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Study Protocol and Results Novartis Confidential Page 2 Amended Protocol Version 08 (Clean) Protocol No. CEGF816X2201C Table of contents Table of contents .................................................................................................................2 List of figures ......................................................................................................................6 List of tables ........................................................................................................................6 List of abbreviations ............................................................................................................8 Glossary of terms...............................................................................................................10 Protocol summary:.............................................................................................................12 Amendment 8 (12-Mar-2020) ...........................................................................................14 Amendment 7 (21-Jun-2018) ............................................................................................17 Amendment 6 (29-Jan-2018).............................................................................................18 Amendment 5 (13- Apr-2017)............................................................................................20 Amendment 4 (19-May-2016)...........................................................................................22 Amendment 3 ....................................................................................................................26 Amendment 2 ....................................................................................................................29 Amendment 1 ....................................................................................................................31 1 Background........................................................................................................................35 1.1 Overview of disease pathogenesis, epidemiology and current treatment..............35 1.2 Introduction to investigational treatment(s) and other study treatment(s).............37 1.2.1 Overview of EGF816 ............................................................................37 1.2.2 Overview of INC280.............................................................................42 1.2.3 Overview of Nivolumab........................................................................46 2 Rationale............................................................................................................................49 2.1 Study rationale and purpose...................................................................................49 2.2 Rationale for the study design ...............................................................................49 2.3 Rationale for dose and regimen selection..............................................................50 2.4 Rationale for choice of combination drugs............................................................51 2.5 Rationale for maximum 2-year duration of Nivolumab treatment ........................51 3 Objectives and endpoints...................................................................................................52 4 Study design ......................................................................................................................54 4.1 Description of study design ...................................................................................54 4.2 Timing of interim analyses and design adaptations...............................................56 4.3 Definition of end of the study................................................................................57 4.4 Early study termination..........................................................................................57 5 Population..........................................................................................................................57 5.1 Patient population ..................................................................................................57 5.2 Inclusion criteria ....................................................................................................58 Novartis Confidential Page 3 Amended Protocol Version 08 (Clean) Protocol No. CEGF816X2201C 5.3 Exclusion criteria...................................................................................................58 6 Treatment...........................................................................................................................61 6.1 Study treatment......................................................................................................61 6.1.1 Dosing regimen .....................................................................................62 6.1.2 Sequence of drug administration...........................................................63 6.1.3 Treatment duration................................................................................64 6.2 Dose modification and dose delay.........................................................................64 6.2.1 Dose modification and dose interruption for EGF816, INC280 and Nivolumab.............................................................................................64 6.2.2 Follow-up for toxicities.........................................................................75 6.2.3 Follow up on potential drug-induced liver injury (DILI) cases ............82 6.2.4 Criteria to resume treatment with Nivolumab after dose delay ............82 6.2.5 Treatment of Nivolumab-related infusion reactions and other immune-related AEs..............................................................................83 6.3 Concomitant medications ......................................................................................85 6.3.1 Permitted concomitant therapy requiring caution and/or action...........85 6.3.2 Prohibited concomitant therapy ............................................................86 6.4 Patient numbering, treatment assignment, or randomization ................................87 6.4.1 Patient numbering .................................................................................87 6.4.2 Treatment assignment or randomization...............................................87 6.5 Study drug preparation and dispensation...............................................................87 6.5.1 Study drug packaging and labeling.......................................................87 6.5.2 Study drug supply and storage ..............................................................87 6.5.3 Study drug compliance and accountability ...........................................88 6.5.4 Disposal and destruction .......................................................................88 7 Visit schedule and assessments .........................................................................................88 7.1 Study flow and visit schedule................................................................................88 7.1.1 Molecular pre-screening........................................................................97 7.1.2 Screening...............................................................................................97 7.1.3 Treatment period ...................................................................................98 7.1.4 End of treatment visit including study completion and premature withdrawal.............................................................................................99 7.1.5 Follow up period .................................................................................101 7.1.6 Lost to follow-up.................................................................................102 7.2 Assessment types .................................................................................................102 7.2.1 Efficacy assessments...........................................................................102 7.2.2 Safety and tolerability assessments.....................................................105 Novartis Confidential Page 4 Amended Protocol Version 08 (Clean) Protocol No. CEGF816X2201C 7.2.3 Pharmacokinetics ................................................................................108 7.2.4 Biomarkers ..........................................................................................111 8 Safety monitoring and reporting......................................................................................114 8.1 Adverse events.....................................................................................................114 8.1.1 Definitions and reporting ....................................................................114 8.1.2 Laboratory test abnormalities..............................................................115 8.2 Serious adverse events.........................................................................................116 8.2.1 Definitions...........................................................................................116 8.2.2 Reporting.............................................................................................116 8.3 Pregnancies ..........................................................................................................117 8.4 Warnings and precautions....................................................................................118 8.5 Data Monitoring Committee................................................................................118
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