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Bavarian Nordic, Inc. Study Protocol Protocol BNIT-PRV-301; Amendment 7 PROSTVAC-V/F Bavarian Nordic, Inc. Study Protocol Protocol Title A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer Protocol Number BNIT-PRV-301 IND No. / OBA Protocol Number BB-IND 13946 / #1104-1101 NCT Number: NCT01322490 EudraCT No. 2010-021196-85 Investigational Product PROSTVAC-V/F Sponsor Bavarian Nordic, Inc. CRO Medical Monitor Drug Safety Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 1 Amend 7 Disclosure requires written consent from Bavarian Nordic, Inc. Protocol BNIT-PRV-301; Amendment 7 PROSTVAC-V/F TABLE OF CONTENTS TABLE OF CONTENTS .................................................................................................. 3 LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .......................................... 7 1.0 BACKGROUND AND RATIONALE ................................................................... 16 1.1 Rationale .................................................................................................. 16 1.2 Background .............................................................................................. 16 1.3 Placebo Rationale .................................................................................... 21 1.4 Summary of Findings from Human Clinical Studies ................................. 22 1.5 Safety of Poxviral Vectors ........................................................................ 24 1.6 Potential Benefits and Risks to Human Subjects ..................................... 27 1.7 Rationale for Double-Blinding .................................................................. 28 2.0 NAME AND DESCRIPTION OF STUDY AGENTS ............................................ 29 2.1 Formulation, Packaging, and Labeling ..................................................... 29 2.2 Investigational Drug Product (PROSTVAC-V/F) ...................................... 29 2.3 GM-CSF ................................................................................................... 30 2.4 PROSTVAC-V/F Placebo: Empty fowlpox vector ................................... 31 2.5 GM-CSF Placebo ..................................................................................... 31 3.0 STUDY OBJECTIVES AND ENDPOINTS ......................................................... 32 3.1 Study Objectives ...................................................................................... 32 3.2 Study Endpoints ....................................................................................... 33 4.0 INVESTIGATIONAL PLAN ................................................................................ 34 4.1 Study Design ........................................................................................... 34 4.2 Sample Size ............................................................................................. 34 4.3 Selection of Study Population .................................................................. 34 4.4 Targeted Enrollment of Minorities ............................................................ 35 4.5 Method of Assigning Subjects to Treatment Groups ................................ 35 4.6 Inclusion Criteria ...................................................................................... 35 4.7 Exclusion Criteria ..................................................................................... 36 5.0 SAFETY MONITORING ..................................................................................... 38 5.1 Data Monitoring Committee (DMC) .......................................................... 38 5.2 Dose-limiting Toxicities and Trial Stopping Rules .................................... 38 5.3 Emergency Unblinding Of Treatment Assignment (If Applicable) ............ 39 5.4 Removal of Subjects from Therapy or Assessment ................................. 39 5.5 Replacement Policy ................................................................................. 40 Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 3 Amend 7 Disclosure requires written consent from Bavarian Nordic, Inc. Protocol BNIT-PRV-301; Amendment 7 PROSTVAC-V/F 6.0 STUDY TREATMENTS ...................................................................................... 41 6.1 Investigational Study Drug Accountability ................................................ 41 6.2 Assessment of Study Drug Compliance................................................... 41 6.3 Disposal of Drug Supplies ........................................................................ 41 6.4 PROSTVAC-V/F ...................................................................................... 42 6.5 GM-CSF ................................................................................................... 42 6.6 Subject Instructions and Supplies ............................................................ 43 6.7 Dose Reductions and Contraindications for PROSTVAC-V/F ................. 43 6.8 Procedures for Potential Serious Vaccinia Reaction ................................ 43 6.9 Concomitant and Excluded Medications .................................................. 44 6.10 Overdose ................................................................................................. 44 7.0 STUDY PROCEDURES BY STUDY PERIOD ................................................... 45 7.1 Screening Assessments (Days –28 –1) ................................................... 45 7.2 Day 1 (Day of first dose of PROSTVAC-V/F or placebo), Week 1 ........... 46 7.3 Week 3 Through Week 21 (booster vaccinations) ................................... 47 7.4 End-of-Treatment Visit – Week 25 or When A Subject Discontinues Treatment ................................................................................................ 48 7.5 Assessments During Long-Term Follow-Up ............................................ 49 7.6 Safety Assessments ................................................................................ 50 7.7 Biological and Immune Response Assessments ..................................... 50 7.8 Laboratory Tests and Radiological Assessments .................................... 50 8.0 ADVERSE EVENTS ........................................................................................... 52 8.1 Investigator’s Responsibilities .................................................................. 52 8.2 Definition of Adverse Events (AE) ............................................................ 52 8.3 Definition of Expected and Unexpected Events ....................................... 53 8.4 Collecting and Recording Adverse Events ............................................... 54 8.5 Assessment of Relationship to Study Drug (Causality) ............................ 56 8.6 Severity of Adverse Events (Grading) ...................................................... 56 8.7 Dose Modifications for Toxicity ................................................................ 57 8.8 Definition of Serious Adverse Events ....................................................... 57 8.9 Definition of Unexpected Serious Adverse Events ................................... 58 8.10 Definition of Suspected Adverse Reaction ............................................... 58 8.11 Documenting and Reporting of Adverse Events and Serious Adverse Events ...................................................................................................... 59 8.12 Adverse Event Reporting Period .............................................................. 60 Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 4 Amend 7 Disclosure requires written consent from Bavarian Nordic, Inc. Protocol BNIT-PRV-301; Amendment 7 PROSTVAC-V/F 8.13 Assessment of Adverse Events ............................................................... 60 8.14 Serious Adverse Events ........................................................................... 60 8.15 Treatment and Follow-up of Adverse Events or Serious Adverse Events ...................................................................................................... 61 9.0 STATISTICAL CONSIDERATIONS ................................................................... 62 9.1 Study Design ........................................................................................... 62 9.2 Randomization ......................................................................................... 62 9.3 Analysis Sets ........................................................................................... 62 9.4 Primary Efficacy Analysis ......................................................................... 63 9.5 Trial Size .................................................................................................. 63 9.6 Secondary Efficacy Endpoint ................................................................... 63 9.7 Safety Analyses ....................................................................................... 64 9.8 Interim Analyses ...................................................................................... 64 10.0 STUDY ADMINISTRATION AND INVESTIGATOR OBLIGATIONS ................. 66 10.1 Regulatory and Ethical Compliance ......................................................... 66 10.2 Institutional Review Board (IRB), Research Ethics Board (REB), and Independent Ethics Committee (IEC) Approval ....................................... 66 10.3 Institutional Biosafety Committee (IBC) (where applicable)
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