Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer
Phase: PHASE2
Conditions: Cervical Cancer
Sponsor: BeiGene

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Protocol Amendment Version 0.1 (Russia) 
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CLINICAL STUDY PROTOCOL 
Protocol Title:  
Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 
Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or 
Without Anti-TIGIT Monoclonal Antibody BGB-A1217 in Patients 
With Previously Treated Recurrent or Metastatic Cervical Cancer  
Protocol Number: 
BGB-A317-A1217-202 (AdvanTIG-202) 
Phase: 
2 
Investigational Products: 
BGB-A1217 and Tislelizumab (BGB-A317) 
Proposed Indication(s): 
Cervical Cancer   
Sponsor: 
BeiGene, Ltd. 
c/o BeiGene USA, Inc. 
1840 Gateway Drive, 3rd Floor 
San Mateo, California 94404, USA 
Sponsor Medical Monitor: 
 
Telephone: 
 
 
Original Protocol 
04 September 2020 
Protocol Amendment 0.1 
(Russia): 
04 May 2023 
 
 
 
 
Confidentiality Statement 
This Document Is Not for Distribution – Do Not Copy 
This document contains confidential information and is the proprietary property of BeiGene, Ltd., and its 
subsidiaries. This document is for use by individuals and their designated representatives for their review, 
consideration, and/or participation in investigational trial(s). This document may not be copied or 
distributed for review by any unauthorized individuals without the prior written authorization of 
BeiGene, Ltd., or one of its subsidiaries.  Your acceptance of this document constitutes agreement that 
you will not disclose the information contained herein to others without prior written authorization from 
BeiGene, Ltd., or one of its subsidiaries. 

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FINAL PROTOCOL APPROVAL SHEET  
 
Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal Antibody 
Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody 
BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer  
 
BeiGene, Ltd. Approval: 
 
 
See electronic signature approval 
 

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INVESTIGATOR SIGNATURE PAGE  
 
Protocol Title:  
Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal 
Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-
TIGIT Monoclonal Antibody BGB-A1217 in Patients With Previously 
Treated Recurrent or Metastatic Cervical Cancer  
 
Protocol Identifier:  
BGB-A317-A1217-202 
 
This protocol is a confidential communication of BeiGene, Ltd., and its subsidiaries. I confirm 
that I have read this protocol, I understand it, and I will work according to this protocol and the 
terms of the clinical study agreement governing the study. I will also work consistently with the 
ethical principles that have their origin in the Declaration of Helsinki and that are consistent with 
good clinical practices and the applicable laws and regulations. Acceptance of this document 
constitutes my agreement that no unpublished information contained herein will be published or 
disclosed without prior written approval from BeiGene, Ltd., or one of its subsidiaries. 
 
Instructions for Investigator: Please SIGN and DATE this signature page. PRINT your 
name, title, and the name and address of the center in which the study will be conducted.  
 
 
I have read this protocol in its entirety and agree to conduct the study accordingly: 
 
Signature of Investigator: 
_______________________________ Date: _____________ 
Printed Name: 
_______________________________ 
Investigator Title: 
_______________________________ 
Name/Address of Center: 
_______________________________ 
 
_______________________________ 
 
_______________________________ 
 
_______________________________ 
 

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TABLE OF CONTENTS 
FINAL PROTOCOL APPROVAL SHEET ....................................................................................2 
INVESTIGATOR SIGNATURE PAGE .........................................................................................3 
TABLE OF CONTENTS .................................................................................................................4 
LIST OF TABLES .........................................................................................................................10 
LIST OF FIGURES .......................................................................................................................11 
SYNOPSIS ....................................................................................................................................12 
LIST OF ABBREVIATIONS AND TERMS ................................................................................20 
1. 
INTRODUCTION AND RATIONALES ..................................................................22 
1.1. 
Background Information on Cervical Cancer .............................................................22 
1.2. 
Current Treatment of Recurrent or Metastatic Cervical Cancer .................................22 
1.3. 
BGB-A1217 as a TIGIT Inhibitor ..............................................................................25 
1.3.1. 
Nonclinical ..................................................................................................................27 
1.3.1.1. 
Pharmacology .............................................................................................................27 
1.3.1.2. 
Toxicology ..................................................................................................................28 
1.3.2. 
Clinical Experience .....................................................................................................29 
1.3.2.1. 
Clinical Experience From Other TIGIT Inhibitors .....................................................29 
1.3.2.2. 
Preliminary Safety ......................................................................................................31 
1.3.2.3. 
Clinical Pharmacology ................................................................................................31 
1.3.2.4. 
Efficacy .......................................................................................................................32 
1.4. 
Tislelizumab as a PD-1 Inhibitor ................................................................................36 
1.4.1. 
Pharmacology .............................................................................................................36 
1.4.2. 
Toxicology ..................................................................................................................36 
1.4.3. 
Clinical Pharmacology ................................................................................................37 
1.4.4. 
Prior Clinical Experience of Tislelizumab .................................................................37 
1.4.4.1. 
Pooled Safety Assessment of Monotherapy Studies ..................................................37 
1.4.4.2. 
Efficacy Assessment of Tislelizumab .........................................................................43 
1.5. 
Study Rationale ...........................................................................................................44 
1.5.1. 
Rationale for the Dose Selection ................................................................................45 
1.5.1.1. 
Rationale for the Selection of BGB-A1217 Dose .......................................................45 
1.5.1.2. 
Rationale for the Selection of Tislelizumab Dose ......................................................45 
1.5.2. 
Rationale for Combination of BGB-A1217 and Tislelizumab in the 
Treatment of Previously Treated Recurrent or Metastatic Cervical Cancer ...............46 

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1.5.3. 
Biomarker Strategy Rationale.....................................................................................46 
1.6. 
Benefit-Risk Assessment ............................................................................................47 
1.7. 
Study Conduct ............................................................................................................48 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................49 
2.1. 
Study Objectives .........................................................................................................49 
2.1.1. 
Primary Objectives .....................................................................................................49 
2.1.2. 
Secondary Objectives .................................................................................................49 
2.1.3. 
Exploratory Objectives ...............................................................................................49 
2.2. 
Study Endpoints ..........................................................................................................49 
2.2.1. 
Primary Endpoints ......................................................................................................49 
2.2.2. 
Secondary Endpoints ..................................................................................................50 
2.2.3. 
Exploratory Endpoints ................................................................................................50 
3. 
STUDY DESIGN .......................................................................................................52 
3.1. 
Summary of Study Design ..........................................................................................52 
3.2. 
Screening Period .........................................................................................................54 
3.3. 
Treatment Period ........................................................................................................54 
3.3.1. 
Stage 1 ........................................................................................................................54 
3.3.2. 
Stage 2 ........................................................................................................................54 
3.4. 
End of Treatment/Safety Follow-up ...........................................................................55 
3.5. 
Survival Follow-up .....................................................................................................56 
3.6. 
Discontinuation From the Study Treatment or From the Study .................................56 
3.6.1. 
Patient Discontinuation From Study Treatment .........................................................56 
3.6.2. 
Patient Discontinuation From Study (End of Study for an Individual Patient) ..........57 
3.7. 
End of Study ...............................................................................................................57 
3.7.1. 
Study Drug Treatment for Russian Patients After End of Study ................................58 
4. 
STUDY POPULATION .............................................................................................60 
4.1. 
Inclusion Criteria ........................................................................................................60 
4.2. 
Exclusion Criteria .......................................................................................................61 
5. 
STUDY TREATMENT ..............................................................................................65 
5.1. 
Formulation, Packaging, and Handling ......................................................................65 
5.1.1. 
BGB-A1217 ................................................................................................................65 
5.1.2. 
Tislelizumab ...............................................................................................................65 

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5.2. 
Dosage, Administration, and Compliance ..................................................................65 
5.2.1. 
BGB-A1217 and Tislelizumab ...................................................................................66 
5.2.2. 
Tislelizumab ...............................................................................................................67 
5.3. 
Incorrect Administration or Overdose ........................................................................67 
5.4. 
Investigational Medicinal Product Accountability .....................................................67 
5.5. 
Dose Delay or Modification .......................................................................................68 
5.5.1. 
Dose Interruption or Delay for BGB-A1217 and Tislelizumab .................................68 
5.5.2. 
Dose Reductions for BGB-A1217 and Tislelizumab .................................................69 
6. 
PRIOR AND CONCOMITANT THERAPY .............................................................70 
6.1. 
Prior Therapy ..............................................................................................................70 
6.2. 
Permitted Concomitant Medications/Procedures .......................................................70 
6.2.1. 
Systemic Corticosteroids ............................................................................................70 
6.2.2. 
Hepatitis B Treatment .................................................................................................70 
6.2.3. 
Hepatitis C Treatment .................................................................................................70 
6.2.4. 
Radiation Therapy ......................................................................................................71 
6.3. 
Prohibited Concomitant Medications/Procedures ......................................................71 
6.4. 
Restricted Concomitant Medications/Procedures .......................................................71 
6.5. 
Potential Interactions Between the Study Drugs and Concomitant 
Medications .................................................................................................................72 
7. 
STUDY ASSESSMENT AND PROCEDURES ........................................................73 
7.1. 
Screening Period .........................................................................................................73 
7.1.1. 
Informed Consent and Screening Log ........................................................................73 
7.1.2. 
Patient Numbering ......................................................................................................73 
7.1.3. 
Demographic Data and Medical History ....................................................................73 
7.1.4. 
Females of Childbearing Potential and Contraception ...............................................74 
7.1.5. 
Pulmonary Function Tests ..........................................................................................74 
7.2. 
Enrollment ..................................................................................................................74 
7.2.1. 
Confirmation of Eligibility .........................................................................................74 
7.2.2. 
Randomization ............................................................................................................74 
7.3. 
Study Drug Dispensation ............................................................................................74 
7.4. 
Safety Assessment ......................................................................................................75 
7.4.1. 
Vital Signs ..................................................................................................................75 
7.4.2. 
Physical Examinations ................................................................................................75 

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7.4.3. 
Eastern Cooperative Oncology Group Performance Status ........................................75 
7.4.4. 
Laboratory Safety Tests ..............................................................................................75 
7.4.4.1. 
Cardiac Enzyme Monitoring .......................................................................................76 
7.4.5. 
Electrocardiograms .....................................................................................................76 
7.4.6. 
Adverse Events ...........................................................................................................76 
7.4.7. 
Hepatitis B and C Testing ...........................................................................................77 
7.5. 
Tumor and Response Evaluations ..............................................................................77 
7.6. 
Pharmacokinetic and Antidrug Antibody Testing ......................................................79 
7.7. 
Biomarker ...................................................................................................................79 
7.8. 
Health Related Quality of Life/Quality of Life ..........................................................80 
7.9. 
Visit Windows ............................................................................................................80 
7.10. 
Unscheduled Visits .....................................................................................................80 
8. 
SAFETY MONITORING AND REPORTING .........................................................81 
8.1. 
Risks Associated With Study Drugs ...........................................................................81 
8.1.1. 
Risks Associated With BGB-A1217 and Tislelizumab ..............................................81 
8.2. 
General Plan to Manage Safety Concerns ..................................................................81 
8.2.1. 
Eligibility Criteria .......................................................................................................81 
8.2.2. 
Safety Monitoring Plan ...............................................................................................81 
8.3. 
Adverse Events ...........................................................................................................82 
8.3.1. 
Definitions and Reporting ...........................................................................................82 
8.3.2. 
Assessment of Severity ...............................................................................................82 
8.3.3. 
Assessment of Causality .............................................................................................83 
8.3.4. 
Follow-up of Adverse Events .....................................................................................84 
8.3.5. 
Laboratory Test Abnormalities ...................................................................................84 
8.4. 
Definition of a Serious Adverse Event .......................................................................85 
8.5. 
Suspected Unexpected Serious Adverse Reaction .....................................................86 
8.6. 
Timing, Frequency, and Method of Capturing Adverse Events and Serious 
Adverse Events ...........................................................................................................86 
8.6.1. 
Adverse Event Reporting Period ................................................................................86 
8.6.2. 
Reporting Serious Adverse Events .............................................................................87 
8.6.2.1. 
Prompt Reporting of Serious Adverse Events ............................................................87 
8.6.2.2. 
Completion and Transmission of the Serious Adverse Event Report ........................87 
8.6.2.3. 
Regulatory Reporting Requirements for Serious Adverse Events .............................88 

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8.6.3. 
Eliciting Adverse Events ............................................................................................88 
8.6.4. 
Disease Progression ....................................................................................................88 
8.6.5. 
Deaths .........................................................................................................................89 
8.6.6. 
Pregnancies .................................................................................................................89 
8.6.7. 
Expedited Reporting to Health Authorities, Investigators, Institutional 
Review Boards, and Independent Ethics Committees ................................................89 
8.6.8. 
Assessing and Recording Immune-Mediated Adverse Events ...................................89 
8.6.9. 
Recording Infusion-Related Reactions .......................................................................89 
8.7. 
Management of Adverse Events of Special Interest ...................................................90 
8.7.1. 
Infusion-Related Reactions .........................................................................................90 
8.7.2. 
Severe Hypersensitivity Reactions and Flu-Like Symptoms .....................................91 
8.7.3. 
Immune-Mediated Adverse Events ............................................................................92 
9. 
STATISTICAL METHODS AND SAMPLE SIZE DETERMINATION .................94 
9.1. 
Statistical Analysis ......................................................................................................94 
9.1.1. 
Analysis Sets ...............................................................................................................94 
9.1.2. 
Patient Disposition ......................................................................................................94 
9.1.3. 
Demographic and Other Baseline Characteristics ......................................................95 
9.1.4. 
Prior and Concomitant Medications ...........................................................................95 
9.2. 
Efficacy Analyses .......................................................................................................95 
9.2.1. 
Primary Efficacy Analysis ..........................................................................................95 
9.2.2. 
Secondary Efficacy Analysis ......................................................................................96 
9.2.3. 
Sensitivity Analysis ....................................................................................................98 
9.3. 
Safety Analyses ..........................................................................................................98 
9.3.1. 
Extent of Exposure .....................................................................................................98 
9.3.2. 
Adverse Events ...........................................................................................................98 
9.3.3. 
Laboratory Analyses ...................................................................................................99 
9.3.4. 
Vital Signs ..................................................................................................................99 
9.4. 
Pharmacokinetic Analyses ..........................................................................................99 
9.5. 
Immunogenicity Analyses ..........................................................................................99 
9.6. 
Other Exploratory Analyses .......................................................................................99 
9.7. 
Sample Size Consideration .......................................................................................100 
10. 
STUDY COMMITTEES ..........................................................................................101 
10.1. 
Independent Review Committee ...............................................................................101 

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11. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE 
DATA/DOCUMENTS .............................................................................................102 
11.1. 
Access to Information for Monitoring ......................................................................102 
11.2. 
Access to Information for Auditing or Inspections ..................................................102 
12. 
QUALITY ASSURANCE AND QUALITY CONTROL .......................................103 
12.1. 
Regulatory Authority Approval ................................................................................103 
12.2. 
Quality Assurance .....................................................................................................103 
12.3. 
Study Site Inspections...............................................................................................103 
12.4. 
Drug Accountability .................................................................................................103 
13. 
ETHICS/PROTECTION OF HUMAN PATIENTS ................................................105 
13.1. 
Ethical Standard ........................................................................................................105 
13.2. 
Institutional Review Board/Independent Ethics Committee ....................................105 
13.2.1. 
Protocol Amendments ..............................................................................................105 
13.3. 
Informed Consent .....................................................................................................106 
13.4. 
Patient and Data Confidentiality ...............................................................................106 
13.5. 
Financial Disclosure .................................................................................................107 
14. 
DATA HANDLING AND RECORD KEEPING ....................................................108 
14.1. 
Data Collection and Management Responsibilities ..................................................108 
14.1.1. 
Data Entry in the Electronic Case Report Form .......................................................108 
14.1.2. 
Data Collection .........................................................................................................108 
14.1.3. 
Data Management/Coding ........................................................................................108 
14.2. 
Data Integrity and In-house Blinding .......................................................................109 
14.3. 
Study Records Retention ..........................................................................................109 
14.4. 
Protocol Deviations ..................................................................................................110 
14.5. 
Study Report and Publications..................................................................................110 
14.6. 
Study and Study Center Closure ...............................................................................111 
14.7. 
Information Disclosure and Inventions ....................................................................111 
15. 
REFERENCES .........................................................................................................113 
16. 
APPENDICES ..........................................................................................................119 
APPENDIX 1. SCHEDULE OF ASSESSMENTS ..................................................................120 
APPENDIX 2. CLINICAL LABORATORY ASSESSMENTS ..............................................125 
APPENDIX 3. ECOG PERFORMANCE STATUS.................................................................126 

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APPENDIX 4. PREEXISTING IMMUNE DEFICIENCIES OR AUTOIMMUNE 
DISEASES ................................................................................................................127 
APPENDIX 5. CONTRACEPTION GUIDELINES AND DEFINITIONS OF 
“WOMEN OF CHILDBEARING POTENTIAL,” “NO CHILDBEARING 
POTENTIAL” ...........................................................................................................128 
APPENDIX 6. NEW YORK HEART ASSOCIATION FUNCTIONAL 
CLASSIFICATION ..................................................................................................130 
APPENDIX 7. EORTC-QLQ-C30 QUESTIONNAIRE ..........................................................131 
APPENDIX 8. EORTC-QLQ-CX24 QUESTIONNAIRE .......................................................133 
APPENDIX 9. EQ-5D-5L QUESTIONNAIRE........................................................................135 
APPENDIX 10. CHRONIC KIDNEY DISEASE EPIDEMIOLOGY 
COLLABORATION (CKD-EPI) EQUATION .......................................................137 
APPENDIX 11. IMMUNE-MEDIATED ADVERSE EVENT EVALUATION AND 
MANAGEMENT .....................................................................................................138 
APPENDIX 12. THE RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
(RECIST) GUIDELINES, VERSION 1.1 ................................................................148 
 
LIST OF TABLES  
Table 1: 
Summary of Reported Second-Line Single Agents for Recurrent or 
Metastatic Cervical Cancer .........................................................................................23 
Table 2: 
Overview of Treatment-Emergent Adverse Events (Safety Analysis Set) .................33 
Table 3: 
Treatment-Emergent Adverse Events by System Organ Class, Preferred 
Term and Maximum Severity (Safety Analysis Set) ..................................................34 
Table 4: 
Demographics, Baseline Characteristics, Treatment Exposure Duration, and 
Study Follow-up Duration in Pooled Monotherapy Studies.......................................39 
Table 5: 
Immune-Related Adverse Events of Any Grade Occurring in ≥ 1% in Pooled 
Monotherapy Studies ..................................................................................................41 
Table 6: 
Treatment-Emergent Fatal Adverse Events Regardless of Causality in 
Pooled Monotherapy Studies ......................................................................................43 
Table 7: 
Planned Dose, Frequency of Administration, and Route of Administration 
for BGB-A1217 and Tislelizumab..............................................................................66 
Table 8: 
Administration of BGB-A1217 and Tislelizumab and Monitoring Time ..................66 
Table 9: 
Administration of Tislelizumab and Monitoring Time ..............................................66 
Table 10: Guidance for Duration of Recording New or Worsening Adverse Events in 
All Cohorts..................................................................................................................87 
Table 11: Time Frames and Documentation Methods for Reporting Serious Adverse 
Events to the Sponsor or Designee .............................................................................87 

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Table 12: Treatment Modifications for Symptoms of Infusion-Related Reactions Due 
to Study Drugs ............................................................................................................90 
Table 13: Immune-Mediated Adverse Events ............................................................................92 
 
LIST OF FIGURES  
Figure 1: 
Study Schema .............................................................................................................53 
 

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SYNOPSIS  
Name of 
Sponsor/Company: 
BeiGene, Ltd. 
Investigational 
Product(s):  
BGB-A1217 and tislelizumab (BGB-A317) 
Title of Study: 
Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal 
Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT 
Monoclonal Antibody BGB-A1217 in Patients With Previously Treated 
Recurrent or Metastatic Cervical Cancer 
Protocol Identifier: 
BGB-A317-A1217-202 
Phase of 
Development 
2 
Number of 
Patients: 
Approximately 167 patients in total  
Study Centers: 
Approximately 100 centers globally 
Study Objectives: 
Primary: 
• 
To evaluate the efficacy of BGB-A1217 combined with tislelizumab as measured by objective 
response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST), 
version 1.1 (RECIST v1.1), by Independent Review Committee (IRC) in patients who had 
previously treated recurrent or metastatic cervical cancer with PD-L1 visually-estimated 
Combined Positive Score (vCPS) ≥ 5% or regardless of PD-L1 expression  
Secondary: 
• 
To evaluate the efficacy of BGB-A1217 combined with tislelizumab as assessed by ORR by 
investigator review 
• 
To evaluate the efficacy of tislelizumab monotherapy as assessed by ORR by both IRC and 
investigator review 
• 
To evaluate the efficacy of BGB-A1217 combined with tislelizumab and tislelizumab 
monotherapy as measured by duration of response (DOR), progression-free survival (PFS), 
time to response (TTR), disease control rate (DCR), and clinical benefit rate (CBR) by both 
IRC and investigator review  
• 
To evaluate the efficacy of BGB-A1217 combined with tislelizumab and tislelizumab 
monotherapy as measured by overall survival (OS) 
• 
To evaluate Health Related Quality of Life (HRQoL) via cancer-specific patient-reported 
outcomes (PROs) in patients treated with BGB-A1217 combined with tislelizumab and 
tislelizumab monotherapy 
• 
To evaluate the safety and tolerability of BGB-A1217 combined with tislelizumab and 
tislelizumab monotherapy 
• 
To characterize the pharmacokinetics (PK) of BGB-A1217 and tislelizumab 

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• 
To assess host immunogenicity to BGB-A1217 and tislelizumab 
Exploratory: 
• 
To evaluate quality of life (QoL) via a generic PRO in patients treated with BGB-A1217 
combined with tislelizumab and tislelizumab monotherapy 
• 
To evaluate potential association of biomarkers with patient prognosis, response, or resistance 
to BGB-A1217 in combination with tislelizumab or tislelizumab alone  
Study Endpoints: 
Primary: 
• 
ORR, defined as the proportion of patients who had complete response (CR) or partial response 
(PR) assessed by IRC per RECIST v1.1 for Cohort 1 
Secondary: 
• 
ORR, defined as above assessed by investigator’s review per RECIST v1.1 for Cohort 1 
• 
ORR, defined as above assessed by both IRC and investigator’s review per RECIST v1.1 for 
Cohort 2 
• 
DOR, defined as the time from the first confirmed objective response until the first 
documentation of progression or death, whichever comes first, assessed by both IRC and 
investigator’s review according to RECIST v1.1 for Cohorts 1 and 2 
• 
Other efficacy endpoints (PFS, TTR, DCR, and CBR) that need tumor assessments by both IRC 
and investigator’s review per RECIST v1.1 for Cohorts 1 and 2 
− 
PFS, defined as the time from the date of first dose of study drug to the date of first 
documentation of disease progression or death, whichever occurs first 
− 
TTR, defined as the time from the date of first dose of study drug to first documentation 
of response 
− 
DCR, defined as the proportion of patients who achieve CR, PR, or stable disease (SD) 
− 
CBR, defined as the proportion of patients who achieve CR, PR, or durable SD (SD ≥ 24 
weeks) 
• 
OS, defined as the time from the date of first dose of study drug until the date of death from any 
cause for Cohorts 1 and 2 
• 
HRQoL, defined as assessment of the European Organisation for Research and Treatment of 
Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), European Organisation for 
Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module 
(EORTC QLQ-CX24) for Cohorts 1 and 2   
• 
Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, 
severity (as graded by National Cancer Institute – Common Terminology Criteria for Adverse 
Events [NCI-CTCAE] v5.0), timing, seriousness, and relationship to study drugs, physical 
examinations, electrocardiograms (ECGs), and laboratory assessments for Cohorts 1 and 2 
• 
Serum BGB-A1217 and tislelizumab concentrations at specified timepoints 

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• 
Immunogenic responses to BGB-A1217 and tislelizumab, evaluated through the detection of 
antidrug antibodies (ADAs)    
Exploratory: 
• 
Evaluate status of exploratory biomarkers including but not limited to expression of TIGIT, 
CD226, CD155, CD112 and PD-L1; gene expression profiling; tumor mutation burden; tumor-
infiltrating immune cells in archival and/or fresh tumor tissue and blood before study treatment, 
during study treatment, or at disease progression/reoccurrence; and the association between 
these biomarkers with clinical efficacy, disease status, and resistance  
• 
QoL is measured by assessment of the European Quality of Life 5-Dimensional-5-Level 
Questionnaire (EQ-5D-5L)  
Study Design: 
This is an open-label, 2-cohort, multicenter, Phase 2 study to evaluate the efficacy and safety of 
tislelizumab combined with or without BGB-A1217 in patients with previously treated recurrent or 
metastatic cervical cancer. The study is composed of two stages: 
• 
Stage 1 (randomization): Approximately 80 patients whose tumor regardless of PD-L1 expression 
will be randomized at 1:1 ratio to receive either tislelizumab (200 mg intravenously [IV] once every 
3 weeks [Q3W]) combined with BGB-A1217 (900 mg IV Q3W) or tislelizumab (200 mg IV Q3W) 
monotherapy.  
• 
Stage 2 (expansion): After the enrollment is completed in Stage 1, the sample size of the 
combination therapy cohort will continue to be expanded in Stage 2 with approximately 87 
additional patients who will receive tislelizumab (200 mg IV Q3W) combined with BGB-A1217 
(900 mg IV Q3W).  
The total sample size of the combination therapy cohort (Cohort 1) will be approximately 127 patients. 
The total sample size of the tislelizumab monotherapy cohort (Cohort 2) will be approximately 40 
patients.  
In Stage 1, the PD-L1 expression will be retrospectively tested centrally. In Stage 2, PD-L1 expression 
will be prospectively tested centrally, and only patients whose tumors are evaluable for PD-L1 expression 
will be enrolled. For Cohort 1 (including patients enrolled in Stage 1 and Stage 2), the percentage of 
patients whose tumors have PD-L1 vCPS < 5% or whose tumors are not evaluable for PD-L1 expression 
would be capped to be no more than 40%, to reflect the natural distribution of PD-L1 expression in 
cervical cancer. vCPS is the total percentage of the tumor area covered by tumor cells with PD-L1 
membrane staining and tumor‑associated immune cells with PD-L1 staining at any intensity.  
Study drugs will be administered until disease progression per RECIST v1.1 by IRC, unacceptable 
toxicity, or withdrawal for other reasons, whichever occurs first. End-of-Treatment (EOT), safety follow-
up and survival follow-up visits will be conducted following study drug discontinuation. 
The study design schema is shown in Figure 1. 
Study Assessments: 
Tumor Assessment: 
Tumor imaging will be performed ≤ 28 days before the first dose of study drugs. During the study, tumor 
imaging will be performed approximately every 6 weeks (± 7 days) for the first 54 weeks, then every 12 
weeks (± 7 days) thereafter. 
Response and progressive disease (PD) will be assessed using RECIST v1.1. When PD is assessed by the 

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investigator, IRC is required to complete central image review and convey the results to the investigator 
as soon as possible. If PD is NOT confirmed by IRC, it is recommended to continue the study treatment 
until PD is confirmed by IRC, if this is in the best interest of the patient as discussed with the medical 
monitor. In the situation where the investigator believes the patient must urgently discontinue study 
treatment without waiting for IRC confirmation, the investigator must contact the medical monitor to 
inform the decision of treatment discontinuation.  
A patient who discontinues study drugs early for reasons other than disease progression by IRC (eg, 
toxicity, PD by the investigator) will continue to undergo tumor assessments following the original plan 
until the patient experiences PD per RECIST v1.1 by IRC, withdraws consent, is lost to follow-up, death, 
or until the study terminates, whichever occurs first. 
If at the investigator’s discretion a patient could continue to benefit from tislelizumab and BGB-A1217 
combination treatment or tislelizumab monotherapy (patients’ assigned treatment) after PD per RECIST 
v1.1 by IRC, the patient may continue their assigned treatment. The following criteria must be met in 
order to treat patients who may continue to benefit from study treatment after PD:  
• 
Absence of clinical symptoms and signs of PD (including clinically significantly worsening of 
laboratory values) 
• 
Stable Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1  
• 
Absence of rapid progression of disease or of progressive tumor at critical anatomical sites (eg, 
cord compression) that requires urgent alternative medical intervention 
• 
Investigators must obtain written informed consent for treatment beyond radiologic PD and 
inform patients that this practice is not considered standard in the treatment of cancer. 
The decision to continue study drugs beyond initial progression must be agreed by the medical monitor 
and documented in the study records. Patients who receive study treatment beyond progression will have 
tumor assessments performed according to the original schedule until study treatment discontinuation.   
Safety Assessment: 
Patients will be evaluated for any AEs and SAEs occurring up to 30 days after the last dose of study drugs 
(all severity grades, per NCI-CTCAE v5.0) or initiation of a new anticancer therapy, whichever occurs 
first, and immune-mediated AEs (imAEs) occurring up to 90 days after the last dose of study drugs, 
regardless of initiation of a subsequent anticancer therapy. All drug-related SAEs will be recorded by the 
investigator after treatment discontinuation until patient death, withdrawal of consent, or loss to follow-
up, whichever occurs first. All study drug-related SAEs will be followed until they resolve to baseline or 
≤ Grade 1, the investigator assesses the AE as stable and unlikely to improve, or the patient is lost to 
follow-up, whichever occurs first.   
Duration of Patient Participation: 
Duration of patient participation will vary by patient. Each patient’s visit course will include: screening 
(up to 28 days), treatment (until disease progression, intolerable toxicity, or withdrawal for other reasons, 
and EOT Visit), safety follow-up (30 [±7], 60 [± 14], and 90 [± 14] days after the last dose of study 
drugs), and survival follow-up (approximately every 3 months ± 14 days after the last Safety Follow-up 
Visit). 
Study Population:  
The study will enroll approximately 167 patients who meet the following inclusion/exclusion criteria, 

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with approximately 127 patients in Cohort 1(tislelizumab combined with BGB-A1217) and 40 patients in 
Cohort 2 (tislelizumab monotherapy).  
Key Eligibility Criteria: 
Adult patients (≥ 18 years of age or the legal age of consent, at the time of voluntarily signing of informed 
consent) with histologically or cytologically confirmed squamous cell carcinoma, adenosquamous 
carcinoma, or adenocarcinoma of the cervix and who had progression on or after one or more lines of 
chemotherapy for management of recurrent or metastatic disease and are not amenable to curative 
treatment are eligible. Patients must submit qualified archival tumor tissue with an associated pathology 
report or agree to a tumor biopsy for determination of PD-L1 expression and other biomarker analyses. 
Patients must have an ECOG PS of ≤ 1 and life expectancy ≥ 12 weeks with adequate organ functions. 
Patients must have ≥ 1 measurable lesion as defined per RECIST v1.1. Patients who have received prior 
therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically 
targeting T-cell costimulation or checkpoint pathways are excluded. Patients with disease or condition 
treatment within limited period as mentioned in Section 4.2 are excluded. 
Investigational Product, Dose, and Mode of Administration: 
Tislelizumab, 200 mg Q3W administered by IV infusion   
BGB-A1217, 900 mg Q3W administered by IV infusion   
Statistical Methods: 
Analysis Sets: 
• 
The Safety Analysis Set (SAS) includes all patients of each cohort who received ≥ 1 dose of 
study drugs. This will be the primary analysis set for efficacy analysis, and the analysis set for 
safety analysis. 
• 
The Efficacy Evaluable Analysis Set (EAS) includes all treated patients (SAS) without critical 
protocol deviation of each cohort who had measurable disease at baseline per RECIST v1.1 by 
IRC and who had ≥ 1 evaluable post-baseline tumor assessment unless discontinued due to 
clinical PD or death within 7 weeks after the first dose. It will be used for the sensitivity analysis 
of the primary efficacy endpoint ORR.  
• 
The PK Analysis Set includes all patients who received ≥ 1 dose of any component of study drug 
per the protocol, for whom any postdose PK data are available.  
• 
The Immunogenicity Analysis Set includes all patients who received at least 1 dose of any 
component of study drug for whom both baseline antidrug antibody results and at least 1 post-
baseline antidrug antibody result are available. 
 
Efficacy Analysis: 
Primary Efficacy Analysis 
The primary efficacy endpoint is confirmed ORR as determined by IRC using the RECIST v1.1 in Cohort 
1. ORR is defined as the proportion of patients achieving best overall responses of CR or PR.  
The binomial exact test will be performed among the patients whose tumor with PD-L1 vCPS ≥ 5% and 
patients whose tumor regardless of PD-L1 expression in Safety Analysis Set in a sequential way. 
Patients whose tumor with PD-L1 vCPS ≥ 5% 
The ORR in this population is assumed as 30%, which is deemed a clinically meaningful improvement 

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based on a historical control of 15%. Hence, the null and alternative hypotheses are set as the following: 
H0: ORR ≤ 15% 
Ha: ORR > 15% 
Patients whose tumor regardless of PD-L1 expression 
The ORR in this population is assumed as 25%, which is deemed a clinically meaningful improvement 
based on a historical control of 15%. Hence, the null and alternative hypotheses are set as the following: 
H0: ORR ≤ 15% 
Ha: ORR > 15% 
If the obtained one-sided p-value is ≤ 0.025, it will be concluded that BGB-A1217 combined with 
tislelizumab statistically significantly increases ORR compared with the historical control in patients 
whose tumor with PD-L1 vCPS ≥ 5% or regardless of PD-L1 expression population. Therefore, the 
superiority of BGB-A1217 combined with tislelizumab will be demonstrated. A Clopper-Pearson 95% 
confidence interval (CI) of ORR will be constructed to assess the precision of the rate estimate.  
The primary efficacy analysis will be conducted when ORR data are mature, which is 6 months 
(approximately 4 tumor assessments) after the last patient receives the first dose of study drug in Stage 2 
and will be based on the Safety Analysis Set.  
Approximately 4 months after the enrollment is completed in Stage 1, there will be a preliminary analysis 
of ORR and safety (using descriptive statistics) for the first 40 patients in Cohort 1 and for all 40 patients 
in Cohort 2. Enrollment of Stage 2 will continue in parallel. At the time of preliminary analysis, if no 
more than 5 responders are observed in Cohort 1 at Stage 1, which corresponds to a Bayesian predictive 
probability of success less than 0.1 (Chen et al 2019; Lee and Liu 2008), the study will be terminated. 
Sensitivity analysis of ORR will be carried out in the Efficacy Evaluable Analysis Set. 
 
Secondary Efficacy Analysis 
ORR as assessed by investigator’s review will be summarized for secondary efficacy analysis in the 
Safety Analysis Set in Cohort 1, and ORR assessed by both IRC and investigator will be summarized in 
Cohort 2. 
Other efficacy endpoints with necessary tumor assessments, as well as OS, will also be summarized for 
secondary efficacy analysis. The secondary efficacy analysis will be conducted in the Safety Analysis Set 
assessed by both IRC and investigator (if applicable) in Cohort 1 and Cohort 2.  
DOR will be analyzed among the responders in the Safety Analysis Set. The median and other quartiles of 
DOR will be estimated using the Kaplan-Meier method. The 2-sided 95% CIs will be constructed with the 
generalized Brookmeyer and Crowley method (Brookmeyer and Crowley 1982). Event-free rates at 
selected timepoints for DOR will be estimated using the Kaplan-Meier method with corresponding 95% 
CI constructed using Greenwood’s formula (Greenwood 1926). The DOR censoring rule will follow US 
Food and Drug Administration (FDA) Guidance for Industry Clinical Trial Endpoints for the Approval of 
Cancer Drugs and Biologics (US FDA 2018).   
PFS and OS will be analyzed in the Safety Analysis Set using methods similar to those described for 
DOR. The PFS censoring rule will follow the same as DOR. For OS, patients will be censored either at 
the date that the patient was last known to be alive or the date of data cutoff, whichever comes earlier, in 

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the absence of death. 
PFS and OS rates at 3 months, 6 months, 9 months, and 12 months will be calculated based on Kaplan-
Meier method. 
TTR will be analyzed in the Safety Analysis Set using sample statistics such as mean, median, and 
standard deviation for patients who have achieved an objective response.  
DCR and CBR will be summarized similarly as ORR in the Safety Analysis Set and as well as in the 
Efficacy Evaluable Analysis Set for sensitivity analysis. 
HRQoL is an assessment of a patient’s health state using the scores of EORTC QLQ-C30 and the EORTC 
QLQ-CX24 scales. The postbaseline scores will be analyzed in Safety Analysis Set. 
 
Safety Analyses: 
Extent of exposure to each study drug will be summarized by duration, dosage, and dose intensity for 
each arm. 
Verbatim description of AEs will be mapped to the Medical Dictionary for Regulatory Activities 
(MedDRA®) terms and graded per NCI-CTCAE v5.0. All treatment-emergent AEs (TEAEs) will be 
summarized. A TEAE is defined as an AE that had an onset date or a worsening in severity from baseline 
(pretreatment) on or after the first dose of study drug up to 30 days of last dose of study drugs or initiation 
of a new anticancer therapy. The TEAE classification also applies to imAEs that are recorded up to 
90 days after the last dose of study drugs, regardless of whether the patient starts a new anticancer 
therapy. 
Clinical laboratory data with values outside of the normal ranges will be identified. Selected laboratory 
data will be summarized by grade. Changes in vital signs will also be summarized by visit. 
 
Pharmacokinetic Analyses: 
Tislelizumab and BGB-A1217 serum concentration data will be tabulated and summarized by visit/cycle 
at which these concentrations are collected. Descriptive statistics will include means, medians, ranges, 
and standard deviations, as appropriate.  
Additional PK analyses may be conducted as appropriate. 
 
Sample Size Consideration: 
The sample size calculation of Cohort 1 was based on the power of the comparison between the estimated 
ORR in the study and the historical rate in a sequential way as patients whose tumor with PD-L1 vCPS ≥ 5% 
followed by regardless of PD-L1 expression. An assumed ORR of 30% in the patients whose tumor with PD-
L1 vCPS ≥ 5% compared to the historical rate of 15%; an assumed ORR of 25% in patients whose tumor 
regardless of PD-L1 expression compared to the historical rate of 15%.  
• 
With 76 patients (60% whose tumor with PD-L1 vCPS ≥ 5%), the power is 0.860 to demonstrate 
that the ORR in patients whose tumor with PD-L1 vCPS ≥ 5% is statistically higher than the 
historical rate of 15% using a binomial exact test; the 95% CI of an observed 30% ORR is 20.2% to 
41.9%. 
• 
With 89 patients (70% whose tumor with PD-L1 vCPS ≥ 5%), the power is 0.927 to demonstrate 
that the ORR in patients whose tumor with PD-L1 vCPS ≥ 5% is statistically higher than the 
historical rate of 15% using a binomial exact test; the 95% CI of an observed 30% ORR is 21.0% to 

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40.0%. 
• 
With 102 patients (80% whose tumor with PD-L1 vCPS ≥ 5%), the power is 0.940 to demonstrate 
that the ORR in patients whose tumor with PD-L1 vCPS ≥ 5% is statistically higher than the 
historical rate of 15% using a binomial exact test; the 95% CI of an observed 30% ORR is 21.7% to 
40.3%. 
• 
With 127 patients, the power is 0.807 to demonstrate that the ORR in the patient population whose 
tumor regardless of PD-L1 expression is statistically higher than the historical rate of 15% using a 
binomial exact test; the 95% CI of an observed 25% ORR is 17.9% to 33.7%. 
The PD-L1 expression will be closely monitored for Cohort 1, and enrollment of patients whose tumors are 
PD-L1 vCPS < 5% or not evaluable will be stopped as necessary when reaching approximately 40%. This is to 
ensure that the percentage of patients with tumor PD-L1 vCPS ≥ 5% is no less than 60% of the Safety Analysis 
Set.   
In addition, 40 patients will be enrolled in Cohort 2 to investigate the safety and efficacy of tislelizumab 
monotherapy in patients with previously treated recurrent or metastatic cervical cancer. 
 

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LIST OF ABBREVIATIONS AND TERMS  
Abbreviation 
Definition 
ADAs 
antidrug antibodies 
AE 
adverse event 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BOR 
best overall response 
CBR 
clinical benefit rate 
CD 
cluster of differentiation 
CK-MB 
creatine kinase-muscle/brain 
CPS 
Combined Positive Score 
CR 
complete response 
CT 
computed tomography 
DCR 
disease control rate 
DLT 
dose-limiting toxicity 
DOR 
duration of response 
ECG 
electrocardiogram 
ECOG  
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture (system) 
EORTC 
European Organisation for Research and Treatment of Cancer 
EOT 
End-of-Treatment (Visit) 
FDG 
fluorine-18 [F-18] fluorodeoxyglucose 
GCP 
Good Clinical Practice 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HPV 
Human papilloma virus 
HRQoL 
Health related quality of life 
ICF 
informed consent form 
IEC 
Independent Ethics Committee 
IgG 
immunoglobulin G 
imAE 
immune-mediated adverse event 
IRB 
Institutional Review Board 
IRC 
Independent Review Committee 
ITIM 
immunoreceptor tyrosine-based inhibitory motif 
IV 
intravenous(ly) 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
magnetic resonance imaging 
NCI-CTCAE 
National Cancer Institute-Common Terminology Criteria for Adverse Events 
NK 
natural killer 
ORR 
objective response rate 

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Abbreviation 
Definition 
OS 
overall survival 
PBMC 
peripheral blood mononuclear cells 
PD 
progressive disease 
PD-1 
programmed cell death protein-1 
PD-L1 
programmed death-ligand 1 
PET 
positron-emission tomography 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 
PR 
partial response 
PRO 
Patient reported outcomes 
PVR 
Poliovirus receptor 
Q3W 
every 3 weeks 
QoL 
Quality of life 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
serious adverse event 
SD 
stable disease 
SOC 
system organ class 
TEAE 
treatment-emergent adverse event 
TIGIT 
T-cell immunoreceptor with Ig and ITIM domains 
TTR 
time to response 
TIL 
tumor-infiltrating lymphocyte 
ULN 
upper limit of normal 
vCPS 
visually-estimated Combined Positive Score 
 

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1. 
INTRODUCTION AND RATIONALES  
1.1. 
Background Information on Cervical Cancer  
Cervical cancer is the fourth most common cancer and the fourth leading cause of cancer death 
in women with approximately 570,000 new diagnoses and 311,000 deaths worldwide in 2018. 
The estimated age-standardized incidence of cervical cancer was 13.1 per 100,000 women 
globally and varied widely among countries, with rates ranging from less than 2 to 75 per 
100,000 women. China and India together contributed more than one-third of the global cervical 
cancer burden, with 106,000 cases and 48,000 deaths in China and 97,000 cases and 60,000 
deaths in India (Arbyn et al 2020).  
Squamous, glandular, and other epithelial tumors including adenosquamous carcinoma, 
neuroendocrine tumors, and undifferentiated carcinoma are the 3 categories of epithelial tumors 
of the cervix recognized by the World Health Organization (WHO). Squamous cell carcinomas 
account for 70% to 80% of cervical cancers and adenocarcinomas account for 20% to 25%. 
The most significant cause of cervical cancer is persistent papillomavirus infection. Human 
papilloma virus (HPV) is detected in 99% of cervical tumors, particularly the oncogenic 
subtypes, such as HPV 16 and 18. Post-licensure reports from countries with established HPV 
vaccination programs indicated that HPV vaccination has a beneficial effect at the population 
level as early as 3 years after the introduction of an HPV vaccination program, including 
decreases in the incidence of high-grade cervical abnormalities and the incidence of genital warts 
(Markowitz et al 2016; Ali et al 2013).  
HPV has been recognized as the most important etiological factor in cervical cancer. HPV 16/18 
account for at least two-thirds of cervical carcinomas. Squamous cell carcinomas and their 
precursor, intraepithelial squamous lesions, are related to HPV infection in almost all cases, and 
the presence of HPV 16 DNA is associated with poor prognosis. Adenocarcinomas encompass a 
heterogeneous group of tumors. Endocervical adenocarcinoma of usual type and its precursor, 
the adenocarcinoma in situ, have been shown to be positive for HPV in nearly 90% and 100% of 
cases, respectively. HPV 18 is more common in adenocarcinomas and adenosquamous 
carcinomas than in squamous cell carcinomas (Marth et al 2017). 
1.2. 
Current Treatment of Recurrent or Metastatic Cervical Cancer  
The primary treatment of advanced cervical cancer includes surgery, chemoradiotherapy, or 
combination of surgery and chemoradiation. In some cases, the tumor might be eradicated, and 
the treatment response can be durable. Patients who develop metastatic disease (ie, stage IVB) 
account for less than 5% of new cases and are rarely curable, with the primary treatment often as 
platinum-containing chemotherapy. It is estimated that recurrent or metastatic disease develops 
in 15% to 61% of women, usually within the first 2 years after completing primary treatment 
(Pfaendler and Tewari 2016). For recurrent or metastatic disease, highly selected patients (ie, 
locoregional recurrence and isolated distance metastasis) may be candidates for radical 
retreatment (ie, surgery, radiotherapy, and/or chemotherapy), but the treatment options are 
limited, and the prognosis is poor for the majority of women who are not amenable to therapy 

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with curative intent. Palliative systemic therapy with the aim of relieving symptoms and 
improving quality of life is usually indicated.  
For first-line treatment of recurrent or metastatic disease, the standard of care has been cisplatin-
based doublets with or without bevacizumab. There were 2 Phase 3 trials demonstrating the 
superiority of combination treatment of cisplatin with topotecan or paclitaxel to cisplatin 
monotherapy in terms of response rate and progression-free survival (PFS) (Moore et al 2004; 
Long et al 2005). There were no statistically significant differences in terms of 
overall survival (OS) from a large randomized Phase 3 study, which consisted of four different 
cisplatin-based doublets with paclitaxel, topotecan, gemcitabine or vinorelbine as the first-line 
treatment setting. Nevertheless, the paclitaxel-cisplatin combination treatment showed the 
highest response rate (29%), median PFS (5.8 months), and median OS (12.8 months) and was 
considered the preferred regimen (Monk et al 2009). The combination of paclitaxel and 
carboplatin could be considered an alternative for patients who are not candidates for cisplatin. 
Recently, a Phase 3, randomized trial (GOG 240) enrolled patients with primary stage IVB or 
recurrent/persistent disease who had not been treated with chemotherapy for recurrence and were 
not amenable to curative therapy. Patients were randomized to paclitaxel-cisplatin or 
paclitaxel-topotecan doublet, both with or without bevacizumab. The results showed that the 
addition of bevacizumab to chemotherapy was associated with increased OS (17.0 months versus 
13.3 months; hazard ratio (HR), 0.71; 95% CI, 0.54 to 0.95; p = 0.004) and higher response rates 
(48% versus 36%, p = 0.008). Bevacizumab, as compared with chemotherapy alone, was 
associated with an increased incidence of ≥ Grade 2 hypertension (25% versus 2%), ≥ Grade 3 
thromboembolic events (8% versus 1%), and ≥ Grade 3 gastrointestinal fistulas (3% versus 0%) 
(Tewari et al 2014).  
For patients who have progressed after first-line platinum-based therapy, the treatment options 
are even more limited, and no standard of care has been established. Single cytostatic agents, 
including vinorelbine, topotecan, gemcitabine, or nanoparticle albumin-bound paclitaxel, have 
been evaluated as second-line treatment. However, response rates are low, and duration of 
response (DOR) is short. Summary of reported second-line single agents for recurrent/advanced 
cervical cancer is shown in Table 1 (Boussios et al 2016). 
Table 1: 
Summary of Reported Second-Line Single Agents for Recurrent or 
Metastatic Cervical Cancer  
Study 
Agent 
N 
ORR 
(%) 
PFS 
(months) 
OS 
(months) 
Thigpen T 2003 
Cisplatin 
190 23 
NS 
NS 
Ifosfamide 
35 14–40 NS 
NS 
Takeuchi S 1991 
Irinotecan 
55 24 
NS 
NS 
Verschraegen CF 1997 
Irinotecan 
42 21 
NS 
NS 
Garcia AA 2007 
Capecitabine 
26 15.4 
2.9 
5.9 
Look KY 2008 
Capecitabine 
21 0 
NS 
NS 
Lorvidhaya V 2010 
Capecitabine 
45 2 
4.1 
9.3 
Katsumata N 2011 
S-1 
36 31.8 
5.2 
15.4 

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Bookman MA 2000 
Topotecan 
45 12.5 
2.1 
6.6 
Noda K 1996 
Topotecan 
22 18 
NS 
NS 
Abu-Rustum NR 2000 
Topotecan 
12 17 
NS 
NS 
Nascimento de Oliveira 2013 
Topotecan 
21 10 
2.93 
4.66 
Coronel J 2009 
Topotecan 
18 NS 
3.5 
7.0 
Fiorica JV 2009 
Topotecan 
25 NS 
2.4 
6.2 
Muggia FM 2004 
Vinorelbine 
44 13.7 
NS 
NS 
Muggia FM 2005 
Vinorelbine 
28 7.1 
NS 
NS 
Miller DS 2008 
Pemetrexed 
29 15 
3.1 
7.4 
Lorusso D 2010 
Pemetrexed 
43 13.9 
2.5 
8.8 
Garcia AA 2007 
Docetaxel 
27 8.7 
3.8 
7.0 
Schilder RJ 2005 
Gemcitabine 
22 4.5 
2.1 
6.5 
Schilder RJ 2000 
Gemcitabine 
24 8 
1.9 
4.9 
Thigpen T 1981 
Cisplatin 
12 17 
NS 
NS 
Rose PG 2006 
Pegylated liposomal 
doxorubicin 
26 11 
NS 
NS 
Rose PG 1996 
Altretamine 
29 0 
NS 
4.6 
Rose PG 1998 
Etoposide 
24 8 
NS 
3.7 
Curtin JP 2001 
Paclitaxel 
41 32 
NS 
7.3 
Sutton GP 1993 
Ifosfamide 
39 15 
NS 
4.2 
Sutton GP 1989 
Ifosfamide 
27 11 
NS 
NS 
Vermorken JB 1991 
DAC 
15 0 
NS 
NS 
van der Burg ME 1992 
4∗-epidoxorubicin 
24 4.2 
3.2 
NS 
Abbreviations: DAC, 5-aza-2∗-deoxycytidine; N, number; NS, not stated; OS, overall survival; ORR, objective 
response rate; PFS, progression free survival 
Virus-induced cancers are attractive targets for immunotherapy because viral proteins are strong 
immune stimulants. In June 2018, pembrolizumab received accelerated approval by the US FDA 
for the treatment of patients with recurrent or metastatic cervical cancers with disease 
progression on or after chemotherapy whose tumors express programmed death-ligand 1 
(PD-L1) (Keytruda prescribing information 2020). The efficacy of pembrolizumab was 
investigated in a single cohort (Cohort E) in KEYNOTE-158 (NCT02628067), a multicenter, 
non-randomized, open-label, multi-cohort trial. The cohort enrolled 98 patients in total, and 77 
patients had tumors that expressed PD-L1 with a Combined Positive Score (CPS) ≥ 1 and 
received at least 1 line of chemotherapy in the metastatic setting. For those 77 patients, 95% had 
M1 disease and 5% had recurrent disease; 35% had 1 prior line of therapy while 65% had ≥ 2 
prior lines of therapy in the recurrent or metastatic setting. The objective response rate (ORR) 
was 14.3% (95% CI 7.4%, 24.1%). At the time of data cutoff, the median DOR was not reached, 
with 91% of responders having a response duration ≥ 6 months. Meanwhile, no responses were 

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observed in patients whose tumors did not have PD-L1 expression (CPS ˂ 1) (Chung et al 2019). 
In CheckMate 358, a Phase I/II study evaluating nivolumab-based therapy in virus-associated 
tumors, 19 patients who had recurrent or metastatic cervical cancer with ≤ 2 prior systemic 
therapies were treated with nivolumab monotherapy 240 mg every 2 weeks. The ORR was 
26.3% (95% CI, 9.1% to 51.2%), and DOR was not reached at data cutoff (range, 23.3 to 29.5+ 
months) (Naumann et al 2019). With those reports of moderate efficacy combined with durable 
response, immunotherapy remains an active compound of investigation in late line treatment of 
cervical cancer. 
1.3. 
BGB-A1217 as a TIGIT Inhibitor  
BGB-A1217 is a humanized immunoglobulin G (IgG) 1 monoclonal antibody binding to T-cell 
immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) 
under clinical development for the treatment of human malignancies.  
TIGIT (also known as VSIG9, VSTM3, or WUCAM) is a 26 kDa type I transmembrane 
glycoprotein and an immune checkpoint receptor, a member of the poliovirus receptor 
(PVR)/nectin family that plays an important role in promoting T-cell exhaustion in both chronic 
viral infections and tumor escape from immune surveillance (Yu et al 2009; Boles et al 2009; 
Stanietsky et al 2009; Levin et al 2011; Johnston et al 2014). TIGIT was initially discovered in a 
genomic search for genes specifically expressed in T cells that had a protein domain that 
consisted of inhibitory signaling motifs. The genes and cDNAs coding for TIGIT were cloned 
and characterized in mouse and human (Yu et al 2009). Mature human TIGIT contains 223 
amino acid residues (National Center for Biotechnology Information 2018). Its extracellular 
domain consists of amino acid residues 1 through 120, and the transmembrane domain and 
cytoplasmic C-terminal tail comprises residues 121 through 223. 
TIGIT-deficient mice (TIGIT-/-) showed increased susceptibility to an experimental autoimmune 
model (Joller et al 2014). TIGIT overexpressing natural killer (NK) cells produced less 
interferon-gamma (IFN-γ) upon TIGIT/PVR ligation. In contrast, NK cells from TIGIT-deficient 
mice produced more IFN-γ in the presence of PVR-expressing target cells (Li et al 2014). 
Agonistic anti-TIGIT antibody could reduce the production of proinflammatory cytokines, 
including IFN- and IL-17, by antigen-restimulated splenocytes and antigen-specific 
proliferation. Consistent with these observations, blockade of TIGIT pathway in vivo by TIGIT 
blocking antibody alone or in combination with an anti-programmed cell death protein-1(PD-1) 
antibody reduced tumor growth in syngeneic mouse models (College of American Pathologist 
(CAP) Guidelines 2018; Argast et al 2018; Dixon et al 2018). All these findings strongly suggest 
that TIGIT is a critical immune checkpoint receptor in the maintenance of immune tolerance. 
TIGIT is primarily expressed on immune cells, such as T cells, and NK cells (Manieri et al 
2017). When expressed on effector T cells (cluster of differentiation [CD] 4+ [CD4+] and CD8+), 
activation of TIGIT has been shown to reduce cytokine production and T-cell proliferation, all of 
which could be rescued by TIGIT blocking antibodies or TIGIT expression knockdown (Joller et 
al 2014; Lozano et al 2012; Chauvin et al 2015). A similar phenomenon was also observed for 
NK cells (Stanietsky et al 2009; Zheng et al 2017). 
TIGIT is also expressed on FoxP3+ regulatory T (Treg) cells, especially in tumor tissues (Joller 
et al 2014; Kurtulus et al 2015). TIGIT-positive Treg cells demonstrated greater suppressive 

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functions when compared to TIGIT-negative Tregs, with higher expression of effector molecules, 
such as IL-10, granzymes, and Fgl2 (Joller et al 2014). A high TIGIT/CD226 ratio in Tregs is 
associated with increased Treg frequencies in tumors and poor clinical outcome upon immune 
checkpoint blockade (Fourcade et al 2018). Some studies have also shown that TIGIT suppresses 
immune responses mediated by dendritic cells by binding with PVR, especially in enhancement 
of IL-10 production and inhibition of IL-12 production (Yu et al 2009). 
As an immune “checkpoint” molecule, TIGIT initiates inhibitory signaling in immune cells when 
engaged by its ligands, PVR (CD155) and poliovirus receptor-related 2 (PVR-L2) (CD112 or 
nectin-2). These ligands are primarily expressed on antigen-presenting cells and tumor cells 
(Casado et al 2009; Stanietsky et al 2009; Yu et al 2009; Levin et al 2011). The binding affinity 
of TIGIT to PVR (equilibrium dissociation constant [KD]: ~1 nM) is much higher than to 
PVR-L2, and whether the TIGIT:PVR-L2 interaction is functionally relevant in mediating 
inhibitory signals remains to be determined. The co-stimulatory receptor, CD226, binds to the 
same ligands with lower affinity (KD: ~100nM) but delivers a positive signal and enhances the 
cytotoxicity of T cells and NK cells (Bottino et al 2003; Stanietsky et al 2009). High affinity 
binding of TIGIT to PVR could compete off CD226-PVR interaction, thereby reducing the 
activation of T cells or NK cells (Stanietsky et al 2009). 
The cytoplasmic tail of TIGIT has an inhibitory immunoreceptor tyrosine-based inhibitory motif 
(ITIM) and an immunoreceptor tail tyrosine-like motif. In NK cells, TIGIT engagement induces 
the phosphorylation of tyrosine residues in its ITIM and immunoreceptor tail tyrosine-like motifs 
through the Src kinases Fyn and Lck. Then, the phosphorylations of TIGIT lead to binding of 
Grb2 and β-arrestin 2 and subsequent recruitment of SHIP-1 and SHP-2 to terminate PI3K and 
NK-κB signaling in the NK cells (Liu et al 2013; Stanietsky et al 2009). Engagement of agonistic 
TIGIT antibody induces T-cell receptor complex disruption (Stanietsky et al 2009). Additionally, 
interaction between TIGIT and PVR on dendritic cells could lead to phosphorylation of PVR and 
modulation of ERK activation in dendritic cells (Yu et al 2009).  
Up-regulation of TIGIT expression in tumor-infiltrating lymphocytes (TILs) has been reported in 
many types of cancers, such as lung (Tassi et al 2017), stomach (He et al 2017), breast (Gandara 
et al 2018; Gil Del Alcazar et al 2017), esophageal (Xie et al 2016), brain (Hung et al 2018), 
acute myeloid leukemia (Kong et al 2016), and melanoma (Mahnke and Enk et al 2016). 
Interestingly, TIGIT expression appears to be minimally expressed by peripheral effector cells 
while being significantly up-regulated by tumor localized effector cells, which strongly suggests 
that the tumor microenvironment utilizes TIGIT signaling to further suppress/evade immune-
mediated tumor cytotoxicity (Johnston et al 2014). Further, up-regulation of TIGIT signaling 
plays an important role in immune tolerance to cancer, similar to its function in the presence of 
chronic viral infections (Yin et al 2018; Chauvin et al 2015. Blockade of TIGIT receptor alone or 
in combination with PD-1/PD-L1 blockade has been shown both in vitro and in vivo to rescue 
functionally “exhausted” T cells (Johnston et al 2014; Chauvin et al 2015). In mouse models, 
TIGIT blockade in combination with anti–PD-1/PD-L1 antibodies demonstrated significantly 
better antitumor efficacy than either monotherapy (Johnston et al 2014; Dixon et al 2018).  
In mouse models, Fc with effector functions is critical for TIGIT antibody-mediated antitumor 
activity (College of American Pathologist (CAP) Guidelines 2018; Argast et al 2018; Leroy et al 
2018). In CT26.WT mouse colon cancer model, anti-mouse TIGIT antibody of mIgG2a isotype 
(antibody-dependent cellular cytotoxicity enabling) demonstrated potent antitumor activity either 

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in monotherapy or in combination with anti-PD-1 antibody. In contrast, anti-TIGIT antibody 
with Fc devoid of effector functions did not show any of the antitumor efficacies in the same 
model, indicating that Fc-mediated effector functions are required for TIGIT antibody-mediated 
antitumor effects. Additionally, the observed efficacy was associated with an increased activity of 
effector T cells (CD8+ and CD4+) and also with Treg depletion within the tumor 
microenvironment. Argast and colleagues (College of American Pathologist (CAP) Guidelines 
2018; Argast et al 2018) also observed that effector functions were critical for TIGIT antibody-
induced in vivo efficacy. Waight and colleagues (Waight et al 2018), reported the interaction of 
anti-TIGIT with FcγR on antigen-presenting cells enhanced antigen-specific T cell responses and 
antitumor activity. 
Taken as a whole, targeting TIGIT provides a potential mechanism to rescue immune cells 
(eg, T cells, NK cells, and dendritic cells) from the immunosuppressive tumor 
microenvironment, thereby inducing an efficient antitumor immune response. Blocking 
antibodies targeting the PD-1/PD-L1 pathway have achieved remarkable results in the treatment 
of many different tumor types. However, based upon the rate of primary and secondary 
resistance to PD-1 blockade, it is apparent that additional immuno-regulatory mechanism(s) 
underlie tumor immune escape. Indeed, research shows that the TIGIT pathway cooperates with 
PD-1 to maximize the suppression of effector TILs as well as to promote resistance to anti-PD-1 
therapy. Therefore, TIGIT represents an ideal target with the potential to significantly improve 
and/or extend the therapeutic benefit of anti-PD-1 therapy to a greater number of patients. 
1.3.1. 
Nonclinical  
1.3.1.1. 
Pharmacology  
BGB-A1217 binds to the extracellular domain of human TIGIT with high specificity and affinity 
(KD = 0.135 nM), as demonstrated by target-binding assays and surface plasmon resonance 
characterization. It competitively blocks TIGIT binding to PVR. In in vitro cell-based assays, 
BGB-A1217 “in a dose dependent manner”: “consistently and dose-dependently enhances the 
functional activities of activated human peripheral blood mononuclear cells (PBMCs)”. 
Additionally, BGB-A1217 has shown antitumor activities in both the GL261 mouse glioma 
tumor model and the CT26.WT mouse colon cancer model in humanized TIGIT knock-in mice. 
In the MC-38 mouse colon cancer model in humanized TIGIT knock-in mice, BGB-A1217 in 
combination with anti-mouse PD-1 significantly inhibited tumor growth compared with either 
therapy alone. 
BGB-A1217 has the constant region of a wild-type human IgG1 to enable the Fc-mediated 
effector functions. BGB-A1217 has demonstrated competent binding to complement 1q (C1q) 
and all FcRs, including FcRI, FcRIIA, FcRIIB, and FcRIIIA, in in vitro binding assays, and 
induces antibody-dependent cellular cytotoxicity against TIGIT overexpressing cell line, but no 
antibody-dependent cellular cytotoxicity or complement-dependent cytotoxicity against primary 
T cells in cell-based assays. 
Refer to the BGB-A1217 Investigator’s Brochure for detailed information regarding 
pharmacology studies. 

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1.3.1.2. 
Toxicology  
Humanized TIGIT knock-in mice containing human TIGIT gene and cynomolgus monkeys were 
selected for nonclinical safety evaluation of BGB-A1217 based on the homology of TIGIT 
amino acid sequence, binding affinity, and efficacy studies. Cynomolgus monkeys were the most 
relevant species based on the homology sequence of TIGIT, though it demonstrates a relatively 
lower BGB-A1217 binding affinity compared to human TIGIT (with EC50 756-fold weaker). 
BGB-A1217 does not bind to mouse TIGIT due to the significant sequence divergence between 
human and mouse TIGIT; however, BGB-A1217 demonstrates a comparable binding affinity in 
TIGIT receptor occupancy assays with CD3+ splenocytes from humanized TIGIT knock-in mice 
compared to CD3+ human PBMCs (with EC50 of 48.8 ng/mL versus 63.2 ng/mL, respectively). 
In addition, BGB-A1217 shows significant inhibition of GL261 tumor growth in humanized 
TIGIT knock-in mice at a dose of 0.4 mg/kg and above via weekly intraperitoneal dosing.  
The toxicity and safety profile of BGB-A1217 was characterized in a 4-week repeat dose 
toxicology study in humanized TIGIT knock-in mice and a 13-week repeat dose toxicology 
study in cynomolgus monkeys. Furthermore, BGB-A1217 was evaluated in a 4-week repeat dose 
study in humanized TIGIT knock-in mice with subcutaneous MC-38 tumors. The dose levels 
spanned from the intended human therapeutic doses to 10-fold higher in the 4-week mouse 
studies and 20-fold higher in the 13-week monkey study. The cynomolgus monkey was 
considered the relevant species for toxicity studies based upon the target sequence homology and 
cross-species TIGIT binding activities of BGB-A1217. The tissue cross reactivity was evaluated 
in the normal frozen tissues from humans. The cytokine release responses were also evaluated 
using fresh human PBMCs. 
No apparent toxicity was noted in humanized mice after repeated dosing of BGB-A1217 at either 
5 or 50 mg/kg weekly for 4 weeks, nor in monkeys following repeated dosing at 10, 30, or 
100 mg/kg once every 2 weeks for 13 weeks. The toxicokinetic profile was characterized in both 
the mouse and monkey studies, and the systemic exposure appeared to be dose-proportional with 
no gender difference in either study. A trend of accumulation was noted after repeated doses in 
mice; however, no accumulation was observed over the 13-week dosing period in monkeys. No 
immunotoxicity was apparent as no changes in clinical pathology or histopathology were 
observed in these studies. Immunogenicity with positive antidrug antibodies (ADAs) against 
BGB-A1217 was noted in several mice dosed at 5 and 50 mg/kg over the 4 weeks; however, with 
the exception of one animal with strong ADA response at 5 mg/kg dose, most of these animals 
showed weak ADA signal or were proved to be false positives. In monkeys dosed at 10, 30, and 
100 mg/kg, positive ADAs against BGB-A1217 were observed in 6 of 10, 3 of 10, and 4 of 10 
animals during the dosing period and 3 of 4, 2 of 4, and 2 of 4 animals during the recovery 
period, respectively. The anti-BGB-A1217 antibodies showed a rapid clearance of BGB-A1217 
in serum in a few individual animals but did not appear to have an effect on the overall systemic 
exposure (area under the concentration-time curve [AUC]) or toxicity assessment. 
The tissue cross reactivity of BGB-A1217 was evaluated in frozen normal human tissues using 
an immunohistochemistry method, with appropriate positive and negative controls. No specific 
binding of BGB-A1217 was noted with normal human tissues. A variety of factors might 
contribute to the negative results, including negligible target expression in normal tissues (Yang 
2016; Human Protein Atlas 2019) and sensitivity of the immunohistochemistry method. 

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No significant increase in cytokine release was observed from an in vitro cytokine release assay 
following treatment of non-activated PBMCs with BGB-A1217 when compared to human IgG.  
The results suggested that BGB-A1217 had potentially low risks of causing acute cytokine 
release syndrome. 
Overall, no apparent toxicity was noted in the monkey or transgenic mice toxicity studies. No 
unexpected tissue cross reactivity was found in human or monkey tissues. The toxicokinetic 
profile was well characterized with dose-proportional increases in systemic exposure without 
apparent accumulation or sex difference. Immunogenicity was observed without apparent 
immunotoxicity or effect on the systemic exposure. The no-observed-adverse-effect level 
(NOAEL) of BGB-A1217 was 50 mg/kg in the 4-week mouse study and 100 mg/kg in the 
13-week monkey toxicity study. The safety profile of BGB-A1217 is considered adequate to 
support first-in-human dosing. 
Refer to the BGB-A1217 Investigator’s Brochure for detailed information regarding toxicology 
studies. 
1.3.2. 
Clinical Experience  
1.3.2.1. 
Clinical Experience From Other TIGIT Inhibitors  
To date, the first-in-human Phase 1 and 2 clinical studies have been initiated for 6 anti-TIGIT 
antibodies: MTIG7192A from Genentech/Roche (NCT02794571 and NCT03563716), 
BMS-986207 from Bristol-Myers Squibb (NCT02913313), MK-7684 from Merck Sharp & 
Dohme (NCT02964013), OMP-313M32 from OncoMed (NCT03119428), ASP8374 from 
Astellas/Potenza (NCT03260322), and AB-154 from Arcus (NCT03628677). The goals for these 
clinical studies are to evaluate the safety and efficacy of anti-TIGIT antibodies alone and/or in 
combination with anti-PD-1 or anti-PD-L1 antibodies. 
To date, clinical data have been released for OncoMed’s OMP-313M32 (Sharma et al 2018), 
Merck’s MK-7684 (Golan et al 2018), and Genentech/Roche’s tiragolumab (Bendell et al 2020; 
Rodriguez-Abreu et al 2020).   
A total of 68 patients have been treated with MK-7684 alone or MK-7684 in combination with 
pembrolizumab (an anti-PD-1 antibody) in a Phase 1 study sponsored by Merck Sharp & 
Dohme, with doses of MK-7684 ranging from 2.1 mg to 700 mg. The preliminary results showed 
that MK-7684 was well tolerated in the dose escalation phase of the study, with no dose-limiting 
toxicity (DLT). Adverse events (AEs) that occurred in > 15% of patients were fatigue (n = 5, 
15%) for MK-7684 monotherapy and pruritus (n = 10, 21%) for MK-7684 and pembrolizumab 
combination therapy. Furthermore, only 2 treatment-related AEs ≥ Grade 3 were reported (Grade 
3 anemia and Grade 3 diarrhea) for monotherapy and 5 treatment-related AEs ≥ Grade 3 were 
reported for combination with pembrolizumab (5 Grade 3: alanine aminotransferase [ALT] 
increased, colitis, γGT increased, hypersensitivity, and rash maculopapular). Of the 34 evaluable 
patients treated with MK-7684 alone, one partial response (1 of 34 [3.0%]) and a 35% disease 
control rate were observed. For combination of MK-7684 and pembrolizumab, 6 partial 
responses (6 of 34 [18%]) and a 48% disease control rate were observed. In addition, 
pharmacokinetic (PK) findings were linear above 200 mg. 

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A total of 18 patients have been treated with OMP-313M32 monotherapy in a Phase 1 study 
sponsored by OncoMed, with doses ranging from 0.3 mg/kg to 20 mg/kg. The preliminary 
results showed that OMP-313M32 was well tolerated in the dose escalation phase of the study, 
with no DLT. Treatment-related AEs that occurred in > 15% of patients were rash (n = 5; 
27.8%), fatigue (n = 3, 16.7%), nausea (n = 3, 16.7%), and pruritus (n = 3, 16.7%) for OMP-
313M32 monotherapy. Grade ≥ 3 treatment-related AEs included rash (n = 3, 16.7%), fatigue 
(n = 1, 5.6%), hypophosphatemia (n = 1, 5.6%), and autoimmune hepatitis (n = 1, 5.6%). Based 
upon the safety profile of OMP-313M32 monotherapy, OncoMed has initiated the dose 
expansion with the combination of OMP-313M32 and nivolumab (an anti-PD-1 antibody) in 
patients with non-small cell lung, head and neck, esophageal, gastric, cervical, triple negative 
breast, anal, and hepatocellular cancers or with microsatellite instability-high tumors 
(NCT03119428).  
The Phase 1 data for tiragolumab was released at the 2020 American Association of Cancer 
Research meeting (Bendell et al 2020). No objective responses occurred in 24 patients treated 
with tiragolumab monotherapy in Phase 1a. However, in Phase 1b, 5 of 44 patients (11.4%) 
treated with tiragolumab combined with atezolizumab had achieved partial response 
(Bendell et al 2020). In the Phase 1a (tiragolumab monotherapy) cohort, there were no Grade 3-5 
immune-mediated AEs (imAEs). Grade 1-2 imAEs included infusion-related reaction (n = 2, 
8%), rash (n = 2, 8%), hepatitis (n = 1, 4%), and pancreatitis (n = 1, 4%). In the Phase 1b 
(tiragolumab combined with atezolizumab) cohort, 4% of patients experienced Grade 3-5 
imAEs; no Grade 5 imAEs were associated with tiragolumab and/or atezolizumab. These imAEs 
included infusion-related reaction (n = 4, 8%), rash (n = 14, 29%), hepatitis (n = 10, 20%), 
pancreatitis (n = 1, 2%), hyperthyroidism (n = 4, 8%), hypothyroidism (n = 3, 6%), and anemia 
(n = 1, 2%). 
A total of 135 patients with previously untreated PD-L1-selected non-small cell lung cancer were 
treated with tiragolumab 600 mg intravenously (IV) every 3 weeks (Q3W) plus atezolizumab 
1200 mg IV Q3W (n = 67) or atezolizumab 1200 mg IV Q3W plus placebo IV Q3W (n = 68) in 
a Phase 2 study (CITYSCAPE) sponsored by Genentech/Roche. Patients were randomly 
assigned to 1 of these treatment groups and were stratified by tumor proportion score (1% to 
49% or ≥ 50%), histology (squamous versus nonsquamous), and tobacco use (yes or no). 
Preliminary efficacy results showed a clinically meaningful improvement in ORR and PFS in 
patients treated with tiragolumab plus atezolizumab (ORR 31%; PFS 5.42 months) compared 
with those treated with atezolizumab plus placebo (ORR 16%; PFS 3.58 months). This 
improvement was still observed 6 months later: tiragolumab plus atezolizumab (ORR 37%; PFS 
5.55 months) compared with atezolizumab plus placebo (ORR 21%; PFS 3.88 months). In 
addition, analysis at this 6-month follow-up timepoint showed a greater improvement in ORR in 
patients in the PD-L1 tumor proportion score ≥ 50% subgroup who received tiragolumab plus 
atezolizumab (ORR 66%) compared with atezolizumab plus placebo (ORR 24%). Preliminary 
safety results showed that study treatment with tiragolumab plus atezolizumab was well 
tolerated; results were generally similar between the 2 treatment groups. More patients in the 
tiragolumab plus atezolizumab group experienced imAEs compared with those in the 
atezolizumab plus placebo group (46 [69%] versus 32 [47%]); most imAEs were Grade 1 or 
Grade 2 events of infusion-related reaction and rash and were manageable. Based on these 
observed efficacy and safety results, Genentech/Roche is conducting an ongoing Phase 3 study 

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(SKYSCRAPER-01) in first-line PD-L1 tumor proportion score ≥ 50 non-small cell lung cancer  
(NCT04294810). 
All of these findings support further development of anti-TIGIT antibody in combination with 
existing therapeutic modalities. 
1.3.2.2. 
Preliminary Safety  
The first-in-human study BGB-900-105 evaluating the safety and tolerability of BGB-A1217 in 
combination with tislelizumab in advanced solid tumors is still ongoing. 
As of 16 June 2020, 11 DLT evaluable patients had received at least 1 dose of BGB-A1217 
combined with tislelizumab 200 mg Q3W in the dose escalation stage. The dosage of 
BGB-A1217 ranged from 50 mg to 900 mg Q3W. One patient received a BGB-A1217 dosage of 
50 mg Q3W, 3 patients received 150 mg Q3W, 4 patients received 450 mg Q3W, and 3 patients 
received 900 mg Q3W. The maximum administered dose was BGB-A1217 900 mg combined 
with tislelizumab 200 mg Q3W. The maximum tolerated dose (MTD) was not reached. BGB-
A1217 is safe and well-tolerated up to 900 mg dose level. No DLTs, treatment-related serious 
adverse events (SAEs), or high-grade AEs occurred during the treatment period for any dose 
level. Clinical activity documented as stable disease (SD) was observed in 1 patient at each of 
the following BGB-A1217 doses: 150 mg, 450 mg, and 900 mg. Subsequent to the data cutoff 
date of 16 June 2020, 6 additional patients have been enrolled and dosed at the maximum 
administered dose of BGB-A1217 900 mg combined with tislelizumab 200 mg Q3W. BGB-
A1217 continues to appear to be safe and well-tolerated up to and including the 900 mg dose 
level.  
In Study BGB-900-105, a treatment-emergent adverse event (TEAE) was defined as an AE that 
had an onset date or a worsening in severity from baseline (pretreatment) on or after the first 
dose of study drugs up to 30 days following study drug discontinuation or initiation of 
subsequent anticancer therapy, whichever came first.  
As of the data cutoff date of 16 June 2020, 8 (72.7%) of the 11 patients had ≥ 1 TEAE. Most 
TEAEs were Grade 1 or Grade 2. Three TEAEs (atrial flutter, pericardial effusion malignant, and 
dyspnea), which occurred in 1 patient each, were Grade 3. Treatment-related TEAEs, and serious 
TEAEs occurred in 3 (27.3%) patients each.  
No patients had Grade 4 or Grade 5 TEAEs, serious treatment-related TEAEs, TEAEs leading to 
treatment discontinuation, or TEAEs leading to death (Table 2). No TEAE met the criteria of 
DLT. 
The most commonly reported TEAEs were fatigue (3 [27.3%]) and diarrhea and aspartate 
aminotransferase increased (2 [18.2%] each). All other TEAEs occurred in 1 (1 [9.1%]) patient 
each (Table 3). 
Refer to the BGB-A1217 Investigator’s Brochure for detailed safety information. 
The Phase 1 study is still ongoing with more dose levels under exploration.  
1.3.2.3. 
Clinical Pharmacology  
As of the data cutoff date of 16 June 2020, preliminary PK data of BGB-A1217 are available 
from a total of 11 patients treated with BGB-A1217 at 50 mg (n=1), 150 mg (n=3), 450 mg 

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(n=4), and 900 mg (n=3) dose levels in combination with tislelizumab 200 mg in the dose 
escalation portion of Study BGB-900-105. BGB-A1217 serum concentrations declined in a 
biexponential manner after IV infusion and the BGB-A1217 exposures (maximum observed 
plasma concentration [Cmax] and AUC) increased approximately dose-proportionally from 50 mg 
to 900 mg.  
Peripheral TIGIT receptor occupancy data were available for 11 enrolled patients treated with 
BGB-A1217 at 50 mg (n=1), 150 mg (n=3), 450 mg (n=4), and 900 mg (n=3) dose levels in 
Study BGB-900-105. Complete TIGIT receptor occupancy (100%) was observed on CD8, CD4, 
NK and Treg cells in peripheral blood at all the tested dose levels. 
1.3.2.4. 
Efficacy  
The first-in-human study BGB-900-105 evaluating efficacy of BGB-A1217 in combination with 
tislelizumab in advanced solid tumors is still ongoing. As of 16 June 2020, the clinical activity 
documented as SD can be observed in 1 patient each at BGB-A1217 doses of 150 mg, 450 mg, 
and 900 mg.  
 
 

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Table 2: 
Overview of Treatment-Emergent Adverse Events (Safety Analysis Set)  
 
BGB-A1217 
50 mg + 
tislelizumab 
200 mg  
(N = 1) 
n (%) 
BGB-A1217 
150 mg + 
tislelizumab 
200 mg 
(N = 3) 
n (%) 
BGB-A1217 
450 mg + 
tislelizumab 
200 mg 
(N = 4) 
n (%) 
BGB-A1217 
900 mg + 
tislelizumab 
200 mg 
(N = 5) 
n (%) 
Total 
(N = 
11) 
n (%) 
Any TEAE 
1 (100.0) 
3 (100.0) 
3 (75.0) 
1 (33.3) 
8 
(72.7) 
Any treatment-related TEAE 
1 (100.0) 
0 (0.0) 
2 (50.0) 
0 (0.0) 
3 
(27.3) 
Grade ≥ 3 TEAE 
1 (100.0) 
1 (33.3) 
1 (25.0) 
0 (0.0) 
3 
(27.3) 
Grade ≥ 3 treatment-related TEAE 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
Serious TEAE 
1 (100.0) 
1 (33.3) 
1 (25.0) 
0 (0.0) 
3 
(27.3) 
Serious treatment-related TEAE 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
TEAE leading to treatment discontinuation 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
Related TEAE leading to treatment 
discontinuation 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
TEAE leading to death 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
Abbreviations: N = total patients treated; TEAE = treatment-emergent adverse event. 
Notes: A patient with multiple occurrences of an AE is counted only once in the AE category.  Treatment-related TEAE includes patients who had a BGB-A317- or 
BGB-A1217-related TEAE. 
 

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Table 3: 
Treatment-Emergent Adverse Events by System Organ Class, Preferred Term and Maximum Severity 
(Safety Analysis Set)  
System Organ Class 
Preferred Term 
BGB-A1217 
50 mg + 
tislelizumab 200 
mg  
(N = 1) 
n (%) 
BGB-A1217 
150 mg + 
tislelizumab 200 
mg 
(N = 3) 
n (%) 
BGB-A1217 
450 mg + 
tislelizumab 200 
mg 
(N = 4) 
n (%) 
BGB-A1217 
900 mg + 
tislelizumab 200 
mg 
(N = 3) 
n (%) 
Total 
(N = 11) 
n (%) 
Patients with ≥ 1 TEAE 
1 (100.0) 
3 (100.0) 
3 (75.0) 
1 (33.3) 
8 (72.7) 
Gastrointestinal disorders 
1 (100.0) 
1 (33.3) 
2 (50.0) 
0 (0.0) 
4 (36.4) 
Diarrhoea 
0 (0.0) 
1 (33.3) 
1 (25.0) 
0 (0.0) 
2 (18.2) 
Abdominal pain 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Constipation 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Dry mouth 
1 (100.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
General disorders and administration site 
conditions 
1 (100.0) 
0 (0.0) 
1 (25.0) 
1 (33.3) 
3 (27.3) 
Fatigue 
1 (100.0) 
0 (0.0) 
1 (25.0) 
1 (33.3) 
3 (27.3) 
Musculoskeletal and connective tissue 
disorders 
0 (0.0) 
1 (33.3) 
1 (25.0) 
1 (33.3) 
3 (27.3) 
Back pain 
0 (0.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Flank pain 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (33.3) 
1 (9.1) 
Groin pain 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Infections and infestations 
1 (100.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
2 (18.2) 
Influenza 
1 (100.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Otitis externa 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Investigations 
1 (100.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
2 (18.2) 
Aspartate aminotransferase increased 
1 (100.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
2 (18.2) 
Nervous system disorders 
1 (100.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
2 (18.2) 
Neuralgia 
1 (100.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (9.1) 

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System Organ Class 
Preferred Term 
BGB-A1217 
50 mg + 
tislelizumab 200 
mg  
(N = 1) 
n (%) 
BGB-A1217 
150 mg + 
tislelizumab 200 
mg 
(N = 3) 
n (%) 
BGB-A1217 
450 mg + 
tislelizumab 200 
mg 
(N = 4) 
n (%) 
BGB-A1217 
900 mg + 
tislelizumab 200 
mg 
(N = 3) 
n (%) 
Total 
(N = 11) 
n (%) 
Somnolence 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Respiratory, thoracic and mediastinal 
disorders 
0 (0.0) 
1 (33.3) 
1 (25.0) 
0 (0.0) 
2 (18.2) 
Cough 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Dyspnoea 
0 (0.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Skin and subcutaneous tissue disorders 
1 (100.0) 
0 (0.0) 
0 (0.0) 
1 (33.3) 
2 (18.2) 
Drug eruption 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (33.3) 
1 (9.1) 
Dry skin 
1 (100.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Blood and lymphatic system disorders 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Anaemia 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Cardiac disorders 
1 (100.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Atrial flutter 
1 (100.0) 
0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Ear and labyrinth disorders 
0 (0.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Ear discomfort 
0 (0.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Eye disorders 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Dry eye 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Neoplasms benign, malignant and 
unspecified (incl cysts and polyps) 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Cancer pain 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Pericardial effusion malignant 
0 (0.0) 
0 (0.0) 
1 (25.0) 
0 (0.0) 
1 (9.1) 
Psychiatric disorders 
0 (0.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
Confusional state 
0 (0.0) 
1 (33.3) 
0 (0.0) 
0 (0.0) 
1 (9.1) 
N = total patients treated; TEAE = treatment-emergent adverse event. 
Notes: A patient with multiple occurrences of an AE is counted only once in the AE category. MedDRA version 22.0 was used to code adverse events.  Adverse events were 
graded using CTCAE version 5.0 per protocol.  Events are sorted in descending order of the number of patients for SOC and PT in the Total column.   

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1.4. 
Tislelizumab as a PD-1 Inhibitor  
1.4.1. 
Pharmacology  
Tislelizumab (also known as BGB-A317) is a humanized, immunoglobulin G4 (IgG4)-variant 
monoclonal antibody against PD-1 under clinical development for the treatment of several 
human malignancies. 
Tislelizumab acts by binding to the extracellular domain of human PD-1 with high specificity as 
well as high affinity (KD = 0.15 nM). It competitively blocks binding efforts by both PD-L1 and 
programmed cell death protein ligand-2 (PD-L2), thus inhibiting PD-1-mediated negative 
signaling in T cells. In in vitro cell-based assays, tislelizumab was observed to consistently and 
dose-dependently enhance the functional activity of human T cells and pre-activated, primary 
PBMCs. Tislelizumab has demonstrated in-vivo antitumor activity in several allogeneic 
xenograft models, in which PBMCs were co-injected with human cancer cells (A431 
[epidermoid carcinoma]) or tumor fragments (BCCO-028 [colon cancer]) into 
immunocompromised mice.  
Tislelizumab is an IgG4-variant antibody to gamma fragment crystallizable region (Fc) receptors 
(FcγR) such as FcγRI and FcγRIIIA, and it has very low binding affinity to C1q, a subunit of 
complement 1. In vitro assays with tislelizumab suggest either low or no antibody-dependent 
cellular cytotoxicity, antibody-dependent cellular phagocytosis, or complement-dependent 
cytotoxicity effects in humans (Labrijn et al 2009). Tislelizumab was specifically engineered to 
abrogate these potential mechanisms of T-cell clearance and potential resistance to anti-PD-1 
therapy. 
Please refer to the Tislelizumab Investigator’s Brochure for additional details regarding 
nonclinical studies of tislelizumab. 
1.4.2. 
Toxicology  
The toxicity and safety profile of tislelizumab was characterized in single-dose toxicology 
studies in mice and cynomolgus monkeys and in a 13-week, repeat-dose toxicology study in 
cynomolgus monkeys. Tissue cross-reactivity was evaluated in normal frozen tissues from both 
humans and monkeys. The cytokine release assays were conducted using fresh human whole 
blood cells. The single-dosing regimens spanned from the intended human doses to 10-fold 
higher than the maximum of the intended human doses, and the repeat-dosing regimens spanned 
to 3-fold higher than the maximum of the intended human doses. Cynomolgus monkey was the 
only relevant species based on the target sequence homology and binding activity. 
Overall, no apparent toxicity was noted in mice or monkey toxicity studies. No tissue 
cross-reactivity was found in either human or monkey tissues, nor was any effect on cytokine 
release observed in the human whole-blood assay. The toxicokinetic profile was well 
characterized, with dose-proportional increases in systemic exposure without apparent 
accumulation or sex difference. Immunogenicity was observed without apparent immunotoxicity 
or effect on the systemic exposure. The NOAEL of tislelizumab in the 13-week monkey toxicity 
study was considered to be 30 mg/kg. The safety profile of tislelizumab is considered adequate to 
support the current study, BGB-900-105. 

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Please refer to the Tislelizumab Investigator’s Brochure for more detailed information on the 
toxicology of tislelizumab. 
1.4.3. 
Clinical Pharmacology  
Population PK analysis was conducted using data from 798 patients with solid tumors or 
classical Hodgkin lymphoma who had received doses of 0.5, 2.0, 5.0, and 10 mg/kg once every 
2 weeks, 2.0 and 5.0 mg/kg once every 3 weeks, and 200 mg once every 3 weeks. The PK of 
tislelizumab was best characterized using a 3-compartmental linear population PK model with 
linear clearance mechanisms. No time-varying clearance was observed in tislelizumab PK. The 
typical estimates of clearance (CL), central volume (Vc), and peripheral volumes (V2, V3) were 
0.164 L/day, 2.92 L, 0.928 L, and 1.39 L, respectively, with moderate inter-individual variability 
in CL (32.2%), Vc (16.7%), V2 (56.6%), and V3 (94.2%). The volume of distribution at steady 
state (Vss) was 5.238 L, which is typical of monoclonal antibodies with limited distribution, 
which is consistent with a standard IgG monoclonal antibody (Deng et al 2012; Dirks and 
Meibohm 2010; Keizer et al 2010; Ryman and Meibohm 2017). Based on the population PK 
analysis, tislelizumab PK was characterized by a terminal half-life of approximately 25.5 days, 
which is consistent with other therapeutic IgG monoclonal antibodies. 
Population PK analysis demonstrated that baseline age, race, alanine aminotransferase, aspartate 
aminotransferase, bilirubin, lactate dehydrogenase, estimated glomerular filtration rate, Eastern 
Cooperative Oncology Group (ECOG) Performance Status, immunogenicity, and sum of 
products of perpendicular diameters in classical Hodgkin lymphoma patients did not show 
statistically significant impact on the PK of tislelizumab. Although tumor size, albumin, and 
tumor type were significant covariates on CL, while body weight, sex, and tumor type were 
significant covariates on Vc, these covariates are not expected to have a clinically relevant impact 
on tislelizumab exposure. Exposure-response analysis indicated that there was a lack of clinically 
significant exposure-response relationships for ORR and safety endpoints across a variety of 
advanced solid tumors and classical Hodgkin lymphoma for tislelizumab. Population PK analysis 
supports fixed-dosing across different ethnic groups. 
1.4.4. 
Prior Clinical Experience of Tislelizumab  
As of 20 May 2019, there are 22 ongoing studies with tislelizumab with over 1705 patients 
treated. Of these, 13 studies have preliminary data available in the Investigator’s Brochure (IB) 
version 7, 13 September 2019: 7 monotherapy studies, 2 chemotherapy combination therapy 
studies; and 4 investigational agent combination therapy studies. 
Refer to the Tislelizumab Investigator’s Brochure for more detailed information on tislelizumab 
safety and efficacy data when given as monotherapy or in combination with chemotherapy. 
1.4.4.1. 
Pooled Safety Assessment of Monotherapy Studies  
A pooled analysis of 7 monotherapy studies was conducted to provide a comprehensive safety 
assessment separately from combination therapy.   
Overall, there were 1273 patients in the pooled monotherapy studies: 1137 patients treated in 
5 solid tumor studies and 136 patients treated in 2 hematologic malignancies studies.   

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Solid tumor studies included the following: BGB-A317_Study_001 (Phase 1a /1b Advanced 
Solid Tumors), BGB-A317-102 (Phase 1 /2 Advanced Solid Tumors), BGB-A317-204 (Phase 2 
Locally Advanced or Metastatic Urothelial Bladder Cancer), BGB-A317-208 (Phase 2 Locally 
Advanced or Metastatic Urothelial Bladder Cancer), and BGB-A317-209 (Previously-Treated 
Locally Advanced Unresectable or Metastatic Microsatellite Instability-High [MSI-H] or 
Mismatch Repair Deficient (dMMR) Solid Tumors). The 2 studies in hematologic malignancies 
are BGB-A317-203 (Phase 2 Relapsed or Refractory Classical Hodgkin Lymphoma) and 
BGB-A317-207 (Relapsed or Refractory Mature T- and NK-cell Neoplasms). 
Of the 1273 enrolled patients, 544 patients (42.7%) remained on study as of 20 May 2019; and 
272 patients (21.4%) were still receiving tislelizumab treatment. 
Refer to the Tislelizumab Investigator's Brochure for more detailed information on tislelizumab 
safety data when given as monotherapy or in combination with chemotherapy. 
1.4.4.1.1. Pooled Demographics and Baseline Characteristics  
Table 4 shows the demographics and baseline characteristics for the patients treated in the 
Pooled Monotherapy studies. 

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Table 4: 
Demographics, Baseline Characteristics, Treatment Exposure Duration, and 
Study Follow-up Duration in Pooled Monotherapy Studies 
Measure 
Overalla         
N = 1273 
Age (years) 
 
   Median 
59.0 
   Min, Max 
18, 90 
Sex, n (%) 
 
   Male 
852 (66.9) 
   Female 
421 (33.1) 
Race, n (%) 
 
   Asian 
807 (63.4) 
   Black 
11 (0.9) 
   White 
405 (31.8) 
   Missing 
2 (0.2) 
   Other 
48 (3.8) 
Prior systemic anti-cancer therapy regimensb             
 
   Median 
1.0 
   Min, Max 
0, 12 
Prior systemic anti-cancer therapy regimens (grouped)b, n (%) 
   0 
271 (21.3) 
   1 
413 (32.4) 
   2 
265 (20.8) 
   ≥ 3 
324 (25.5) 
Study treatment exposure duration (months) 
 
   Median 
3.58 
   Min, Max 
0.1, 43.6 

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Measure 
Overalla         
N = 1273 
Study follow-up duration (months) 
 
   Median 
8.34 
   Min, Max 
0.1, 47.5 
Source: Tislelizumab Investigator’s Brochure. 
Abbreviations: N, total number of patients treated; n, number of patients within each category. 
Data cutoff 20 May 2019. 
a Solid tumor studies include: BGB-A317_Study_001, BGB-A317-102, BGB-A317-204, BGB-
A317-208, BGB-A317-209, and hematology studies include: BGB-A317-203, BGB-A317-
207. 
b Only systemic therapies were selected. 
Overall, the 1273 patients in the pooled monotherapy analysis had a median treatment exposure 
duration of 3.58 months (range: 0.1 to 43.6 months) and a median study follow-up duration of 
8.34 months (range: 0.1 to 47.5 months). Overall, the total pooled monotherapy population had a 
median age of 59 years and was 66.9% male. 
1.4.4.1.2. Treatment-Related Adverse Events  
Of the 1273 total patients treated in the Pooled Monotherapy studies, 846 (66.5%) experienced at 
least one treatment-related treatment-emergent adverse event (TEAE). The most commonly 
occurring TEAEs (≥ 5% of patients) assessed as related to tislelizumab were aspartate 
aminotransferase increased (128 patients, 10.1%), alanine aminotransferase increased 
(123 patients, 9.7%), hypothyroidism (113 patients, 8.9%), rash (96 patients, 7.5%), and pyrexia 
(94 patients, 7.4%). 
Of the 1273 total patients treated in the Pooled Monotherapy studies, 162 (12.7%) experienced at 
least one ≥ Grade 3 TEAE assessed as related to tislelizumab. The only ≥ Grade 3 TEAEs that 
occurred in ≥ 1% (≥ 12 patients) in the total study population were aspartate aminotransferase 
increased (19 patients, 1.5%) and alanine aminotransferase increased (15 patients, 1.2%). 
1.4.4.1.3. Treatment-Emergent Serious Adverse Events  
Of the 1273 total patients treated in the Pooled Monotherapy studies, 424 (33.3%) experienced at 
least 1 treatment-emergent SAE. The most commonly occurring treatment-emergent SAEs were 
pneumonia (35 patients, 2.7%), pyrexia (22 patients, 1.7%), and ascites (17 patients, 1.3%). 
1.4.4.1.4. Immune-Mediated Adverse Events  
Anti-PD1 therapies are known to cause imAEs in some patients and therefore certain AEs have 
been defined as AEs of special interest in tislelizumab clinical studies. As such, they are being 
reported expeditiously and are being closely monitored. 
Immune-mediated AEs are consistent with an immune-mediated mechanism or immune-
mediated component for which noninflammatory etiologies (eg, infection or tumor progression) 
have been ruled out. Immune-mediated AEs can include events with an alternate etiology which 
was exacerbated by the induction of autoimmunity. There is a potential temporal relationship 

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between the initiation of treatment with tislelizumab and the onset of an imAE that spans a 
window of days to several months. 
All imAEs presented here were assessed as related to study drug by the investigator and 
categorized by the sponsor Safety/Pharmacovigilance team. Certain imAEs have multiple 
Medical Dictionary for Regulatory Activities (MedDRA) terms associated with the same 
category. Special categories have been created to group patients experiencing these events. 
All imAEs that occurred in ≥ 1% patients in the total Pooled Monotherapy studies are shown in 
Table 5. 
Table 5: 
Immune-Related Adverse Events of Any Grade Occurring in ≥ 1% in Pooled 
Monotherapy Studies 
Categories 
   Preferred Term 
Total 
(N = 1273) 
Any Grade 
n (%)a           
Grade ≥ 3 
n (%)a 
Patients with at least one potential immune-mediated AEa 
602 (47.3) 
121 (9.5) 
Immune-related skin adverse reaction 
242 (19.0) 
11 (0.9) 
Rash 
97 (7.6) 
4 (0.3) 
Pruritus 
78 (6.1) 
0 
Pruritus generalized 
29 (2.3) 
0 
Rash maculo-papular 
24 (1.9) 
1 (0.1) 
Immune-related hepatitis 
233 (18.3) 
51 (4.0) 
Aspartate aminotransferase increased 
129 (10.1) 
21 (1.6) 
Alanine aminotransferase increased 
124 (9.7) 
16 (1.3) 
Blood bilirubin increased 
74 (5.8) 
4 (0.3) 
Gamma-glutamyltransferase increased 
45 (3.5) 
17 (1.3) 
Bilirubin conjugated increased 
40 (3.1) 
3 (0.2) 
Immune-related endocrinopathies 
187 (14.7) 
7 (0.5) 
Hypothyroidism 
113 (8.9) 
0 
Hyperthyroidism 
47 (3.7) 
1 (0.1) 
Hyperglycaemia 
17 (1.3) 
4 (0.3) 
Immune-related colitis 
75 (5.9) 
10 (0.8) 
Diarrhoea 
66 (5.2) 
5 (0.4) 
Immune-related pneumonitis 
50 (3.9) 
30 (2.4) 
Pneumonitis 
22 (1.7) 
9 (0.7) 
Lung infection 
13 (1.0) 
8 (0.6) 

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Categories 
   Preferred Term 
Total 
(N = 1273) 
Any Grade 
n (%)a           
Grade ≥ 3 
n (%)a 
Immune-related 
myositis/rhabdomyolysis/cardiomyopathy 
39 (3.1) 
7 (0.5) 
Blood creatine phosphokinase increased 
30 (2.4) 
4 (0.3) 
Immune-related nephritis and renal dysfunction 
33 (2.6) 
6 (0.5) 
Blood creatinine increased 
25 (2.0) 
2 (0.2) 
Source: Tislelizumab Investigator’s Brochure. 
Abbreviations: AE, adverse event; N, total number of patients treated; n, number of patients within each 
category; NCI-CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events; PT, 
preferred term; SOC, system organ class. 
Note: All AEs are coded using Medical Dictionary for Regulatory Activities (MedDRA) and graded 
according to NCI-CTCAE v4.03. Maximum CTCAE grade was selected per patient under each PT.  
Potential immune-mediated AE is identified based on a predefined list of AEs and assessed as treatment-
related by investigators. 
Sorted in descending order of the number of patients in SOC and PT in Any Grade under Total column. 
Data cutoff 20 May 2019. 
a Percentages are based on the total population. 
Of the 1273 total patients from the Pooled Monotherapy studies, 602 (47.3%) experienced at 
least one imAE of any grade. The most commonly occurring imAEs of any grade were aspartate 
aminotransferase increased (129 patients, 10.1%), alanine aminotransferase increased 
(124 patients, 9.7%), hypothyroidism (113 patients, 8.9%), rash (97 patients, 7.6%), and pruritus 
(78 patients, 6.1%). Analysis of the total patients with at least 1 imAE that also was ≥ Grade 3 in 
severity showed that 121 patients (9.5%) experienced such events. The most commonly 
occurring imAEs ≥ Grade 3 in severity were aspartate aminotransferase increased (21 patients, 
1.6%), gamma-glutamyltransferase increased (17 patients, 1.3%), alanine aminotransferase 
increased (16 patients, 1.3%), pneumonitis (9 patients, 0.7%), and lung infection (8 patients, 
0.6%). 
1.4.4.1.5. Infusion-Related Reactions  
Infusion-related reactions, including high-grade hypersensitivity reactions, following 
administration of tislelizumab are common. Of the 1273 total patients in the Pooled 
Monotherapy studies, 97 (7.6%) experienced at least one infusion-related reaction of any grade.  
The most commonly occurring infusion-related reactions of any grade that occurred in the total 
pooled analysis were pyrexia (50 patients, 3.9%), infusion-related reactions (28 patients, 2.2%), 
and pruritus (11 patients, 0.9%). There were 6 patients who reported a total of 7 ≥ Grade 3 
infusion-related reactions in the Pooled Monotherapy studies (reported events included back 
pain, hypotension, infusion-related reaction, musculoskeletal chest pain, pyrexia, and rash). 
1.4.4.1.6. Fatal Adverse Events  
A summary of the treatment-emergent fatal AEs that occurred in the Pooled Monotherapy 
studies is shown in Table 6. 

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Table 6: 
Treatment-Emergent Fatal Adverse Events Regardless of Causality in Pooled 
Monotherapy Studies 
Category 
Overall 
(N = 1273) 
n (%) 
All deaths at data cutoff 
641 (50.4) 
Death ≤ 30 days after last dose 
105 (8.2) 
Primary cause of death 
 
  Adverse event 
21 (1.6) 
  Disease under study 
22 (1.7) 
  Progressive disease 
52 (4.1) 
  Other 
10 (0.8) 
Death > 30 days after last dose 
536 (42.1) 
Primary cause of death 
 
  Adverse event 
14 (1.1) 
  Disease under study 
95 (7.5) 
  Indeterminate 
3 (0.2) 
  Progressive disease 
399 (31.3) 
  Other 
24 (1.9) 
  Missing 
1 (0.1) 
Source: Tislelizumab Investigator’s Brochure. 
Abbreviations: N, total number of patients treated; n, number of patients within each 
category. 
Data cutoff 20 May 2019. 
Table 6 shows that a total of 105 patients (8.2% of the total population) died ≤ 30 days after the 
last study drug dose in the Pooled Monotherapy studies as of the data cutoff date of 
20 May 2019. Of these 105 patients, there were 21 patients (1.6% of the total population) who 
had an AE with a fatal outcome ≤ 30 days after the last study drug dose. Of the 536 patients 
(42.1% of the total population) who died > 30 days after the last study drug dose, 14 patients 
(1.1% of the total population) died as a result of an AE (refer to the Investigator’s Brochure 
Edition 7, Section 5.2.1.9). 
1.4.4.2. 
Efficacy Assessment of Tislelizumab  
Efficacy data are available from 2 of the ongoing monotherapy studies in solid tumors, 
BGB-A317_Study_001 and BGB-A317-102, both of which are summarized below (data cutoff 
20 May 2019). 

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1.4.4.2.1. Study BGB-A317_Study_001  
Study BGB-A317_Study_001 is a 2-stage study consisting of a Phase 1a dose-escalation (0.5 to 
10 mg/kg) and dose-finding component with 3 parts (2 and 5 mg/kg given either once every 2 or 
3 weeks and a fixed dose of 200 mg given once every 3 weeks) to establish the MTD, if any, and 
a recommended Phase 2 dose (RP2D), which is followed by a Phase 1b component to investigate 
efficacy in select tumor types at the RP2D to further evaluate safety and tolerability of 
tislelizumab. Indication specific cohorts included esophageal, gastric, hepatocellular, and  
non-small cell lung cancer.  
Responses were assessed by the investigator per the Response Evaluation Criteria in Solid 
Tumors (RECIST) v1.1 criteria. 
There were 451 patients treated in the study and 441 patients were included in the efficacy 
evaluable set. The Efficacy Evaluable Analysis Set includes all treated patients who had at least 
1 measurable baseline target lesion and had at least 1 evaluable postbaseline tumor assessment.   
Across all disease cohorts, there were 5 patients (1.1%) with a complete response (CR). A total 
of 55 patients (12.5%) had a confirmed partial response (PR). The resulting overall clinical 
response rate was 13.6%. Additionally, there were 142 patients (32.2%) with a best overall 
response (BOR) of SD. A total of 199 patients (45.1%) had a best response of progressive 
disease (PD) in this study. 
1.4.4.2.2. Study BGB-A317-102  
Study BGB-A317-102 is a non-randomized, Phase 1/2 study of tislelizumab monotherapy in 
Chinese patients with advanced solid tumors. Phase 1 includes a dose verification substudy and a 
substudy of PK evaluation of the products derived from 2 manufacturing processes and scales. 
Phase 2 evaluates the activity and safety of tislelizumab at its recommended Phase 2 dose of 
200 mg given once every 3 weeks in indication specific expansion cohorts. 
Responses were assessed by the investigator per the RECIST v1.1 criteria. 
Overall, of the 300 patients treated in Study BGB-A317-102, 249 patients were included in the 
Efficacy Evaluable Analysis Set. The Efficacy Evaluable Analysis Set includes all treated 
patients who had at least 1 measurable baseline target lesion and had at least 1 evaluable 
postbaseline tumor assessment.  
The tumor responses in the efficacy evaluable analysis set of Study BGB-A317-102 across all 
disease cohorts and study phases was 1 patient (0.4%) with a CR and 44 patients (17.7%) with 
confirmed PR. The resulting overall clinical response rate was 18.1%. Additionally, there were 
91 patients (36.5%) with a BOR of SD. A total of 113 patients (45.4%) had a best response of 
PD in this study. 
1.5. 
Study Rationale  
As described earlier, despite the wealth of evidence supporting TIGIT’s role in promoting tumor 
immune tolerance, TIGIT blockade alone (ie, BGB-A1217 monotherapy) is unlikely to result in 
an effective antitumor response according to existing anti-TIGIT clinical data (see Section 1.3).  
Therefore, the clinical development of BGB-A1217 focuses on rational combinations, such as 
with tislelizumab. Taking this into account, the combination use of BGB-A1217 and tislelizumab 

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as well as tislelizumab monotherapy is designed to evaluate the effect of BGB-A1217 
combination with tislelizumab in maximizing the patient’s potential therapeutic benefit with 
simultaneously achieving the clinical objective of characterizing the safety and efficacy. 
1.5.1. 
Rationale for the Dose Selection  
1.5.1.1. 
Rationale for the Selection of BGB-A1217 Dose  
BGB-A1217 doses ranging from 50 mg to 900 mg once every 3 weeks (Q3W), in combination 
with 200 mg of tislelizumab Q3W were explored in the ongoing Ph1/1b Study BGB-900-105. 
All the tested BGB-A1217 dose levels cleared the DLT window without any significant safety or 
tolerability events. BGB-A1217 exposures increased in an approximately dose-proportional 
manner (BGB-A1217 Investigator’s Brochure, Sections 5.1.1 , 5.1.2, and 5.2.1). As of 07 August 
2020, the maximum administered BGB-A1217 dose of 900 mg, was selected as RP2D. 
Complete TIGIT receptor occupancy was observed on circulating T cells and NK cells in 
peripheral blood at all the tested doses in the Phase 1 study. However, since the correlation 
between TIGIT receptor occupancy in periphery and receptor occupancy in tumor tissues is 
unknown, quantitative systems pharmacology (QSP) modeling was performed and preliminary 
results show near complete TIGIT receptor occupancy in tumor tissues is predicted at doses of 
450 mg and above. Due to lack of information on impact of immunogenicity on BGB-A1217 
PK, a conservative estimate of 900 mg dose was selected which was deemed to be safe and 
tolerable in patients. This dose level increases the likelihood of efficacious concentrations and 
saturation of TIGIT receptors in tumor tissues completely over the entire dosing interval. 
Absence of any dose-dependent safety events in the ongoing Phase 1 study additionally supports 
selecting this dose for further evaluation. The preliminary BGB-A1217 PK data from the 
ongoing BGB-900-105 study indicates lack of significant relationship between the BGB-A1217 
exposures and patients body weight supporting the selection of fixed dose for BGB-A1217. 
1.5.1.2. 
Rationale for the Selection of Tislelizumab Dose  
The PK, safety, and efficacy data obtained from the first-in-human study BGB-
A317_Study_001, as well as other clinical study data, were analyzed in aggregate to determine 
the recommended dose for pivotal studies of tislelizumab. The dose of 200 mg IV once every 3 
weeks was selected for further evaluation. 
Rates of treatment-related AEs and SAEs observed in patients receiving 2 mg/kg and 5 mg/kg 
once every 2 weeks and once every 3 weeks were comparable, suggesting no clear 
dose-dependence across these regimens. Similarly, confirmed ORRs in patients treated with 
tislelizumab 2 mg/kg and 5 mg/kg once every 2 weeks ranged between 10% and 15%, compared 
to a range of 15% to 38% for patients treated at 2 mg/kg and 5 mg/kg once every 3 weeks. 
According to PK data from BGB A317_Study_001, Phase 1a, the clearance of tislelizumab was 
found to be independent of body weight, ethnicity, and gender, and the observed serum exposure 
of a 200 mg dose fell between serum exposure observed after 2 mg/kg and 5 mg/kg doses (dose 
range with comparable safety and efficacy rates). 
Additionally, no unexpected treatment-related AEs occurred in the 200 mg fixed dose cohort 
(BGB-A317_Study_001, Phase 1a, Part 3) when compared to body weight-based cohorts. Of the 

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evaluable patients treated (n = 13), 3 patients (23%) had a BOR of PR, 4 patients (31%) had a 
BOR of SD, and 6 patients (46%) had a BOR of PD. Therefore, clinical activity with a 
manageable and tolerable safety profile is expected to be maintained in patients receiving 
tislelizumab 200 mg every 3 weeks. 
Therefore, the recommended dose for pivotal studies for tislelizumab of 200 mg once every 3 
weeks will be utilized for the combination with BGB-A1217; however, alternate doses or dose 
schedules may be evaluated base on emerging clinical data. 
1.5.2. 
Rationale for Combination of BGB-A1217 and Tislelizumab in the Treatment of 
Previously Treated Recurrent or Metastatic Cervical Cancer  
Cervical cancer is the fourth most common cancer and the fourth leading cause of cancer death 
in women. It is estimated that recurrent or metastatic disease develops in 15 to 61% of women, 
usually within the first 2 years after the completing primary treatment. For patients who have 
progressed after first-line platinum-based therapy, the treatment options are limited, and no 
standard of care has been established. Single cytostatic agents bring limited response rates and 
short DOR (Table 1). This indicates significant unmet medical needs in patients with previously 
treated recurrent or metastatic cervical cancer.  
HPV has been recognized as the most important etiological factor in cervical cancers; thus, 
cervical cancers are attractive targets for immunotherapy because viral proteins are strong 
immune stimulants. Available data from clinical studies investigating other anti-PD-1 antibodies, 
pembrolizumab and nivolumab, have shown both a manageable safety profile and promising 
antitumor activity in patients with previously treated recurrent or metastatic cervical cancer. 
As described earlier, targeting TIGIT provides a potential mechanism to rescue immune cells 
from the immunosuppressive tumor microenvironment, thereby inducing an efficient antitumor 
immune response. Research showed that the TIGIT pathway cooperates with PD-1 to maximize 
the suppression of effector TILs and promotes resistance to anti-PD-1 therapy. Blocking 
antibodies targeting the PD-1/PD-L1 pathway have achieved remarkable results in the treatment 
of cervical cancer. Therefore, TIGIT represents an ideal target with the potential to significantly 
improve and/or extend the therapeutic benefit of anti-PD-1 therapy in cervical cancer. 
Given the promising anti-tumor activity of anti-PD-1 antibodies reported in this indication and 
given the scientific rationale that TIGIT may improve the therapeutic benefit of anti-PD-1 
therapy, the combination of BGB-A1217 and tislelizumab may bring significant clinical benefit 
in this indication and support further clinical development. 
1.5.3. 
Biomarker Strategy Rationale  
Biomarker analyses including but not limited to PD-L1 expression, TIGIT pathway molecules, 
gene expression profiling, tumor mutations, and TIL will be performed to explore the association 
with patient prognosis, response, and potential resistance mechanisms to tislelizumab in 
combination with BGB-A1217 and tislelizumab monotherapy. 
PD-L1 was expressed in tumor and tumor infiltrating inflammatory cells in cervical carcinoma, 
and its enhanced expression was correlated with HPV-positivity (Yang et al 2017). A meta-
analysis based on 7 studies with 783 patients showed that PD-L1 was trend to be a prognostic 
factor of poor OS in Asian patients (HR = 4.77, 95% CI = 3.02–7.54, p < 0.001) and of poor PFS 

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in Asian patients (HR = 4.78, 95% CI = 1.77–12.91, p = 0.002), which suggest PD-L1 is a poor 
prognostic indicator for cervical cancer (Gu et al 2019). The potential predictive role of PD-L1 
underlying checkpoint blockade was first reported in KEYNOTE-158 study, in which at a 
median follow-up of 11.7 months (range, 0.6-22.7 months), the ORR was 14.3% (95% CI, 7.4-
24.1) in 77 PD-L1 positive patients (CPS ≥1) previously treated with ≥1 line of chemotherapy in 
the metastatic setting, whereas no responses in patients with PD-L1 expression of CPS < 1. 
Given those results, PD-L1 IHC 22C3 pharmDx was identified as an aid in identifying cervical 
cancer patients for treatment with pembrolizumab. However, the predictive role of PD-L1 in 
combination treatment of immunotherapies with cervical cancer is still not clear. In this study, 
another PD-L1 score algorithm named visually-estimated Combined Positive Score (vCPS) will 
be assessed centrally. vCPS is the total percentage of the tumor area covered by tumor cells with 
PD-L1 membrane staining and tumor associated immune cells with PD-L1 staining at any 
intensity. Based on tumor bank derived cervical cancer tissues, the prevalence of vCPS ≥ 5% 
was approximal 60%. The predictive role of vCPS will be assessed in BGB-A1217 in 
combination of tislelizumab therapies and tislelizumab alone. 
In addition to PD-L1, clinical data from various studies suggested tumor PD-L1 expression, 
tumor mutational burden, abundance and location of TILs, and tumor- and immune-related gene 
expression profile are a few factors associated with response to immunotherapies including anti-
PD-1 antibodies in different cancers (Vilain et al 2017; Goodman et al 2017; Gandara et al 2018; 
Jiang et al 2018). In melanoma patients, a high TIGIT/CD226 ratio on Treg cells correlated with 
poor clinical outcome upon anti-PD1 or anti-PD-L1 antibody treatment, which suggest signaling 
through TIGIT pathway in tumor tissues might contribute to resistance to current immune 
checkpoint inhibitors targeting PD-1 or PD-L1 (Fourcade et al 2018). Therefore, expression of 
TIGIT pathway molecules including TIGIT, CD226, CD155, CD112, as well as tumor 
mutations, TILs, and gene expression profile will be studied, and its relationship with clinical 
response to study treatment will be further assessed.  
Furthermore, mechanisms of resistance to immunotherapeutics are also not well understood and 
need more exploration. Identification of somatic mutations or gene expression profiles that 
associated with disease progression or acquired resistance to study treatment may increase 
understanding of disease pathobiology and collecting biological evidence for combination 
strategy. 
1.6. 
Benefit-Risk Assessment  
Currently, no standard of care has been established as second-line and later treatment of 
recurrent or metastatic cervical cancer. Single cytostatic agents have been used for decades with 
limited response rates and the DOR is short (Table 1). Pembrolizumab received accelerated 
approval by the FDA in PD-L1 positive population based on moderate and durable response. The 
ORR was 14.3% (95% CI 7.4%, 24.1%), and 91% of responders had a duration ≥ 6 months. 
The safety profile of tislelizumab monotherapy is considered as acceptable based on previous 
nonclinical and clinical data. Safety data from OncoMed’s OMP-313M32, Merck’s MK-7684, 
and Genentech/Roche’s tiragolumab indicated a tolerated safety profile for TIGIT monotherapy 
as well as its combination with anti-PD-(L)1 (Section 1.3.2). Similarly, BGB-A1217 combined 
with tislelizumab 200 mg Q3W is safe and well-tolerated, with no DLTs, no treatment-related 

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SAEs, or high-grade AEs occurred during the treatment period for each dose level in the ongoing 
900-105 Phase 1/1b study as of 16 June 2020.  
Given the unmet medical need and limited treatment options in this indication, the benefit/risk 
assessment, based on the available safety data of anti-TIGIT monoclonal antibodies in 
combination of anti-PD-1/L1 antibodies and the available efficacy data from the PD-1 antibodies 
in this indication, the combination of BGB-A1217 and tislelizumab is considered favorable. This 
Phase 2 study will be conducted in order to assess the potential benefit and safety of tislelizumab 
combined with BGB-A1217.  
1.7. 
Study Conduct  
This study will be conducted in compliance with the protocol approved by the Institutional 
Review Board (IRB) or Independent Ethics Committee (IEC) and in accordance with Good 
Clinical Practice (GCP) standards. 

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2. 
STUDY OBJECTIVES AND ENDPOINTS  
2.1. 
Study Objectives  
2.1.1. 
Primary Objectives  
• To evaluate the efficacy of BGB-A1217 combined with tislelizumab as measured by 
ORR according to RECIST v1.1, by Independent Review Committee (IRC) in patients 
who had previously treated recurrent or metastatic cervical cancer with PD-L1 visually-
estimated Combined Positive Score (vCPS) ≥ 5% or regardless of PD-L1 expression  
2.1.2. 
Secondary Objectives  
• To evaluate the efficacy of BGB-A1217 combined with tislelizumab as assessed by 
ORR by investigator review 
• To evaluate the efficacy of tislelizumab monotherapy as assessed by ORR by both IRC 
and investigator review 
• To evaluate the efficacy of BGB-A1217 combined with tislelizumab and tislelizumab 
monotherapy as measured by DOR, PFS, time to response (TTR), disease control rate 
(DCR), and clinical benefit rate (CBR) by both IRC and investigator review  
• To evaluate the efficacy of BGB-A1217 combined with tislelizumab and tislelizumab 
monotherapy as measured by OS 
• To evaluate Health Related Quality of Life (HRQoL) via cancer-specific patient-
reported outcomes (PROs) in patients treated with BGB-A1217 combined with 
tislelizumab and tislelizumab monotherapy 
• To evaluate the safety and tolerability of BGB-A1217 combined with tislelizumab and 
tislelizumab monotherapy 
• To characterize the PK of BGB-A1217 and tislelizumab 
• To assess host immunogenicity to BGB-A1217 and tislelizumab  
2.1.3. 
Exploratory Objectives  
• To evaluate quality of life (QoL) via a generic PRO in patients treated with BGB-
A1217 combined with tislelizumab and tislelizumab monotherapy 
• To evaluate potential association of biomarkers with patient prognosis, response, or 
resistance of BGB-A1217 in combination with tislelizumab or tislelizumab alone 
2.2. 
Study Endpoints  
2.2.1. 
Primary Endpoints  
• ORR, defined as the proportion of patients who had CR or PR assessed by IRC per 
RECIST v1.1 for Cohort 1 

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2.2.2. 
Secondary Endpoints  
• ORR, defined as above assessed by investigator’s review per RECIST v1.1 for Cohort 1  
• ORR, defined as above assessed by both IRC and investigator’s review per RECIST 
v1.1 for Cohort 2  
• DOR, defined as the time from the first confirmed objective response until the first 
documentation of progression or death, whichever comes first, assessed by both IRC 
and investigator’s review according to RECIST v1.1 for Cohorts 1 and 2  
• Other efficacy endpoints (PFS, TTR, DCR, and CBR) that need tumor assessments by 
both IRC and investigator’s review per RECIST v1.1 for Cohorts 1 and 2  
− PFS, defined as the time from the date of first dose of study drug to the date of 
first documentation of disease progression or death, whichever occurs first  
− TTR, defined as the time from the date of first dose of study drug to first 
documentation of response 
− DCR, defined as the proportion of patients who achieve CR, PR, or SD  
− CBR, defined as the proportion of patients who achieve CR, PR, or durable SD 
(SD ≥ 24 weeks)  
• OS, defined as the time from the date of first dose of study drug until the date of death 
from any cause for Cohorts 1 and 2  
• HRQoL questionnaires, assessment of the patient’s overall health status using the 
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire-Core 30 (EORTC QLQ-C30), European Organisation for Research and 
Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC 
QLQ-CX24), for Cohorts 1 and 2 
• AEs and SAEs as characterized by type, frequency, severity (as graded by National 
Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 [NCI-
CTCAE v5.0]), timing, seriousness, and relationship to study drugs, physical 
examinations, electrocardiograms (ECGs), and laboratory assessments for Cohorts 1 
and 2  
• Serum BGB-A1217 and tislelizumab concentrations at specified timepoints   
• Immunogenic responses to BGB-A1217 and tislelizumab, evaluated through the 
detection of ADAs  
2.2.3. 
Exploratory Endpoints  
• Evaluate status of exploratory biomarkers including but not limited to expression of 
TIGIT, CD226, CD155, CD112 and PD-L1; gene expression profiling; tumor mutation 
burden; tumor infiltrating immune cells in archival and/or fresh tumor tissue and blood 
before study treatment, during study treatment, or at disease progression/reoccurrence; 
and the association between these biomarker and clinical efficacy, disease status, and 
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• QoL is measured by assessment of the European Quality of Life 5-Dimensional - 5-
Level Questionnaire (EQ-5D-5L) 

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3. 
STUDY DESIGN  
3.1. 
Summary of Study Design  
This is an open-label, 2-cohort, multicenter, Phase 2 study to evaluate the efficacy and safety of 
tislelizumab (BGB-A317) combined with or without BGB-A1217 in patients with previously 
treated recurrent or metastatic cervical cancer. The study is composed of two stages:    
• Stage 1 (randomization): Approximately 80 patients whose tumor regardless of 
PD-L1 expression will be randomized at a 1:1 ratio to receive either tislelizumab 
(200 mg IV Q3W) combined with BGB-A1217 (900 mg IV Q3W) or tislelizumab 
(200 mg IV Q3W) monotherapy.    
• Stage 2 (expansion): After the enrollment is completed in Stage 1, the sample size of 
the combination therapy cohort will continue to be expanded in Stage 2 with 
approximately 87 additional patients. These patients will receive tislelizumab (200 mg 
IV Q3W) combined with BGB-A1217 (900 mg IV Q3W).     
The total sample size of the combination therapy cohort (Cohort 1) will be approximately 127 
patients. The total sample size of the tislelizumab monotherapy cohort (Cohort 2) will be 
approximately 40 patients. 
In Stage 1, the PD-L1 expression will be retrospectively tested centrally. In Stage 2, PD-L1 
expression will be prospectively tested centrally and only patients whose tumors are evaluable 
for PD-L1 expression will be enrolled.  
For Cohort 1 (including patients enrolled in Stage 1 and Stage 2), the percentage of patients 
whose tumors have PD-L1 vCPS < 5% or whose tumors are not evaluable for PD-L1 expression  
would be capped to be no more than 40%, to reflect the natural distribution of PD-L1 expression 
in cervical cancer (Section 1.5.3). vCPS is the total percentage of the tumor area covered by 
tumor cells with PD-L1 membrane staining and tumor‑associated immune cells with PD-L1 
staining at any intensity.   
Study drugs will be administered until disease progression per RECIST v1.1, unacceptable 
toxicity, or withdrawal for other reasons, whichever occurs first. End-of-Treatment (EOT), safety 
follow-up, and survival follow-up visits will be conducted following study drug discontinuation.   
The 2-stage schema is presented in Figure 1. 

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Figure 1: 
Study Schema 
 
Abbreviations: DCR, disease control rate; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; HRQoL, Health-Related Quality of Life; 
INV, investigator; IRC, Independent Review Committee; ORR, overall response rate; OS, overall survival; PD-L1, programmed cell death protein-ligand 1; PFS, 
progression-free survival; QoL, Quality of Life; RECIST, Response Evaluation Criteria in Solid Tumors; vCPS, visually-estimated Combined Positive Score.    
For all study procedures see Section 7 and Appendix 1. 

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3.2. 
Screening Period  
Screening evaluations will be performed within 28 days before the first dose of study drug. 
Patients who agree to participate in this study will sign the informed consent form (ICF) before 
undergoing any screening procedure. Screening evaluations may be repeated as needed within 
the screening period; the investigator is to assess preliminary patient eligibility according to the 
latest screening assessment results. 
Archival tumor tissue must be collected for the purpose of biomarker analysis. If no archival 
samples are available, a fresh tumor biopsy at baseline is mandatory (Section 7.7). 
3.3. 
Treatment Period  
3.3.1. 
Stage 1  
After completing all screening activities, approximately 80 patients confirmed to be eligible by 
the sponsor will be randomized in a 1:1 ratio to receive either tislelizumab and BGB-A1217 
combination treatment or tislelizumab monotherapy. 
Patients will receive:  
Cohort 1: Tislelizumab 200 mg and BGB-A1217 900 mg IV once every 3 weeks until disease 
progression assessed per RECIST v1.1, unacceptable toxicity, or withdrawal for other reasons, 
whichever should occur first.  
Cohort 2: Tislelizumab 200 mg IV once every 3 weeks until disease progression assessed per 
RECIST v1.1, unacceptable toxicity, or withdrawal for other reasons, whichever should occur 
first. 
3.3.2. 
Stage 2  
After 80 patients were enrolled in Stage 1, the enrollment will continue for Cohort 1 in Stage 2 
with approximately 87 additional patients. These patients will receive tislelizumab 200 mg and 
BGB-A1217 900 mg IV once every 3 weeks until disease progression assessed per RECIST 
v1.1, unacceptable toxicity, or withdrawal for other reasons, whichever should occur first.  
For Both Stage 1 and 2:  
All patients will undergo tumor assessments at baseline (≤ 28 days before the first dose of study 
drugs) and every 6 weeks (± 7 days) for the first 54 weeks and then every 12 weeks (± 7 days) 
thereafter based on RECIST v1.1.       
Response and PD will be assessed using RECIST v1.1. When PD is assessed by the investigator, 
IRC is required to complete central image review and convey the results to the investigator as 
soon as possible. If PD is NOT confirmed by IRC, it is recommended to continue the study 
treatment until PD is confirmed by IRC, if this is in the best interest of the patient as discussed 
with the medical monitor. In the situation where the investigator believes the patient must 
urgently discontinue study treatment without waiting for IRC confirmation, the investigator must 
contact the medical monitor to inform the decision of treatment discontinuation.  
A patient who discontinues study drugs early for reasons other than disease progression by IRC 
(e.g., toxicity, PD by the investigator) will continue to undergo tumor assessments following the 

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original plan until the patient experiences PD per RECISTv1.1 by IRC, withdraws consent, is 
lost to follow-up, death or until the study terminates, whichever occurs first. 
If at the investigator’s discretion a patient could continue to benefit from tislelizumab and BGB-
A1217 or tislelizumab alone (original assigned treatment) after PD per RECIST v1.1 by IRC, the 
patient may continue their original assigned treatment. The following criteria must be met in 
order to treat patients who may continue to benefit from study treatment after PD:  
• Absence of clinical symptoms and signs of PD (including clinically significantly 
worsening of laboratory values) 
• Stable ECOG Performance Status ≤ 1  
• Absence of rapid progression of disease or of progressive tumor at critical anatomical 
sites (eg, cord compression) that requires urgent alternative medical intervention 
• Investigators must obtain written informed consent for treatment beyond radiologic PD 
and inform patients that this practice is not considered standard in the treatment of 
cancer. 
The decision to continue study drugs beyond initial progression must be agreed by the medical 
monitor and documented in the study records. Patients who receive study treatment beyond 
progression will have tumor assessments performed according to the original schedule until 
study treatment discontinuation.  
To determine the PK properties of tislelizumab and BGB-A1217 and host immunogenic response 
to tislelizumab and BGB-A1217, blood samples will be collected at various timepoints as 
outlined in Appendix 1. 
An optional blood sample will be taken at baseline (predose at Day 1 of Cycle 1), at the time of 
first tumor response (predose at Day 1 of the following Cycle) and at EOT after disease 
progression (10 mL each timepoint) for all patients to explore the association of blood-based 
biomarkers with response, prognosis and resistance to tislelizumab in combination with BGB-
A1217 and/or tislelizumab alone.  
Safety will be assessed throughout the study by monitoring AEs/SAEs (toxicity grades assigned 
per NCI-CTCAE v5.0), and laboratory results. Vital signs, physical examinations, ECOG PS 
change, ECG results, and other examinations will also be used for safety assessment. Safety 
assessments are further detailed in Section 7.4 and the Schedule of Assessments (Appendix 1).   
3.4. 
End of Treatment/Safety Follow-up  
The EOT Visit is conducted when the investigator determines that study drugs will no longer be 
used. If routine laboratory tests (eg, hematology, serum chemistry) are completed within 7 days 
before the EOT Visit, these tests need not to be repeated. Tumor assessment is not required at the 
EOT Visit and should follow the regular schedule of assessment in Appendix 1.    
Patients who discontinue study treatment for any reason will be asked to return to the clinic for 
the EOT Visit, which is required to be conducted within 7 days of the EOT decision is made 
unless otherwise specified or before the initiation of a new anticancer treatment, whichever 
occurs first. An on-site Safety Follow-up Visit at 30 days (± 7 days) after last dose of study drugs 
is required. If the time windows of this Safety Follow-up Visit and EOT Visit are overlapped, the 

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safety follow-up can be exempted and the tests required at Safety Follow-up Visit will be 
conducted at EOT Visit. In addition, 2 Safety Follow-up Visits (by telephone) with patients 
should be conducted to assess imAEs and concomitant medications (if appropriate, such as 
being associated with an imAE or is a new anticancer therapy) at 60 (± 14 days) and 90 days 
(± 14 days) after the last dose of study drugs regardless of whether patients started a new 
subsequent anticancer therapy. If patients report a suspected imAE at a Safety Follow-up Visit, 
the investigator should arrange an unscheduled visit if further assessment is indicated.    
All AEs, including SAEs, will be collected as described in Section 8.6. 
Patients who discontinue study treatment before disease progression will need to undergo tumor 
assessments as outlined in Section 7.5. 
Optional biopsy will also be taken at the EOT Visit for the patients who have confirmed disease 
progression during the study from accessible tumor sites to obtain samples, which could be used 
for exploratory study including but not limited to the resistance mechanism. If feasible, any 
follow-up biopsy should be ideally taken from the same tumor lesion as the baseline biopsy. 
Written informed consent is required before fresh tumor biopsies. 
See Appendix 1 for assessments to be performed at the EOT/Safety Follow-up Visits.    
3.5. 
Survival Follow-up  
Patients will be followed for survival and further anticancer therapy information after 
discontinuation of study treatment via telephone calls, patient medical records, and/or clinic 
visits approximately every 3 months (± 14 days) after the last Safety Follow-up Visit or as 
directed by the sponsor until death, loss to follow-up, withdrawal of consent, or end of study.     
3.6. 
Discontinuation From the Study Treatment or From the Study  
3.6.1. 
Patient Discontinuation From Study Treatment  
Patients have the right to withdraw from the study or discontinue study treatment at any time for 
any reason. In addition, the investigator has the right to discontinue a patient from the study 
treatment at any time. Patients who discontinue study treatment for reasons other than disease 
progression should be followed for assessments of antitumor activity (Section 7.5), safety 
(Section 7.4), and survival (Section 3.5), if possible. 
The primary reason for discontinuation from the study treatment should be documented on the 
appropriate electronic case report form (eCRF).  
Patients may discontinue from the study treatment for reasons that include but are not limited to 
the following: 
• Radiographic disease progression per RECIST v1.1 
• AE 
• Patient decision 
• Pregnancy 

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• Any medical condition that the investigator determines may jeopardize the patient’s 
safety, if he or she were to continue the study treatment 
• Use of any concurrent antineoplastic therapy (ie, chemotherapy, hormonal therapy, 
immunotherapy, or standard or investigational agents [including Chinese herbal 
medicine and Chinese patent medicines] for the treatment of cancer) (Section 6.3). 
• Patient noncompliance 
Investigative site staff should first counsel patients who are significantly noncompliant (eg, 
missing 2 treatment cycles) on the importance of study drug compliance and drug accountability. 
The investigator may, in consultation with the medical monitor, discontinue patients from 
treatment who are consistently noncompliant.  
3.6.2. 
Patient Discontinuation From Study (End of Study for an Individual Patient)  
Patients may discontinue study for reasons which include but are not limited to the following:  
• Patient withdrawal of consent 
• Death 
• Lost to follow-up 
• Patients have completed all study assessments 
3.7. 
End of Study  
The end of study is defined as the timepoint when the final data point is collected from the last 
patient in the study. This is when the last patient dies, withdraws consent, completes all study 
assessments, or is lost to follow-up. Alternatively, the end of study is when the sponsor decides 
to terminate the study. In that case, the date that the last patient is followed-up upon the study 
termination would be the Last Patient Last Visit (LPLV). 
The sponsor has the right to terminate this study at any time. Reasons for terminating the study 
early may include but are not limited to the following:  
• The incidence or severity of AEs in this or other studies indicates a potential health 
hazard to patients  
• Overall patient enrollment is unsatisfactory 
• A rollover study or other post-trial supply program becomes available. 
The sponsor will notify each investigator if a decision is made to terminate the study. Should this 
be necessary, prematurely discontinued patients should be seen as soon as possible for EOT 
Visits. 
The investigators may be informed of additional procedures to be followed to ensure that 
adequate consideration is given to the protection of the patient’s interests. The investigator will 
be responsible for informing Institutional Review Boards (IRBs)/Independent Ethics Committees 
(IECs) of the early termination of the study. 

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At the end of study, any patients who, in the opinion of the investigator, continue to benefit from 
tislelizumab/BGB-A1217 at study termination, may be offered the option to continue treatment 
in a company-sponsored clinical trial until it is commercially available in the country of the 
patient’s residence. 
The sponsor has the right to close a site at any time. The decision will be notified to the site in 
advance. Reasons for closing a site may include but are not limited to the following:  
• Excessively slow recruitment  
• Poor protocol adherence  
• Inaccurate or incomplete data recording  
• GCP noncompliance 
• Study activity is completed (ie, all patients have completed, and all obligations have 
been fulfilled) 
3.7.1. 
Study Drug Treatment for Russian Patients After End of Study  
In Russia, the long-term extension study or the post-trial supply program may not be available at 
the time of end of study.  
At the end of the study, Russian patients who do not meet the treatment discontinuation criteria 
by the time of study closure, but may continue to benefit from the study drugs in the opinion of 
the investigator, may be offered the option to have continuous treatment (per current 
assignment). 
For patients who receive the post-study drug treatment, the study drugs will be administered per 
current assignment until investigator-assessed disease progression, adverse events, the patient 
receives approximately 3 years of study drug treatment, or reasons specified in Section 3.6.1, 
whichever occurs first. The study drugs will be managed manually via the local depot per local 
regulation. 
The investigator is encouraged to communicate with the sponsor for any questions regarding 
patient management and monitoring during study drug treatment. Patient management and 
monitoring including tumor and response evaluations, safety assessments, study drug 
modifications, and follow-ups will be generally concordant with the current approved protocol or 
per investigator’s discretion, with guidance provided below. 
Tumor and Response Evaluations 
• The patient will continue to undergo tumor assessments following the current plan per 
Section 7.5 or per investigator’s discretion.  
Safety Assessment, Monitoring, and Reporting 
• Safety will be assessed and monitored per Section 7.4 and Section 8 or per 
investigator’s discretion.  
• Safety tests (eg, laboratory tests, ECGs, hepatitis B and C testing) will be performed by 
qualified local laboratories. 

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• While all adverse events should be adequately evaluated and recorded in the clinical 
source documents, only SAEs will be reported to BeiGene’s Global Patient Safety. 
Pharmacokinetic and Biomarker Testing 
• No blood or tissue samples will be collected for PK, ADA, biomarker, or other 
exploratory analysis.  
End of Treatment/Safety Follow-up 
• The study drugs will be discontinued when disease progression is assessed by the 
investigator, and no IRC confirmation will be conducted. 
• Treatment beyond investigator-assessed PD is not suggested unless otherwise specified. 
• The EOT Visit and 30-day Follow-up Visit are required to be conducted per 
Section 3.4.  
• The 60-day Safety Follow-up, 90-day Safety Follow-up, or Survival Follow-up Visits 
will not be conducted. 
Data Collection and Management 
• All the data generated after study termination will not be collected into the eCRFs. 
• As part of patient management, the investigator must collect and maintain patient 
clinical source documents per the requirement of local institutions. 

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4. 
STUDY POPULATION  
The specific eligibility criteria for selection of patients are provided in Section 4.1 and 
Section 4.2. The sponsor will not grant any eligibility waivers. 
4.1. 
Inclusion Criteria  
Each patient must meet all of the following inclusion criteria to be considered eligible for 
participation in this study: 
1. Able to provide written informed consent and can understand and agree to comply with 
the requirements of the study and the schedule of assessments 
2. Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the 
jurisdiction in which the study is taking place) 
3. Histologically or cytologically confirmed squamous cell carcinoma, adenosquamous 
carcinoma, or adenocarcinoma of the cervix  
4. Progression on or after one or more lines of chemotherapy for management of recurrent 
or metastatic disease and is not amenable to curative treatment (eg, systemic 
chemotherapy, surgery, or radiotherapy)  
a. Chemotherapy administered in conjunction with primary radiation as a radio-
sensitizer would not be counted as a line of chemotherapy 
b. Patients intolerant to most recent regimen due to Grade 4 hematologic toxicity or 
Grade 3 or 4 non-hematologic toxicity may also be eligible 
5. Measurable disease as assessed by RECIST v1.1. Note: A lesion in an area subjected to 
prior loco-regional therapy, including previous radiotherapy, is not considered 
measurable unless there has been demonstrated progression in the lesion since the therapy 
as defined by RECIST v1.1 
6. Patients must submit qualified archival tumor tissue (formalin-fixed paraffin-embedded 
block containing tumor [preferred] or approximately 15 [at least 6] unstained slides) with 
an associated pathology report, or agree to a tumor biopsy for determination of PD-L1 
expression and other biomarker analyses (fresh tumor biopsies are strongly recommended 
at baseline in patients with readily accessible tumor lesions and who consent to the 
biopsies). PD-L1 expression will be assessed centrally. For Stage 2, patients with 
evaluable PD-L1 expression are eligible 
7. ECOG performance status of 0 or 1 
8. Life expectancy of at least 12 weeks 
9. Patient must have adequate organ function as indicated by the following screening 
laboratory values obtained within 7 days before the first study treatment: 
a. Patients must not have required blood transfusion or growth factor support ≤ 14 
days before sample collection at screening for the following: 
i. Absolute neutrophil count ≥ 1.5 x 109/L  

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ii. Platelets ≥ 75 x 109/L  
iii. Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol /L (Note: Criteria must be met without a 
transfusion within 14 days of obtaining the sample) 
b. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated Glomerular 
Filtration Rate ≥ 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology 
Collaboration equation (Appendix 7) 
c. Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients 
with Gilberts syndrome) 
d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x 
ULN or ≤ 5 x ULN if hepatic metastases present 
10. Women of childbearing potential must be willing to use a highly effective method of 
birth control for the duration of the study, and for ≥ 120 days after the last dose of study 
drug, as well as have a negative urine or serum pregnancy test ≤ 7 days before first dose 
of study drug 
4.2. 
Exclusion Criteria  
Patients who meet any of the following criteria will be excluded from this study: 
1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or 
drug specifically targeting T-cell costimulation or checkpoint pathways 
2. Prior randomization in a tislelizumab or BGB-A1217 study, regardless of the treatment 
arm, until the primary and key secondary endpoints of the study have read out 
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis 
Note: Patients with a history of treated and, at the time of screening, stable central 
nervous system metastases are eligible, provided they meet all the following: 
a. Brain imaging at screening shows no evidence of progression, clinically stable for 
at least 2 weeks, and have no evidence of new brain metastases 
b. Measurable and/or evaluable disease outside the central nervous system  
c. No ongoing requirement for corticosteroids as therapy for central nervous system  
disease; off steroids 3 days before the first study treatment; anticonvulsants at a 
stable dose are allowed 
d. No stereotactic radiation or whole-brain radiation within 14 days before the first 
study treatment 
4. Active autoimmune diseases or history of autoimmune diseases (Appendix 4) that may 
relapse 
Note: Patients with the following diseases are not excluded and may proceed to further 
screening: 
a. Controlled Type I diabetes 
b. Hypothyroidism (provided it is managed with hormone replacement therapy only) 
c. Controlled celiac disease 
d. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia) 

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e. Any other disease that is not expected to recur in the absence of external 
triggering factors 
5. Any active malignancy ≤ 2 years before first dose of study drug except for the specific 
cancer under investigation in this study and any locally recurring cancer that has been 
treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder 
cancer, carcinoma in situ of breast) 
6. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily 
of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before 
first dose of study drug 
Note: Patients who are currently or have previously been on any of the following steroid 
regimens are not excluded: 
a. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) 
b. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal 
systemic absorption 
c. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for 
contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, 
delayed-type hypersensitivity reaction caused by contact allergen 
7. Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or 
corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia 
≤ 14 days before first dose of study drug 
8. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent 
drainage (recurrence within 2 weeks of intervention) 
9. History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung 
diseases including pulmonary fibrosis, acute lung diseases, etc. Patients with significantly 
impaired pulmonary function, or who require supplemental oxygen at baseline must 
undergo an assessment of pulmonary function at screening 
10. Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, 
antifungal, or antiviral therapy within 14 days before the first dose of study drugs 
Note: Antiviral therapy is permitted for patients with chronic hepatitis B virus (HBV) or 
hepatitis C virus (HCV) infection. 
11. Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA > 500 IU/mL (or 
> 2500 copies/mL) at screening 
Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B 
(HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Patients with detectable 
HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients 
receiving antivirals at screening should have been treated for > 2 weeks before enrollment. 
12. Patients with active hepatitis C 
Note: Patients with a negative HCV antibody test at screening or positive HCV antibody test 
followed by a negative HCV RNA test at screening are eligible. The HCV RNA test will be 

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performed only for patients testing positive for HCV antibody. Patients receiving antivirals at 
screening should have been treated for > 2 weeks before enrollment. 
13. Known history of HIV infection 
14. Any major surgical procedure ≤ 28 days before first dose of study drug. Patients must 
have recovered adequately from the toxicity and/or complications from the intervention 
before the first dose of study drug 
15. Prior allogeneic stem cell transplantation or organ transplantation 
16. Any of the following cardiovascular risk factors: 
a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of 
daily living, ≤ 28 days before first dose of study drug 
b. Pulmonary embolism ≤ 28 days before first dose of study drug 
c. Any history of acute myocardial infarction ≤ 6 months before first dose of study 
drug 
d. Any history of heart failure meeting New York Heart Association (NYHA) 
Classification III or IV ≤ 6 months before first dose of study drug 
e. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first 
dose of study drug 
f. Any history of cerebrovascular accident ≤ 6 months before first dose of study 
drug 
g. Uncontrolled hypertension that cannot be managed by standard anti-hypertension 
medications ≤ 28 days before first dose of drug 
For France only, specify: Systolic pressure ≥ 140 mmHg or diastolic pressure 
≥ 90 mmHg on repeated measurements 
h. Any episode of syncope or seizure ≤ 28 days before first dose of study drug  
17. A history of severe hypersensitivity reactions to other monoclonal antibodies 
18. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, 
etc.) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) 
before the first dose of study drug or has received palliative radiation treatment or other 
local regional therapies within 14 days before the first dose of study drug 
19. Patients with toxicities (as a result of prior anticancer therapy) who have not recovered to 
baseline or stabilized, except for AEs not considered a likely safety risk (eg, alopecia, 
neuropathy, and specific laboratory abnormalities) 
20. Administration of a live vaccine ≤ 28 days before first dose of study drug 
Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed.  
Intranasal vaccines are live vaccines and are not allowed. 
21. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug 
abuse or dependence that will be unfavorable for the administration of study drug or 
affect the explanation of drug toxicity or AEs, or result in insufficient or impaired 
compliance with study conduct 
22. Women who are pregnant or breastfeeding  

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23. Concurrent participation in another therapeutic clinical study 
Note: Concurrent participation in observational or non-interventional studies is allowed.  In 
addition, patients who have completed active treatment in a clinical study and are in the 
follow-up period can be enrolled in this study. 

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5. 
STUDY TREATMENT  
5.1. 
Formulation, Packaging, and Handling  
5.1.1. 
BGB-A1217  
BGB-A1217 is a monoclonal antibody formulated for intravenous injection in a single-use vial 
(20 mL glass vial, United States Pharmacopeia Type I) containing a total of 200 mg antibody in 
10 mL (or 300 mg antibody in 15 mL) of buffered isotonic solution. BGB-A1217 has been 
aseptically filled in single-use vials with a Flurotec-coated butyl rubber stopper and an aluminum 
cap. Each vial is packaged into a single carton box. 
The contents of the label will be in accordance with all applicable local regulatory requirements. 
The study drug must be kept at the temperature condition as specified on the label. Shaking 
should be avoided. 
Refer to the Pharmacy Manual for details regarding intravenous administration, accountability, 
and disposal. Refer to the BGB-A1217 Investigator’s Brochure for other details regarding 
BGB-A1217. 
5.1.2. 
Tislelizumab  
Tislelizumab is a monoclonal antibody formulated for intravenous injection in a single-use vial 
(20R glass, United States Pharmacopeia Type I), containing a total of 100 mg of antibody in 10 
mL of isotonic solution. Tislelizumab has been aseptically filled in single-use vials with a 
Flurotec-coated butyl rubber stopper and an aluminum cap. Each vial is packaged into a single 
carton box. 
The contents of the label will be in accordance with all applicable local regulatory requirements. 
The study drug must be kept at the temperature condition as specified on the label. Shaking 
should be avoided. 
Refer to the Pharmacy Manual for details regarding intravenous administration, accountability, 
and disposal. Refer to the Tislelizumab Investigator’s Brochure for other details regarding 
tislelizumab. 
5.2. 
Dosage, Administration, and Compliance  
Planned dosage and dosing frequency for BGB-A1217 and tislelizumab are presented in Table 7.  
The first dose of study drug is to be administered within 2 business days of randomization. The 
initial infusion (Cycle 1 and Cycle 2, Day 1) will be delivered over 60 minutes for each drug of 
tislelizumab and BGB-A1217; if this is tolerated well, then the subsequent infusions may be 
administered over 30 minutes of each drug, which is the shortest period permissible for infusion 
(Table 8 and Table 9).  
All patients will be monitored continuously for AEs. Treatment modifications (eg, dose delay, 
interruption, or discontinuation) will be based on specific laboratory and AE criteria, as 
described in Section 5.5. Guidelines for dose modification, treatment interruption, or 

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discontinuation and for the management of imAEs and infusion-related reactions are provided in 
detail in Section 8.7 and Appendix 11.  
Accurate records of all study drugs received, dispensed, returned, and disposed should be 
maintained in the site’s Drug Inventory Log. Refer to the Pharmacy Manual for details of study 
drug management, drug preparation, storage, and administration. 
Table 7: 
Planned Dose, Frequency of Administration, and Route of Administration 
for BGB-A1217 and Tislelizumab 
Study Drugs 
Dose 
Frequency of 
Administration 
Route of 
Administration 
Duration of Treatment 
BGB-A1217 
900 mg  
Day 1 of each cycle (21 days) 
Intravenous 
Refer to Section 3.3  
Tislelizumab 
200 mg  
Day 1 of each cycle (21 days) 
Intravenous 
Refer to Section 3.3  
Table 8: 
Administration of BGB-A1217 and Tislelizumab and Monitoring Time  
Cycle 
BGB-A1217 and Tislelizumab Combination (Cohort 1) 
C1D1 and C2D1 
Tislelizumab infusion over 60 (± 5) minutes followed by 
BGB-A1217 infusion over 60 (± 5) minutes 
Patient monitoring for ≥ 120 minutes 
C3D1 onwards 
Tislelizumab infusion over 30 (± 5) minutes followed by 
BGB-A1217 infusion over 30 (± 5) minutes 
Patient monitoring for ≥ 30 minutes 
Table 9: 
Administration of Tislelizumab and Monitoring Time  
Cycle 
Tislelizumab Monotherapy (Cohort 2) 
C1D1 and C2D1 
Tislelizumab infusion over 60 (± 5) minutes  
Patient monitoring for ≥ 60 minutes 
C3D1 onwards 
Tislelizumab infusion over 30 (± 5) minutes  
Patient monitoring for ≥ 30 minutes 
5.2.1. 
BGB-A1217 and Tislelizumab  
Patients will receive tislelizumab 200 mg on Day 1 of each 21-day cycle (ie, once every 3 weeks) 
followed by the administration of BGB-A1217 900 mg.  
Tislelizumab and BGB-A1217 must be administered by intravenous infusion through an 
intravenous line containing a sterile, nonpyrogenic, low-protein-binding 0.2- or 0.22 micron in-
line or add-on filter. Specific instructions for product preparation and administration are 
provided in the Pharmacy Manual. 
Use of a volumetric pump is recommended to control the infusion speed and to avoid potential 
infusion reactions associated with too rapid administration. The pump may not be needed if the 
infusion speed is controlled through alternative means and consistent with approved institutional 
procedures.  

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At the end of the infusion period, flush the line with enough normal saline to ensure all study 
drugs are administrated to the patient.  
As a routine precaution, after infusion of tislelizumab and BGB-A1217 on Day 1 of Cycle 1 and 
Cycle 2, patients must be monitored for ≥ 2 hours afterward in an area with resuscitation 
equipment and emergency agents. From Cycle 3 onward, at least a 30‑minute monitoring period 
is required in an area with resuscitation equipment and emergency agents. 
Tislelizumab and BGB-A1217 must not be concurrently administered with any other drug 
(Section 6).  
5.2.2. 
Tislelizumab    
Tislelizumab 200 mg will be administered on Day 1 of each 21-day cycle (Q3W).  
Tislelizumab will be administered by IV infusion through an IV line containing a sterile, 
nonpyrogenic, low-protein-binding 0.2 or 0.22 micron in-line or add-on filter. Specific 
instructions for product preparation and administration are provided in the Pharmacy Manual. 
Use of a volumetric pump is recommended to control the infusion speed and to avoid potential 
infusion reactions associated with too rapid administration. The pump may not be needed if the 
infusion speed is controlled through alternative means and consistent with approved institutional 
procedures.  
At the end of the infusion period, flush the line with enough normal saline to ensure all study 
drug is administrated to the patient. 
As a routine precaution, after infusion of tislelizumab on Day 1 of Cycle 1 and Cycle 2, patients 
must be monitored for ≥ 1 hour afterward in an area with resuscitation equipment and emergency 
agents. From Cycle 3 onward, at least a 30-minute monitoring period is required in an area with 
resuscitation equipment and emergency agents. 
Tislelizumab must not be concurrently administered with any other drug (Section 6).      
5.3. 
Incorrect Administration or Overdose  
Any incorrect administration of BGB-A1217 or overdose of tislelizumab (defined as ≥ 600 mg in 
a 24-hour period) should be noted in the patient’s chart and on the appropriate eCRF. 
AEs associated with an incorrect administration or overdose of study drugs will be recorded on 
the AE eCRF. Any SAEs associated with an incorrect administration or overdose must be 
reported within 24 hours of awareness via the SAE reporting process as described in 
Section 8.6.2. Supportive care measures should be administered as appropriate. 
5.4. 
Investigational Medicinal Product Accountability  
The investigational medicinal products required for completion of this study (BGB-A1217 and 
tislelizumab) will be provided by the sponsor. The investigational site will acknowledge receipt 
of investigational medicinal products. Any damaged shipments will be replaced.  
Accurate records of all investigational medicinal products received, dispensed, returned, and 
disposed should be recorded on the site’s Drug Inventory Log. Refer to the Pharmacy Manual for 
details of investigational medicinal product management.  

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5.5. 
Dose Delay or Modification  
Every effort should be made to administer the study drugs according to the planned dose and 
schedule. In the event of significant toxicities, dosing may be delayed and/or interrupted based 
on the guidelines provided below. Reasons for dose interruptions or delays, the supportive 
measures taken, and the outcome will be documented in the patient's chart and recorded in the 
eCRF.   
For AEs that are assessed as related to tislelizumab and/or BGB-A1217, the following general 
guidance should be followed unless otherwise specified: 
• ≤ Grade 2: Maintain dose level 
• Grade 3: Omit dose until resolved to ≤ Grade 1 or baseline except for alopecia or AEs 
that, in the opinion of the investigator, are not considered a safety risk for patient 
• Grade 4: Permanent discontinuation from study. Exceptions may be considered 
following consultation with the medical monitor. 
5.5.1. 
Dose Interruption or Delay for BGB-A1217 and Tislelizumab  
A dose interruption is an interruption of an infusion. A dose delay is a deviation from the 
prescribed dosing schedule (ie, the drug is withheld beyond the visit window).  
If a dose delay is required, both study drugs are to be delayed (ie, BGB-A1217 and tislelizumab 
must both be delayed and, if applicable, re-started at the same time). Exceptions may be 
considered following consultation between the investigator and the medical monitor. 
If treatment is delayed due to TEAEs, treatment may resume only after the AEs have returned to 
baseline or ≤ Grade 1 severity except for alopecia or AEs that, in the opinion of the investigator, 
are not considered a safety risk to the patient. If a treatment delay is due to worsening of 
hematologic or biochemical parameters, the frequency of relevant blood tests should be 
increased as clinically indicated. 
In general, dose delays for reasons other than management of AEs are prohibited. A dose delay 
of ≤ 12 weeks is allowed under the following guidance and at the discretion of the investigator 
after consultation with the medical monitor or designee. 
If a dose is delayed for ≤ 10 days for a planned dosing cycle (eg, Cycle 3 Day 1), the study drug 
should be administered. If the delay is > 10 days, the patient should skip both tislelizumab and 
BGB-A1217. Both tislelizumab and BGB-A1217 will be administered on Day 1 of the next 
planned cycle (eg, Cycle 4 Day 1). 
If immune-mediated AEs are persistent without any improvement for more than 12 weeks, 
permanent discontinuation of the study drug should be considered. In the combination treatment 
cohort, the treatment discontinuation in response to treatment-related AEs should be applied to 
both tislelizumab and BGB-A1217 because the causality of imAEs may not be distinguished 
from one study drug to the other. 
If the patient recovers from the treatment-related AE after 12 weeks, re-initiation of study drug is 
permitted only in patients who are deemed to be deriving clinical benefit per the opinion of the 
investigator following agreement between the investigator and the medical monitor. 

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Management guidelines for imAEs and infusion-related reactions in patients treated with 
tislelizumab and BGB-A1217 are presented in Section 8.7 and Appendix 11. 
The tumor assessment schedule will not be altered even if the administration of study drug is 
delayed.  
5.5.2. 
Dose Reductions for BGB-A1217 and Tislelizumab  
There will be no dose reductions allowed for tislelizumab or BGB-A1217.  

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6. 
PRIOR AND CONCOMITANT THERAPY  
6.1. 
Prior Therapy  
The exclusion criteria (Section 4.2) specify that patients should not have received prior therapies 
targeting PD-1, PD-L1, PD-L2, TIGIT, T-cell costimulation or checkpoint pathways, 
chemotherapy, immunotherapy (eg, interleukin, interferon, or thymosin), or investigational 
therapy ≤ 14 days or 5 half-lives (whichever is longer) before the first dose of study drugs. 
6.2. 
Permitted Concomitant Medications/Procedures  
Unless noted otherwise, most concomitant medications and therapies deemed necessary and in 
keeping with local standards of medical care at the discretion of the investigator for supportive 
care (eg, antiemetics, antidiarrheals, hematopoietic growth factors, red blood cell/platelet 
transfusions) and in a patient’s interest are allowed. Opiates and other medication required for 
palliative management of patients are allowed.  
All concomitant medication will be recorded on the eCRF, including all prescription and over-
the-counter drugs, herbal supplements, and intravenous medications and fluids.  
Bisphosphonates and RANKL inhibitors are allowed for bone metastases if initiated before 
enrollment and at a stable dose. Bisphosphonates are permitted during the study for a 
nonmalignant indication. Use of potentially hepatotoxic drugs in patients with impaired hepatic 
function is allowed but should be carefully monitored. 
6.2.1. 
Systemic Corticosteroids  
Systemic corticosteroids administered for the control of imAEs must be tapered gradually (see 
Appendix 11) and must be administered at nonimmunosuppressive doses (≤ 10 mg/day of 
prednisone or equivalent) before the next tislelizumab and BGB-A1217 or tislelizumab 
administration. The short-term use of steroids as prophylactic treatments (eg, patients with 
contrast allergies to diagnostic imaging contrast dyes) is permitted.   
6.2.2. 
Hepatitis B Treatment  
Management of prophylactic antiviral therapy for patients with inactive, treated, and stable 
hepatitis B (HBV DNA < 500 IU/mL) is at the discretion of the investigator, as aligned with 
local guidance. Such medications must be documented in the patient’s chart and recorded in the 
eCRF. Patients receiving antivirals at screening should be treated for > 2 weeks before 
enrollment and continue treatment during the study and for 6 months after study drug treatment 
discontinuation. 
6.2.3. 
Hepatitis C Treatment  
Patients with detectable HCV RNA who are receiving treatment at screening should remain on 
continuous, effective antiviral therapy during the study. Investigators can consider treatment with 
antivirals agent following the international or local guidelines as appropriate. However, 
interferon-based therapy for HCV is not permitted on study. Patients who are given antiviral 

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therapy must initiate treatment > 2 weeks before enrollment and continue treatment during the 
study and for 6 months after study drug treatment discontinuation. 
6.2.4. 
Radiation Therapy  
Palliative (limited-field) radiation therapy is permitted, but only for pain control or prophylaxis 
of bone fracture to sites of bone disease present at baseline if the following criteria are met: 
• Repeat imaging demonstrates no new sites of bone metastases 
• The lesion being considered for palliative radiation is not a target lesion for RECIST 
v1.1 
• The case is discussed with the medical monitor and he/she agrees that the conditions 
required to receive palliative radiation are met 
Additionally, palliative radiation or other focally ablative therapy for other nontarget sites of the 
disease is permitted if clinically indicated per the investigator’s discretion and after consultation 
with the medical monitor. Whenever possible, these patients should have a tumor assessment of 
the lesion(s) before receiving the radiation therapy to rule out progression of disease. It is not 
required to withhold study drugs during palliative radiotherapy. 
6.3. 
Prohibited Concomitant Medications/Procedures  
The following medications are prohibited during the study: 
• Any concurrent anticancer therapy (ie, chemotherapy, hormonal therapy, 
immunotherapy, or standard or investigational agents including Chinese [or other 
Country] herbal medicine and Chinese [or other Country] patent medicines for the 
treatment of cancer [regardless of cancer type]) 
• Live vaccines within 28 days before the first dose of study drugs and 60 days following 
the last dose of study drugs 
• Herbal remedies with immune-stimulating properties (eg, mistletoe extract) or that are 
known to potentially interfere with liver or other major organ functions (eg, hypericin)   
6.4. 
Restricted Concomitant Medications/Procedures  
The following medications are restricted during the study: 
• Immunosuppressive agents (except to treat a drug-related AE) 
• Systemic corticosteroids > 10 mg daily (prednisone or equivalent), except to treat or 
control a drug-related AE (per protocol) or for short-term use as prophylactic treatment 
• Patients should not abuse alcohol or other drugs during the study 
• Use of potentially hepatotoxic drugs in patients with impaired hepatic function should 
be carefully monitored 
• Radiation therapy, except for palliative radiation therapy described in Section 6.2.4  

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6.5. 
Potential Interactions Between the Study Drugs and Concomitant 
Medications  
Information regarding clinical drug interactions with BGB-A1217 is not available, and no 
dedicated drug-drug interaction studies are planned. However, the potential for drug-drug 
interaction between the study drugs (BGB-A1217 and tislelizumab) and other drug products is 
very low because BGB-A1217 and tislelizumab are therapeutic monoclonal antibodies. Because 
BGB-A1217 and tislelizumab are expected to be degraded into amino acids and recycled into 
other proteins, they are unlikely to influence drug-metabolizing enzymes or transporters. 
 

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7. 
STUDY ASSESSMENT AND PROCEDURES  
A table of scheduled study assessments is provided in Appendix 1. Patients will be closely 
monitored for safety and tolerability throughout the study. All assessments must be performed 
and documented in the medical record for each patient. 
Dosing will occur only if the clinical assessment and local laboratory test values (that must be 
available before any dosing) have been reviewed and found to be acceptable per protocol 
guidelines.   
7.1. 
Screening Period  
Screening evaluations will be performed ≤ 28 days before the first dose of study drugs. A patient 
who agrees to participate in this study will sign the ICF before undergoing any screening 
assessment. The screening period begins on the first day that a screening assessment is 
conducted. Screening evaluations may be repeated as needed within the screening period. The 
investigator is to assess patient eligibility according to the latest screening assessment results. 
Results of standard-of-care tests or examinations performed before informed consent has been 
obtained and ≤ 28 days before the first dose of study drugs may be used for the purposes of 
screening rather than repeating the standard-of-care tests unless otherwise indicated. 
Procedures conducted only during the Screening Visit are described in this section. For the 
description of other assessments that are conducted during screening as well as throughout the 
study, refer to Safety Assessments (Section 7.4), Tumor and Response Evaluations (Section 7.5), 
PK and ADA Assessments (Section 7.6) and Biomarkers (Section 7.7) sections. 
Rescreening under limited conditions may be allowed after consultation with sponsor (eg, when 
a patient’s laboratory result narrowly miss laboratory criterion and it is correctable and not due to 
rapidly deteriorating condition or PD). Rescreening is allowed only once.   
7.1.1. 
Informed Consent and Screening Log  
Voluntary, written informed consent for participation in the study must be obtained before 
performing any study-specific procedures. The ICFs for enrolled patients and for patients who 
are screened but not enrolled will be maintained at the study site.   
All screening evaluations must be completed and reviewed to confirm that patients meet all 
eligibility criteria before the first dose of study drugs. The investigator will maintain a screening 
log to record details of all patients screened and to confirm eligibility or record reasons for 
screening failure, as applicable.    
7.1.2. 
Patient Numbering  
After obtaining informed consent, study site personnel will access the Interactive Response 
Technology (IRT) system to assign a unique patient number to a potential study participant. 
7.1.3. 
Demographic Data and Medical History  
Demographic data will include age or date of birth, gender, and self-reported race/ethnicity.  

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Medical history includes any history of clinically significant disease, surgery, or cancer history; 
reproductive status (ie, of childbearing potential or no childbearing potential); history of alcohol 
consumption and tobacco (ie, former, current, or never); and all medications (eg, prescription 
drugs, over-the-counter drugs, herbal or homeopathic remedies, nutritional supplements) used by 
the patient within 30 days before the first dose of study drugs.  
Cancer history will include an assessment of prior surgery, prior radiotherapy, and prior drug 
therapy including start and stop dates, best response, and reason for discontinuation.   
7.1.4. 
Females of Childbearing Potential and Contraception  
Childbearing potential is defined as being physiologically capable of becoming pregnant. Refer 
to Appendix 5 for contraception guidelines and definitions of “women of childbearing potential” 
and “no childbearing potential.” 
7.1.5. 
Pulmonary Function Tests  
Patients who are suspected of having or known to have serious/severe respiratory conditions, 
exhibiting significant respiratory symptoms unrelated to the underlying cancer, or having a 
history of thoracic radiotherapy will undergo pulmonary function testing that may include but is 
not limited to spirometry and assessment of diffusion capacity done during the screening period 
to assist the determination of suitability on the study.  
The test may be repeated as clinically indicated while on study (refer to Appendix 1 for details). 
7.2. 
Enrollment  
7.2.1. 
Confirmation of Eligibility  
The investigator will assess and the sponsor will confirm the eligibility of each patient. All 
screening procedure results and relevant medical history must be available before eligibility can 
be determined. All inclusion criteria must be met, and none of the exclusion criteria may apply. 
No eligibility waivers will be granted.  
After a patient is screened and the investigator determines the patient is eligible for enrollment, 
study site personnel will complete an Eligibility Authorization Packet and send it to the medical 
monitor or designee to confirm the eligibility before enrollment. Study site personnel should 
ensure that a medical monitor’s confirmation has been received before proceeding with study 
procedures.    
7.2.2. 
Randomization  
Site personnel will access the IRT system to randomize the patient to treatment assignment and 
assign study drugs in Stage 1 in the study. Study treatment must commence within 2 business 
days after randomization/treatment assignment.  
7.3. 
Study Drug Dispensation  
Tislelizumab and BGB-A1217 will be dispensed and administered as described in Section 5.2.   

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7.4. 
Safety Assessment  
7.4.1. 
Vital Signs  
Vital signs will include measurements of body temperature (˚C), pulse rate, respiratory rate, and 
blood pressure (systolic and diastolic). Pulse rate and blood pressure will be measured while the 
patient is in a seated position after resting for 10 minutes. If coinciding with study drugs 
administration, the patient’s vital signs are required to be recorded within 60 minutes before, 
during, and approximately 30 minutes after the first 2 cycles of study drug administration. For 
subsequent cycles, vital signs will be collected within 60 minutes before the infusion of study 
drug, and if clinically indicated, during and approximately 30 minutes after the infusion of study 
drug. Height should only be measured and recorded during screening. Weight will be measured 
before study drug administration in every cycle. 
7.4.2. 
Physical Examinations  
During the Screening Visit, a complete physical examination will be conducted, including 
evaluations of 1) head, eyes, ears, nose, and throat; 2) cardiovascular; 3) dermatological; 
4) musculoskeletal; 5) respiratory; 6) gastrointestinal; and 7) neurological systems. Any 
abnormality identified during screening will be graded according to NCI-CTCAE v5.0 and 
recorded on the eCRF with appropriate disease/condition terms. 
At subsequent visits (and as clinically indicated), limited, symptom-directed physical 
examinations will be performed. New or worsened clinically significant abnormalities are to be 
recorded as AEs on the eCRF. Refer to Section 8.3 regarding AE definitions and reporting and 
follow-up requirements.    
7.4.3. 
Eastern Cooperative Oncology Group Performance Status  
ECOG Performance Status (Appendix 3) will be assessed during the study. 
7.4.4. 
Laboratory Safety Tests  
Local and/or central laboratory assessments of clinical chemistry, hematology, coagulation, and 
urinalysis will be conducted as outlined in Appendix 2 per the timepoints shown in Appendix 1. 
If laboratory tests at screening are not performed ≤ 7 days before study drug administration on 
Day 1 of Cycle 1, these tests should be repeated and reviewed before study drug administration. 
After Cycle 1, these laboratory tests are to be performed and reviewed within 48 hours before 
study drug administration. 
Laboratory assessments will include the following:   
• Hematology (complete blood count [CBC], including red blood cell [RBC] count, 
hemoglobin, hematocrit, white blood cell [WBC] count with differential [neutrophils, 
lymphocytes, monocytes, basophils, eosinophils], and platelet count) 
• Serum chemistry (glucose, blood urea nitrogen or urea, creatinine, sodium, potassium, 
magnesium, chloride, calcium, phosphorus, direct bilirubin, total bilirubin, ALT, AST, 
alkaline phosphatase, lactate dehydrogenase, total protein, albumin, creatine kinase, 
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• Coagulation test (international normalized ratio, prothrombin time, and activated partial 
thromboplastin time) 
• Urine or serum pregnancy test (for women of childbearing potential, including 
premenopausal women who have had a tubal ligation) ≤ 7 days before the first dose of 
study drugs 
• Urinalysis (complete [including, but not limited to specific gravity, pH, glucose, 
protein, ketones, blood] and/or microscopic at screening and if clinically indicated) 
• Thyroid function testing (thyroid stimulating hormone [TSH], free triiodothyronine 
[T3], free Thyroxine [T4]).  
Details about sample collection and shipment will be provided in a separate instruction manual. 
Investigators should use results from the same local laboratories for assessing eligibility, safety 
monitoring, and dosing decision for each patient.   
7.4.4.1. 
Cardiac Enzyme Monitoring   
Although immune-mediated myocarditis is a rare complication of immune checkpoint inhibitors, 
serum creatine kinase and creatine kinase cardiac isoenzyme are monitored in all tislelizumab 
studies to protect study patients and to quantify the risk of muscle inflammation (see Appendix 1 
for the blood collection schedule and Appendix 11 for guidelines for management of suspected 
immune-mediated myocarditis, respectively).  
Serum creatine kinase and CK-MB testing will be implemented for all patients at screening, 
predose at Day 1 of every scheduled cycle, at the EOT Visit, and at the on-site Safety Follow-up 
Visit. In the event that CK-MB fractionation is not available, serum troponins (troponin I and/or 
T) measurements will be performed instead per local guidelines if used consistently throughout 
the study.  
7.4.5. 
Electrocardiograms  
The ECG recordings will be obtained during screening, the EOT Visit, the on-site Safety Follow-
up Visit, and as clinically indicated.   
For safety monitoring purposes, the investigator must review, sign, and date all ECG tracings.  
Paper or electronic copies of ECG tracings will be kept as part of the patient’s permanent study 
file at the site. 
All ECGs are to be obtained before other assessments scheduled at that same time (eg, vital sign 
measurements, blood draws, etc). The patient should rest in semi-recumbent supine position for 
≥ 10 minutes in the absence of environmental distractions that may induce changes in heart rate 
(eg, television, radio, conversation, etc) before each ECG collection.   
7.4.6. 
Adverse Events   
AEs will be graded and recorded throughout the study according to NCI-CTCAE v5.0. 
Characterization of toxicities will include severity, duration, and time to onset.   
All AEs, including SAEs, will be collected as described in Section 8.6. 

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7.4.7. 
Hepatitis B and C Testing   
Testing will be performed by a central laboratory and/or the local laboratory at screening -and as 
clinically indicated till EOT Visit and will include HBV/HCV serology (HBsAg, hepatitis B 
surface antibody [HBsAb], hepatitis B core antibody [HBcAb], and HCV antibody) and viral 
load assessment (HBV DNA and HCV RNA). For patients who have detectable HBV DNA or 
HCV RNA at screening, a respective viral load test will be performed every 4 cycles (ie, Day 1 
of Cycle 5, 9, 13, etc) starting from Cycle 5.  
7.5. 
Tumor and Response Evaluations  
Tumor imaging will be performed ≤ 28 days before the first dose of study drug. Results of 
standard-of-care tests or examinations performed before obtaining informed consent and 
≤ 28 days before the first dose of study drug may be used for the purposes of screening rather 
than repeating the standard-of-care tests. During the study, tumor imaging will be performed 
approximately every 6 weeks (± 7 days), from Day 1 of Cycle 1, for 54 weeks, then every 
12 weeks (± 7 days) thereafter, based on RECIST v1.1. If a tumor assessment is missed or 
conducted outside of the specified assessment window, all subsequent scans should be conducted 
according to the planned schedule. 
Screening assessments and each subsequent assessment must include computed tomography 
(CT) scans (with oral/IV contrast) of the chest, abdomen, and pelvis. If contraindication exists, 
other modalities can be allowed after consultation with the medical monitor (eg. magnetic 
resonance imaging [MRI], CT with contrast). CT/MRI of the head at baseline is required for 
patients who are suspected to have central nervous system metastases. Bone scan or positron 
emission tomography (PET) scan is required if clinically indicated. Other known or suspected 
sites of disease must be included in the imaging assessments (neck, extremities, etc).  
All measurable and evaluable lesions should be assessed and documented at the Screening Visit 
and reassessed at each subsequent tumor evaluation. The same radiographic procedure used to 
assess disease sites at screening must be used throughout the study (eg, the same contrast 
protocol for CT scans).   
• If a patient is known to have a contraindication to CT contrast media or develops a 
contraindication during the study, a non-contrast CT of the chest plus a 
contrast-enhanced MRI (if possible) of abdomen and pelvis should be performed. 
• If a CT scan for tumor assessment is performed on a PET/CT scanner, the CT 
acquisition must be consistent with the standards of a diagnostic CT scan. 
• Bone scans (Technetium-99m [TC-99m]) or PET scans should be performed at 
screening if clinically indicated. If bone metastases are present at screening and cannot 
be seen on CT or MRI scans, TC-99m or PET bone scans should be repeated when a 
CR is suspected in target lesion or when progression in bone is suspected. 
• Images of brain, neck, or extremities should be performed at screening, only if 
clinically indicated, and followed throughout the study, if there is evidence of 
metastatic disease in these regions at screening.   

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• At the investigator’s discretion, other methods of assessment of target lesion and non-
target lesions per RECIST v1.1 may be used. 
Response will be assessed by the IRC and the investigator using RECIST v1.1 (see 
Appendix 12). The same evaluator should perform assessments, if possible, to ensure internal 
consistency across visits.  
After first documentation of response (CR or PR), confirmation of tumor response should occur 
at 4 weeks or later after the first response or at the next scheduled assessment timepoint. 
When PD is assessed by the investigator, IRC is required to complete central image review and 
convey the results to the investigator as soon as possible. If PD is NOT confirmed by IRC, it is 
recommended to continue the study treatment until PD is confirmed by IRC, if this is in the best 
interest of the patient as discussed with the medical monitor. In the situation where the 
investigator believes the patient must urgently discontinue study treatment without waiting for 
IRC confirmation, the investigator must contact the medical monitor to inform the decision of 
treatment discontinuation.  
A patient who discontinues study drugs early for reasons other than disease progression by IRC 
(eg, toxicity, PD by the investigator) will continue to undergo tumor assessments following the 
original plan until the patient experiences PD per RECISTv1.1 by IRC, withdraws consent, is 
lost to follow-up, death or until the study terminates, whichever occurs first. 
If at the investigator’s discretion a patient could continue to benefit from tislelizumab and 
BGB-A1217 combination treatment or tislelizumab monotherapy (original assigned treatment) 
after PD per RECIST v1.1 criteria by IRC, the patient may continue their assigned treatment. 
The following criteria must be met in order to treat patients who may continue to benefit from 
study treatment after PD:  
• Absence of clinical symptoms and signs of PD (including clinically significantly 
worsening of laboratory values) 
• Stable ECOG Performance Status ≤ 1 
• Absence of rapid progression of disease or of progressive tumor at critical anatomical 
sites (eg, cord compression) that requires urgent alternative medical intervention 
• Investigators must obtain written informed consent for treatment beyond radiologic PD 
and inform patients that this practice is not considered standard in the treatment of 
cancer. 
The decision to continue study drugs beyond initial progression must be agreed to with the 
medical monitor and documented in the study records.  
Tumor assessment should continue as planned in patients receiving study drug(s) beyond initial 
disease progression. Tumor assessment in such patients should continue until study treatment 
discontinuation.  
Tumor assessments must be performed on schedule regardless of whether study treatment has 
been administered or withheld. That is, they should not be adjusted for delays in cycles.  

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7.6. 
Pharmacokinetic and Antidrug Antibody Testing  
BGB-A1217 and tislelizumab may elicit an immune response. Patients with signs of any 
potential immune response will be closely monitored. Validated screening and confirmatory 
assays will be employed to detect ADA at multiple timepoints throughout the study. In addition, 
blood samples will be collected for characterization of BGB-A1217 and tislelizumab PK at the 
timepoints specified in the Schedule of Assessments (Appendix 1).  
PK and ADA assays of BGB-A1217 and tislelizumab will be managed through a central 
laboratory. Serum samples will be assayed for BGB-A1217 and tislelizumab concentrations 
using validated immunoassays.   
• ADA assays: serum samples will be tested for the presence of ADAs to BGB-A1217 
and tislelizumab using a validated immunoassay 
• PK assay: serum samples will be assayed for BGB-A1217 and tislelizumab 
concentration with use of a validated immunoassay 
Refer to the laboratory manual for instructions regarding sample collection, handling, labeling, 
storage, and shipping of laboratory samples.   
7.7. 
Biomarker  
Shipping, storage, and handling of blood as well as archival tumor and/or fresh tumor tissues for 
the assessment of biomarkers will be handled by a central laboratory. Refer to the laboratory 
manual for details of sample handling and the Schedule of Assessments (Appendix 1) for 
timepoints. 
Patients are required to provide tumor tissues (archival tumor tissues [formalin-fixed paraffin 
embedded blocks or approximately 15 freshly cut unstained slides (at least 6)] or fresh biopsy) 
for biomarker analysis, including but not limited to expression of PD-L1, TIGIT pathway related 
markers (including but not limited to TIGIT, CD226, CD155, and CD112), TILs, gene 
expression profiling, and tumor mutation burden/gene mutation/MSI. If archival tumor tissues 
are not available, a fresh tumor biopsy is mandatory at baseline. Acceptable fresh biopsy samples 
include core needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps 
biopsies for cutaneous, subcutaneous, or mucosal lesions.    
If clinically feasible, it is highly recommended to obtain a tumor biopsy at the time of confirmed 
disease progression to explore the immune- or tumor-related biomarkers and biological changes 
that might drive disease progression or acquired resistance to tislelizumab in combination with 
BGB-A1217 and tislelizumab alone (written informed consent is required before fresh tumor 
biopsy).  
Optional blood samples will be collected at baseline (pre-dose of C1D1), at the time of first 
tumor response (predose at Day1 of the following cycle) and at the time of confirmed PD 
(Appendix 1) to explore association of blood based biomarkers with response, resistance and 
prognosis.  
Written informed consent is required for any of the fresh tumor biopsies and blood. Tumor tissue 
should be of good quality in terms of total and viable tumor content. Fine needle aspiration, 
brushing, cell pellets from pleural effusion, and lavage samples are not acceptable. 

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7.8. 
Health Related Quality of Life/Quality of Life  
Patients will be asked to complete three PROs, that include EORTC QLQ-CX24, EORTC QLQ-
C30, and EQ-5D-5L before any clinical activities are performed during on-study clinic visits 
according to the schedule in Appendix 1. The questionnaires will be provided in the patient’s 
preferred language. 
7.9. 
Visit Windows  
All visits must occur within ± 3 days from the scheduled date, unless otherwise noted (see 
Appendix 1). All assessments will be performed on the day of the specified visit unless an 
acceptable time window is specified. Assessments scheduled on the day of study treatment 
administration (Day 1) of each cycle should be performed before any study treatment is given 
unless otherwise noted. Laboratory results must be reviewed before dosing. 
If the timing of a protocol-mandated study visit coincides with a holiday, weekend, or other 
events, the visit should be scheduled for the nearest feasible date (the visit window is provided in 
Appendix 1), with subsequent visits conducted according to the planned schedule every 3 weeks 
from Day 1 of Cycle 1.   
7.10. 
Unscheduled Visits  
Unscheduled visits may be performed at any time at the patient’s or the investigator’s request 
and may include vital signs/physical examination, ECOG Performance Status, AE review, 
concomitant medications and procedures review, radiographic assessments, disease-related 
symptoms, and laboratory assessments. The date and reason for the unscheduled visit must be 
recorded in the source documentation. 
If an unscheduled visit is necessary to assess toxicity or for suspected PD, then diagnostic tests 
may be performed based on the investigator assessment as appropriate, and the results of these 
tests should be entered on the unscheduled visit eCRF. 

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8. 
SAFETY MONITORING AND REPORTING  
The investigator is responsible for the monitoring and documentation of events that meet the 
criteria and definition of an AE or SAE as provided in this protocol. 
8.1. 
Risks Associated With Study Drugs  
8.1.1. 
Risks Associated With BGB-A1217 and Tislelizumab  
BGB-A1217 and tislelizumab are investigational agents that are currently in clinical 
development. Limited safety data are available in patients, and the full safety profile has not been 
characterized. The following recommendation is based on results from nonclinical and clinical 
studies with tislelizumab and BGB-A1217 and published data on other molecules within the 
same biologic class. 
The PD-L1/PD-1 pathway is involved in peripheral immune tolerance; therefore, such therapy 
may increase the risk of imAEs, specifically the induction or enhancement of autoimmune 
conditions. AEs observed with anti-PD-1 therapy are presented in Section 8.7.3. BGB-A1217-
mediated TIGIT inhibition may increase the risk of immune-mediated AEs. However, no 
apparent immunotoxicity, or toxicity in general, have been observed in animal models treated 
with BGB-A1217. Furthermore, in the absence of activation, peripheral effector T-cells do not 
typically express TIGIT, thereby minimizing any potential negative additive affect as it relates to 
peripheral immune tolerance. 
Although most imAEs observed with immunomodulatory agents have been mild and self-
limiting, such events should be recognized early and treated promptly to avoid potential major 
complications. Suggested workup procedures for suspected imAEs are provided in Appendix 11.      
8.2. 
General Plan to Manage Safety Concerns  
8.2.1. 
Eligibility Criteria  
Eligibility criteria were selected to guard the safety of patients in this study. Results from the 
nonclinical toxicology studies and clinical data with BGB-A1217 and tislelizumab, as well as the 
nonclinical/clinical data from other TIGIT and PD-L1/PD-1 inhibitors, were considered. 
Specifically, patients at risk for study-emergent active autoimmune diseases or with a history of 
autoimmune diseases that may relapse, patients who have undergone allogeneic stem cell or 
organ transplantation, and patients who have received a live vaccine ≤ 28 days before the first 
dose of study drug are excluded from the study. Refer to Section 4.2 for the full list of exclusion 
criteria.  
8.2.2. 
Safety Monitoring Plan  
Safety will be evaluated in this study through the monitoring of all AEs, defined and graded 
according to NCI-CTCAE v5.0. 
All enrolled patients will be evaluated clinically and with standard laboratory tests at regular 
intervals during their participation in this study. Safety evaluations will consist of medical 
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(hematology, clinical chemistry, etc), and other assessments including those listed in 
Appendix 1. In addition, patients will be closely monitored for the development of any signs or 
symptoms of autoimmune conditions or infection. 
At the start of each cycle, study drug(s) will be administered only after clinical laboratory results 
have been reviewed. Administration of study drugs will be performed in a setting where 
emergency medical equipment and staff who are trained to respond to medical emergencies are 
available (for additional information, see Section 5.2).  
Serum samples will be drawn for determination of ADAs to BGB-A1217 and tislelizumab in all 
patients.    
Investigators are instructed to report all AEs (includes pregnancy-related AEs). 
The potential safety issues anticipated in this study, as well as measures intended to avoid or 
minimize such toxicities, are outlined in Section 8.7. 
8.3. 
Adverse Events  
8.3.1. 
Definitions and Reporting  
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
drugs, whether considered related to study drugs or not. 
Examples of AEs include:  
• Worsening of a chronic or intermittent pre-existing condition, including an increase in 
severity, frequency, duration, and/or has an association with a significantly worse 
outcome 
• New conditions detected or diagnosed after administration of study drugs even though 
the condition might have been present before the start of the study 
• Signs, symptoms, or the clinical sequelae of a suspected interaction 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drugs 
or a concurrent medication (overdose per se should not be reported as an AE or SAE) 
When an AE or SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory results, and diagnostics reports) relative to 
the AE or SAE. The investigator will then record all relevant information regarding an AE or 
SAE in the eCRF. However, there may be instances when copies of medical records for certain 
cases are requested by the sponsor. In this instance, all patient identifiers will be blinded on the 
copies of the medical records before submission to the sponsor. 
8.3.2. 
Assessment of Severity  
The investigator will assess the severity of each AE and SAE reported during the study. AEs and 
SAEs should be assessed and graded based upon NCI-CTCAE v5.0. 

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Toxicities that are not specified in NCI-CTCAE will be defined as follows: 
• Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated 
• Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living 
• Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-
care, activities of daily living 
• Grade 4: Life-threatening consequences; urgent intervention indicated 
• Grade 5: Death related to AE 
Note: The terms “severe” and “serious” are not synonymous. Severity is a measure of intensity 
(for example, grade of a specific AE, mild [Grade 1], moderate [Grade 2], severe [Grade 3], or 
life-threatening [Grade 4]); whereas, seriousness is classified by the criteria based on the 
regulatory definitions. Seriousness serves as the guide for defining regulatory reporting 
obligations from the sponsor to applicable regulatory authorities as described in Section 8.6.2. 
8.3.3. 
Assessment of Causality  
The investigator is obligated to assess the relationship between the study drugs and the 
occurrence of each AE or SAE using best clinical judgement. Alternative causes, such as natural 
history of the underlying diseases, concomitant therapy, and other risk factors, and the temporal 
relationship of the AE or SAE to the study drugs should be considered and investigated. The 
investigator should consult the Tislelizumab Investigator’s Brochure and the BGB-A1217 
Investigator’s Brochure in the determination of his/her assessment. 
There may be situations when an SAE has occurred, and the investigator has minimal 
information to include in the initial report to the sponsor. However, it is very important that the 
investigator always assesses causality for every SAE before transmission of the SAE report to 
the sponsor because the causality assessment is 1 of the criteria used when determining 
regulatory reporting requirements. The investigator may change his/her opinion of causality 
considering follow-up information, amending the SAE report accordingly. 
The causality of each AE should be assessed and classified by the investigator as “related” or 
“not related.” An AE is considered related if there is “a reasonable possibility” that the AE may 
have been caused by the study drugs (ie, there are facts, evidence, or arguments to suggest 
possible causation). A number of factors should be considered in making this assessment 
including: 
• Temporal relationship of the AE to the administration of study treatment/study 
procedure 
• Whether an alternative etiology has been identified 
• Mechanism of action of the study drugs 
• Biological plausibility 

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An AE should be considered “related” to study drugs if any of the following are met; otherwise, 
the event should be assessed as “not related”: 
• There is clear evidence to suggest a causal relationship, and other possible contributing 
factors can be ruled out 
• There is evidence to suggest a causal relationship, and the influence of other factors is 
unlikely 
• There is some evidence to suggest a causal relationship (eg, the AE occurred within a 
reasonable time after administration of the study drug[s]). However, the influence of 
other factors may have contributed to the AE (eg, the patient’s clinical condition or 
other concomitant AEs). 
8.3.4. 
Follow-up of Adverse Events  
After the initial AE or SAE report, the investigator is required to proactively follow each patient 
and provide further information to the sponsor on the patient’s condition. 
All AEs and SAEs documented at a previous visit/contact and designated as ongoing will be 
reviewed at subsequent visits/contacts. 
All AEs and SAEs will be followed until resolution, the condition stabilizes or is considered 
chronic, the AE or SAE is otherwise explained, the patient is lost to follow-up, or the patient 
withdraws consent. The investigator will ensure that follow-up includes any supplemental 
investigations as may be indicated to elucidate the nature and/or causality of the AE or SAE.  
This may include additional laboratory tests or investigations, histopathological examinations, 
radiographic imaging, or consultation with other health care professionals. 
The sponsor may request that the investigator perform or arrange for the conduct of supplemental 
measurements and/or evaluations to elucidate as fully as possible the nature and/or causality of 
the AE or SAE. The investigator is obligated to assist. If a patient dies during participation in the 
study or during a recognized follow-up period, the sponsor will be provided with a copy of any 
postmortem findings, including histopathology. 
New or updated information should be reported to the sponsor according to the SAE instructions 
provided by the sponsor within the time frames outlined in Section 8.6.2. 
8.3.5. 
Laboratory Test Abnormalities  
Abnormal laboratory findings (eg, clinical chemistry, complete blood count, coagulation, or 
urinalysis) or other abnormal assessments (eg, ECGs, x-rays, or vital signs) that are judged by 
the investigator as clinically significant will be recorded as AEs or SAEs. This includes clinically 
significant abnormal laboratory findings or other abnormal assessments that are present at 
baseline and that worsen significantly during the study. The definition of clinically significant is 
based on the judgement of the investigator. In general, these are the laboratory test abnormalities 
or other abnormal assessments that:  
• are associated with clinical signs or symptoms, or  
• require active medical intervention, or  

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• lead to dose interruption or discontinuation, or 
• require close observation, more frequent follow-up assessments, or further diagnostic 
investigation. 
If a clinically significant laboratory abnormality is a sign of a disease or syndrome (eg, alkaline 
phosphatase and bilirubin 5 x ULN associated with cholestasis), only the diagnosis (ie, 
cholestasis) should be recorded on the Adverse Event eCRF.  
If the laboratory abnormality can be characterized by a precise clinical term per standard 
definitions, the clinical term should be recorded as the adverse event. For example, an elevated 
serum potassium level of 7.0 mEq/L should be recorded as “hyperkalemia.”  
Observations of the same clinically significant laboratory abnormality from visit to visit should 
not be repeatedly recorded on the Adverse Event eCRF, unless the etiology changes. The initial 
severity of the event should be recorded, and the severity or seriousness should be updated any 
time the event worsens. 
8.4. 
Definition of a Serious Adverse Event  
An SAE is any untoward medical occurrence that, at any dose: 
• Results in death 
• Is life-threatening 
Note: The term “life-threatening” in the definition of “serious” refers to an AE in 
which the patient was at risk of death at the time of the AE. It does not refer to an AE 
that hypothetically might have caused death if it was more severe. 
• Requires hospitalization or prolongation of existing hospitalization 
Note: In general, hospitalization signifies that the patient was admitted (usually 
involving at least an overnight stay) to the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the physician’s 
office or outpatient setting. 
• Results in disability/incapacity 
Note: The term “disability” means a substantial disruption of a person’s ability to 
conduct normal life functions. This definition is not intended to include experiences 
of relatively minor medical significance, such as uncomplicated headache, nausea, 
vomiting, diarrhea, influenza, and accidental trauma (eg, sprained ankle), which may 
interfere with or prevent everyday life functions but do not constitute a substantial 
disruption. 
• Is a congenital anomaly/birth defect 
• Is considered a significant medical AE by the investigator based on medical judgement 
(eg, may jeopardize the patient or may require medical/surgical intervention to prevent 
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The following are NOT considered SAEs: 
• Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline 
• Hospitalization for social/convenience considerations 
• Scheduled therapy for the target disease of the study, including admissions for 
transfusion support or convenience 
8.5. 
Suspected Unexpected Serious Adverse Reaction  
A suspected unexpected serious adverse reaction (SUSAR) is a serious adverse reaction that is 
both unexpected (ie, not present in the study drug’s reference safety information [RSI]) and 
meets the definition of a serious adverse drug reaction (SADR), the specificity or severity of 
which is not consistent with those noted in Tislelizumab Investigator’s Brochure or  
BGB-A1217 Investigator’s Brochure. 
8.6. 
Timing, Frequency, and Method of Capturing Adverse Events and 
Serious Adverse Events  
8.6.1. 
Adverse Event Reporting Period  
After the ICF has been signed, but before the administration of the study drugs, only SAEs 
should be reported to the sponsor. 
After initiation of study drugs, all AEs and SAEs, regardless of relationship to study drugs, will 
be reported until either 30 days after last dose of study drugs, initiation of new anticancer 
therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first. Immune-
mediated AEs (serious or nonserious) should be reported until 90 days after the last dose of study 
drugs (regardless of initiation of new anticancer therapy), death, withdrawal of consent, or loss to 
follow-up, whichever occurs first. All SAEs considered related to the study drug(s) that are 
brought to the attention of the investigator should be reported regardless of time since the last 
dose of treatment.  
AEs and SAEs should be recorded according to the details in Table 10. For the follow-up period 
for AEs, see Section 8.3.4. For the definition of treatment-emergent adverse events (TEAEs), see 
Section 9.3.2. 

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Table 10: 
Guidance for Duration of Recording New or Worsening Adverse Events in 
All Cohorts 
Event Type 
Record new or worsening events that occur during this period 
Begin 
End 
SAEsa             
Signing of informed 
consent 
Up to 30 days after last dose, initiation of new 
anticancer therapy, death, withdrawal of 
consent, or loss to follow-up, whichever 
occurs first 
Nonserious AEs due to PD 
Do not record (see Section 8.6.4) 
All nonserious AEs, 
except those due to PD 
First dose of study drug 
Up to 30 days after last dose, initiation of new 
anticancer therapy, death, withdrawal of 
consent, or loss to follow-up, whichever 
occurs first 
Immune-mediated AEs 
(serious or nonserious) 
First dose of study drug 
Up to 90 days after last dose (regardless of 
initiation of new anticancer therapy), death, 
withdrawal of consent, or loss to follow-up, 
whichever occurs first 
Abbreviations: AE, adverse event; PD, progressive disease; SAE, serious adverse event. 
a All SAEs considered related to the study drug(s) that are brought to the attention of the investigator should be 
reported regardless of time since the last dose of treatment. 
8.6.2. 
Reporting Serious Adverse Events  
8.6.2.1. 
Prompt Reporting of Serious Adverse Events  
As soon as the investigator determines that an AE meets the protocol definition of an SAE, the 
event must be reported promptly (within 24 hours) to the sponsor or designee as described in 
Table 11. 
Table 11: 
Time Frames and Documentation Methods for Reporting Serious Adverse 
Events to the Sponsor or Designee 
 
Time Frame for 
Sending Initial 
Report 
Documentation 
Method 
Time Frame for 
Sending Follow-
up Report 
Documentation 
Method 
Reporting 
Method 
All SAEs 
Within 24 hours 
of first 
knowledge of the 
SAE 
SAE report 
As expeditiously 
as possible 
SAE report 
Email or fax 
SAE report form 
Abbreviations: AE, adverse event; SAE, serious adverse event. 
8.6.2.2. 
Completion and Transmission of the Serious Adverse Event Report  
Once an investigator becomes aware that an SAE has occurred in a patient, he/she is to report the 
information to the sponsor within 24 hours, as outlined above in Section 8.6.2.1. The SAE report 
will always be completed as thoroughly as possible, including all available details of the event, 
and forwarded to the sponsor or designee within the designated time frames. 

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If the investigator does not have all information regarding an SAE, he/she is not to wait to 
receive additional information before notifying the sponsor or designee of the SAE and 
completing the form. The form will be updated when additional information is received. 
The investigator must always provide an assessment of causality for each SAE as described in 
Section 8.3.3. 
The sponsor will provide contact information for SAE receipt. 
8.6.2.3. 
Regulatory Reporting Requirements for Serious Adverse Events  
The investigator will promptly report all SAEs to the sponsor in accordance with the procedures 
detailed in Section 8.6.2.1. The sponsor has a legal responsibility to notify, as appropriate, both 
the local regulatory authority and other regulatory agencies about the safety of a drug under 
clinical investigation. 
The investigator, or the responsible person according to local requirements, will comply with the 
applicable local regulatory requirements related to the reporting of SAEs to regulatory authorities 
and the IRB/IEC. 
All SUSARs (as defined in Section 8.5) will be submitted to all applicable regulatory authorities 
and investigators for BGB-A1217 and tislelizumab studies. 
When a study center receives an initial or follow-up safety report or other safety information 
(eg, revised Investigator’s Brochure) from the sponsor, the investigator or designated responsible 
person is required to promptly notify his/her IRB or IEC. The investigator should place copies of 
safety reports from the sponsor in the investigator site file. 
8.6.3. 
Eliciting Adverse Events  
The investigator or designee will ask patients about AEs by asking the following standard 
questions: 
• How are you feeling? 
• Have you had any medical problems since your last visit? 
• Have you taken any new medicines since your last visit? 
8.6.4. 
Disease Progression  
PD, which is expected in this study population and measured as an efficacy endpoint, should not 
be recorded as an AE term. Similarly, nonserious AEs that are clearly consistent with the pattern 
of progression of the underlying disease and are considered unequivocally due to disease 
progression should not be recorded. However, if there is any uncertainty as to whether a 
nonserious AE is due to disease progression, it should be recorded as an AE. All SAEs and 
deaths regardless of relatedness to disease progression should be recorded and reported (see 
Section 8.6.2).   

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8.6.5. 
Deaths  
Death is an outcome and not usually considered an AE. If the only information available is death 
and the cause of death is unknown, then the death is reported as an event (eg, “death,” “death of 
unknown cause,” or “death unexplained”). 
8.6.6. 
Pregnancies  
If a patient becomes pregnant while receiving study drugs or within 120 days after the last dose 
of study drugs, a pregnancy report form must be completed and expeditiously submitted to the 
sponsor to facilitate outcome follow-up. Information on the status of the mother and child will be 
forwarded to the sponsor. Generally, follow-up will be no longer than 6 to 8 weeks following the 
estimated delivery date. Any premature termination of the pregnancy will be reported. 
While pregnancy itself is not considered to be an AE, any pregnancy complication or elective 
termination of a pregnancy for medical reasons will be recorded as an AE or SAE. 
An abortion, whether accidental, therapeutic, or spontaneous, should always be reported as an 
SAE. Similarly, any congenital anomaly/birth defect in a child born to a patient exposed to the 
study drugs should be recorded and reported as an SAE. 
8.6.7. 
Expedited Reporting to Health Authorities, Investigators, Institutional Review 
Boards, and Independent Ethics Committees  
The sponsor will promptly assess all SAEs against cumulative study drug experience to identify 
and expeditiously communicate new safety findings to regulatory authorities, investigators, 
IRBs, and IECs based on applicable legislation. 
To determine the reporting requirements for individual SAEs, the sponsor will assess the 
expectedness of the SAEs using the following reference safety information documents: 
• Tislelizumab Investigator’s Brochure 
• BGB-A1217 Investigator’s Brochure 
8.6.8. 
Assessing and Recording Immune-Mediated Adverse Events  
Since treatment with anti-PD-1 or immune checkpoint inhibitors can cause autoimmune 
disorders, AEs considered by the investigator to be immune-mediated (see Section 8.7.3) should 
be classified as imAEs and identified as such on the eCRF AE page until Day 90 after the last 
dose of study drugs.   
Investigators should consult the guidance on diagnostic evaluation and management of imAEs, 
which are commonly seen with immune checkpoint inhibitors, in Appendix 11. 
An extensive list of potential imAEs appears in Section 8.7.3, Table 13. All conditions like those 
listed should be evaluated to determine whether they are imAEs based on a similar diagnostic 
process to those reactions that are presented in more detail in Appendix 11. 
8.6.9. 
Recording Infusion-Related Reactions  
The symptoms of infusion-related reactions may include but are not limited to fever, chills/rigor, 
nausea, pruritus, angioedema, hypotension, headache, bronchospasm, urticaria, rash, vomiting, 

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myalgia, dizziness, or hypertension. Severe reactions may include acute respiratory distress 
syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Individual signs 
and symptoms of an infusion reaction should be recorded each as a separate AE in the eCRF and 
identified as an infusion-related reaction. 
8.7. 
Management of Adverse Events of Special Interest  
As a routine precaution, patients must be monitored for ≥ 2 hour after infusion of tislelizumab 
combined with BGB-A1217 (Cohort 1) and for ≥ 1 hour after infusion of tislelizumab 
monotherapy (Cohort 2) on Day 1 of Cycle 1 and Cycle 2 in an area with resuscitation 
equipment and emergency agents. From Cycle 3 onward, at least a 30-minute monitoring period 
is required in an area with resuscitation equipment and emergency agents. 
The management for infusion-related reactions, severe hypersensitivity reactions, and imAEs 
according to the NCI-CTCAE criteria are outlined in the following subsections. 
8.7.1. 
Infusion-Related Reactions  
Patients should be closely monitored for infusion-related reactions. Immediate access to an 
Intensive Care Unit or equivalent environment and appropriate medical therapy (including 
epinephrine, corticosteroids, intravenous antihistamines, bronchodilators, and oxygen) must be 
available to treat infusion-related reactions. 
Treatment modifications for symptoms of infusion-related reactions due to study drugs are 
provided in Table 12. 
Table 12: 
Treatment Modifications for Symptoms of Infusion-Related Reactions Due to 
Study Drugs 
NCI-CTCAE Grade 
Treatment Modification for BGB-A1217 and 
Tislelizumab  
Grade 1 - mild 
Mild transient reaction; infusion interruption not 
indicated; intervention not indicated. 
Decrease infusion rate by 50%. Any worsening is 
closely monitored. Medical management as needed.   
Grade 2 - moderate 
Therapy or infusion interruption indicated but responds 
promptly to symptomatic treatment (eg, antihistamines, 
nonsteroidal anti-inflammatory drugs, narcotics, 
intravenous fluids); prophylactic medications indicated 
for ≤ 24 hours. 
Stop infusion. Infusion may be resumed at 50% of 
previous rate once infusion-related reactions has 
resolved or decreased to Grade 1 in severity. Any 
worsening is closely monitored. Proper medical 
management should be instituted as described in the text 
following this table.   
 
Grade 3 – severe 
Prolonged (eg, not rapidly responsive to symptomatic 
medication and/or brief interruption of infusion); 
recurrence of symptoms following initial improvement; 
hospitalization indicated for clinical sequelae. 
Immediately stop the infusion. Proper medical 
management should be instituted as described in the text 
following this table. 
The patient should be withdrawn from study drug 
treatment. 

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NCI-CTCAE Grade 
Treatment Modification for BGB-A1217 and 
Tislelizumab  
Grade 4 – life-threatening 
Life-threatening consequences; urgent intervention 
indicated. 
Immediately stop the infusion. Proper medical 
management should be instituted as described in the text 
following this table. 
The patient should be withdrawn from study drug 
treatment. 
Hospitalization is recommended. 
Abbreviations: IV, intravenous; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse 
Events. 
Once the BGB-A1217 or tislelizumab infusion rate has been decreased by 50% or suspended due 
to an infusion-related reaction, it must remain decreased for all subsequent infusions. If the 
patient has a second infusion-related reaction (≥ Grade 2) on the slower infusion rate, the 
infusion should be discontinued, and the patient should be withdrawn from BGB-A1217 + 
tislelizumab combination treatment or tislelizumab monotherapy.   
NCI-CTCAE Grade 1 or 2 infusion reaction: Proper medical management should be 
instituted, as indicated per the type of reaction. This includes but is not limited to an 
antihistamine (eg, diphenhydramine or equivalent), antipyretic (eg, paracetamol or equivalent), 
and, if considered indicated, oral or intravenous glucocorticoids, epinephrine, bronchodilators, 
and oxygen. In the next cycle, the patient should receive oral premedication with an 
antihistamine (eg, diphenhydramine or equivalent) and an antipyretic (eg, paracetamol or 
equivalent), and the patient should be closely monitored for clinical signs and symptoms of an 
infusion reaction. 
NCI-CTCAE Grade 3 or 4 infusion reaction: Proper medical management should be instituted 
immediately, as indicated per type and severity of the reaction. This includes but is not limited to 
oral or intravenous antihistamine, antipyretic, glucocorticoids, epinephrine, bronchodilators, and 
oxygen. 
8.7.2. 
Severe Hypersensitivity Reactions and Flu-Like Symptoms  
If hypersensitivity reaction occurs, the patient must be treated according to the best available 
medical practice as described in the complete guideline for emergency treatment of anaphylactic 
reactions according to the Working Group of the Resuscitation Council (United Kingdom) 
(Soar et al 2008). Patients should be instructed to report any delayed reactions to the investigator 
immediately. 
In the event of a systemic anaphylactic/anaphylactoid reaction, the infusion must be stopped 
immediately, and the patient discontinued from the study. Systemic anaphylactic/anaphylactoid 
reactions typically manifest within minutes following administration of the drug/antigen and are 
characterized by: respiratory distress; laryngeal edema; and/or intense bronchospasm; and are 
often followed by vascular collapse or shock without antecedent respiratory difficulty; cutaneous 
manifestations such as pruritus and urticaria with/without edema; and gastrointestinal 
manifestations such as nausea, vomiting, crampy abdominal pain, and diarrhea. 

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The patient will be administered epinephrine injection and dexamethasone infusion if 
hypersensitivity reaction is observed, and then the patient should be placed on monitor 
immediately and an Intensive Care Unit should be alerted for possible transfer if needed. 
For prophylaxis of flu-like symptoms, a dose of 25 mg indomethacin or a comparable dose of 
nonsteroidal anti-inflammatory drugs (ie, 600 mg ibuprofen, 500 mg naproxen sodium) may be 
administered 2 hours before and 8 hours after the start of each dose of study drug infusion.  
Alternative treatments for fever (ie, paracetamol) may be administered to the patient at the 
discretion of the investigator. 
8.7.3. 
Immune-Mediated Adverse Events  
Immune-mediated AEs are of special interest in this study. If the events listed below or similar 
events occur, the investigator should exclude alternative explanations (eg, combination drugs, 
infectious disease, metabolic, toxin, PD, or other neoplastic causes) with appropriate diagnostic 
tests that may include but are not limited to serologic, immunologic, and histologic (biopsy) data.  
If alternative causes have been ruled out, the AE required the use of systemic steroids, other 
immunosuppressants, or endocrine therapy and is consistent with an immune-mediated 
mechanism of action, the imAE indicator on the eCRF AE page should be checked. 
A list of potential imAEs is shown below in Table 13. All conditions similar to those listed 
should be evaluated in patients receiving tislelizumab or BGB-A1217 to determine whether they 
are immune-mediated. 
Recommendation for diagnostic evaluation and management of imAEs is based on European 
Society for Medical Oncology and American Society of Clinical Oncology guidelines 
(Haanen et al 2017; Brahmer et al 2018) and common immune-mediated toxicities are detailed in 
Appendix 11. For any AEs not included in Appendix 11, refer to the American Society of 
Clinical Oncology Clinical Practice Guideline (Brahmer et al 2018) for further guidance on 
diagnostic evaluation and management of immune-mediated toxicities. 
Table 13: 
Immune-Mediated Adverse Events 
Body System Affected 
Events 
Skin (mild-common) 
pruritus or maculopapular rash; vitiligo 
Skin (moderate) 
follicular or urticarial dermatitis; erythematous/lichenoid rash; Sweet syndrome 
Skin (severe-rare) 
full-thickness necrolysis/Stevens-Johnson syndrome 
Gastrointestinal 
colitis (includes diarrhea with abdominal pain or endoscopic/radiographic evidence 
of inflammation); pancreatitis; hepatitis; aminotransferase (ALT/AST) elevation; 
bowel perforation 
Endocrine 
thyroiditis, hypothyroidism, hyperthyroidism; hypophysitis with features of 
hypopituitarism (eg, fatigue, weakness, weight gain); insulin-dependent diabetes 
mellitus; diabetic ketoacidosis; adrenal insufficiency 
Respiratory 
pneumonitis/diffuse alveolitis 
Eye 
episcleritis; conjunctivitis; iritis/uveitis 
Neuromuscular 
arthritis; arthralgia; myalgia; neuropathy; Guillain-Barre syndrome; aseptic 
meningitis; myasthenic syndrome/myasthenia gravis; meningoencephalitis; myositis 

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Body System Affected 
Events 
Blood 
anemia; leukopenia; thrombocytopenia 
Renal 
interstitial nephritis; glomerulonephritis; acute renal failure 
Cardiac 
pericarditis; myocarditis; heart failure 
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase. 
Recommendations for managing imAEs are detailed in Appendix 11. 
If a toxicity does not resolve to ≤ Grade 1 within 12 weeks, study drugs should be discontinued 
after consultation with the sponsor. Patients who experience a recurrence of any event at the 
same or higher severity grade with rechallenge should permanently discontinue treatment. 
 

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9. 
STATISTICAL METHODS AND SAMPLE SIZE 
DETERMINATION  
The statistical analyses will be performed by the sponsor or designee after the data collection is 
completed and the database is locked and released. Data will be listed and summarized using 
SAS® Version 9.3 or higher (SAS Institute, Inc., Cary, North Carolina) per sponsor agreed 
reporting standards, where applicable. Details of the statistical analyses will be included in a 
separate Statistical Analysis Plan (SAP).   
9.1. 
Statistical Analysis  
The following descriptive statistics will be used to summarize the trial data on the basis of their 
nature unless otherwise specified: 
• Continuous variables: number of non-missing observations, mean, standard deviation, 
median, minimum, and maximum  
• Categorical variables: frequencies and percentages 
• Time-to-event variables: number of non-missing observations (N), median, minimum and 
maximum. Kaplan-Meier event rates may also be provided if applicable for specific time 
to event variables 
9.1.1. 
Analysis Sets  
The Safety Analysis Set (SAS) includes all patients who received ≥ 1 dose of study drugs of each 
cohort. This will be the primary analysis set for efficacy analysis, and the analysis set for safety 
analysis.   
The Efficacy Evaluable Analysis Set (EAS) includes all treated patients (SAS) without critical 
protocol deviation of each cohort who had measurable disease at baseline per RECIST v1.1 and 
who had ≥ 1 evaluable post-baseline tumor assessment unless discontinued due to clinical PD or 
death within 7 weeks after the first dose. It will be used for the sensitivity analysis of the primary 
efficacy endpoint ORR. 
The PK Analysis Set includes all patients who received ≥ 1 dose of any component of study drug 
per the protocol, for whom any postdose PK data are available.  
The Immunogenicity Analysis Set includes all patients who received at least 1 dose of any 
component of study drug for whom both baseline antidrug antibody result and at least 1 post-
baseline antidrug antibody result are available.   
9.1.2. 
Patient Disposition  
The number of patients randomized, treated, and discontinued from study drug and/or study and 
those with critical protocol deviations will be counted. The primary reason for study drug and/or 
the study being discontinued will be summarized according to the categories in the eCRF. The 
end-of-study status (alive, dead, withdrew consent, or lost to follow-up) as of the data cutoff date 
will be summarized using the data from the eCRF. 

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Critical protocol deviations will be summarized and listed by each category. 
9.1.3. 
Demographic and Other Baseline Characteristics  
Demographic and other baseline characteristics will be summarized using descriptive statistics in 
the Safety Analysis Set. Continuous variables include age, weight, vital signs, time since initial 
cancer diagnosis, time since advanced/metastatic disease diagnosis, etc. Categorical variables 
include gender, ECOG Performance Status, region/country, race, PD-L1 subgroup, prior 
systemic therapies, stage of disease, metastatic site, etc. 
9.1.4. 
Prior and Concomitant Medications  
Prior medications will be defined as medications that stopped before the day of first dose of 
study drugs. Concomitant medications will be defined as medications that 1) started before the 
first dose of study drugs and were continuing at the time of the first dose of study drugs, or 
2) started on or after the date of the first dose of study drugs up to 30 days after the patient’s last 
dose (as of the on-site Safety Follow-up Visit).   
Concomitant medications will be coded using the WHO Drug Dictionary drug codes and further 
coded to the appropriate Anatomical Therapeutic Chemical code indicating therapeutic 
classification. Prior and concomitant medications will be summarized and listed by drug and 
drug class in the clinical study report (CSR) for this protocol.   
9.2. 
Efficacy Analyses  
ORR is the primary objective in the study. Response assessments will be determined by IRC and 
by investigator using RECIST v1.1. 
Efficacy Analyses will be provided by subgroups as appropriate, such as PD-L1 subgroups, etc. 
Per-patient listings may be generated with limited patients for analysis. 
General statistical considerations of efficacy analysis will be demonstrated here and more details 
will be provided in the Statistical Analysis Plan (SAP). 
9.2.1. 
Primary Efficacy Analysis    
The primary efficacy endpoint is confirmed ORR as determined by IRC using the RECIST v1.1 
in Cohort 1.  
ORR is defined as the proportion of patients achieving BOR of CR or PR. BOR is defined as the 
best response recorded from the first dose of study drug until data cut or the initiation of new 
anticancer treatment, whichever occurs earlier. Patients with no postbaseline response 
assessment (due to any reason) will be considered as nonresponders for BOR. The proportion of 
patients in each response category will be presented. 
The binomial exact test will be performed among the patients whose tumor with PD-L1 
vCPS ≥ 5% and patients whose tumor regardless of PD-L1 expression in Safety Analysis Set in a 
sequential way: 
 
 

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Patients whose tumor with vCPS ≥ 5% 
The ORR in this population is assumed as 30%, which is deemed a clinically meaningful 
improvement based on a historical control of 15%. Hence, the null and alternative hypotheses are 
set as the following:   
H0: ORR ≤ 15% 
Ha: ORR > 15% 
Patients whose tumor regardless of PD-L1 expression   
The ORR in this population is assumed as 25%, which is deemed a clinically meaningful 
improvement based on a historical control of 15%. Hence, the null and alternative hypotheses are 
set as the following:  
H0: ORR ≤ 15% 
Ha: ORR > 15% 
If the obtained one-sided p-value is ≤ 0.025, it will be concluded that BGB-A1217 combined 
with tislelizumab statistically significantly increases ORR compared with the historical controls 
in the PD-L1 vCPS ≥ 5% or/and regard less of PD-L1 expression population. Therefore, the 
superiority of BGB-A1217 combined with tislelizumab will be demonstrated. A Clopper-Pearson 
95% confidence interval (CI) of ORR will be constructed to assess the precision of the rate 
estimate in the Safety Analysis Set.    
The primary efficacy analysis will be conducted when ORR data is mature, which is 6 months 
(approximately 4 tumor assessments) after the last patient receives the first dose of study drug in 
Stage 2 and will be based on the Safety Analysis Set.    
Approximately 4 months after the enrollment is completed in Stage 1, there will be a preliminary 
analysis of ORR and safety (using descriptive statistics) for the first 40 patients in Cohort 1 and 
all 40 patients in Cohort 2. Enrollment of Stage 2 will continue in parallel. At the time of 
preliminary analysis, if no more than 5 responders are observed in Cohort 1 at Stage 1, which 
corresponds to a Bayesian predictive probability of success less than 0.1 (Chen et al 2019; Lee 
and Liu 2008), the study will be terminated.   
9.2.2. 
Secondary Efficacy Analysis     
Objective Response Rate (ORR) 
ORR as assessed by investigator’s review will be summarized for secondary efficacy analysis in 
the Safety Analysis Set in Cohort 1, and ORR as assessed by both IRC and investigator will be 
summarized in Cohort 2. A 2-sided Clopper-Pearson 95% CI of ORR will be constructed to 
assess the precision of the point estimate of ORR. 
Other efficacy endpoints with necessary tumor assessments, as well as OS, will be summarized 
for secondary efficacy analysis. The secondary efficacy analysis will be conducted by both IRC 
and investigator (if applicable) in Cohort 1 and Cohort 2.  
Disease Control Rate (DCR) 

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DCR is defined as the proportion of patients who achieve CR, PR, or SD. DCR will be 
summarized similarly as ORR in the Safety Analysis Set and also in Efficacy Evaluable Analysis 
Set for sensitivity analysis. 
Clinical Benefit Rate (CBR) 
CBR is defined as the proportion of patients who achieve CR, PR, or durable SD (SD ≥ 24 
weeks). 
CBR will be summarized similarly as ORR in the Safety Analysis Set and also in the Efficacy 
Evaluable Analysis Set for sensitivity analysis.   
Duration of Response (DOR) 
DOR is defined as the time from the first confirmed objective response to disease progression 
documented after treatment initiation or death, whichever occurs first.  
DOR will be analyzed among the responders in the Safety Analysis Set. The median and other 
quartiles of DOR will be estimated using the Kaplan-Meier method. The 2-sided 95% CIs will be 
constructed with the generalized Brookmeyer and Crowley method 
(Brookmeyer and Crowley 1982). Event-free rates at selected timepoints for DOR will be 
estimated using the Kaplan-Meier method with corresponding 95% CI constructed using 
Greenwood’s formula (Greenwood 1926). The DOR censoring rule will follow US Food and 
Drug Administration (FDA) Guidance for Industry Clinical Trial Endpoints for the Approval of 
Cancer Drugs and Biologics (US FDA 2018).  
More details, including the censoring rules, will be provided in the SAP.  
Progression-Free Survival (PFS) 
PFS is defined as the time from treatment initiation to disease progression or death due to any 
cause, whichever occurs first.  
PFS will be analyzed in the Safety Analysis Set using methods similar to those described for 
DOR. The PFS censoring rule will follow the same as followed by DOR. PFS rates at 3 months, 
6 months, 9 months, and 12 months will be calculated based on Kaplan-Meier method. 
Overall Survival (OS) 
OS is defined as the time from treatment initiation to death due to any cause. 
OS will be analyzed in the Safety Analysis Set using similar methods to those described for PFS 
similarly, except for censoring rules. For OS, patients will be censored either at the date that the 
patient was last known to be alive or the date of data cutoff, whichever comes earlier, in the 
absence of death. OS rates at 3 months, 6 months, 9 months, and 12 months will be calculated 
based on Kaplan-Meier method. 
Time to Response (TTR) 
TTR is defined as the time from treatment initiation to the first documented response.  
TTR will be summarized for responders (who have achieved an objective response) only using 
sample statistics such as mean, median, and standard deviation.  
Health Related Quality of Life (HRQoL) 

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HRQoL is measured by assessment of a patient’s overall health status using the EORTC QLQ-
C30 and EORTC QLQ-CX24. The postbaseline scores will be summarized for Cohorts 1 and 2, 
and the changes from the baseline scores will be summarized descriptively. 
9.2.3. 
Sensitivity Analysis  
A sensitivity analysis of ORR will be carried out in the Efficacy Evaluable Analysis Set.    
9.3. 
Safety Analyses  
Safety will be assessed by the monitoring and recording of all AEs graded by NCI-CTCAE v5.0. 
Laboratory values (eg, hematology, clinical chemistry, urinalysis), vital signs, ECGs, and 
physical examinations will also be used to assess safety. Descriptive statistics will be used to 
analyze all safety data in the Safety Analysis Set. 
9.3.1. 
Extent of Exposure  
Extent of exposure to each study drug will be summarized descriptively as the number of cycles 
received (number and percentage of patients), duration of exposure (days), cumulative total dose 
received per patient (mg), dose intensity (mg/day), and relative dose intensity. 
The number (percentage) of patients with dose interruption, dose delay, and drug discontinuation 
because of AEs will be summarized for each study drug. Reasons for above dose modifications 
and discontinuation will be summarized as well. 
Patient data listings will be provided for all dosing records. 
9.3.2. 
Adverse Events  
The AE verbatim descriptions (investigator’s description from the eCRF) will be classified into 
standardized medical terminology using MedDRA. AEs will be coded to the MedDRA lowest 
level term closest to the verbatim term, preferred term, and primary system organ class.   
A TEAE is defined as an AE that had an onset date or a worsening in severity from baseline 
(pretreatment) on or after the first dose of study drugs up to 30 days following the last treatment 
of monotherapy/combination therapy or initiation of subsequent anticancer therapy, whichever 
comes first. The TEAE classification also applies to imAEs that are recorded up to 90 days after 
the last dose of the study drugs, regardless of whether the patient starts a subsequent anticancer 
therapy. Only those AEs that were treatment emergent will be included in summary tables. All 
AEs, treatment emergent or otherwise, will be presented in patient data listings.   
The incidence of TEAEs will be reported as the number (percentage) of patients with TEAEs by 
system organ class (SOC) and preferred term (PT). A patient will be counted only once by the 
highest severity grade per NCI-CTCAE v5.0 within an SOC and PT, even if the patient 
experienced > 1 TEAE within a specific SOC and preferred term.  
The number (percentage) of patients with TEAEs will also be summarized by relationship to the 
study drugs. Treatment-related AEs include those events considered by the investigator to be 
related to study drug or with missing assessment of the causal relationship. 
SAEs, deaths, ≥ Grade 3 TEAEs, imAEs, treatment-related TEAEs, and TEAEs that led to 
treatment discontinuation, dose interruption, or dose delay will be summarized. 

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9.3.3. 
Laboratory Analyses  
Clinical laboratory (eg, hematology, clinical chemistry, coagulation, and urinalysis) values will 
be evaluated for each laboratory parameter as appropriate. Abnormal laboratory values will be 
flagged and identified as those outside (above or below) the normal range. Reference (normal) 
ranges for laboratory parameters will be included in the clinical study report for this protocol.  
Descriptive summary statistics (eg, n, mean, standard deviation, median, minimum, and 
maximum for continuous variables; n [%] for categorical variables) for laboratory parameters 
and their changes from baseline will be calculated. Laboratory values will be summarized by 
visit and by worst postbaseline change. 
Laboratory parameters that are graded in NCI-CTCAE v5.0 or newer will be summarized by 
NCI-CTCAE grade. In the summary of laboratory parameters by NCI-CTCAE grade, parameters 
with NCI-CTCAE grading in both high and low directions (eg, calcium, glucose, magnesium, 
potassium, and sodium) will be summarized separately. 
9.3.4. 
Vital Signs   
Descriptive statistics for vital sign parameters (body temperature, pulse rate, respiratory rate, and 
blood pressure [systolic and diastolic]) and weight as well as their changes from baseline will be 
presented by visit. Vital signs will be listed by patient and visit. 
9.4. 
Pharmacokinetic Analyses  
Pharmacokinetic samples will be collected in this study as outlined in Appendix 1. 
Tislelizumab and BGB-A1217 serum concentration data will be tabulated and summarized by 
visit/cycle at which these concentrations are collected. Descriptive statistics will include means, 
medians, ranges, and standard deviations, as appropriate. 
Additional PK analyses, including population PK analyses and exposure-response (efficacy or 
safety endpoints) analyses, may be conducted as appropriate, and the results of such analyses 
may be reported separately from the CSR.    
9.5. 
Immunogenicity Analyses  
Samples to assess anti-BGB-A1217 and anti-tislelizumab antibodies will be collected only in 
patients who receive study drugs and at sites that are able to adequately perform sampling, 
handling, and processing as outlined in the laboratory manual.  
The immunogenicity results will be summarized using descriptive statistics by the number and 
percentage of patients who develop detectable ADAs. The incidence of positive ADAs and 
neutralizing ADAs will be reported for evaluable patients. The effect of immunogenicity on PK, 
efficacy, and safety may be evaluated if data warrants.  
9.6. 
Other Exploratory Analyses  
Summary statistics might be provided for exploratory biomarkers including but not limited to 
expression of PD-L1, TIGIT, CD226, CD155, CD112 in tumor tissues, and tumor mutation 
burden/gene mutation/MSI and gene expression profiling in tumor tissues and/or peripheral 
blood. 

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An exploratory analysis on a potential correlation of these tumor tissue or blood-based 
biomarkers with response, resistance, and prognosis might be performed to understand disease 
pathobiology and explore potential predictive biomarkers. 
QoL is measured by the assessment of the EQ-5D-5L. The postbaseline scores will be 
summarized for Cohorts 1 and 2, as appropriate. 
9.7. 
Sample Size Consideration  
The sample size calculation of Cohort 1 was based on the power of the comparison between 
estimated ORR in the study and the historical rate in a sequential way with patients whose tumor 
with PD-L1 vCPS ≥ 5% followed by patients whose tumor regardless of PD-L1 expression. An 
assumed ORR of 30% in the patients whose tumor with PD-L1 vCPS ≥ 5% as compared to 
historical rate of 15%; an assumed ORR of 25% in the patients whose tumor regardless of PD-L1 
expression as compared to historical rate of 15%.  
• With 76 patients (60% whose tumor with PD-L1 vCPS ≥ 5%), the power is 0.860 to 
demonstrate that the ORR in patients whose tumor with PD-L1 vCPS ≥ 5% is 
statistically higher than the historical rate of 15% using a binomial exact test; the 95% 
CI of an observed 30% ORR is (20.2%, 41.9%). 
• With 89 patients (70% whose tumor with PD-L1 vCPS ≥ 5%), the power is 0.927 to 
demonstrate that the ORR in patients whose tumor with PD-L1 vCPS ≥ 5% is 
statistically higher than the historical rate of 15% using a binomial exact test; the 95% 
CI of an observed 30% ORR is (21.0%, 40.0%). 
• With 102 patients (80% whose tumor with PD-L1 vCPS ≥ 5%), the power is 0.940 to 
demonstrate that the ORR in patients whose tumor with PD-L1 vCPS ≥ 5% is 
statistically higher than the historical rate of 15% using a binomial exact test; the 95% 
CI of an observed 30% ORR is (21.7%, 40.3%). 
• With 127 patients, the power is 0.807 to demonstrate that the ORR in the patient 
population whose tumor regardless of PD-L1 expression is statistically higher than the 
historical rate of 15% using a binomial exact test; the 95% CI of an observed 25% ORR 
is (17.9%, 33.7%). 
The PD-L1 expression will be closely monitored for Cohort 1, and enrollment of patients whose 
tumors are PD-L1 vCPS < 5%/not evaluable will be stopped as necessary when reaching ~40%. 
This is to ensure that the percentage of patients whose tumor with PD-L1 vCPS ≥ 5% is no less 
than 60% of the Safety Analysis Set.  
In addition, 40 patients will be enrolled in Cohort 2 to investigate the safety and efficacy of 
tislelizumab monotherapy in patients with previously treated recurrent or metastatic cervical 
cancer. 
 

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10. 
STUDY COMMITTEES  
10.1. 
Independent Review Committee  
An Independent Review Committee (IRC) will be established to perform an independent review 
of all radiological images for the efficacy analysis and to determine all instances of response and 
disease progression based on RECIST v1.1 criteria, in addition to the local investigator review of 
radiographs. The results from the investigator’s review of radiographic images will be used to 
determine whether patients should be enrolled or should continue study treatment. The tumor 
assessment by the IRC will be used for the reporting of the study results.   
All decisions made during the performance of the study will be based on the local investigator’s 
assessments of radiographic images, clinical status, and relevant examination of the patients. 
Sites will submit specific radiographic image files to the centralized data review facility during 
the study at an ongoing basis or at the sponsor’s request. Detailed rules and guidelines for 
radiographic imaging and tumor assessments by the IRC are outlined separately in the Imaging 
Manual and the IRC Charter.   

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11. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE 
DATA/DOCUMENTS  
The investigator must maintain adequate and accurate records to ensure that the conduct of the 
study may be fully documented. Such records include but are not limited to the protocol, 
protocol amendments, ICFs, and documentation of IRB/IEC and governmental approvals. In 
addition, at the end of the study, the investigator will receive patient data, which will include an 
audit trail containing a complete record of all changes to such data. 
11.1. 
Access to Information for Monitoring  
In accordance with International Council for Harmonisation GCP guidelines, the study monitor 
must have direct access to the investigator’s source documentation to verify the data recorded in 
the eCRFs for consistency. 
The monitor is responsible for routine review of the eCRFs at regular intervals throughout the 
study to verify adherence to the protocol and the completeness, consistency, and accuracy of the 
data being entered on them. The monitor should have access to any patient records needed to 
verify the entries on the eCRFs. The investigator agrees to cooperate with the monitor to ensure 
that any problems detected during these monitoring visits are resolved. 
11.2. 
Access to Information for Auditing or Inspections  
Representatives of regulatory authorities or of the sponsor may conduct inspections or audits any 
time during or after completion of this clinical study. If the investigator is notified of an 
inspection by a regulatory authority, the investigator agrees to notify the sponsor or its designee 
immediately. The investigator agrees to provide to representatives of a regulatory agency or the 
sponsor access to records, facilities, and personnel for the effective conduct of any inspection or 
audit. 

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12. 
QUALITY ASSURANCE AND QUALITY CONTROL  
12.1. 
Regulatory Authority Approval  
The sponsor will obtain approval to conduct the study from the appropriate regulatory agency in 
accordance with any applicable country-specific regulatory requirements or file the protocol to 
the appropriate regulatory agency before the study is initiated at a study center in that country. 
12.2. 
Quality Assurance  
To ensure compliance with GCP and all applicable regulatory requirements, the sponsor may 
conduct a quality assurance audit. Regulatory agencies may also conduct a regulatory inspection 
of this study. Such audits/inspections can occur at any time during or after completion of the 
study. If an audit or inspection occurs, the investigator and institution agree to allow the 
auditor/inspector direct access to all relevant documents and to allocate his/her time and the time 
of his/her personnel to the auditor/inspector to discuss findings and any relevant issues. 
12.3. 
Study Site Inspections  
This study will be organized, performed, and reported in compliance with the protocol, standard 
operating procedures, working practice documents, and applicable regulations and guidelines.  
Site audits may be performed periodically by the sponsor’s or the contract research 
organization’s qualified compliance auditing team, which is an independent function from the 
study team responsible for conduct of the study. 
Site visits will be conducted by the sponsor or an authorized representative to inspect study data, 
patients’ medical records, and eCRFs. The investigator is to permit national and local health 
authorities; sponsor study monitors, representatives, and collaborators; and IRB/IEC members to 
inspect all facilities and records relevant to this study. 
12.4. 
Drug Accountability  
The investigator or designee (ie, pharmacist) is responsible for ensuring adequate accountability 
of all used and unused study drugs. This includes acknowledgment of receipt of each shipment of 
study drugs (quantity and condition), patient drug dispensation records, and returned or 
destroyed study drugs. Dispensation records will document quantities received from the 
sponsor’s designated depot or its designee and quantities dispensed to patients, including 
batch/lot number, date dispensed, patient identifier number, and the initials of the person 
dispensing the medication. 
At study initiation, the monitor will evaluate the site’s standard operating procedure for study 
drug disposal/destruction to ensure that it complies with the sponsor requirements specified in 
the Pharmacy Manual. At appropriate times during the conduct of the study or at the end of the 
study following final drug inventory reconciliation by the monitor, the study site will dispose of 
and/or destroy all unused study drug supplies, including empty containers, according to these 
procedures. If the site cannot meet the sponsor’s requirements specified in the Pharmacy Manual 
for disposal, arrangements will be made between the site and the sponsor or its representative for 
destruction or return of unused study drug supplies. 

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All drug supplies and associated documentation will be periodically reviewed and verified by the 
study monitor over the course of the study. 

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13. 
ETHICS/PROTECTION OF HUMAN PATIENTS  
13.1. 
Ethical Standard  
This study will be conducted by the principal investigator and the study center in full 
conformance with the International Council for Harmonisation E6 guideline for GCP and the 
principles of the Declaration of Helsinki or the laws and regulations of the country in which the 
research is conducted, whichever affords the greater protection to the individual. The study will 
also comply with the requirements of the International Council for Harmonisation E2A guideline 
(Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 
13.2. 
Institutional Review Board/Independent Ethics Committee  
This protocol, the ICFs, any information to be given to the patient, and relevant supporting 
information must be submitted, reviewed, and approved by the IRB/IEC before the study is 
initiated. In addition, any patient recruitment materials must be approved by the IRB/IEC.  
Copies of the IRB/IEC correspondence and approval of the amended ICF/other information and 
the approved amended ICF/other information must be forwarded to the sponsor promptly. 
The principal investigator is responsible for providing written summaries of the status of the 
study to the IRB/IEC annually or more frequently in accordance with the requirements, policies, 
and procedures established by the IRB/IEC. Investigators are also responsible for promptly 
informing the IRB/IEC of any protocol amendments. In addition to the requirements for 
reporting all AEs to the sponsor, investigators must comply with requirements for reporting 
SAEs to the local health authority and IRB/IEC. Investigators may receive written 
Investigational New Drug Safety Reports or other safety-related communications from the 
sponsor. Investigators are responsible for ensuring that such reports are reviewed and processed 
in accordance with health authority requirements and the policies and procedures established by 
their IRB/IEC and archived in the site’s study file. 
13.2.1. 
Protocol Amendments  
Any protocol amendments will be prepared by the sponsor. All protocol modifications must be 
submitted to competent authorities according to local requirements and to the IRB/IEC together 
with, if applicable, a revised model ICF in accordance with local requirements. Written 
documentation from competent authorities (according to local requirements) and from the 
IRB/IEC and required site approval must be obtained by the sponsor before changes can be 
implemented, except for changes necessary to eliminate an immediate hazard to patients or 
changes that involve logistical or administrative aspects only (eg, change in medical monitor or 
contact information). 
Information on any change in risk and/or change in scope must be provided to patients already 
actively participating in the study, and they must read, understand, and sign each revised ICF 
confirming their willingness to remain in the study. 

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13.3. 
Informed Consent  
The sponsor’s sample ICF will be provided to each site. If applicable, it will be provided in a 
certified translation of the local language. The final IRB/IEC-approved ICFs must be provided to 
the sponsor for health authority submission purposes according to local requirements. 
The ICFs must be signed and dated by the patient or the patient’s legally authorized 
representative before his or her participation in the study. The case history or clinical records for 
each patient shall document the informed consent process and that written informed consent was 
obtained before participation in the study. 
The ICFs will be revised whenever there are changes to study procedures or when new 
information becomes available that may affect the willingness of the patient to participate. The 
final revised IRB/IEC-approved consent forms must be provided to the sponsor for health 
authority submission purposes. 
Patients must be reconsented to the most current version of the ICFs (or to a significant new 
information/findings addendum in accordance with applicable laws and IRB/IEC policy) during 
their participation in the study. For any updated or revised ICFs, the case history or clinical 
records for each patient shall document the informed consent process and that written informed 
consent was obtained using the updated/revised ICFs for continued participation in the study. 
A copy of each signed ICF must be provided to the patient or the patient’s legally authorized 
representative. All signed and dated ICFs must remain in each patient’s study file or in the site 
file and must be available for verification by study monitors at any time. 
13.4. 
Patient and Data Confidentiality  
The principal investigator and sponsor will maintain confidentiality and privacy standards by 
following applicable data privacy laws covering the collection, storage, transmission, and 
processing of patients’ personal and medical information. 
The principal investigator shall code the medical information obtained during the study with a 
unique patient identification number assigned to each patient enrolled in the study. This approach 
ensures that patients’ names are not included in any data set transmitted to any sponsor location. 
Patient medical information obtained during this study is confidential and may only be disclosed 
to third parties as permitted by the signed ICF (or a separate authorization for the use and 
disclosure of personal health information that has been signed by the patient), unless permitted or 
required by law. 
In the event of a breach of the confidentiality of a patient’s personal and medical information, the 
principal investigator and sponsor, as appropriate, shall fulfill all mediation steps and reporting 
obligations under applicable data privacy laws. 
Medical information may be given to a patient’s personal physician or other appropriate medical 
personnel responsible for the patient’s welfare for treatment purposes. 
Data generated during this study must be available for inspection upon request by representatives 
of the National Medical Products Administration and all other national and local health 
authorities; by sponsor monitors, representatives, and collaborators; and by the IRBs/IECs for 
each study site, as appropriate. 

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The investigator must assure that patients’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. The investigator agrees that all information 
received from the sponsor, including but not limited to Tislelizumab Investigator’s Brochure, 
BGB-A1217 Investigator’s Brochure, this protocol, eCRFs, the Investigational New Drug, and 
any other study information, remain the sole and exclusive property of the sponsor during the 
conduct of the study and thereafter. This information is not to be disclosed to any third party 
(except employees or agents directly involved in the conduct of the study or as required by law) 
without prior written consent from the sponsor. The investigator further agrees to take all 
reasonable precautions to prevent the disclosure by any employee or agent of the study site to 
any third party or otherwise into the public domain.  
If a written contract for the conduct of the study that includes confidentiality provisions 
inconsistent with this section is executed, that contract’s provisions shall apply to the extent they 
are inconsistent with this section. 
13.5. 
Financial Disclosure  
Investigators are required to provide the sponsor with sufficient accurate financial information in 
accordance with regulations to allow the sponsor to submit complete disclosure or certification to 
the absence of certain financial interest of clinical investigators and/or disclose those financial 
interests, as required, to the appropriate health authorities. This is intended to ensure financial 
interests and arrangements of clinical investigators with BeiGene that could affect reliability of 
data submitted to health authorities are identified and disclosed by the sponsor. Investigators are 
responsible for providing information about their financial interests before participation in the 
study and to update this information if any relevant changes occur during the study and for 
1 year after completion of the study (ie, last patient, last visit). 
 

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14. 
DATA HANDLING AND RECORD KEEPING  
14.1. 
Data Collection and Management Responsibilities  
14.1.1. 
Data Entry in the Electronic Case Report Form  
All study-related data collected or received by the investigator or study team shall be promptly 
entered into the eCRFs. In no event should the entry of the study data into the eCRF be later than 
what is stipulated in the site contract after the data is collected or received by the investigator or 
study team without prior communication with and approval by the sponsor. 
14.1.2. 
Data Collection  
Data required by the protocol will be entered into an electronic data capture (EDC) system. 
Data collection in the eCRF should follow the instructions described in the eCRF Completion 
Guidelines. The investigator has ultimate responsibility for the collection and reporting of all 
clinical data entered in the eCRF. The investigator or designee must sign the completed 
casebooks to attest to their accuracy, authenticity, and completeness. 
Data contained in the eCRFs are the sole property of the sponsor and should not be made 
available in any form to third parties without written permission from the sponsor, except for 
authorized representatives of the sponsor or appropriate regulatory authorities. 
14.1.3. 
Data Management/Coding  
All final patient data, both eCRF and external data (eg, laboratory data), collected according to 
the protocol, will be stored by the sponsor at the end of the study. 
Standard procedures (including following data review guidelines, computerized validation to 
produce queries, and maintenance of an audit file that includes all database modifications) will 
be followed to support accurate data collection. Data will be reviewed for outliers, logic, data 
inconsistencies, and completeness. 
During the course of the study, a study monitor will make site visits to review protocol 
compliance, compare eCRFs against individual patient’s medical records, and ensure that the 
study is being conducted according to pertinent regulatory requirements. 
The eCRF entries will be verified with source documentation. The review of medical records 
will be performed in a manner to ensure that patient confidentiality is maintained. Checking the 
eCRFs for completeness, clarity, and cross-checking with source documents is required to 
monitor the progress of the study. Direct access to source data is also required for inspections 
and audits and will be carried out giving due consideration to data protection and medical 
confidentiality. 
The AE verbatim descriptions (the investigator’s description from the eCRF) will be coded using 
MedDRA. AEs will be coded to MedDRA by lowest level term, preferred term, and primary 
SOC. Concomitant medications will be coded using the WHO Drug Dictionary. Concomitant 
diseases/medical history will be coded using MedDRA.  

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14.2. 
Data Integrity and In-house Blinding  
Due to the open-label design of the study, access to the patient-level clinical data in the EDC 
system will be assigned to predefined study personnel only. Functions/persons with access to the 
EDC system shall be prohibited from using the EDC system to generate unnecessary 
listings/summaries that may introduce unwanted bias or to share such outputs from the EDC 
system with other functions/persons who do not have access to the EDC. In addition, the central 
imaging vendor will perform the central imaging review without knowledge of treatment arm 
assignment. Although the study is open label, analyses or summaries generated by randomized 
treatment assignment and actual treatment received will be limited and documented.   
14.3. 
Study Records Retention  
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least 1 of the following 2 categories: 1) investigator’s study file and 
2) patient clinical source documents. 
The investigator’s study file will contain the protocol/amendments, eCRF and query forms, 
IRB/IEC and governmental approval with correspondence, ICFs, drug records, staff curriculum 
vitae and authorization forms, and other appropriate documents and correspondence. 
Patient clinical source documents (usually defined by the project in advance to record key 
efficacy/safety parameters independent of the eCRFs) would include but not be limited to 
documents such as the following: patient hospital/clinic records, physician’s and nurse’s notes, 
appointment book, original laboratory reports, ECG, electroencephalogram, x-ray, pathology and 
special assessment reports, consultant letters, and screening and enrollment log, etc. 
Following closure of the study, the investigator must maintain all study records in a safe and 
secure location. The records must be maintained to allow easy and timely retrieval when needed 
(eg, audit or inspection) and, whenever feasible, to allow any subsequent review of data in 
conjunction with assessment of the facility, supporting systems, and personnel. Where permitted 
by local laws/regulations or institutional policy, some or all of these records can be maintained in 
a format other than hard copy (eg, microfiche, scanned, electronic); however, caution needs to be 
exercised before such action is taken. The investigator must assure that all reproductions are 
legible, are a true and accurate copy of the original, and meet accessibility and retrieval 
standards, including regenerating a hard copy, if required. Furthermore, the investigator must 
ensure there is an acceptable backup of these reproductions and that an acceptable quality control 
process exists for making these reproductions. 
The sponsor will inform the investigator of the time period for retaining these records to comply 
with all applicable regulatory requirements. The minimum retention time will meet the strictest 
standard applicable to that study center for the study, as dictated by any institutional 
requirements or local laws or regulations, or the sponsor’s standards/procedures; otherwise, the 
retention period will default to 15 years. 
The investigator must notify the sponsor of any changes in the archival arrangements including 
but not limited to the following: archival at an off-site facility or transfer of ownership of or 
responsibility for the records in the event the investigator leaves the study center. 

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If the investigator cannot guarantee this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and the sponsor to 
store these in sealed containers outside of the site so that they can be returned sealed to the 
investigator in case of a regulatory audit. When source documents are required for the continued 
care of the patient, appropriate copies should be made for storage outside of the site. 
Biological samples at the conclusion of this study may be retained as outlined in the agreement 
with the contract research organization managing the biological samples, for the shorter of either 
a period of up to 10 years or as allowed by the IRB/IEC. 
14.4. 
Protocol Deviations  
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol. Investigators assert they will apply due 
diligence to avoid protocol deviations and shall report all protocol deviations to the sponsor. 
The investigator is to document and explain any deviations from the approved protocol. The 
investigator must promptly report any important deviations that might impact patient safety 
and/or data integrity to the sponsor and to the IRB/IEC, in accordance with established IRB/IEC 
policies and procedures. 
14.5. 
Study Report and Publications  
A clinical study report will be prepared and provided to the regulatory agency(ies). The sponsor 
will ensure that the report meets the standards set out in the International Council for 
Harmonisation Guideline for Structure and Content of Clinical Study Reports (ICH E3). An 
abbreviated report may be prepared in certain cases. 
The results of this study will be published or presented at scientific meetings in a timely, 
objective, and clinically meaningful manner that is consistent with good science, industry and 
regulatory guidance, and the need to protect the intellectual property of the sponsor, regardless of 
the outcome of the study. The data generated in this clinical study are the exclusive property of 
the sponsor and are confidential. For a multicenter study, the first publication or disclosure of 
study results shall be a complete, joint multicenter publication, or disclosure coordinated by the 
sponsor. Thereafter, any secondary publications will reference the original publication(s).  
Authorship will be determined by mutual agreement and all authors must meet the criteria for 
authorship established by the International Committee of Medical Journal Editors or stricter local 
criteria (International Committee of Medical Journal Editors 2019). 
Each investigator agrees to submit all manuscripts, abstracts, posters, publications, and 
presentations (both oral and written) to the sponsor for review before submission or presentation 
in accordance with the clinical study agreement. This allows the sponsors to protect proprietary 
information, provide comments based on information from other studies that may not yet be 
available to the investigator, and ensure scientific and clinical accuracy. Each investigator agrees 
that, in accordance with the terms of clinical study agreement, a further delay of the 
publication/presentation may be requested by the sponsor to allow for patent filings and/or 
protection in advance of the publication/presentation. 

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14.6. 
Study and Study Center Closure  
Upon completion of the study, the monitor will conduct the following activities in conjunction 
with the investigator or study center personnel, as appropriate: 
• Return of all study data to the sponsor 
• Resolution and closure of all data queries 
• Accountability, reconciliation, and arrangements for unused study drugs 
• Review of study records for completeness 
• Collection of all study documents for the trial master file filing according to GCP and 
local regulation 
• Shipment of samples (including but not limited to those for PK, ADA, and biomarkers) 
to the assay laboratory for central laboratory analysis according to protocol and 
laboratory manual requirements 
In addition, the sponsor reserves the right to suspend the enrollment or prematurely discontinue 
this study either at a single study center or at all study centers at any time for any reason. 
Potential reasons for suspension or discontinuation include but are not limited to: safety or 
ethical issues or noncompliance with this protocol, GCP, the sponsor’s written instructions, the 
clinical study agreement, or applicable laws and regulations. If the sponsor determines such 
action is needed, the sponsor will discuss this with the investigator (including the reasons for 
taking such action) at that time. When feasible, the sponsor will provide advance notification to 
the investigator of the impending action before it takes effect. 
The sponsor will promptly inform all other investigators and/or institutions conducting the study 
if the study is suspended or terminated for safety reasons and will also inform the regulatory 
authorities of the suspension or termination of the study and the reason(s) for the action. If 
required by applicable regulations, the investigator must inform the IEC/IRB promptly and 
provide the reason for the suspension or termination. 
If the study is prematurely discontinued, all study data must still be provided to the sponsor. In 
addition, arrangements will be made for the return of all unused study drugs in accordance with 
the applicable sponsor procedures for the study. 
Financial compensation to investigators and/or institutions will be in accordance with the clinical 
study agreement established between the investigator and/or institutions and the sponsor. 
14.7. 
Information Disclosure and Inventions  
All rights, title, and interests in any inventions, expertise, or other intellectual or industrial 
property rights that are conceived or reduced to practice by the study center personnel during the 
course of or as a result of the study are the sole property of the sponsor and are hereby assigned 
to the sponsor. 
If a written contract for the conduct of the study, which includes ownership provisions 
inconsistent with this statement, is executed between the sponsor and the study center, that 
contract’s ownership provisions shall apply rather than this statement. 

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All information provided by the sponsor and all data and information generated by the study 
center as part of the study (other than a patient’s medical records) are the sole property of the 
sponsor and will be kept confidential by the investigator and other study center personnel.   
This information and data will not be used by the investigator or other study center personnel for 
any purpose other than conducting the study without the prior written consent of the sponsor. 
These restrictions do not apply to: 
• Information that becomes publicly available through no fault of the investigator or 
study center personnel 
• Information that is necessary to disclose in confidence to an IEC/IRB solely for the 
evaluation of the study 
• Information that is necessary to disclose to provide appropriate medical care to a patient 
• Study results that may be published as described in Section 14.5 
If a written contract for the conduct of the study, which includes provisions inconsistent with this 
statement is executed, that contract’s provisions shall apply rather than this statement. 

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Haanen J, Carbonnel F, Robert C, et al. Management of toxicities from immunotherapy: ESMO 
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Li M, Xia P, Du Y, et al. T-cell immunoglobulin and ITIM domain (TIGIT) receptor/poliovirus 
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versus placebo plus atezo as first-line (1L) treatment in patients with PD-L1-selected NSCLC 
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16. 
APPENDICES  
 

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Patients will be randomized into either Cohort 1 or Cohort 2 via IRT in Stage 1. After the Stage 1 enrollment completes, patients in Cohort 1 will continue to participate in Stage 2 receiving the same 
treatment as in Stage 1. An additional approximately 87 patients will be enrolled in Cohort 1 Stage 2. All patients are required to receive study treatment within 2 business days of randomization. 
Includes age or date of birth, gender, and self-reported race/ethnicity; history of treatment for the primary diagnosis, including prior medication, loco-regional treatment(s), and surgical treatment(s). 
Information on radiographic studies performed before study entry may be collected for review by the investigator. 
Vital signs collected on study include temperature, pulse rate, respiratory rate, and blood pressure. The patient’s vital signs are required to be recorded within 60 minutes before, during, and 
approximately 30 minutes after the first 2 cycles of study drugs. For subsequent cycles, vital signs will be collected within 60 minutes before infusion and if clinically indicated, during, and 30 
minutes after the infusion. Height should only be measured and recorded during screening. Weight will be measured before study drug administration in every cycle. 
During the Screening Visit, a complete physical examination (as detailed in Section 7.4.2) will be conducted. At subsequent visits (and as clinically indicated), limited, symptom-directed physical 
examinations will be performed.  
The ECG recordings will be obtained during screening, EOT Visit, on-site Safety Follow-up Visit, and as clinically indicated at other timepoints. When coinciding with blood draws, ECG assessment 
should be performed before blood draws. Patients should be resting in semirecumbent supine position for ≥ 10 minutes in the absence of environmental distractions before each ECG 
measurement. 
The AEs and laboratory abnormalities will be graded per NCI-CTCAE v5.0. All AEs will also be evaluated for seriousness. After the informed consent form has been signed, but before the 
administration of study drug, only SAEs should be reported. After the first dose of study drug, all AEs and SAEs, regardless of their assessed relationship to study drug, are to be reported until 
either 30 days after the last dose of study drugs, the initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first. In addition, telephone contacts 
with patients should be conducted to assess immune-mediated AEs and concomitant medications (if appropriate, ie, associated with an immune-mediated AE or is a new anticancer therapy) at 60 
days, and 90 days (± 14 days) after the last dose of study treatment, regardless of whether the patient starts a new anticancer therapy. Immune-mediated AEs (serious or nonserious) will be 
reported until 90 days after the last dose of study drugs, regardless of whether the patient starts a new anticancer therapy, death, withdrawal of consent, or loss to follow-up. The investigator 
should report any SAEs that are assessed as related to tislelizumab/BGB-A1217 treatment, at any time after treatment discontinuation. 
Laboratory assessments on serum chemistry, hematology, coagulation, total CK and CK-MB, and urinalysis will be conducted, of which certain elements will be collected as specified in Section 7.4.4. If 
laboratory tests at screening are not performed within 7 days before the first dose of study drugs, these tests should be repeated and reviewed before randomization. After Cycle 1, these laboratory 
tests are to be performed and reviewed within 48 hours before study drug administration. Urinalysis is to be conducted during the treatment period only if clinically warranted. Refer to Section 
8.3.5 for additional information regarding clinical assessment and management of clinical laboratory abnormalities.  
Serum CK and CK-MB testing is included in total CK and CK-MB assessment, which will be implemented for all patients at screening, predose at Day 1 of every scheduled cycles, at EOT Visit, and at 
the on-site Safety Follow-up Visit. In the event that CK-MB fractionation is not available, serum troponins (troponin I and/or T) measurements will be performed instead. 
Includes international normalized ratio, prothrombin time, and activated partial thromboplastin time. 
Urine or serum pregnancy test would be conducted during screening and whenever clinically indicated only for women of childbearing potential, including 
women who have had a tubal ligation (see Appendix 5 for related definition). When indicated, the test must be performed and documented as negative 
within 7 days before the first dose of study drugs. A serum pregnancy test must be performed if the urine pregnancy test is positive or equivocal. 
Analysis of free T3, free T4, and TSH will be performed by a central laboratory or the local study site laboratory. Thyroid function tests will be performed at screening and every 3 cycles (ie, Cycles 4, 
7, 10, etc), EOT Visit, and Safety Follow-up Visit. For sites where free T3 or free T4 test is not available, alternative tests can be considered by communication with medical monitor. 
Testing will be performed by a central laboratory and/or the local laboratory at screening and will include HBV/HCV serology (HBsAg, HBsAb, HBcAb, and HCV antibody) and viral load assessment 
(HBV DNA and HCV RNA). Patients who have detectable HBV DNA or HCV RNA at screening will perform the respective viral load test every 4 cycles (ie, Day 1 of Cycle 5, 9, 13, etc) from 
Cycle 5 onwards. 
Pulmonary function testing includes spirometry and assessment of oxygenation, at a minimum pulse oximetry at rest and with exercise, or alternatively, assessment of diffusion capacity. Patients who 
are suspected of having serious/severe respiratory conditions, or who exhibit significant respiratory symptoms unrelated to the underlying cancer, or with a history of thoracic radiotherapy should 
be evaluated for the suitability on the study at screening. Tests may be repeated as clinically indicated while on study. Respective test results need to be submitted to the sponsor.  
PK samples will be collected in all patients who received ≥ 1 dose of any component of study drug per the protocol and whose postdose PK data are available. For both tislelizumab and/or BGB-A1217, 
predose (within 60 minutes before starting infusion) samples are required to be collected at Day 1 of Cycles 1, 2, 5, 9, and 17. A postdose (within 30 minutes after completing tislelizumab and 
BGB-A1217 combination treatment or tislelizumab monotherapy) sample is required to be collected on Day 1 of Cycles 1 and 5. An additional PK sample is required to be collected at the Safety 
Follow-up Visit for both drugs. Should a patient present with any ≥ Grade 3 imAE, an additional blood PK sample may be taken to determine the serum concentration of tislelizumab and/or BGB-
A1217. These tests are required when it is allowed by local regulations/IRBs/IECs.  
ADA samples will be collected only in sites that are able to adequately perform ADA sampling and handling in all patients. Blood used to test for anti-tislelizumab and anti-BGB-A1217 antibodies 
should be collected within 60 minutes before beginning the Day 1 infusion of Cycles 1, 2, 5, 9 and 17, and at Safety Follow-up Visit. All samples should be drawn at the same time as blood 
collection for predose PK analysis. These tests are required when it is allowed by local regulations/IRBs/IECs. 
Radiological images captured as standard of care before obtaining written informed consent and ≤ 28 days before the first dose of study drugs may be used rather than repeating tests. All measurable and 
evaluable lesions are required to be assessed and documented at the Screening Visit and reassessed at each subsequent tumor evaluation. The same radiographic procedure used to assess disease 
sites at Screening is required to be used throughout the study (eg, the same imaging protocol for CT or MRI). CT/MRI of the head at baseline is required for patients who are suspected to have 
central nervous system metastases; bone scan or PET is required if clinically indicated.  

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Patients will undergo tumor assessments approximately every 6 weeks (± 7 days) for the first 54 weeks and every 12 weeks (± 7 days) thereafter (based on RECIST v1.1 assessment). Tumor 
assessments must be performed on schedule regardless of whether study treatment has been administered or withheld. That is, they should not be adjusted for delays in cycles. Patients who 
discontinue study treatment early for reasons other than disease progression (eg, toxicity) will continue to undergo tumor assessments following the original plan until the patient begins a 
subsequent anticancer treatment, experiences disease progression per RECISTv1.1 by IRC, withdraws consent, is lost to follow-up, death, or until the study terminates, whichever occurs first. See 
also Section 7.5. 
Patients are required to provide archival tumor tissues (FFPE blocks or approximately 15 [≥ 6] unstained slides) for biomarker analysis. Fresh biopsy: In the absence of sufficient archival tumor tissues, 
a fresh biopsy of a tumor lesion at baseline is mandatory. See Section 7.7 for more information. Patients who have PD will be asked to provide an optional biopsy for the assessment of mechanism 
of resistance (written informed consent is required before fresh tumor biopsy).  
Blood samples will be taken optionally at baseline (predose, on Cycle 1 Day 1), at the time of first tumor response (predose of Day1 of the following cycle) and at the time of confirmed PD (10 mL each 
timepoint) for all patients to explore the association with response, resistance and prognosis to tislelizumab in combination with BGB-A1217 or tislelizumab alone. Written patient consent is 
required for blood sample collection.  
Tislelizumab will be given IV Q3W for patients in Cohort 1 and Cohort 2. The initial infusion (Cycle 1 and Cycle 2, Day 1) will be delivered over 60 minutes, and then can be administered over 30 
minutes for subsequent infusions if well tolerated. Patients must be monitored for ≥ 2 hours after infusion of tislelizumab combined with BGB-A1217 (Cohort 1) and for ≥ 1 hour after infusion of 
tislelizumab monotherapy (Cohort 2) on Day 1 of Cycle 1 and Cycle 2; from Cycle 3 onward, a monitoring period of ≥ 30 minutes is required. Treatment could continue beyond progression if 
clinical benefit is seen and treatment is tolerated per the investigator’s discretion. Patients should sign an informed consent form for continued treatment beyond progression per RECIST v1.1.   
BGB-A1217 will be given to patients in Cohort 1. The initial infusion (Cycle 1 and Cycle 2, Day 1) will be delivered over 60 minutes, and then can be administered over 30 minutes for subsequent 
infusions if well tolerated. Patients must be monitored for ≥ 2 hour after infusion of tislelizumab combined with BGB-A1217 on Day 1 of Cycle 1 and Cycle 2; from Cycle 3 onward, a monitoring 
period of ≥ 30 minutes is required. Treatment could continue beyond progression if clinical benefit is seen and treatment is tolerated per the investigator’s discretion. Patients should sign an 
informed consent form for continued treatment beyond progression per RECIST v1.1. 
To be completed before any clinical activities during on-study site study visits. The questionnaires will be completed at Cycle 1 (baseline), at every other cycle (i.e., Cycle 1, Cycle 3, Cycle 5, Cycle 7) 
in the first 54 weeks and then every 4 cycles thereafter, and at Safety Follow-up Visit. 
Review of AEs and concomitant medications may be conducted by telephone on Day 8 and Day 15. 
 
 
 
 

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APPENDIX 2. CLINICAL LABORATORY ASSESSMENTS  
Serum Chemistry 
Hematology 
Coagulation 
Urinalysis (screening 
and as clinically 
indicated) 
Alkaline phosphatase 
Red blood cell count 
Prothrombin time 
pH 
Alanine aminotransferase 
Hematocrit 
Partial thromboplastin 
time or activated partial 
thromboplastin time 
Specific gravity 
Aspartate aminotransferase 
Hemoglobin 
International 
normalized ratio 
Glucose 
Albumin 
Monocyte count 
 
Protein 
Total bilirubin 
Basophil count 
 
Ketones 
Direct bilirubin 
Eosinophil count 
 
Blood 
Blood urea nitrogen or urea 
Platelet counts 
 
24-hour proteina 
Potassium 
White blood cell count with 
differential 
 
 
Sodium 
Neutrophil count 
 
 
Calcium 
Lymphocyte count  
 
 
Phosphorus 
 
 
 
Magnesium  
 
 
 
Chloride 
 
 
 
Creatinine 
 
 
 
Glucose 
 
 
 
Lactate dehydrogenase 
 
 
 
Total protein 
 
 
 
Creatine 
kinase/ 
CK-MBb 
 
 
 
Abbreviations: CK-MB, creatine kinase-muscle/brain. 
a.   On routine urinalysis, if urine protein is ≥ 2+ by dipstick then obtain a 24-hour urine sample for total protein or a 
random urine sample for total protein and creatinine to determine a protein-to-creatinine ratio. 
b. Cardiac enzyme testing has been added to monitor for potential event of immune-mediated myocarditis. In the 
event that CK-MB fractionation is not available, assess troponin I and/or troponin T instead. Investigators should 
make every effort to perform either CK-MB, troponin I and/or troponin T consistently at screening and at 
follow-up visits. 
 

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APPENDIX 3. ECOG PERFORMANCE STATUS  
Grade 
Description 
0 
Fully active, able to carry on all predisease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature, eg, light housework, office work 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and 
about more than 50% of waking hours 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 
5 
Dead 
Source: Oken et al 1982.  Eastern Cooperative Oncology Group, Robert Comis MD, Group Chair. 

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APPENDIX 4. PREEXISTING IMMUNE DEFICIENCIES OR 
AUTOIMMUNE DISEASES  
Prospective patients should be carefully questioned to determine whether they have any history 
of an acquired or congenital immune deficiency or autoimmune disease. 
Contact the medical monitor regarding any uncertainty about immune deficiency/autoimmune 
disease exclusions. 
Acute disseminated encephalomyelitis 
Addison disease 
Ankylosing spondylitis 
Antiphospholipid antibody syndrome 
Aplastic anemia 
Autoimmune hemolytic anemia 
Autoimmune hepatitis 
Autoimmune hypoparathyroidism 
Autoimmune hypophysitis 
Autoimmune myocarditis 
Autoimmune oophoritis 
Autoimmune orchitis 
Autoimmune thrombocytopenic purpura 
Behcet disease 
Bullous pemphigoid 
Chronic inflammatory demyelinating polyneuropathy 
Chung-Strauss syndrome 
Crohn disease 
Dermatomyositis 
Dysautonomia  
Epidermolysis bullosa acquisita  
Gestational pemphigoid  
Giant cell arteritis  
Goodpasture syndrome  
Granulomatosis with polyangiitis  
Graves disease  
Guillain-Barré syndrome 
Hashimoto disease 
Immunoglobulin A (IgA) neuropathy 
Inflammatory bowel disease  
Interstitial cystitis  
Kawasaki disease  
Lambert-Eaton myasthenia syndrome  
Lupus erythematosus  
Lyme disease (chronic) 
Mooren ulcer  
Morphea  
Multiple sclerosis  
Myasthenia gravis 
Neuromyotonia  
Opsoclonus myoclonus syndrome  
Optic neuritis  
Ord thyroiditis  
Pemphigus  
Pernicious anemia  
Polyarteritis nodosa  
Polyarthritis  
Polyglandular autoimmune syndrome  
Primary biliary cirrhosis  
Psoriasis  
Reiter syndrome  
Rheumatoid arthritis  
Sarcoidosis  
Sjögren syndrome  
Stiff person syndrome 
Takayasu arteritis 
Ulcerative colitis 
Vogt-Koyanagi-Harada disease 

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APPENDIX 5. CONTRACEPTION GUIDELINES AND DEFINITIONS 
OF “WOMEN OF CHILDBEARING POTENTIAL,” 
“NO CHILDBEARING POTENTIAL”  
Contraception Guidelines 
The Clinical Trials Facilitation Group’s recommendations related to contraception and 
pregnancy testing in clinical trials include the use of highly effective forms of birth control. 
(Clinical Trials Facilitation Group 2014) These methods include the following: 
• Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with the inhibition of ovulation (oral, intravaginal, or transdermal) 
• Progestogen-only hormonal contraception associated with the inhibition of ovulation: 
− oral 
− injectable 
− implantable  
• Intrauterine device 
• Intrauterine hormone-releasing system 
• Bilateral tubal occlusion 
• Vasectomized male partner, provided that the vasectomized partner is the sole sexual 
partner of the woman of childbearing potential study participant and that the 
vasectomized partner has received medical assessment of surgical success 
• Sexual abstinence (defined as refraining from heterosexual intercourse during the entire 
period of exposure associated with the study treatment). 
NOTE: Total sexual abstinence should only be used as a contraceptive method if it is in 
line with the patient’s usual and preferred lifestyle. 
Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods), 
declaration of abstinence for the duration of exposure to study drugs, and withdrawal are 
not acceptable methods of contraception. 
Of note, barrier contraception (including male and female condoms with or without spermicide) 
is not considered a highly effective method of contraception and if used, this method must be 
combined with another acceptable method listed above. 
Definitions of “Women of Childbearing Potential,” “Women of No Childbearing Potential” 
As defined in this protocol, “women of childbearing potential” are female patients who are 
physiologically capable of becoming pregnant. 
Conversely, “women of no childbearing potential” are defined as female patients meeting any of 
the following criteria: 

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• Surgically sterile (ie, through bilateral salpingectomy, bilateral oophorectomy, or 
hysterectomy) 
• Postmenopausal, defined as: 
− ≥ 55 years of age with no spontaneous menses for ≥ 12 months OR 
− < 55 years of age with no spontaneous menses for ≥ 12 months AND with a 
postmenopausal follicle-stimulating hormone (FSH) concentration > 30 IU/mL 
and all alternative medical causes for the lack of spontaneous menses for 
≥ 12 months have been ruled out, such as polycystic ovarian syndromes, 
hyperprolactinemia, etc. 
If an FSH measurement is required to confirm postmenopausal state, concomitant use of 
hormonal contraception or hormonal replacement therapy should be excluded.  
Adapted from: Recommendations related to contraception and pregnancy testing in clinical trials 

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APPENDIX 6. NEW YORK HEART ASSOCIATION FUNCTIONAL 
CLASSIFICATION  
Class 
Symptoms 
I 
No limitation of physical activity. Ordinary physical activity does not cause undue 
fatigue, palpitation, dyspnea (shortness of breath). 
II 
Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity 
results in fatigue, palpitation, dyspnea (shortness of breath). 
III 
Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity 
causes fatigue, palpitation, or dyspnea. 
IV 
Unable to carry on any physical activity without discomfort. Symptoms of heart failure at 
rest. If any physical activity is undertaken, discomfort increases. 
Adapted from Dolgin et al 1994. 
Original source: Criteria Committee, New York Heart Association, Inc. Diseases of the Heart and Blood Vessels.  
Nomenclature and Criteria for diagnosis, 6th edition Boston, Little, Brown and Co. 1964, p 114. 

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APPENDIX 7. EORTC-QLQ-C30 QUESTIONNAIRE  
 

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APPENDIX 8. EORTC-QLQ-CX24 QUESTIONNAIRE  
 

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APPENDIX 9. EQ-5D-5L QUESTIONNAIRE  
 

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APPENDIX 10. CHRONIC KIDNEY DISEASE EPIDEMIOLOGY 
COLLABORATION (CKD-EPI) EQUATION  
In adults, the most widely-used equations for estimating glomerular filtration rate (GFR) from 
serum creatinine are the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 
(Levey et al 2009) equation and the Modification of Diet in Renal Disease Study equation.  
National Kidney Disease Education Program calculators rely on creatinine determinations which 
are isotope dilution mass spectrometry traceable. All laboratories should be using creatinine 
methods calibrated to be isotope dilution mass spectrometry traceable. 
The CKD-EPI equation calculator should be used when serum creatinine (Scr) reported in mg/dL.  
This equation is recommended when estimated GFR values above 60 mL/min/1.73 m2 are 
desired. 
GFR = 141 × min (Scr/κ, 1)α × max(Scr/κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] 
where: 
Scr is serum creatinine in mg/dL, 
κ is 0.7 for females and 0.9 for males, 
α is -0.329 for females and -0.411 for males, 
min indicates the minimum of Scr/κ or 1, and 
max indicates the maximum of Scr/κ or 1. 
The equation does not require weight because the results are reported normalized to 1.73 m2 
body surface area, which is an accepted average adult surface area. 
The online calculator for CKD-EPI can be found here:  
https://www.niddk.nih.gov/health-information/communication-programs/nkdep/laboratory-
evaluation/glomerular-filtration-rate-calculators 

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APPENDIX 11. IMMUNE-MEDIATED ADVERSE EVENT EVALUATION 
AND MANAGEMENT  
The recommendations below for the diagnosis and management of any immune-mediated 
adverse event (imAE) are intended as guidance. This document should be used in conjunction 
with expert clinical judgement (by specialist physicians experienced in the treatment of cancer 
using immunological agents) and individual institutional guidelines or policies. 
Criteria used to diagnose imAEs include blood tests, diagnostic imaging, histopathology, and 
microbiology assessments to exclude alternative causes such as infection, PD, and adverse 
effects of concomitant drugs. In addition to the results of these tests, the following factors should 
be considered when making an imAE diagnosis: 
• What was the temporal relationship between initiation of study drugs and the AE? 
• How did the patient respond to withdrawal of study drugs? 
• Did the event recur when study drugs was/were reintroduced? 
• Was there a clinical response to corticosteroids? 
• Is the event an autoimmune endocrinopathy? 
• Is PD or an alternative diagnosis a more likely explanation? 
When alternative explanations to autoimmune toxicity have been excluded, the imAE field 
associated with the AE in the electronic case report form should be checked. 
Recommended diagnostic tests in the management of possible immune-mediated adverse events 
Immune-mediated toxicity 
Diagnostic evaluation guideline 
Thyroid disorders 
Scheduled and repeat thyroid function tests (TSH and T4).   
Hypophysitis 
Check visual fields and consider pituitary endocrine axis blood profile.  Perform 
pituitary and whole brain MRI in patients with headache, visual disturbance, 
unexplained fatigue, asthenia, weight loss, and unexplained constitutional 
symptoms. 
Consider consultation with an endocrinologist if an abnormality is detected. 
Pneumonitis 
All patients presenting with new or worsened pulmonary symptoms or signs, 
such as an upper respiratory infection, new cough, shortness of breath or hypoxia 
should be assessed by high-resolution CT.  Consider pulmonary function test 
including DLCO. 
Radiographic appearance is often nonspecific.  Depending on the location of the 
abnormality, bronchoscopy and bronchoalveolar lavage or lung biopsy may be 
considered.  Consult with a respiratory medicine physician for cases of uncertain 
cause.   
Neurological toxicity 
Perform a comprehensive neurological examination and brain MRI for all CNS 
symptoms; review alcohol history and other medications.  Conduct a diabetic 
screen, and assess blood B12/folate, HIV status, TFTs, and consider autoimmune 
serology.  Consider the need for brain/spine MRI/MRA and nerve conduction 
study for peripheral neuropathy.  Consult with a neurologist if there are abnormal 
findings. 

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Recommended diagnostic tests in the management of possible immune-mediated adverse events 
Immune-mediated toxicity 
Diagnostic evaluation guideline 
Colitis 
Review dietary intake and exclude steatorrhea.  Consider comprehensive testing, 
including the following: FBC, UEC, LFTs, CRP, TFTs, stool microscopy and 
culture, viral PCR, Clostridium difficile toxin, and cryptosporidia (drug-resistant 
organism). 
In case of abdominal discomfort, consider imaging, eg, X-ray, CT scan.  If a 
patient experiences bleeding, pain or distension, consider colonoscopy with 
biopsy and surgical intervention, as appropriate.   
Eye disorders 
If a patient experiences acute, new onset, or worsening of eye inflammation, 
blurred vision, or other visual disturbances, refer the patient urgently to an 
ophthalmologist for evaluation and management.   
Hepatitis 
Check ALT/AST/total bilirubin, INR/albumin; the frequency will depend on 
severity of the AE (eg, daily if ≥ 3-4; every 2-3 days if Grade 2, until recovering).  
Review medications (eg, statins, antibiotics) and alcohol history.  Perform liver 
screen including hepatitis A/B/C serology, hepatitis E PCR and assess anti-
ANA/SMA/LKM/SLA/LP/LCI, iron studies.  Consider imaging (eg, ultrasound 
scan for metastases or thromboembolism).  Consult with a hepatologist and 
consider liver biopsy.   
Renal toxicity 
Review hydration status and medication history.  Test and culture urine.  
Consider renal ultrasound scan, protein assessment (dipstick/24-hour urine 
collection), or phase-contrast microscopy.  Refer to nephrology for further 
management assistance.   
Dermatology 
Consider other causes by conducting a physical examination; consider 
dermatology referral for skin biopsy. 
Joint or muscle inflammation 
Conduct musculoskeletal history and perform complete musculoskeletal 
examination.  Consider joint X-ray and other imaging as required to exclude 
metastatic disease.  Perform autoimmune serology and refer to rheumatology for 
further management assistance. 
For suspected myositis/rhabdomyolysis/myasthenia include: CK, ESR, CRP, 
troponin I and consider a muscle biopsy. 
Myocarditis 
Perform ECG, echocardiogram, troponin I, and refer to a cardiologist. 
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; ANA, antinuclear antibody; AST, aspartate 
aminotransferase; CK, creatine kinase; CNS, central nervous system; CRP, C-reactive protein; CT, computed 
tomography; DLCO, diffusing capacity for carbon monoxide; ECG, electrocardiogram; ESR, erythrocyte 
sedimentation rate; FBC, full blood count; INR, international normalized ratio; LCI, liver cytosolic antigen; 
LFT, liver function test; LKM, liver kidney microsomal antibody; LP, liver pancreas antigen; MRA, magnetic 
resonance angiogram; MRI, magnetic resonance imaging; PCR, polymerase chain reaction; SLA, soluble liver 
antigen; SMA, smooth muscle antibody; T4, thyroxine; TFT, thyroid function tests; TSH, thyroid-stimulating 
hormone; UEC, urea electrolytes and creatinine. 
Treatment of Immune-Mediated Adverse Events 
• Immune-mediated AEs can escalate quickly; study treatment interruption, close 
monitoring, timely diagnostic work-up, and treatment intervention, as appropriate, with 
patients is required 

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• Immune-mediated AEs should improve promptly after introduction of 
immunosuppressive therapy.  If this does not occur, review the diagnosis, seek further 
specialist advice, and contact the medical monitor 
• For some Grade 3 toxicities that resolve quickly, rechallenge with study drugs may be 
considered if there is evidence of a clinical response to study treatment after 
consultation with the medical monitor 
• Steroid dosages in the table below are for oral or intravenous (methyl)prednisolone.  
Equivalent dosages of other corticosteroids can be substituted.  For steroid-refractory 
imAEs, consider use of steroid-sparing agents (eg, mycophenolate mofetil [MMF]) 
• Consider prophylactic antibiotics for opportunistic infections if the patient is receiving 
long-term immunosuppressive therapy 
Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
Thyroid 
disorders 
1-2 
Asymptomatic TFT 
abnormality or mild 
symptoms 
Replace thyroxine if hypothyroid, 
until TSH/T4 levels return to normal 
range. 
Thyrotoxic patients should be 
referred to an endocrinologist.  In 
cases with systemic symptoms: 
withhold study treatment, treat with a 
beta blocker and consider oral 
prednisolone 0.5 mg/kg/day for 
thyroid pain.  Taper corticosteroids 
over 2-4 weeks.  Monitor thyroid 
function regarding the need for 
hormone replacement. 
Continue study 
treatment or withhold 
treatment in cases with 
systemic symptoms. 
3-4 
Severe symptoms, 
hospitalization required 
Refer patient to an endocrinologist. 
If hypothyroid, replace with 
thyroxine 0.5-1.6 µg/kg/day (for the 
elderly or those with co-morbidities, 
the suggested starting dose is 
0.5 μg/kg/day).  Add oral 
prednisolone 0.5 mg/kg/day for 
thyroid pain.  Thyrotoxic patients 
require treatment with a beta blocker 
and may require carbimazole until 
thyroiditis resolves. 
Hold study treatment; 
resume when 
resolved/improved to 
Grade 0-1. 
Hypophysitis 
1-2 
Mild symptoms 
Refer patient to an endocrinologist 
for hormone replacement.  Add oral 
prednisolone 0.5-1 mg/kg/day for 
patients with pituitary inflammation.  
Taper corticosteroids over at least 
1 month.  If there is no improvement 
in 48 hours, treat as Grade 3-4.  Taper 
corticosteroids over at least 1 month. 
Continue study 
treatment. 

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Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
3-4 
Moderate-severe 
symptoms 
Refer patient to an endocrinologist 
for assessment and treatment.  Initiate 
pulse IV methylprednisolone 1 mg/kg 
for patients with headache/visual 
disturbance due to pituitary 
inflammation.  Convert to oral 
prednisolone and taper over at least 
1 month.  Maintain hormone 
replacement according to 
endocrinology advice.  Maintain 
hormone replacement according to 
endocrinology advice. 
Hold study treatment 
for patients with 
headache/visual 
disturbance due to 
pituitary inflammation 
until resolved/improved 
to Grade 2 or less.  
Discontinuation is 
usually not necessary. 
Pneumonitis 
1 
Radiographic changes 
only 
Monitor symptoms every 2-3 days. 
If appearance worsens, treat as 
Grade 2. 
Consider holding study 
treatment until 
appearance improves 
and cause is 
determined. 
2 
Symptomatic: exertional 
breathlessness 
Commence antibiotics if infection 
suspected.  Add oral prednisolone 
1 mg/kg/day if symptoms/appearance 
persist for 48 hours or worsen.  
Consider Pneumocystis infection 
prophylaxis.  Taper corticosteroids 
over at least 6 weeks. 
Consider prophylaxis for adverse 
steroid effects: eg, blood glucose 
monitoring, vitamin D/calcium 
supplement. 
Hold study treatment.  
Retreatment is 
acceptable if symptoms 
resolve completely or 
are controlled on 
prednisolone 
≤ 10 mg/day.  
Discontinue study 
treatment if symptoms 
persist with 
corticosteroid 
treatment. 
3-4 
Severe or life-threatening 
symptoms 
Breathless at rest 
Admit to a hospital and initiate 
treatment with IV 
methylprednisolone 2-4 mg/kg/day.  
If there is no improvement, or 
worsening after 48 hours, add 
infliximab 5 mg/kg (if no hepatic 
involvement).  Convert to oral 
prednisolone and taper over at least 
2 months.  Cover with empiric 
antibiotics and consider prophylaxis 
for Pneumocystis infection and other 
adverse steroid effects, eg, blood 
glucose monitoring, 
vitamin D/calcium supplement. 
Discontinue study 
treatment. 
Neurological 
toxicity 
1 
Mild symptoms 
– 
Continue study 
treatment. 
2 
Moderate symptoms 
Treat with oral prednisolone 0.5-
1 mg/kg/day.  Taper over at least 
4 weeks.  Obtain neurology 
consultation. 
Hold study treatment; 
resume when 
resolved/improved to 
Grade 0-1. 

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Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
3-4 
Severe/life-threatening 
Initiate treatment with oral 
prednisolone or IV 
methylprednisolone 1-2 mg/kg/day, 
depending on symptoms.  Taper 
corticosteroids over at least 4 weeks. 
Consider azathioprine, MMF, 
cyclosporine if no response within 
72-96 hours. 
Discontinue study 
treatment. 
Colitis/diarrhea 
1 
Mild symptoms: < 3 liquid 
stools per day over 
baseline and feeling well 
Symptomatic management: fluids, 
loperamide, avoid high fiber/lactose 
diet. 
If Grade 1 persists for > 14 days 
manage as a Grade 2 event. 
Continue study 
treatment. 
2 
Moderate symptoms: 4-
6 liquid stools per day 
over baseline, or 
abdominal pain, or blood 
in stool, or nausea, or 
nocturnal episodes 
Oral prednisolone 0.5 mg/kg/day 
(non-enteric coated). 
Do not wait for any diagnostic tests 
to start treatment.  Taper steroids over 
2-4 weeks, consider endoscopy if 
symptoms are recurring. 
Hold study treatment; 
resume when 
resolved/improved to 
baseline grade. 
3 
Severe symptoms: 
> 6 liquid stools per day 
over baseline, or if 
episodic within 1 hour of 
eating 
 
Initiate IV methylprednisolone 1-
2 mg/kg/day. 
Convert to oral prednisolone and 
taper over at least 4 weeks.  Consider 
prophylaxis for adverse steroid 
effects, eg, blood glucose monitoring, 
vitamin D/calcium supplement. 
If no improvement in 72 hours or 
symptoms worsen, consider 
infliximab 5 mg/kg if no perforation, 
sepsis, TB, hepatitis, NYHA 
Grade III/IV CHF or other 
immunosuppressive treatment: MMF 
or tacrolimus. 
Consult gastroenterologist to conduct 
colonoscopy/sigmoidoscopy. 
Hold study treatment; 
retreatment may be 
considered when 
resolved/improved to 
baseline grade and after 
discussion with the 
study medical monitor. 
4 
Life-threatening 
symptoms 
Discontinue study 
treatment. 

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Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
Skin reactions 
1 
Skin rash, with or without 
symptoms, < 10% BSA 
Avoid skin irritants and sun 
exposure; topical emollients 
recommended. 
Continue study 
treatment. 
2 
Rash covers 10%-30% of 
BSA 
Avoid skin irritants and sun 
exposure; topical emollients 
recommended. 
Topical steroids (moderate strength 
cream once a day or potent cream 
twice a day) ± oral or topical 
antihistamines for itch.  Consider a 
short course of oral steroids. 
Continue study 
treatment. 
3 
Rash covers > 30% BSA 
or Grade 2 with substantial 
symptoms 
Avoid skin irritants and sun 
exposure; topical emollients 
recommended. 
Initiate steroids as follows based on 
clinical judgement: 
For moderate symptoms: oral 
prednisolone 0.5-1 mg/kg/day for 
3 days then taper over 2-4 weeks. 
For severe symptoms: IV 
methylprednisolone 0.5-1 mg/kg/day; 
convert to oral prednisolone and taper 
over at least 4 weeks. 
Hold study treatment. 
Re-treat when AE is 
resolved or improved to 
mild rash (Grade 1-2) 
after discussion with 
the study medical 
monitor. 
4 
Skin sloughing > 30% 
BSA with associated 
symptoms (eg, erythema, 
purpura, epidermal 
detachment) 
Initiate IV methylprednisolone 1-
2 mg/kg/day.  Convert to oral 
prednisolone and taper over at least 
4 weeks. 
Admit to a hospital and seek urgent 
dermatology consultation. 
Discontinue study 
treatment. 
Hepatitis 
1 
ALT or AST > ULN to 3X 
ULN 
Check LFTs within 1 week and 
before the next dose check LFTs to 
verify that there has been no 
worsening. 
If LFTs are worsening, recheck every 
48-72 hours until improvement is 
seen. 
Continue study 
treatment if LFTs are 
unchanged or 
improving. 
Hold study treatment if 
LFTs are worsening 
until improvement is 
seen. 
2 
ALT or AST 3-5X ULN 
Recheck LFTs every 48-72 hours: 
For persistent ALT/AST elevation: 
consider oral prednisolone 0.5-
1 mg/kg/day for 3 days then taper 
over 2-4 weeks. 
For rising ALT/AST: start oral 
prednisolone 1 mg/kg/day and taper 
over 2-4 weeks; re-escalate dose if 
LFTs worsen, depending on clinical 
judgement.   
Hold study treatment; 
treatment may be 
resumed when 
resolved/improved to 
baseline grade and 
prednisolone tapered to 
≤ 10 mg. 

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Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
3 
ALT or AST 5-20X ULN 
ALT/AST < 400 IU/L and normal 
bilirubin/INR/albumin: Initiate oral 
prednisolone 1 mg/kg and taper over 
at least 4 weeks. 
ALT/AST > 400 IU/L or raised 
bilirubin/INR/low albumin: Initiate 
IV (methyl)prednisolone 
2 mg/kg/day.  When LFTs improve to 
Grade 2 or lower, convert to oral 
prednisolone and taper over at least 
4 weeks.   
Hold study treatment 
until improved to 
baseline grade; 
reintroduce only after 
discussion with the 
study medical monitor. 
4 
ALT or AST > 20X ULN 
Initiate IV methylprednisolone 
2 mg/kg/day.  Convert to oral 
prednisolone and taper over at least 
6 weeks.   
Discontinue study 
treatment. 
Worsening LFTs despite steroids: 
If on oral prednisolone, change to pulsed IV methylprednisolone 
If on IV, add MMF 500-1000 mg twice a day 
If worsens on MMF, consider addition of tacrolimus 
Duration and dose of steroid required will depend on severity of event 
Nephritis 
1 
Creatinine 1.5X baseline 
or > ULN to 1.5X ULN 
Repeat creatinine weekly. 
If symptoms worsen, manage as per 
criteria below. 
Continue study 
treatment. 
2 
Creatinine > 1.5X-3X 
baseline or > 1.5X-3X 
ULN 
Ensure hydration and review 
creatinine in 48-72 hours; if not 
improving, consider creatinine 
clearance measurement by 24-hour 
urine collection.  Discuss with 
nephrologist the need for kidney 
biopsy. 
If attributed to study drug, initiate 
oral prednisolone 0.5-1 mg/kg and 
taper over at least 2 weeks. 
Repeat creatinine/U&E every 48-
72 hours. 
Hold study treatment. 
If not attributed to drug 
toxicity, restart 
treatment. 
If attributed to study 
drug and 
resolved/improved to 
baseline grade: Restart 
study drug if tapered to 
< 10 mg prednisolone. 
3 
Creatinine > 3X baseline 
or > 3X-6X ULN 
Hospitalize patient for monitoring 
and fluid balance; repeat creatinine 
every 24 hours; refer to a 
nephrologist and discuss need for 
biopsy.  If worsening, initiate IV 
(methyl)prednisolone 1-2 mg/kg.  
Taper corticosteroids over at least 
4 weeks. 
Hold study treatment 
until the cause is 
investigated. 
If study drug suspected: 
Discontinue study 
treatment. 
4 
Creatinine > 6X ULN 
As per Grade 3, patient should be 
managed in a hospital where renal 
replacement therapy is available. 
Discontinue study 
treatment. 

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Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
Diabetes/ 
hyperglycemia 
1 
Fasting glucose value 
ULN to 160 mg/dL; ULN 
to 8.9 mmol/L 
Monitor closely and treat according 
to local guideline.  Check for 
C-peptide and antibodies against 
glutamic acid decarboxylase and islet 
cells are recommended. 
Continue study 
treatment. 
2 
Fasting glucose value 160-
250 mg/dL; 8.9-
13.9 mmol/L 
Obtain a repeat blood glucose level at 
least every week.  Manage according 
to local guideline. 
Continue study 
treatment or hold 
treatment if 
hyperglycemia is 
worsening.  Resume 
treatment when blood 
glucose is stabilized at 
baseline or Grade 0-1. 
3 
Fasting glucose value 250-
500 mg/dL; 13.9-27.8 
mmol/L 
Admit patient to hospital and refer to 
a diabetologist for hyperglycemia 
management.  Corticosteroids may 
exacerbate hyperglycemia and should 
be avoided. 
Hold study treatment 
until patient is 
hyperglycemia 
symptom-free, and 
blood glucose has been 
stabilized at baseline or 
Grade 0-1. 
4 
Fasting glucose value 
> 500 mg/dL; 
> 27.8 mmol/L 
Admit patient to hospital and institute 
local emergency diabetes 
management.  Refer the patient to a 
diabetologist for insulin maintenance 
and monitoring. 
Ocular toxicity 
1 
Asymptomatic eye 
exam/test abnormality 
Consider alternative causes and 
prescribe topical treatment as 
required. 
Continue study 
treatment. 
2 
Anterior uveitis or mild 
symptoms 
Refer patient to an ophthalmologist 
for assessment and topical 
corticosteroid treatment.  Consider a 
course of oral steroids. 
Continue study 
treatment or hold 
treatment if symptoms 
worsen or if there are 
symptoms of visual 
disturbance. 
3 
Posterior 
uveitis/panuveitis or 
significant symptoms 
Refer patient urgently to an 
ophthalmologist.  Initiate oral 
prednisolone 1-2 mg/kg and taper 
over at least 4 weeks. 
Hold study treatment 
until improved to 
Grade 0-1; reintroduce 
only after discussion 
with the study medical 
monitor. 
4 
Blindness (at least 20/200) 
in the affected eyes 
Initiate IV (methyl)prednisolone 
2 mg/kg/day.  Convert to oral 
prednisolone and taper over at least 
4 weeks. 
Discontinue study 
treatment. 
Pancreatitis 
2 
Asymptomatic, blood test 
abnormalities 
Monitor pancreatic enzymes. 
Continue study 
treatment. 
3 
Abdominal pain, nausea 
and vomiting 
Admit to hospital for urgent 
management.  Initiate IV 
(methyl)prednisolone 1-2 mg/kg/day.  
Convert to oral prednisolone when 
amylase/lipase improved to Grade 2, 
and taper over at least 4 weeks. 
 
Hold study treatment; 
reintroduce only after 
discussion with the 
study medical monitor. 
4 
Admit to hospital for emergency 
Discontinue study 

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Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
Acute abdominal pain, 
surgical emergency 
management and appropriate referral.   treatment. 
Arthritis 
1 
Mild pain with 
inflammation, swelling 
Management per local guideline.   
Continue study 
treatment. 
2 
Moderate pain with 
inflammation, swelling, 
limited instrumental (fine 
motor) activities 
Management as per local guideline.  
Consider referring patient to a 
rheumatologist.  If symptoms worsen 
on treatment manage as a Grade 3 
event. 
Continue treatment or, 
if symptoms continue 
worsens, hold study 
treatment until 
symptoms improve to 
baseline or Grade 0-1. 
3 
Severe pain with 
inflammation or 
permanent joint damage, 
daily living activity 
limited 
Refer patient urgently to a 
rheumatologist for assessment and 
management.  Initiate oral 
prednisolone 0.5-1 mg/kg and taper 
over at least 4 weeks. 
Hold study treatment 
unless improved to 
Grade 0-1; reintroduce 
only after discussion 
with the study medical 
monitor. 
Mucositis/ 
stomatitis 
1 
Test findings only or 
minimal symptoms 
Consider topical treatment or 
analgesia as per local guideline. 
Continue study 
treatment. 
2 
Moderate pain, reduced 
oral intake, limited 
instrumental activities 
As per local guidelines, treat with 
analgesics, topical treatments, and 
oral hygiene care.  Ensure adequate 
hydration.  If symptoms worsen or 
there is sepsis or bleeding, manage as 
a Grade 3 event. 
Continue study 
treatment. 
3 
Severe pain, limited food 
and fluid intake, daily 
living activity limited 
Admit to hospital for appropriate 
management.  Initiate IV 
(methyl)prednisolone 1-2 mg/kg/day.  
Convert to oral prednisolone when 
symptoms improved to Grade 2 and 
taper over at least 4 weeks. 
Hold study treatment 
until improved to 
Grade 0-1. 
4 
Life-threatening 
complications or 
dehydration 
Admit to hospital for emergency care.  
Consider IV corticosteroids if not 
contraindicated by infection. 
Discontinue study 
treatment. 
Myositis/ 
rhabdomyolysis 
1 
Mild weakness 
with/without pain 
Prescribe analgesics. 
If CK is significantly elevated and 
patient has symptoms, consider oral 
steroids and treat as Grade 2.   
Continue study 
treatment. 
2 
Moderate weakness 
with/without pain 
If CK is 3 X ULN or worse initiate 
oral prednisolone 0.5-1 mg/kg and 
taper over at least 4 weeks. 
Hold study treatment 
until improved to 
Grade 0-1. 
3-4 
Severe weakness, limiting 
self-care 
Admit to hospital and initiate oral 
prednisolone 1 mg/kg.  Consider 
bolus IV (methyl)prednisolone and 1-
2 mg/kg/day maintenance for severe 
activity restriction or dysphagia.  If 
symptoms do not improve add 
immunosuppressant therapy. Taper 
oral steroids over at least 4 weeks. 
Hold study treatment 
until improved to 
Grade 0-1.  
Discontinue if any 
evidence of myocardial 
involvement. 
Myocarditis 
< 2 
Asymptomatic but 
Admit to hospital and refer to a 
cardiologist. 
Hold study treatment 
until completely 

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Autoimmune 
toxicity 
Grade 
Treatment guidelines (subject to 
clinical judgement) 
Study drug 
management 
significantly increased 
CK-MB or increased 
troponin OR clinically 
significant 
intraventricular 
conduction delay 
Transfer all patients with 
moderate/severe cardiac symptoms or 
any increase in cardiac serum 
markers to the coronary care unit. 
Initiate oral prednisolone or IV 
(methyl)prednisolone at 1-
2 mg/kg/day.  Manage symptoms of 
cardiac failure according to local 
guidelines. 
If no immediate response change to 
pulsed doses of (methyl)prednisolone 
1 g/day and add MMF, infliximab or 
anti-thymocyte globulin. 
resolved or myocarditis 
has been ruled out. 
2 
Symptoms on mild-
moderate exertion 
Discontinue study 
treatment unless 
cardiac involvement 
has been excluded and 
symptoms have 
completely resolved. 
3 
Severe symptoms with 
mild exertion 
4 
Life-threatening 
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BSA, body 
surface area; CK, creatine kinase; CK-MB, creatine kinase-muscle-brain; CHF, congestive heart failure; 
INR, international normalized ratio; IV, intravenous; LFT, liver function test; MMF, mycophenolate mofetil; 
NYHA, New York Heart Association; T4, thyroxine; TB, tuberculosis; TFT, thyroid function test; 
TSH, thyroid-stimulating hormone; U&E, urea and electrolytes; ULN, upper limit of normal. 

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APPENDIX 12. THE RESPONSE EVALUATION CRITERIA IN SOLID 
TUMORS (RECIST) GUIDELINES, VERSION 1.1  
The text below was obtained from the following reference: Eisenhauer et al 2009. 
DEFINITIONS 
Response and progression will be evaluated in this trial using the international criteria proposed 
by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (Version 1.1).  
Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are 
used in the RECIST criteria. 
Note: Lesions are either measurable or non-measurable using the criteria provided below.  The 
term “evaluable” in reference to measurability will not be used because it does not provide 
additional meaning or accuracy. 
Measurable Disease 
Tumor lesions: Must be accurately measured in at least 1 dimension (longest diameter in the 
plane of measurement is to be recorded) with a minimum size of: 
• 10 mm by computed tomography (CT) scan (irrespective of scanner type) and magnetic 
resonance imaging (MRI) (no less than double the slice thickness and a minimum of 
10 mm). 
• 10 mm caliper measurement by clinical examination (when superficial). 
• 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung). 
Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph 
node must be ≥ 15 mm in short axis when assessed by CT or MRI scan (CT/MRI scan slice 
thickness recommended to be ≥ 5 mm).  At baseline and in follow-up, only the short axis will be 
measured and followed. 
Non-measurable Disease 
All other lesions (or sites of disease), including small lesions (longest diameter ≥ 10 to < 15 mm 
with conventional techniques or < 10 mm using spiral CT scan), are considered non-measurable 
disease.  Leptomeningeal disease, ascites, pleural, or pericardial effusion, inflammatory breast 
disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly 
identified by physical examination that is not measurable by reproducible imaging techniques are 
all non-measurable. 
Bone lesions: 
• Bone scan, positron-emission tomography (PET) scan, or plain films are not considered 
adequate imaging techniques to measure bone lesions.  However, these techniques can 
be used to confirm the presence or disappearance of bone lesions. 
• Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue 
components, that can be evaluated by cross sectional imaging techniques such as CT or 

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MRI can be considered as measurable lesions if the soft tissue component meets the 
definition of measurability described above. 
• Blastic bone lesions are non-measurable. 
Cystic lesions: 
• Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) since they 
are, by definition, simple cysts. 
• Cystic lesions thought to represent cystic metastases can be considered as measurable 
lesions, if they meet the definition of measurability described above.  However, if non-
cystic lesions are present in the same patient, these are preferred for selection as target 
lesions. 
Lesions with prior local treatment: 
• Tumor lesions situated in a previously irradiated area, or in an area subjected to other 
loco-regional therapy, are usually not considered measurable unless there has been 
demonstrated progression in the lesion.  Trial protocols should detail the conditions 
under which such lesions would be considered measurable. 
Target Lesions 
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, should be 
identified as target lesions and recorded and measured at baseline.  Target lesions should be 
selected on the basis of their size (lesions with the longest diameter), be representative of all 
involved organ, but in addition should be those that lend themselves to reproducible repeated 
measurements. 
Lymph nodes merit special mention since they are normal anatomical structures which may be 
visible by imaging even if not involved by tumor.  Pathological nodes which are defined as 
measurable and may be identified as target lesions must meet the criterion of a short axis of 
≥ 15 mm by CT or MRI scan.  Only the short axis of these nodes will contribute to the baseline 
sum.  The short axis of the node is the diameter normally used by radiologists to judge if a node 
is involved by solid tumor.  Nodal size is normally reported as 2 dimensions in the plane in 
which the image is obtained (for CT scan, this is almost always the axial plane; for MRI the 
plane of acquisition may be axial, sagittal, or coronal).  The smaller of these measures is the 
short axis.  For example, an abdominal node which is reported as being 20 mm × 30 mm has a 
short axis of 20 mm and qualifies as a malignant, measurable node.  In this example, 20 mm 
should be recorded as the node measurement.  All other pathological nodes (those with short axis 
≥ 10 mm but < 15 mm) should be considered non-target lesions.  Nodes that have a short axis 
< 10 mm are considered non-pathological and should not be recorded or followed. 
A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target 
lesions will be calculated and reported as the baseline sum diameters.  If lymph nodes are to be 
included in the sum, then as noted above, only the short axis is added into the sum.  The baseline 
sum diameters will be used as reference to further characterize any objective tumor regression in 
the measurable dimension of the disease. 

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Non-target Lesions 
All other lesions (or sites of disease) including pathological lymph nodes should be identified as 
non-target lesions and should also be recorded at baseline.  Measurements are not required, and 
these lesions should be followed as “present,” “absent,” or in rare cases “unequivocal 
progression” (more details to follow).  In addition, it is possible to record multiple non-target 
lesions involving the same organ as a single item on the case record form (eg, “multiple enlarged 
pelvic lymph node” or “multiple liver metastases”). 
GUIDELINES FOR EVALUATION OF MEASURABLE DISEASE 
All measurements should be recorded in metric notation, using calipers if clinically assessed.  All 
baseline evaluations should be performed as close as possible to the treatment start and never 
more than 4 weeks before the beginning of the treatment. 
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at baseline and during follow-up.  Imaging-based evaluation 
should always be done rather than clinical examination unless the lesion(s) being followed 
cannot be imaged but are accessible by clinical examination. 
Clinical lesions: Clinical lesions will only be considered measurable when they are superficial 
and P10 mm diameter as assessed using calipers (eg, skin nodules).  For the case of skin lesions, 
documentation by color photography including a ruler to estimate the size of the lesion is 
suggested.  As noted above, when lesions can be evaluated by both clinical examination and 
imaging, imaging evaluation should be undertaken since it is more objective and may also be 
reviewed at the end of the trial. 
• Chest x-ray: Chest CT is preferred over chest x-ray, particularly when progression is an 
important endpoint, because CT is more sensitive than x-ray, particularly in identifying 
new lesions.  However, lesions on chest x-ray may be considered measurable if they are 
clearly defined and surrounded by aerated lung. 
• CT, MRI: CT is the best currently available and reproducible method to measure 
lesions selected for response assessment.  This guideline has defined measurability of 
lesions on CT scan based on the assumption that CT slice thickness is 5 mm or less.  
When CT scans have slice thickness greater than 5 mm, the minimum size for a 
measurable lesion should be twice the slice thickness.  MRI is also acceptable in certain 
situations (eg, for body scans). 
• Ultrasound: Ultrasound is not useful in assessment of lesion size and should not be used 
as a method of measurement.  Ultrasound examinations cannot be reproduced in their 
entirety for independent review at a later date and, because they are operator dependent, 
it cannot be guaranteed that the same technique and measurements will be taken from 
one assessment to the next.  If new lesions are identified by ultrasound in the course of 
the study, confirmation by CT or MRI is advised.  If there is concern about radiation 
exposure at CT, MRI may be used instead of CT in selected instances. 
• Endoscopy, laparoscopy: The utilization of these techniques for objective tumor 
evaluation is not advised.  However, they can be useful to confirm complete 

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pathological response when biopsies are obtained or to determine relapse in trials where 
recurrence following CR or surgical resection is an endpoint. 
• Tumor markers: Tumor markers alone cannot be used to assess objective tumor 
response.  If markers are initially above the upper normal limit, however, they must 
normalize for a patient to be considered in CR.  Because tumor markers are disease 
specific, instructions for their measurement should be incorporated into protocols on a 
disease specific basis.  Specific guidelines for both CA-125 response (in recurrent 
ovarian cancer) and prostate-specific antigen response (in recurrent prostate cancer), 
have been published.  In addition, the Gynecologic Cancer Intergroup has developed 
CA-125 progression criteria which are to be integrated with objective tumor assessment 
for use in first-line trials in ovarian cancer. 
• Cytology, histology: These techniques can be used to differentiate between partial 
response (PR) and CR in rare cases if required by protocol (for example, residual 
lesions in tumor types such as germ cell tumors, where known residual benign tumors 
can remain).  When effusions are known to be a potential adverse effect of treatment 
(eg, with certain taxane compounds or angiogenesis inhibitors), the cytological 
confirmation of the neoplastic origin of any effusion that appears or worsens during 
treatment can be considered if the measurable tumor has met criteria for response or 
stable disease (SD) to differentiate between response (or SD) and progressive disease 
(PD). 
RESPONSE CRITERIA 
Evaluation of Target Lesions 
• Complete Response (CR): Disappearance of all target lesions.  Any pathological lymph 
nodes (whether target or non-target) must have reduction in short axis to < 10 mm. 
• Partial Response (PR): At least a 30% decrease in the sum of diameters of target 
lesions, taking as reference the baseline sum diameters. 
• PD: At least a 20% increase in the sum of diameters of target lesions, taking as 
reference the smallest sum on study (this includes the baseline sum if that is the 
smallest on study).  In addition to the relative increase of 20%, the sum must also 
demonstrate an absolute increase of at least 5 mm.  (Note: the appearance of 1 or more 
new lesions is also considered progression). 
• Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum diameters while on study. 
• Lymph nodes: Lymph nodes identified as target lesions should always have the actual 
short axis measurement recorded (measured in the same anatomical plane as the 
baseline examination), even if the nodes regress to below 10 mm on study.  This means 
that when lymph nodes are included as target lesions, the “sum” of lesions may not be 
zero even if CR criteria are met, since a normal lymph node is defined as having a short 
axis of < 10 mm.  Case report recorded in a separate section where, o qualify for CR, 
each node must achieve a short axis < 10 mm.  For PR, SD, and PD, the actual short 
axis measurement of the nodes is to be included in the sum of target lesions. 

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• Target lesions that become “too small to measure.” While on study, all lesions (nodal 
and non-nodal) recorded at baseline should have their actual measurements recorded at 
each subsequent evaluation, even when very small (eg, 2 mm).  However, sometimes 
lesions or lymph nodes which are recorded as target lesions at baseline become so faint 
on CT scan that the radiologist may not feel comfortable assigning an exact measure 
and may report them as being “too small to measure.” 
• When this occurs, it is important that a value be recorded on the electronic case report 
form (eCRF).  If it is the opinion of the radiologist that the lesion has likely 
disappeared, the measurement should be recorded as 0 mm.  If the lesion is believed to 
be present and is faintly seen but too small to measure, a default value of 5 mm should 
be assigned (Note: It is less likely that this rule will be used for lymph nodes since they 
usually have a definable size when normal and are frequently surrounded by fat such as 
in the retroperitoneum; however, if a lymph node is believed to be present and is faintly 
seen but too small to measure, a default value of 5 mm should be assigned in this 
circumstance as well).  This default value is derived from the 5 mm CT slice thickness 
(but should not be changed with varying CT slice thickness).  The measurement of 
these lesions is potentially non-reproducible, therefore providing this default value will 
prevent false responses or progressions based upon measurement error.  To reiterate, 
however, if the radiologist is able to provide an actual measure, that should be recorded, 
even if it is below 5 mm. 
• Lesions that split or coalesce on treatment: When non-nodal lesions “fragment,” the 
longest diameters of the fragmented portions should be added together to calculate the 
target lesion sum.  Similarly, as lesions coalesce, a plane between them may be 
maintained that would aid in obtaining maximal diameter measurements of each 
individual lesion.  If the lesions have truly coalesced such that they are no longer 
separable, the vector of the longest diameter in this instance should be the maximal 
longest diameter for the “coalesced lesion.” 
Evaluation of Non-target Lesions 
While some non-target lesions may actually be measurable, they need not be measured and 
instead should be assessed only qualitatively at the timepoints specified in the protocol. 
• CR: Disappearance of all non-target lesions and normalization of tumor marker level.  
All lymph nodes must be non-pathological in size (< 10 mm short axis). 
• PD: Unequivocal progression (as detailed below) of existing non-target lesions.  
(Note: the appearance of 1 or more new lesions is also considered progression.) 
• Non-CR/Non-PD: Persistence of 1 or more non-target lesion(s) and/or maintenance of 
tumor marker level above the normal limits. 
• When the patient also has measurable disease: In this setting, to achieve “unequivocal 
progression” on the basis of the non-target disease, there must be an overall level of 
substantial worsening in non-target disease such that, even in presence of SD or PR in 
target disease, the overall tumor burden has increased sufficiently to merit 
discontinuation of therapy.  A modest “increase” in the size of 1 or more non-target 
lesions is usually not sufficient to qualify for unequivocal progression status.  The 

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designation of overall progression solely on the basis of change in non-target disease in 
the face of SD or PR of target disease will therefore be extremely rare. 
• When the patient has only non-measurable disease: This circumstance arises in some 
Phase 3 trials when it is not a criterion of trial entry to have measurable disease.  The 
same general concept applies here as noted above, however, in this instance there is no 
measurable disease assessment to factor into the interpretation of an increase in 
non-measurable disease burden.  Because worsening in non-target disease cannot be 
easily quantified (by definition: if all lesions are truly non-measurable) a useful test that 
can be applied when assessing patients for unequivocal progression is to consider if the 
increase in overall disease burden based on the change in non-measurable disease is 
comparable in magnitude to the increase that would be required to declare PD for 
measurable disease: ie, an increase in tumor burden representing an additional 73% 
increase in “volume” (which is equivalent to a 20% increase diameter in a measurable 
lesion). 
• Examples include an increase in a pleural effusion from “trace” to “large,” an increase 
in lymphangitic disease from localized to widespread, or may be described in protocols 
as “sufficient to require a change in therapy.” If “unequivocal progression” is seen, the 
patient should be considered to have had overall PD at that point.  While it would be 
ideal to have objective criteria to apply to non-measurable disease, the very nature of 
that disease makes it impossible to do so, therefore the increase must be substantial. 
New Lesions 
The appearance of new malignant lesions denotes PD; therefore, some comments on detection of 
new lesions are important.  There are no specific criteria for the identification of new 
radiographic lesions; however, the finding of a new lesion should be unequivocal: ie, not 
attributable to differences in scanning technique, change in imaging modality or findings thought 
to represent something other than tumor (for example, some “new” bone lesions may be simply 
healing or flare of pre-existing lesions).  This is particularly important when the patient’s 
baseline lesions show partial or complete response.  For example, necrosis of a liver lesion may 
be reported on a CT scan report as a “new” cystic lesion, which it is not. 
A lesion identified on a follow-up trial in an anatomical location that was not scanned at baseline 
is considered a new lesion and will indicate PD.  An example of this is the patient who has 
visceral disease at baseline and while on trial has a CT or MRI brain scan ordered that reveals 
metastases.  The patient’s brain metastases are considered to be evidence of PD even if he/she 
did not have brain imaging at baseline. 
If a new lesion is equivocal, for example because of its small size, continued therapy and follow-
up evaluation will clarify if it represents truly new disease.  If repeat scans confirm there is 
definitely a new lesion, then progression should be declared using the date of the initial scan. 
While fluorine-18 [F-18] fluorodeoxyglucose (FDG)-PET response assessments need additional 
study, it is sometimes reasonable to incorporate the use of FDG-PET scanning to complement 
CT scanning in assessment of progression (particularly possible “new” disease).  New lesions on 
the basis of FDG-PET imaging can be identified according to the following algorithm: 

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• Negative FDG-PET at baseline, with a positive FDG-PET at follow-up, is a sign of PD 
based on a new lesion.   
• No FDG-PET at baseline and a positive FDG-PET at follow-up: If the positive FDG-
PET at follow-up corresponds to a new site of disease confirmed by CT, this is PD.  If 
the positive FDG-PET at follow-up is not confirmed as a new site of disease on CT, 
additional follow-up CT scans are needed to determine if there is truly progression 
occurring at that site (if so, the date of PD will be the date of the initial abnormal 
FDG-PET scan).  If the positive FDG-PET at follow-up corresponds to a pre-existing 
site of disease on CT that is not progressing on the basis of the anatomic images, this is 
not PD. 
Evaluation of Best Overall Response 
The BOR is the best response recorded from the start of the study drug treatment until the end of 
treatment considering any requirement for confirmation.  On occasion a response may not be 
documented until after the end of therapy so protocols should be clear if post-treatment 
assessments are to be considered in determination of best overall response.  Protocols must 
specify how any new therapy introduced before progression will affect best response 
designation.  The patient’s BOR assignment will depend on the findings of both target and non-
target disease and will also take into consideration the appearance of new lesions.  Furthermore, 
depending on the nature of the trial and the protocol requirements, it may also require 
confirmatory measurement.  Specifically, in nonrandomized trials where response is the primary 
endpoint, confirmation of PR or CR is needed to deem either one the “best overall response.” 
The BOR is determined once all the data for the patient is known.  Best response determination 
in trials where confirmation of complete or partial response IS NOT required: Best response in 
these trials is defined as the best response across all timepoints (for example, a patient who has 
SD at first assessment, PR at second assessment, and PD on last assessment has a BOR of PR).  
When SD is believed to be best response, it must also meet the protocol specified minimum time 
from baseline.  If the minimum time is not met when SD is otherwise the best timepoint 
response, the patient’s best response depends on the subsequent assessments.  For example, a 
patient who has SD at first assessment, PD at second and does not meet minimum duration for 
SD, will have a best response of PD.  The same patient lost to follow-up after the first SD 
assessment would be considered inevaluable. 
 
Target lesions 
Non-target lesions 
New lesions 
Overall response 
CR 
CR 
No 
CR 
CR 
Non-CR/non-PD 
No 
PR 
CR 
Not evaluated 
No 
PR 
PR 
Non-PD or not all 
evaluated 
No 
PR 
Stable disease 
Non-PD or not all 
evaluated 
No 
Stable disease 

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Target lesions 
Non-target lesions 
New lesions 
Overall response 
Not all evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
Abbreviations: CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response. 
When nodal disease is included in the sum of target lesions and the nodes decrease to “normal” 
size (< 10 mm), they may still have a measurement reported on scans.  This measurement should 
be recorded even though the nodes are normal in order not to overstate progression should it be 
based on increase in size of the nodes.  As noted earlier, this means that patients with CR may 
not have a total sum of “zero” on the eCRF. 
In trials where confirmation of response is required, repeated ‘NE’ timepoint assessments may 
complicate best response determination.  The analysis plan for the trial must address how 
missing data/assessments will be addressed in determination of response and progression.  For 
example, in most trials it is reasonable to consider a patient with timepoint responses of 
PR-NE-PR as a confirmed response. 
Patients with a global deterioration of health status requiring discontinuation of treatment 
without objective evidence of PD at that time should be reported as “symptomatic deterioration.” 
Every effort should be made to document objective progression even after discontinuation of 
treatment.  Symptomatic deterioration is not a descriptor of an objective response: it is a reason 
for stopping trial therapy. 
Conditions that define “early progression, early death, and inevaluability” are trial specific and 
should be clearly described in each protocol (depending on treatment duration, treatment 
periodicity). 
In some circumstances it may be difficult to distinguish residual disease from normal tissue.  
When the evaluation of CR depends upon this determination, it is recommended that the residual 
lesion be investigated (fine needle aspirate/biopsy) before assigning a status of CR.  FDG-PET 
may be used to upgrade a response to a CR in a manner similar to a biopsy in cases where a 
residual radiographic abnormality is thought to represent fibrosis or scarring.  The use of FDG-
PET in this circumstance should be prospectively described in the protocol and supported by 
disease specific medical literature for the indication.  However, it must be acknowledged that 
both approaches may lead to false positive CR due to limitations of FDG-PET and biopsy 
resolution/sensitivity. 
For equivocal findings of progression (eg, very small and uncertain new lesions; cystic changes, 
or necrosis in existing lesions), treatment may continue until the next scheduled assessment.  If at 
the next scheduled assessment, progression is confirmed, the date of progression should be the 
earlier date when progression was suspected. 

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CONFIRMATORY MEASUREMENT/DURATION OF RESPONSE 
Confirmation 
In nonrandomized trials where response is the primary endpoint, confirmation of PR and CR is 
required to ensure responses identified are not the result of measurement error.  This will also 
permit appropriate interpretation of results in the context of historical data where response has 
traditionally required confirmation in such trials.  However, in all other circumstances, ie, in 
randomized trials (Phase 2 or 3) or trials where SD or progression are the primary endpoints, 
confirmation of response is not required since it will not add value to the interpretation of trial 
results. However, elimination of the requirement for response confirmation may increase the 
importance of central review to protect against bias, in particular in trials which are not blinded. 
In the case of SD, measurements must have met the SD criteria at least once after trial entry at a 
minimum interval (in general not less than 6 weeks). 
Duration of Overall Response 
The duration of overall response is measured from the time measurement criteria are first met for 
CR/PR (whichever is first recorded) until the first date that recurrent or PD is objectively 
documented (taking as reference for PD the smallest measurements recorded on study). 
The duration of overall CR is measured from the time measurement criteria are first met for CR 
until the first date that recurrent disease is objectively documented. 
Duration of Stable Disease 
Stable disease is measured from the start of the treatment until the criteria for progression are 
met, taking as reference the smallest sum on study (if the baseline sum is the smallest, this is the 
reference for calculation of PD). 
The clinical relevance of the duration of SD varies in different studies and diseases. If the 
proportion of patients achieving SD for a minimum period of time is an endpoint of importance 
in a particular trial, the protocol should specify the minimal time interval required between 
2 measurements for determination of SD. 
Note: The duration of response (DOR) and SD as well as the progression-free survival (PFS) are 
influenced by the frequency of follow-up after baseline evaluation. It is not in the scope of this 
guideline to define a standard follow-up frequency. The frequency should consider many 
parameters including disease types and stages, treatment periodicity, and standard practice.  
However, these limitations of the precision of the measured endpoint should be considered if 
comparisons between trials are to be made.