after confirmation of eligibility and will continue on a Q2W schedule for a m...	[ "Study drug administration", "Monitoring of dose administration" ]
NCT02125461	5.5.3	Management of toxicity	5.5.3 Management of toxicity The following general guidance should be followed for management of toxicities. - 1. Treat each of the toxicities with maximum supportive care (including holding the agent suspected of causing the toxicity where required). - 2. If the symptoms promptly resolve with supportive care, consider...	[ "MEDI4736 adverse events of special interest", "AESIs observed with MEDI4736 include:", "Pneumonitis", "Radiation pneumonitis" ]
NCT02125461	5.5.4	Additional study drug	5.5.4 Additional study drug No additional study drug is required in this study.	[]
NCT02125461	5.5.5	Labelling	5.5.5 Labelling Labels will be prepared in accordance with Good Manufacturing Practice (GMP) and local regulatory guidelines. The labels will fulfil GMP Annex 13 requirements for labelling. Label text will be translated into local language. The label will include the following information: - x Name of sponsor (AstraZen...	[]
NCT02125461	5.5.6	Storage	5.5.6 Storage All study drugs should be kept in a secure place under appropriate storage conditions and may only be dispensed by a pharmacist or a qualified designee. The investigational product label on the kit specifies the appropriate storage. MEDI4736 must be stored at 2°C to 8°C.	[]
NCT02125461	5.6	Concomitant and post-study treatment(s)	5.6 Concomitant and post-study treatment(s) Investigators may prescribe concomitant medications or treatments (eg, acetaminophen, diphenhydramine) deemed necessary to provide adequate prophylactic or supportive care except for those medications identified as "excluded" as listed below: - x Any investigational anticance...	[]
NCT02125461	5.7	Treatment compliance	5.7 Treatment compliance Treatment compliance will be assured by site reconciliation of medication dispensed. The administration of all study drugs (including investigational products) should be recorded in the appropriate sections of the eCRF. The Investigator or pharmacy must retain records of all study drugs adminis...	[]
NCT02125461	5.7.1	Accountability	5.7.1 Accountability The study drug provided for this study will be used only as directed in the study protocol. The study personnel will account for all study drugs dispensed to and returned from the patient. Study site personnel will account for all study drugs received at the site, unused study drugs and for appropr...	[]
NCT02125461	5.8	Discontinuation of investigational product	5.8 Discontinuation of investigational product Patients may be discontinued from investigational product in the following situations: - x Patient decision. The patient is at any time free to discontinue treatment, without prejudice to further treatment. - x Adverse Event, that in the opinion of the Investigator or the ...	[]
NCT02125461	5.8.1	Procedures for discontinuation of a patient from investigational product	5.8.1 Procedures for discontinuation of a patient from investigational product Patients who are permanently discontinued from further receipt of study drug, regardless of the reason (withdrawal of consent, due to an AE, other), will be identified as having permanently discontinued study drug. A patient that decides to ...	[ "Assessments following withdrawal of study drug" ]
NCT02125461	5.9	Withdrawal from study	5.9 Withdrawal from study Patients may be discontinued from the study in the following situations: - x Patient decision. The patient is at any time free to discontinue treatment, without prejudice to further treatment - x Severe non-compliance to study protocol that, in the opinion of the Investigator or sponsor, warra...	[]
NCT02125461	6	COLLECTION OF STUDY VARIABLES	6. COLLECTION OF STUDY VARIABLES The schedule for assessments at Screening and during the Treatment Period is presented in Table 1. The schedule of study procedures during follow-up for patients who have completed study drug and achieved disease control (until confirmed PD) and patients who have discontinued study drug...	[]
NCT02125461	6.1	Recording of data	6.1 Recording of data The InForm Web Based Data Capture (WBDC) system will be used for data collection and query handling until the point of final DCO and database lock for the study. The Investigator will ensure that data are recorded on the eCRFs as specified in the study protocol and in accordance with the instructi...	[]
NCT02125461	6.2	Data collection at enrolment and follow-up	6.2 Data collection at enrolment and follow-up	[]
NCT02125461	6.2.1	Enrolment procedures	6.2.1 Enrolment procedures The following assessments and procedures should be performed within 42 days prior to the first infusion of study drug (Table 1). For details of the nature of the assessments, see below. - x Signed informed consent for the study and assignment of a patient identification number - x Verify elig...	[]
NCT02125461	6.2.2	Follow-up procedures	6.2.2 Follow-up procedures Patients should be discontinued from study drug if any discontinuation criteria are fulfilled, see Section 5.8. The assessments to be carried out during follow-up are detailed in Table 2 (for patients achieving disease control or who are discontinued due to toxicity or a reason other than con...	[ "Survival follow-up", "Second progression" ]
NCT02125461	6.3	Efficacy	6.3 Efficacy For both BICR and Investigator review, RECIST 1.1 criteria will be used to assess patient response to treatment and allow calculation of PFS, ORR, and DoR. The RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria (CR, PR, NED, SD or ...	[]
NCT02125461	6.3.1	Central reading of scans	6.3.1 Central reading of scans The co-primary analysis for this study will be based on PFS from BICR using assessment of tumours using RECIST 1.1. In addition, an exploratory analysis of PFS from BICR by assessment of tumours using irRECIST 1.1 (Wolchok et al 2009, Nishino et al 2013) will be conducted (see Section 12....	[]
NCT02125461	6.4	Safety	6.4 Safety The Principal Investigator is responsible for ensuring that all staff involved in the study is familiar with the content of this section. Safety guidelines around SAE reporting described within the protocol remain in effect after the final DCO for the study.	[]
NCT02125461	6.4.1	Definition of adverse events	6.4.1 Definition of adverse events An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (...	[]
NCT02125461	6.4.2	Definitions of serious adverse event	6.4.2 Definitions of serious adverse event An SAE is an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: - x Results in death - x Is immediately life-threatening - x Requires in-patient hospitalisation or prolongation of existing hospit...	[]
NCT02125461	6.4.3	Recording of adverse events	6.4.3 Recording of adverse events Time period for collection of adverse events Adverse events will be collected from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of study drug). Adverse events not meeting SAE criteria that occur ...	[ "Time period for collection of adverse events", "Follow-up of unresolved adverse events", "Post study events", "Variables", "Causality collection", "Relationship to protocol procedures", "Adverse events based on signs and symptoms", "Adverse events based on examinations and tests", "Criteria for Hy'...
NCT02125461	6.4.4	Reporting of serious adverse events	6.4.4 Reporting of serious adverse events All SAEs occurring whilst the patient is either receiving study drug or in the 90 day safety follow up period after receiving the last dose of study drug have to be reported, whether or not considered causally related to the investigational product, or to the study procedure(s)...	[]

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