Clinical trial NCT02578641
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma (NPC) NPC immunotherapy Nasopharyngeal Cancer Nose Cancer Cell therapy Head and Neck Cancer Cytotoxic T cells chemotherapy Epstein-Barr Virus
Sponsor: Tessa Therapeutics
Start date: 2014-07-01; Completion date: 2022-02-28
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients.

Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T cells (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30 hospital centers across Asia and the United States.

This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma".

Detailed description:
330 patients will be randomized after their eligibility status has been fully determined and informed consent has been obtained. Patients will be randomly allocated to receive either Arm A (Gemcitabine and Carboplatin (GC) x 4\* cycles and EBV-specific CTL) or Arm B (GC x 6 cycles alone) in a 1:1 ratio using a stratified block randomization scheme. The stratification variables are country and disease stage (metastatic vs locally recurrent). \*Additional 1-2 chemotherapy cycles (up to total 6 chemo cycles) might be given upon discretion of Investigator, if EBV-specific CTL infusions are not available in time for the 1st scheduled infusion.

After randomization, patients in Arm A will have their peripheral blood taken for the establishment of cytotoxic T cell line and EBV transformed lymphoblastoid cell line (CTL). Within two weeks of enrollment, patients will commence combination GC chemotherapy for a total of 4 cycles. Patients in Stage 2 of study will receive the EBV-specific CTL immunotherapy.

As of 1 May 2020, patients who have not received the first infusion of EBV-specific CTLs, will instead continue to receive a total of 6 cycles combination of Gemcitabine (1000 mg/m2) and carboplatin (AUC2) on Days 1, 8, 15 every 28 days

Arms: arm 1: 4 cycles\* of combination IV Gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days, followed sequentially by T-cell immunotherapy (2 cycles) of autologous EBV specific Cytotoxic T cells every 2 weeks, followed by EBV-specific CTL immunotherapy (4 cycles) every 8 weeks after 6 weeks from the second cycle.

\*Additional 1-2 chemotherapy cycles (up to total 6 chemo cycles) might be given upon discretion of Investigator, if EBV-specific CTL infusions are not available in time for the 1st scheduled infusion.

As of 1 May 2020, patients who have not received the first infusion of EBV-specific CTLs, will instead continue to receive a total of 6 cycles combination of Gemcitabine (1000 mg/m2) and carboplatin (AUC2) on Days 1, 8, 15 every 28 days arm 2: 6 cycles of combination IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days.
Interventions: intervention 1: autologous EBV specific Cytotoxic T cells intervention 2: combination IV gemcitabine and IV carboplatin (AUC2)
Intervention descriptions: intervention 1: The CTL line will be prepared by co-cultivation of the irradiated EBV-LCL with patient PBMC. A proportion of peripheral blood will be used to generate EBV specific CTLs. intervention 2: 4 cycles for Arm A and 6 cycles for Arm B

Protocol documents:
Prot_000.pdf: 



















































































































































SAP_001.pdf: 
 
 
 
 
 
 
16.1.9 
Statistical Analysis Plan 
16.1.9.1 
Statistical Analysis Plan for Protocol FF01 – Final Version 6.0 (31 Mar 2021) ..................... 2 
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STATISTICAL ANALYSIS PLAN  
FOR PROTOCOL FF01 
 
 
Sponsor: 
 
Tessa Therapeutics Ltd. 
138 Depot Road, #07-01 
Singapore 109683 
 
Telephone: 
+65 6384 0755 
Email: 
clinicaltrials@tessacell.com 
 
Protocol Number: 
FF01 
 
 
Protocol Name 
VANCE 
Protocol Title: 
A Multicenter, Randomized, Open-label, Phase III Clinical 
Trial of Gemcitabine and Carboplatin followed by Epstein-
Barr Virus-specific Autologous Cytotoxic T-Lymphocytes 
versus Gemcitabine and Carboplatin as First Line Treatment 
for Advanced Nasopharyngeal Carcinoma Patients 
 
Phase 
III 
 
Protocol Date / Version: 
 
01 May 2020/  Version 12 
 
 
 
SAP Author: 
Tessa Therapeutics Ltd. 
138 Depot Road 
#07-01 
Singapore 109683 
Telephone:   +65 6384 0755
 
 
 
 
Facsimile: 
+65 6384 4030 
 
 
Plan Version: 
Final Version 6.0 
 
 
Plan Date: 
31 March 2021 
 
 
 
 
 
 
--- confidential---  
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Protocol Number:  
FF01 
Protocol Name 
VANCE 
Protocol Date/ 
Version: 
01 May 2020/ Version 12 
Study Title: 
A Multicenter, Randomized, Open-label, Phase III Clinical 
Trial of Gemcitabine and Carboplatin followed by Epstein-
Barr Virus-specific Autologous Cytotoxic T-Lymphocytes 
versus Gemcitabine and Carboplatin as First Line Treatment 
for Advanced Nasopharyngeal Carcinoma Patients 
 
Sponsor: 
Tessa Therapeutics Ltd. 
138 Depot Road, #07-01 
Singapore 109683 
 
Prepared by: 
Tessa Therapeutics Ltd. 
138 Depot Road, #07-01  
Singapore 109683 
SAP Version: 
Final Version 6.0 
SAP Date: 
31 March 2021 
 
I have read and approve the Statistical Analysis Plan specified above and agree on its 
content: 
 
 
 
 
Cliff Ding 
 
 
 
 
                        
Vice President 
Tessa Therapeutics Ltd.  
138 Depot Road, #07-01 
Singapore 109683 
Telephone: +65 6384 0755 
 
 
Date 
30MAR2021
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TABLE OF CONTENTS 
 
Section   
Page 
ABBREVIATIONS, ACRONYMS, AND DEFINITIONS .................................................................. 5 
1. 
INTRODUCTION ................................................................................................................. 7 
2. 
PROTOCOL DESIGN .......................................................................................................... 7 
2.1 
Design Overview ..................................................................................................... 7 
2.2 
Protocol Objective(s) .............................................................................................. 8 
2.3 
Clinical Trial Duration.............................................................................................. 8 
2.4 
Study Treatments ................................................................................................. 13 
2.4.1 
Treatment Groups ................................................................................... 13 
2.4.2 
Randomization, Blinding, and Stratification ............................................. 13 
2.5 
Study Assessments .............................................................................................. 13 
2.5.1 
Primary Efficacy Endpoint ....................................................................... 13 
2.5.2 
Secondary Efficacy Endpoints ................................................................. 13 
2.5.3 
Safety Assessments ................................................................................ 14 
3. 
SAMPLE SIZE DETERMINATION, STATISTICAL POWER, AND SIGNIFICANCE 
LEVEL ............................................................................................................................... 14 
4. 
HYPOTHESIS TO BE TESTED ........................................................................................ 15 
5. 
ANALYSIS POPULATIONS.............................................................................................. 15 
5.1 
Intent to Treat (ITT) Population ............................................................................ 15 
5.2 
Safety Population (as treated) .............................................................................. 15 
6. 
DATA CONVENTION AND RELATED DEFINITIONS ..................................................... 16 
6.1 
Baseline Definition ................................................................................................ 16 
6.2 
Multiple assessments within a visit window.......................................................... 16 
6.3 
Handling of Missing Data ...................................................................................... 16 
6.3.1 
Handling of Missing Data for Overall Survival ......................................... 16 
6.4 
Definitions of Efficacy and Other Endpoints ......................................................... 16 
6.4.1 
Age........................................................................................................... 16 
6.4.2 
Overall Survival (OS) ............................................................................... 16 
6.4.3 
Progression-free Survival (PFS) .............................................................. 17 
6.4.4 
Overall Response Rate (ORR) ................................................................ 17 
6.4.5 
Clinical Benefit Rate (CBR) ..................................................................... 17 
6.4.6 
Quality of Life (QoL) ................................................................................ 18 
7. 
SUMMARIZING AND TABULATING THE COLLECTED DATA ..................................... 18 
7.1 
Disposition, Demographic and Baseline Characteristics Data ............................. 18 
7.1.1 
Subject Disposition and Study Treatment Completion Status ................ 18 
7.1.2 
Analysis Populations ............................................................................... 19 
7.1.3 
Protocol Deviations .................................................................................. 19 
7.1.4 
Demographics and Baseline Characteristics .......................................... 19 
7.1.5 
Medical History ........................................................................................ 20 
7.1.6 
Venesection and HLA-Typing .................................................................. 20 
7.1.7 
HBsAg/HIV Antibody ............................................................................... 20 
7.1.8 
Prior and Concomitant Medications ........................................................ 20 
7.1.9 
Concomitant Therapy .............................................................................. 20 
7.1.10 Post-study Antineoplastic Therapy .......................................................... 21 
7.1.11 Treatment Exposure and Compliance ..................................................... 21 
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7.2 
Analysis of Efficacy Data ...................................................................................... 22 
7.2.1 
Analysis of the Primary Endpoint ............................................................ 22 
7.2.2 
Analysis of Secondary Endpoints ............................................................ 23 
7.3 
Analysis of Safety Data ........................................................................................ 23 
7.3.1 
Adverse Events........................................................................................ 24 
7.3.2 
Clinical Laboratory Assessments ............................................................ 24 
7.3.3 
Vital Signs ................................................................................................ 25 
7.3.4 
Electrocardiogram (ECG) ........................................................................ 25 
7.3.5 
Research Blood ....................................................................................... 26 
7.3.6 
Urine Pregnancy Test .............................................................................. 26 
7.4 
Multicenter Clinical Trials ...................................................................................... 26 
7.5 
Multiple Testing and Comparisons ....................................................................... 26 
7.6 
Exploratory Analysis ............................................................................................. 26 
7.6.1 
Covariates ................................................................................................ 26 
7.6.2 
Subgroups ............................................................................................... 27 
7.6.3 
Other Exploratory Analyses ..................................................................... 27 
7.7 
Sensitivity Analysis ............................................................................................... 28 
7.7.1 
Analyses to assess the impact of differential withdrawal of study 
treatment between arms .......................................................................... 28 
7.7.2 
Association between the number of CTL infusions received and 
Overall Survival........................................................................................ 29 
8. 
INDEPENDENT DATA MONITORING COMMITTEE (IDMC) .......................................... 30 
9. 
APPENDIX 1 SCHEDULE OF ASSESSMENT (ARM A) ................................................. 31 
10. 
APPENDIX 2 SCHEDULE OF ASSESSMENT (ARM B) ................................................. 35 
11. 
APPENDIX 3 CANDIDATE BIOMARKER LIST ............................................................... 37 
12. 
REFERENCES .................................................................................................................. 38 
13. 
CHANGE HISTORY .......................................................................................................... 39 
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ABBREVIATIONS, ACRONYMS, AND DEFINITIONS 
Abbreviation/Acronym 
 
Definition 
AE 
 
Adverse Event 
ASA 
 
American Statistical Association 
AUC2 
 
Carboplatin 
BOR 
 
Best Overall Response 
CBR 
 
Clinical Benefit Rate 
CI 
 
Confidence Interval  
CP 
 
Conditional Power 
CR 
 
Complete Response 
eCRF 
 
Electronic Case Report Form 
CT 
 
Computed Tomography 
CTCAE 
 
Common Terminology Criteria for Adverse 
Events 
CTL 
 
Cytotoxic T Lymphocytes 
EBV 
 
Epstein-Barr Virus 
ECG  
 
Electrocardiogram  
ECOG 
 
Eastern Cooperative Oncology Group 
FDA 
 
Food and Drug Administration 
FU 
 
Follow-up 
GC 
 
Gemcitabine and Carboplatin 
HR 
 
Hazard Ratio 
ICH 
 
International Conference on Harmonisation 
IDMC 
 
Independent 
Data 
Safety 
Monitoring 
Committee 
ITT 
 
Intent to Treat 
IV 
 
Intravenous 
KM 
 
Kaplan Meier 
LTFU 
 
Lost to Follow-up 
MedDRA 
 
Medical Dictionary for Regulatory Activities  
MITT 
 
Modified Intent to Treat 
MRI 
 
Magnetic Resonance Imaging 
NCCS 
 
National Cancer Center Singapore 
NCI 
 
National Cancer Institute  
NPC 
 
Nasopharyngeal Carcinoma  
ORR 
 
Overall Response Rate 
OS 
 
Overall Survival 
PD 
 
Progressive Disease 
PFS 
 
Progression Free Survival 
PP 
 
Per Protocol 
PR 
 
Partial Response 
PT 
 
Preferred Term 
QoL 
 
Quality of Life 
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RECIST 
 
Response Evaluation Criteria In Solid Tumors 
RR 
 
Response Rate 
SAE 
 
Serious Adverse Event 
SAP 
 
Statistical Analysis Plan 
SD 
 
Stable Disease  
SOC 
 
System Organ Class 
TEAEs 
 
Treatment Emergent Adverse Events 
WHO 
 
World Health Organization 
 
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1. 
INTRODUCTION 
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting for the 
clinical trial protocol FF01, sponsored by Tessa Therapeutics Ltd.. The reader of this SAP 
is encouraged to review the complete protocol, as this plan contains only a limited overview 
of protocol information and related data issues.  The main objective of the plan is to provide 
details pertaining to statistical methodology, data conventions, and processes used for the 
analysis of data from this trial.  
The format and content of this SAP are structured to provide sufficient detail to meet the 
requirements specified by the International Conference on Harmonization (ICH) E9: 
Guidance on Statistical Principles in Clinical Trials.  All work planned and presented in 
this SAP will follow the ethical guidelines published by the American Statistical 
Association (ASA). 
The following documents were reviewed in preparation of this SAP: 
• Protocol Version 12, 01 May 2020 
• Annotated eCRFs 
• US Federal Register, Department of Health and Human Services, FDA, Guidance 
on Statistical Principles for Clinical Trials (1998) 
• ASA Ethical Guidelines for Statistical Practice (1999) [1] 
• The Royal Statistical Society: Code of Conduct (2014) [2] 
• ICH Guidance on the Structure and Content of Clinical Study Reports (ICH E3, 
1996) [4] 
• ICH Guidance on the Statistical Principles for Clinical Trials (ICH E9, 1998) [5] 
2. PROTOCOL DESIGN 
2.1 Design Overview 
This study is a multi-center, randomized, open label, Phase III clinical trial. 
Subjects with metastatic or locally recurrent EBV-positive NPC not amenable to further 
curative chemoradiation or surgery are eligible for this study. Eligible subjects are biopsy 
proven (whether earlier or at diagnosis of de novo advanced disease), non-keratinizing 
and/or undifferentiated carcinoma of the nasopharynx (EBV-related) who have not 
received first line chemotherapy for the treatment of advanced NPC. 
Approximately 30 sites located in Asia and/or United States will enroll subjects in this 
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study. Three hundred and thirty (330) eligible subjects will be randomly allocated to 
receive treatment from either Arm A (GC and EBV-specific CTL) or Arm B (GC alone) in 
a 1:1 ratio using a stratified block randomization scheme. The stratification variables are 
country and disease stage (metastatic vs. locally recurrent).    
2.2 Protocol Objective(s) 
The primary objective is to assess the efficacy of EBV-specific CTL following first line 
chemotherapy compared to chemotherapy alone in terms of Overall Survival (OS) of 
subjects with advanced NPC. 
The secondary objectives are: 
• Evaluate milestone 2, 3 and 5-year Overall Survival rates for the two treatment arms 
• Assess progression-free survival (PFS) for the two treatment arms 
• Compare the Overall Response Rate (ORR), Clinical Benefit Rate (CBR) and 
Quality of Life (QoL) between the two treatment arms 
• Assess safety of both treatment arms 
The exploratory objectives are:  
• Demonstrate persistence of EBV specific immune response in Arm A 
• Evaluate biomarkers of response to therapy and in relation to outcome indices  
• Develop a predictive biomarker classifier 
2.3 Clinical Trial Duration 
This trial is divided into three study phases, Pre-treatment, treatment and follow-up phases.  
These three phases are detailed here.  
Pre-treatment Phase: All pre-treatment screening procedures to be completed within 4 
weeks prior to initiating 1st chemotherapy. 
Treatment Phase: 
• Arm A: GC and EBV-specific CTL  
1) Stage 1:  
Chemotherapy involving 4* cycles of gemcitabine (1000 mg/m2) 
and carboplatin (AUC2), *with the option of an additional 1 to 2 cycles (i.e.: up to a 
total of 6 cycles) when the EBV-specific CTLs are not ready for infusion after the end of 
chemotherapy cycle 4 (EOC4) and patient’s EOC4 evaluation scan shows CR, PR, SD 
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2) Stage 2:  
Immunotherapy involving 6 cycles of EBV-specific CTL infusion 
(1x108 cells/m2)  
After randomization, subjects in Arm A will have their peripheral blood taken for the 
establishment of cytotoxic T-cell line and EBV transformed LCL (CTL). Certain Arm A 
patients may have their blood taken for research evaluation purposes (refer section 6 for 
schedule of study procedures).   
Within 4 weeks of obtaining informed consent, patients will commence combination 
gemcitabine and carboplatin chemotherapy for 4 cycles, with the option of an additional 1 
to 2 cycles (i.e.: the 5th and 6th chemotherapy cycles up to a total of 6 cycles) if the EBV-
specific CTLs are not ready for infusion after EOC4 and the patient’s  evaluation scan after 
the 4th cycle of chemotherapy shows CR, PR, SD , or if patients have not received the first 
infusion of EBV-specific CTLs, patients will remain in Stage 1 to continue receiving 
combination of gemcitabine and carboplatin chemotherapy for a total of 6 cycles and will 
not proceed to Stage 2. Patients who have already received their first EBV-specific CTL 
infusion will continue to receive the rest of their infusions as per treatment schedule. 
Response evaluation using computed tomography (CT)/ magnetic resonance imagining 
(MRI) scan will be performed before the 3rd cycle of chemotherapy. The response to 
chemotherapy will be noted (i.e. CR, PR, SD or PD). Patients who are assessed as PD on 
imaging assessment may decide to seek alternative treatment based on the attending 
clinician’s advice. 
A second evaluation using CT/MRI scan will be repeated after the 4th cycle of 
chemotherapy, or before commencement of EBV-specific CTL infusions..  
Refer to Figure 2-1 Study Schema for further details.  
 
Subjects will be assessed for response to immunotherapy approximately 7 weeks after the 
first EBV-specific CTL infusion using CT/MRI scan. Evaluation CT/MRI scans will 
initially be repeated approximately 7 weeks after receipt of each EBV-specific CTL 
infusion.  Following the end of treatment, patients will be followed up on survival status 
(Refer to Schedule of Assessment [Arm A] table). Subjects who demonstrate clinical 
benefit (CR, PR, and SD) to the first 2 cycles of immunotherapy will continue with 
immunotherapy for the remainder of the study. Subjects who are assessed as asymptomatic 
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PD on imaging assessment can continue with EBV-specific CTL based on the attending 
clinician’s discretion. This is based on the known biological and clinical fact that optimal 
immunotherapy responses may be delayed and frequency-dependent. 
Treatment for Arm A is expected to last approximately 13 months (Stage 1 – 4 to 6 months; 
Stage 2 – 6 to 7 months). 
An End of Treatment assessment will be conducted approximately 30 days after the last 
CTL infusion. 
 
• Arm B: GC only 
Arm B consists of 6 cycles of IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2). 
After randomization, subjects in arm B may have their peripheral blood taken for research 
purposes before commencement of chemotherapy. 
Within 4 weeks of obtaining informed consent, subjects will commence combination 
gemcitabine and carboplatin chemotherapy for a total of 6 cycles. An evaluation CT/MRI 
scan will be performed after the second and then after the 4th and 6th cycle of 
chemotherapy. The response to chemotherapy will be noted (i.e. CR, PR, SD or PD).  
Subjects who are assessed as PD on imaging assessment may decide to seek alternative 
treatment based on the attending clinician’s advice.  
Treatment for Arm B is expected to last approximately 6 months. 
An End of Treatment assessment will be conducted approximately 30 days after the last 
dose of chemotherapy. 
  
Follow-up Phase:  Following EOT, survival status will be followed up every 12 weeks 
(+/- 5 days). 
The duration of participation is up to 4 weeks of screening until death (or lost to follow 
up). The study schema is presented in Figure 2-1. 
  
 
 
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Figure 2-1 Study Schema 
 
** If patients have not received the first infusion of EBV-specific CTLs, patients will remain in Stage 1 to 
continue receiving combination of gemcitabine and carboplatin chemotherapy for a total of 6 cycles and will 
not proceed to Stage 2.  
** 
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** If patients have not received the first infusion of EBV-specific CTLs, patients will remain in Stage 1 to 
continue receiving combination of gemcitabine and carboplatin chemotherapy for a total of 6 cycles and will 
not proceed to Stage 2.  
** 
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2.4 Study Treatments 
2.4.1 Treatment Groups 
This is a comparator study: Arm A (GC and EBV-specific CTL) versus Arm B (GC alone) 
as detailed in Section 2.3. 
2.4.2 Randomization, Blinding, and Stratification 
This study will be conducted at approximately 30 sites in Asia and/or United States. 330 
subjects are planned to be enrolled. All eligible subjects will be centrally randomized to 
receive either Arm A (GC and EBV-specific CTLs) or Arm B (GC alone) in a 1:1 ratio 
using a stratified block randomization scheme. The stratification variables are country 
(Malaysia, Singapore, US, Thailand, Taiwan) and disease stage (metastatic versus locally 
recurrent). Within each stratum, subjects will be allocated with equal probability to either 
treatment in Arm A or treatment in Arm B and the randomization system will be set up in 
such a way that there is a 1:1 balance between the treatment groups from the different 
strata.  
Since this is an open label study, on-site study personnel will have knowledge of the 
treatment assignments after randomization and throughout the study.  To avoid any 
susceptible selection bias, a stratified block randomization scheme with a mixed block size 
will be used and the blocks will be blinded until trial closure to all research personnel 
except the block generating statistician.  
2.5 Study Assessments 
2.5.1 Primary Efficacy Endpoint 
The primary efficacy endpoint is overall survival (OS).  
2.5.2 Secondary Efficacy Endpoints 
The following secondary efficacy endpoints will be evaluated:  
• Milestone 2, 3 and 5-year Overall Survival rates  
• Progression-free survival (PFS)  
• Overall response rate (ORR)  
• Clinical benefit rate (CBR)  
• Quality of life (QoL)  
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2.5.3 Safety Assessments 
Safety will be assessed based on the following assessments:  
• Incidence and severity of treatment-emergent adverse events (TEAEs), including 
serious adverse events and adverse events resulting in permanent discontinuation 
of protocol-defined therapy.  
• Changes in selected laboratory test results (i.e.,  
o Serum chemistry including urea, serum creatinine, sodium, potassium, 
chloride, bicarbonate, glucose, bilirubin, albumin, ALT, AST, ALP, total 
protein; and  
o Full blood count (FBC) including hemoglobin, hematocrit, RBC count, 
Platelets count, total leukocyte count, neutophils, eosinophils, basophils, 
monocytes, absolute neutophil count)  
• Changes in vital signs including systolic and diastolic blood pressure and pulse  
• Changes in electrocardiogram (ECG) results  
• Changes in physical examination results 
• Pregnancy for subjects who are women of child bearing potential (WOCBP) and 
partner/spouse pregnancies of male subjects (if consent is obtained).  
3. SAMPLE SIZE DETERMINATION, STATISTICAL POWER, AND 
SIGNIFICANCE LEVEL 
A total of 330 subjects will be enrolled and randomized in a 1:1 ratio to Arm A and Arm 
B. The final analysis will be performed when 280 deaths have been observed. This sample 
size is sufficient to detect a 33% reduction in the risk of death in Arm A, as compared with 
Arm B (hazard ratio, 0.67) using a 2-sided log-rank test with 71% power and an overall 
significance level of 5%. Given that subjects receiving first line conventional 
chemotherapy at the NCCS have an estimated median OS of 18 months and assuming 
survival times are exponentially distributed, this sample size and target number of events 
also allows a corresponding detection of about 9 months difference in median OS between 
the 2 arms. A hazard ratio of 0.67 or better is considered to still be clinically meaningful 
taking into consideration other treatment options in metastatic incurable solid tumors, 
where an additional minimum of 3 months’ benefit (equivalent to a hazard ratio of 0.85 or 
better) in median overall survival is considered meaningful. An accrual period of about 5.5 
years, an additional 3 years of follow-up, a dropout rate of 10% and a 6-month delay in 
separation of the survival curves are factored in the sample size calculations.  Sample size 
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was calculated  using nQuery Advanced 8.3. 
The final analysis may be triggered when 280 deaths have occurred to conclude the OS 
result, or at the discretion of the Sponsor if it is not likely to reach 280 OS events in a 
reasonable timeframe, to summarize the OS findings which may not be conclusive. No 
interim analysis is planned for this study. 
4.  HYPOTHESIS TO BE TESTED 
The clinical trial is designed to primarily test if Overall Survival among subjects with 
advanced NPC who receive EBV-specific CTL (Arm A) following first line chemotherapy 
differs compared to first line chemotherapy (Arm B). 
Statistical Hypothesis:  
Hazard ratio – the relative risk of death based on comparison of the rates in each group. 
The hazard ratio is calculated using a ratio of Arm A hazard rate by Arm B hazard rate.  
Hypothesis to be tested: 
H0: HR=1  
H1: HR≠1  
5. ANALYSIS POPULATIONS 
The analysis and reporting of the data from this study will be performed using the following 
analysis populations:  
5.1 Intent to Treat (ITT) Population 
The intent-to-treat (ITT) analysis population will be used for the primary analysis of 
efficacy in this study, and is defined as all randomized subjects. Subjects will be included 
in the treatment group corresponding to the group that they were randomized to (i.e., if a 
subject is randomized to Arm B and gets treated with immunotherapy, the subject will be 
included in Arm B for the ITT analysis). 
5.2 Safety Population (as treated) 
The safety population will include all randomized subjects who receive at least one dose 
of chemotherapy treatment. Subjects will be analyzed in the treatment arm corresponding 
to the actual treatment received. 
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6. DATA CONVENTION AND RELATED DEFINITIONS   
6.1 Baseline Definition 
For purposes of all analyses presented here, the baseline value is defined as the last 
available value obtained prior to administration of any study drug.  
6.2 Multiple assessments within a visit window 
For multiple scheduled or unscheduled assessments that fall within a protocol-specified 
visit, the last measured value will be used for the analysis.   
All collected data will be listed.  
6.3 Handling of Missing Data  
Missing data will not be imputed unless otherwise specified. 
6.3.1 Handling of Missing Data for Overall Survival  
Patients known to be deceased without a date of death will be assigned an OS event date 
which is the mid-point between the last date known to be alive and the date the patient’s 
death becomes known. 
6.4 Definitions of Efficacy and Other Endpoints 
6.4.1 Age 
Age will be calculated as:   
Age (years)  =  
 = year of randomization - year of birth, if months and day of 
randomization < month and day of birth, or  
= year of randomization - year of birth +1, otherwise 
 
6.4.2 Overall Survival (OS) 
OS is defined as the duration in months from the day of randomization until death from 
any cause for a patient known to be deceased, or censored at the last contact date for a 
patient known to be alive or lost to follow-up. The last contact date is the last date a patient 
was known to be alive as documented in the database.    
 
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OS = (Death Date/Last Contact Date - Randomization 
Date + 1) / 30.4 
 
  
6.4.3 Progression-free Survival (PFS) 
PFS is defined as the duration from randomization to the first occurrence of documented 
disease progression (based on imaging results) or death from any cause, whichever occurs 
first. Subjects free from disease progression who are alive or lost to follow-up are censored 
at the date of last tumor assessment, as per the December 2018 FDA Guidance for Industry, 
‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics’, Subjects who 
commence new anticancer treatment will be censored using the date of last adequate 
radiological assessment prior to initiation of new anticancer treatment.  
PFS = (Disease Progression Date or Death Date – Randomization Date + 1) / 30.4  
Note: One month is considered 30.4 days. 
 
 
6.4.4 Overall Response Rate (ORR)  
Response will be assessed using CT/ MRI based on RECIST version 1.1.  The ORR for 
each treatment arm will comprise of the proportion of patients who achieve a Best Overall 
Response (BOR) of CR or PR while on treatment (until End of Treatment visit), taking as 
reference the tumour measurement at baseline. The ORR for Arm A will thus assess the 
best response achieved during combined chemo-immunotherapy. 
 
6.4.5 Clinical Benefit Rate (CBR) 
The CBR is defined as the proportion of patients who achieve CR, PR or SD while on 
treatment (until End of Treatment visit), taking as reference the tumour measurement at 
baseline. The CBR for Arm A will thus assess the best clinical benefit achieved during 
combined chemo-immunotherapy. 
Where SD is believed to be the best response, it must be reflected in 2 consecutive 
assessments.   
 
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6.4.6 Quality of Life (QoL) 
QoL will be assessed by using EORTC QLQ-C30 questionnaire. The QLQ-C30 is 
composed of both multi-item scales and single-item measures. These include five 
functional scales, three symptom scales, a global health status / QoL scale, and six single 
items. Each of the multi-item scales includes a different set of items - no item occurs in 
more than one scale. A transformation to a scale of 0 – 100 would be carried out prior to 
analysis for all raw scores, with a higher score representing a higher level of functioning 
or higher level of symptoms. Items will be scaled and scored using the recommended 
EORTC procedures [7]. Descriptive statistics relating to completion of the items at each 
time point and the reason for non-completion will be tabulated.   
7. SUMMARIZING AND TABULATING THE COLLECTED DATA 
All collected study data will be presented in subject data listings. Statistical analyses will 
be performed using SAS® for Windows, version 9.4 or later. Descriptive statistics (n, mean, 
standard deviation, median, minimum, maximum, 25th and 75th percentile) will be 
calculated by treatment group for continuous variables. Frequencies and percentages will 
be presented by treatment group for categorical variables. 
All the efficacy analyses presented here will be conducted using the ITT and Safety 
populations. All safety analyses will be conducted using the Safety population.  
 
7.1 Disposition, Demographic and Baseline Characteristics Data  
7.1.1 Subject Disposition and Study Treatment Completion Status  
The following will be summarized in the disposition table:   
• The number of subjects who signed informed consent 
• The number of subjects who signed informed consent but were not randomized 
• The number of subjects who were randomized by treatment group 
• The number of randomized subjects who received any study treatment by treatment 
group   
• The number of randomized subjects who received CTL (arm A only) 
• The number of subjects who completed the study treatment by treatment group 
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• The number of subjects who discontinued prior to completion of study treatment 
by treatment group 
• The number of subjects lost to follow-up or withdrew consent 
Reasons for discontinuation prior to completion will also be summarized descriptively by 
treatment group.   
In addition, there will also be a listing of all discontinued subjects, which will provide the 
clinical trial center, treatment group, and the specific reason for discontinuation.   
7.1.2 Analysis Populations 
The number of subjects in the ITT (i.e., all randomized subjects) and Safety populations 
will be tabulated and the reason for any subject exclusion from one or more analysis 
populations will be summarized. 
7.1.3 Protocol Deviations 
This study is intended to be conducted as specified in the protocol. In the event of 
significant deviation from the protocol the investigator (or a designee) will contact the 
sponsor and a decision will be made regarding the subject’s continuation in the study. The 
deviations occurring during the clinical trial will be collected and presented as by subject 
listing and will also be summarized descriptively. 
Major protocol deviations will also be identified by the sponsor prior to final database lock 
and this will be used to identify the Per Protocol analysis population for supportive efficacy 
analysis. Per ICH major protocol deviations include:  
• Informed consent deviation 
• Entrance criteria deviation 
• Withdrawal criteria deviation  
• Received wrong treatment or incorrect dose 
• Received an excluded medication  
7.1.4 Demographics and Baseline Characteristics 
The following demographic and baseline characteristics will be summarized:  
• Age, gender, ethnicity 
• Height, weight, BSA 
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• Time since diagnosis of most recent relapse/ progression 
• Disease stage 
• Eastern Cooperative Oncology Group (ECOG) performance status  
• Histological findings 
• Country 
 
Demographic and baseline characteristics will be summarized for ITT and Safety 
populations.  Age (years) will be summarized as a continuous variable and categorical 
variable (<65 years vs.  ≥65 years). By subject listing of all demographic and baseline 
characteristics will also be provided.  
7.1.5 Medical History   
Medical history data will be coded using MedDRA dictionary and summary will be 
presented using SOC and PT. All medical history will also be listed presented as a by-
subject listing. 
7.1.6 Venesection and HLA-Typing 
All the data from venesection (blood sampling) for EBV specific CTL preparation and 
HLA-typing will be presented as a by-subject listing. This will only be for subjects 
randomized to Arm A.  
7.1.7 HBsAg/HIV Antibody    
All the data from HBsAg/ HIV antibody or other confirmatory test will be presented as a 
by-subject listing.  
7.1.8 Prior and Concomitant Medications 
Previous and concomitant medications will be coded using the World Health Organization 
(WHO) dictionary. Concomitant medications will be summarized by frequency of drug 
classification. Previous and concomitant medications will be presented in a data listing.    
7.1.9 Concomitant Therapy  
Concomitant therapy data will be coded using the World Health Organization (WHO) 
dictionary. Concomitant medications will be summarized by frequency of WHO drug 
classification. Concomitant therapy data will also be presented in a data listing. 
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7.1.10 Post-study Antineoplastic Therapy 
Antineoplastic therapy data will be categorized as follows: 
• Immune-checkpoint inhibitors 
• Chemotherapy regimens 
• Other anticancer regimens 
• Surgery 
• Radiation 
Antineoplastic therapy data will be summarized by frequency of WHO drug classification. 
Antineoplastic therapy data will also be presented in a data listing. 
7.1.11 Treatment Exposure and Compliance 
The total number of treatment cycles initiated and completed for each subject will be 
tabulated. The summary for Arm A will include exposure of chemotherapy (i.e., 
gemcitabine and carboplatin) & immunotherapy, and that for Arm B will include exposure 
of chemotherapy (i.e., gemcitabine and carboplatin). Relative dose intensity (RDI) will also 
be computed and these data will be further summarized by calculating the mean, standard 
deviation, median, 25th and 75th percentile, minimum and maximum values for each 
treatment arm.  
Exposure to a treatment is defined as: 
Exposure = (date of last dose – date of first dose +1) / 30.4, in the unit of month. 
The RDI of gemcitabine or carboplatin is defined as: 
𝑅𝐷𝐼= 100% ×
𝑇𝑜𝑡𝑎𝑙 𝑑𝑜𝑠𝑒 𝑟𝑒𝑐𝑒𝑖𝑣𝑒𝑑 × 𝑝𝑙𝑎𝑛𝑛𝑒𝑑 𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡 𝑑𝑢𝑟𝑎𝑡𝑖𝑜𝑛 
𝑇𝑜𝑡𝑎𝑙 𝑑𝑜𝑠𝑒 𝑝𝑙𝑎𝑛𝑛𝑒𝑑 × 𝑎𝑐𝑡𝑢𝑎𝑙 𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡 𝑑𝑢𝑟𝑎𝑡𝑖𝑜𝑛  , 
where 
• Total dose received = cumulative dose received in the prescribed unit (mg/m2 for 
gemcitabine, AUC for carboplatin, and ×108 cells/m2 for EBV-specific CTLs); 
• Total dose planned = number of doses planned × the prescribed dose (1000 mg/m2 for 
gemcitabine, AUC2 for carboplatin, and 1×108 for EBV-CTLs); 
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• Actual treatment duration = date of last dose – date of first dose +6 or 13 (6 if the last 
dose received is the Day 1 or Day 8 dose of a cycle, 13 if it is the Day 15 Dose);  
• Planned treatment duration = the length of time in days it would take for the number of 
doses a patient actually received per study treatment plan, including the planned resting 
period for the last dose. 
The number and proportion of subjects with one or more dosage modification (i.e., 
reduction or delay) of study drug will be tabulated and the primary reason for dosage 
modification.  
7.2 Analysis of Efficacy Data   
All secondary efficacy analyses will be performed for the ITT and Safety populations. 
7.2.1 Analysis of the Primary Endpoint  
The primary endpoint for this study is OS, as determined by the definition in Section 0.  
Median OS, as well as survival rates at 2, 3, and 5-years, along with the corresponding 95% 
CIs, will be estimated using Kaplan-Meier product-limit method. HR and the 95% CI will 
be estimated using Cox proportional hazards regression, stratified by country and disease 
stage. Between-treatment comparison will be assessed using stratified log-rank test.  The 
unstratified estimates and comparison will also be performed.  
The Score likelihood test (i.e., which is equivalent to log-rank test) from the Cox 
proportional hazards model will be used to assess the difference between treatment arms.   
In addition, the Kaplan-Meier plot will be generated, and the Kaplan-Meier method will 
also be used to estimate the median, 25th and 75th percentiles, minimum and maximum and 
the 95% confidence interval for the median time (months) to death from any cause for the 
treatment groups. These summaries will be presented for the ITT and Safety populations.  
 
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7.2.2 Analysis of Secondary Endpoints 
  Progression-Free Survival (PFS)  
PFS will be summarized using methods similar to the methods used for OS. The primary 
analysis of PFS will be right-censored, based on the FDA guidance ‘Clinical Trial 
Endpoints for the Approval of Cancer Drugs and Biologics, Dec 2018’.  
 
 Overall Response Rate (ORR) 
The definition of ORR is presented in Section 0. The ORR estimate and the associated 95% 
CI for each arm will be presented. The difference in ORR between treatment groups and 
the 95% CI for the difference will be estimated using logistic regression with the 
stratification factors (i.e., country and disease stage) included in the model. In addition, the 
odds ratio and its 95% CI from the logistic regression will also be presented. 
 
 Clinical Benefit Rate (CBR) 
The definition of CBR is presented in Section 6.10.6. The CBR estimate and the associated 
95% CI for each arm will be presented. The difference in CBR between treatment groups 
and the 95% CI for the difference will be estimated using logistic regression with the 
stratification factors included in the model. The odds ratio and its 95% CI will also be 
presented. 
 
7.3 Analysis of Safety Data 
The Safety Population will be used for all analyses of safety. All safety parameters will be 
presented descriptively and as data listings.  Safety and tolerability will be assessed by the 
incidence of treatment emergent adverse events (TEAEs) (see below), change from 
baseline in selected laboratory parameters, vital signs parameters and ECGs. Additionally, 
for Arm A, safety will also be summarized separately for the periods before and after 
receipt of the first CTL infusion. Only events occurring prior to 8 weeks (56 calendar days) 
after receipt of the last dose of study treatment will be included in the analysis. 
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7.3.1 Adverse Events 
Adverse event terms recorded on the eCRF will be coded using the Medical Dictionary of 
Regulatory Activities (MedDRA) version xxx. The severity of AEs will be graded 
according to the CTCAE v4.03, as assessed by investigators.  
Treatment-emergent AEs (TEAEs) are defined as those with onset date between the date 
of the first dose of study treatment and 8 weeks (56 calendar days) after the last dose of 
study treatment, inclusive. 
Incidence of TEAEs will be tabulated by treatment arms according to the actual study 
treatment received, and the worst toxicity grade during the treatment period.  Frequency 
distribution of TEAEs in terms of MedDRA system organ class (SOC) and preferred term 
(PT) will be based on the number of patients who reported the AE at least once and the 
worst toxicity grade if there were multiple occurrences of the same AE in various grades. 
The following AE summaries will be generated:  
• ALL TEAEs by the worst toxicity grade 
• TEAEs of toxicity grade 3 or higher 
• Serious AEs 
• TEAEs by relatedness to study treatment (Attributions of definite, probable, and 
possible will be classified as related; unlikely and unrelated will be classified as not 
related). 
• Related TEAEs of toxicity grade 3 or higher 
• Related serious AEs 
• TEAEs resulting in discontinuation of protocol therapy  
• TEAEs with outcome of death  
All AEs, including TEAEs, will be included in individual subject listings. All SAEs with 
details of each event will also be listed. 
7.3.2 Clinical Laboratory Assessments 
The changes in laboratory values will be summarized descriptively for each scheduled 
protocol assessment time point. Change from baseline will be calculated for all post-
baseline assessments. All safety laboratory tests will be graded using CTCAE version 4.03, 
as appliable. 
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o Serum chemistry including urea, serum creatinine, sodium, potassium, 
chloride, bicarbonate, glucose, bilirubin, albumin, ALT, AST, ALP, total 
protein; and  
o Full blood count (FBC) including hemoglobin, hematocrit, RBC count, 
Platelets count, total leukocyte count, neutrophils, eosinophils, basophils, 
monocytes, absolute neutrophil count)  
All hematology and chemistry lab tests gradable by CTCAE v4.03 will be summarized by 
toxicity grade using a shift table at each protocol defined post-baseline visit as well as the 
worst toxicity grade during the study against baseline. 
All hematology and chemistry lab tests will be summarized by below or within or above 
normal limits using a shift table at each protocol defined post-base line visit against 
baseline. 
For change from baseline summaries, subjects with an undefined change from baseline 
because of missing data at a given time point, will be excluded from summaries at that time 
point. All available laboratory data will be included in individual subject listings. 
Laboratory results will be reported in subject listings according to conventional units.  
7.3.3 Vital Signs 
Vital sign results (systolic and diastolic blood pressure and pulse rate) will be summarized 
descriptively for each scheduled protocol time point. Changes will be calculated relative to 
the assessments at baseline and on the first day of each cycle.  For change from baseline 
summaries, subjects with an undefined change from baseline because of missing data at a 
given time point, will be excluded from summaries at that time point. 
7.3.4 Electrocardiogram (ECG)  
ECG results will be listed and summarized in terms of the number and percentage of 
subjects with abnormal and clinically significant, abnormal and not clinically significant,  
and normal findings at the scheduled and unscheduled protocol assessment time point. 
Additionally, descriptive statistics will be tabulated for changes from normal during 
baseline evaluation to abnormal and clinically significant findings during any assessment 
time point. Subjects with missing data for a given time point will not contribute to the 
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tabulations for that time point.  
7.3.5 Research Blood 
Research bloods (approximately up to 40 mL, as much as possible), will be collected before 
commencement of cycle 1 chemotherapy and after completion of every 2 cycles of 
chemotherapy. The timing of blood collections for each subject will be reported as a by-
subject listing.   
7.3.6 Urine Pregnancy Test 
All data from Urine Pregnancy test will be presented as a by-subject listing. 
7.4 Multicenter Clinical Trials  
This is a multicenter clinical trial. However, site will not be considered as a stratification 
variable during the analysis. All data collected will be presented as a by-subject listing.   
7.5 Multiple Testing and Comparisons  
For the primary endpoint only one hypothesis will be tested.  
For the secondary endpoints, the closed test procedure will be used to protect the trial-wise 
error rate. The order of the endpoints is specified in Section Error! Reference source not 
found.; namely: Progression-Free Survival (PFS), Overall Response Rate (ORR), Clinical 
Benefit Rate (CBR) and Quality-of-Life (QoL).   
 
7.6 Exploratory Analysis 
7.6.1 Covariates  
The efficacy analysis of the primary endpoint; namely: Overall Survival will be carried out 
with a single covariate of treatment arm. Covariate-adjusted analyses for the primary 
endpoint will be carried out as a supportive analysis using potential prognostic factors listed 
below. Only covariates that are found to be independently associated with OS (individual 
covariate p-value ≤ 0.05 will be retained in the final stratified Cox regression model.  
• Age (<65 years vs. ≥65 years) 
• Gender (Male vs. Female) 
 
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7.6.2 Subgroups  
During preparation of the final analysis, exploratory subgroup analyses based on the 
following subgroups will be performed for the primary and secondary endpoints if the 
numbers allow.  
• Age (<65 years vs. ≥65 years)  
• Sex (Male vs. Female)  
• Country  
• Treatment center  
• Disease stage (Metastatic vs. Locally recurrent) 
• Applicable only for Arm A: 
o Number of cycles of GC chemotherapy received (≤4 vs. >4) 
 
7.6.3 Other Exploratory Analyses  
Exploratory analyses will be used to investigate the correlation between immune biomarker 
signatures and clinical outcomes (OS, PFS, ORR, CBR), and whether such correlations are 
dependent on the treatment received. In this way, both prognostic and predictive 
biomarkers will be explored. This will involve analyzing values at baseline to identify at 
the outset patients who are more likely to respond to therapy, but also post-baseline to 
understand how the changing biomarker profile through time correlates with clinical 
outcomes and response to therapy. 
A multi-factorial approach, which encompasses measurements of multiple analytes, will 
be applied to take account of the balance and interaction between the immunostimulatory 
and immunosuppressive arms of both the cancer and the immune system. These 
exploratory analyses may include, but are not limited to, the following biomarkers of 
interest: 
• 
EBV viral load 
• 
Inhibitory leukocytes, including regulatory T-cells, monocytic and granulocytic 
MDSCs 
• 
Anti-cancer cells such as effector memory CD8 T-cells 
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• 
Distinct classes of serum associated cytokines, including immune stimulatory 
markers such as IFNγ, and immune suppressive cytokines such IL10, and CCL22 
• 
Transcriptome analysis from PBMCs to incorporate and validate proteomic 
measurements 
Cox proportional hazards models will be used to explore associations between biomarkers 
and time-to-event endpoints such as OS and PFS, with treatment-by-biomarker interaction 
terms included in the model to test for predictive biomarkers. Generalized Linear Models 
will similarly be used to explore biomarker associations with binary endpoints (ORR, CBR, 
2, 3 and 5-year OS). Due to the large number of hypotheses being tested, these analyses 
will be regarded as exploratory rather than confirmatory. 
7.7 Sensitivity Analysis 
7.7.1 Analyses to assess the impact of differential withdrawal of study treatment 
between arms 
The current study schema allows subjects in study Arm B who experience progressive 
disease (PD) after 2 or 4 cycles of chemotherapy to go off study treatment, unless the 
progressive disease is asymptomatic at the discretion of the clinician.  Subjects in Arm A 
who have progressive disease after 2 cycles of chemotherapy are allowed to go off study 
treatment, but those who experience disease progression after 4 cycles of chemotherapy 
are offered cell therapy rather than go off-study. The impact of this differential withdrawal 
of study treatment on the ITT analysis of the primary endpoint will be explored using the 
following sensitivity analyses. 
 Prognostic factors at baseline of subjects who progressed after 4 cycles of chemotherapy 
Prognostic factors at baseline will be summarized descriptively for subjects who 
progressed after 4 cycles of chemotherapy versus those who did not, by treatment arm. 
This will include the same baseline covariates used as those that were significant in the 
multivariable model described in Section 6.8.  
 Censoring of subjects with progressive disease after 4 cycles of chemotherapy  
A sensitivity Cox regression analysis will be performed of the primary endpoint wherein 
subjects from either treatment arm who exit the study due to progressive disease after 4 
cycles of chemotherapy will be censored at the time of progression for analysis of the 
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primary endpoint of OS. 
   
7.7.2 Association between the number of CTL infusions received and Overall Survival  
It is of interest to investigate whether the efficacy of CTL therapy in Arm A subjects is 
dependent on the number of infusions received. There are inherent challenges to 
implementing this type of analysis, owing to what is referred to as ‘immortal-time bias’ 
(also known as ‘survivor bias’ or ‘guarantee-time bias’). This bias occurs when a time-to-
event endpoint is compared across groups defined by a classifying event occurring during 
follow-up. Hence, comparing survival by the number of CTL infusions received can be 
problematic, because a subject can only receive a certain number of infusions if they 
survive until that point.  
It is hypothesized that a minimum of two CTL infusions is needed to demonstrate efficacy. 
The following three sensitivity analyses will be conducted in Arm A subjects to compare 
OS according to the number of CTL infusions received (<2 Vs ≥2), using Cox regression 
models stratified by country and disease stage (following the approach outlined by 
Giobbie-Hurder et. al. [10]): 
• Naïve estimator 
A single binary covariate for the number of CTL infusions received (<2 Vs ≥2) 
will be included in the Cox regression model. 
• Conditional landmark analysis  
Cox regression will be used with a single binary covariate for the number of CTL 
infusions (<2 Vs ≥2). The reference time or ‘time zero’ will equal the scheduled 
time point at which the 2nd CTL infusion should have been administered per 
protocol. Conditioning on this ‘landmark’ restricts the analysis to subjects who 
have survived up until this point, and answers the question ‘among those subjects 
who are still alive at the scheduled time of the 2nd CTL infusion, what is the 
association between number of infusions (<2 Vs ≥2) and survival?’ 
• Extended Cox model with time-varying covariate 
A time-varying binary covariate indicating number of infusions received (<2 Vs 
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≥2) will be included in the Cox regression model. 
The HR’s (≥ 2 Vs < 2 CTL infusions), 95% CI’s, and KM curves corresponding to each of 
the above analyses will be reported to assess whether treatment efficacy is dependent on 
the number of infusions received, and the extent to which the naïve estimator is confounded 
by immortal-time bias. 
8. INDEPENDENT DATA MONITORING COMMITTEE (IDMC) 
The independent data monitoring committee (IDMC) will receive descriptive summary 
tables to aid in review of safety during their annual reviews. These tables will include 
demographics, treatment exposure, adverse events, serious adverse events, laboratory 
findings, physical examinations, vital signs and ECG. 
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9. APPENDIX 1 
SCHEDULE OF ASSESSMENT (ARM A)  
 
Pre-Treatment 
Chemotherapy 
Screening  
(Baseline) 
Cycle 1 to 4s 
(Stage 1) 
End of  
Cycle 2 & 4 
-28 days 
Day 1 
Day 8 
Day 15 
  
Time- Window 
4 weeks from 
signing informed 
consent form to 
1st chemotherapy 
dose 
1. For Cycle 1 Day 1- within 4 weeks of obtaining informed 
consent 
2. Subsequent cycles Day 1 - ±3 days 
3. All cycles Day 8 and 15 - ±3 days 
4. Total duration of each cycle should within 25 to 31 days from 
that cycle Day 1 dosing, unless due to treatment delay as per 
allowed by protocol 
After Day 15, 
before dosing of 
next cycle 
Informed Consent 
X ## 
 
 
 
 
Randomization   
X g 
 
 
 
 
Blood Sampling for Immune Cell Preparation (Venesection; 
only if randomized into Arm A) b 
X 
 
 
 
 
HLA-Typing (only if randomized into Arm A) 
X 
 
 
 
 
Pre-Medication  
 
X d 
X d 
X d 
 
Chemotherapy (Gemcitabine + Carboplatin) 
 
X e 
X f 
X f 
 
Demographics 
X 
 
 
 
 
Medical History and Medication History 
X 
 
 
 
 
Physical Examination ++ 
X 
X c 
 
 
 
Vital signs (BP, PR) 
X 
X c 
 
 
 
Height 
X 
 
 
 
 
Weight 
X 
X c 
 
 
 
ECOG Performance Status 
X 
X c 
 
 
 
Urine Pregnancy Test 
X 
 
 
 
 
FBC + 
X n 
X k 
X k 
X k 
 
Serum chemistry i 
X n 
X k 
 
 
 
HBsAg / HIV Antibody or Other Confirmatory Test a 
X 
 
 
 
 
ECG  
X 
 
 
 
 
Research blood (At least 50 Arm A patients from sites in 
Singapore, Malaysia, Taipei and Taoyuan only) 
 
X d 
 
 
X m 
Concomitant Medication / Therapy 
X 
X 
X 
X 
X 
AE/SAE evaluation q 
X 
X 
X 
X 
X 
CT or MRI scan for Tumor Response j 
X h 
 
 
 
X 
QoL 
 
X d 
 
 
X  
Survival Status  
 
X 
X 
X 
X 
  
 
 
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Immunotherapy 
End of Treatment 
(EOT) 
Follow-up ^ 
 
(Stage 2)  
 
 
 
1st  
Infusion 
2nd 
Infusion 
3rd  
Infusion 
4th  
Infusion 
5th  
Infusion 
6th  
Infusion 
  
 
Time- Window 
≥14 days,  
≤28 days from 
last dose of 
chemotherapy 
14 days 
(±5 days) 
after 1st 
infusion 
of CTL 
6 weeks  
(±5 days) 
after 2nd 
infusion of 
CTL 
1. 8 weeks (±5days) after the 
previous infusion 
2. Schedule may only be 
adjusted after discussion and 
approval by coordinating 
investigator and sponsor 
EOT to be done at 
30 days (± 5 days) 
after last dose *** 
 Survival status will 
be followed up 
every 12 weeks (± 5 
days)   
Pre-Medication  
X k 
X k 
X k 
X k 
X k 
X k 
 
 
Immune Cell Infusion 
X 
X 
X 
X 
X 
X 
 
 
Physical Examination ++ 
X c 
X c 
X c 
X c 
X c 
X c 
X 
 
Vital signs (BP, PR) 
X c 
X c 
X c 
X c 
X c 
X c 
X 
 
Weight 
X 
X 
X 
X 
X 
X 
X 
 
ECOG Performance Status 
X c 
X c 
X c 
X c 
X c 
X c 
X 
 
FBC + 
X k 
X k 
X k 
X k 
X k 
X k 
X 
 
Serum chemistry i 
X k 
X k 
X k 
X k 
X k 
X k 
X 
 
ECG (as indicated) 
X k 
X k 
X k 
X k 
X k 
X k 
X 
 
Research blood (At least 50 
Arm A patients from sites in 
Singapore, Malaysia, Taipei 
and Taoyuan only) 
X k 
X k 
X k 
X k 
X k 
X k 
 
 
Concomitant Medication / 
Therapy 
X 
X 
X 
X 
X 
X 
X 
 
AE/SAE evaluation q 
X 
X 
X 
X 
X 
X 
X 
 
CT or MRI scan for Tumor 
Response j 
 
X * 
X ** 
X ** 
X ** 
X ** 
X 
 
QoL 
 
X o 
 
X o 
 
 
X 
 
Survival Status  
X 
X 
X 
X 
X 
X 
X 
X 
 
* 
To be done approximately 7 weeks (±5days) after 1st cycle of induction immunotherapy 
** To be done approximately 7 weeks (±5days) after each cycle of maintenance immunotherapy 
*** EOT to be done at 30 days (±5days), after last dose of therapy 
**** If patients have not received the first infusion of EBV-specific CTLs, patients will continue receiving combination of gemcitabine and carboplatin 
chemotherapy for a total of 6 cycles and will not proceed to receive EBV-specific CTL infusion 
^ 
Patients who completed treatment will be followed up on the assessments listed for Follow-up. Patients who commence salvage therapy will  exit 
the study treatment.  These patients will be followed up on survival status and initiation of subsequent antineoplastic therapies (medications, 
surgeries, radiotherapies) since discontinuation of study treatment.    
##   Written informed consent to be obtained after study has been fully explained to each subject prior to the conduct of any screening procedures or 
assessments 
+ 
FBC: Hemoglobin, Hematocrit, RBC count, Platelets, Total Leukocyte Count, Neutrophils, Eosinophils, Basophils, Monocytes, Absolute 
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Neutrophil count.   
++ Includes, but not limited to the following systems: Head, Eye, Ear, Nose and Throat / Lymph Nodes / Cardiovascular / Thorax / Abdomen / 
Extremities / Skin and Mucosae / Musculoskeletal / Neurological 
a 
Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests available within 4 weeks of screening  
b 
Additional blood (approximately 200mL, up to 250 ml) may need to be taken if production of CTLs may fail or yield may be insufficient. If cell 
yield is still not sufficient (and it is confirmed that the low yield is not due to production process within control) after this additional blood is 
collected, subject will be withdrawn from the study treatment, undergo EOT visit and followed up on survival status and initiation of subsequent 
antineoplastic therapies (medications, surgeries, radiotherapies) since discontinuation of study treatment. There should be at least a 14 days 
interval from the last dose of chemotherapy to the additional blood collection date. Additional blood collection should also be done at least 8 
weeks after the initial venesection date. Lastly, Hb count (results must be within 7 days from date of additional blood venesection) must be ≥10 
g/dL prior to blood collection. 
c 
To be conducted before the start of each treatment cycle  
d 
To be conducted before 1st dose of chemotherapy 
e 
Patients with ANC <1000/mm3 or Platelet count <100,000/mm3 or Grade 3 and above AEs, on the first day of a new cycle will delay chemotherapy 
until recovery. They will have their FBC repeated at weekly intervals until recovery. Patients who experience delays of more than 28 days because 
of low neutrophil or platelet counts or Grade 3 and above AEs, will be taken off the study treatment.  They will undergo EOT visit and followed 
up on survival status initiation of subsequent antineoplastic therapies (medications, surgeries, radiotherapies) since discontinuation of study 
treatment 
f 
Patients with ANC <1000/mm3 or platelet <100,000/mm3 or Grade 3 and above AEs, during Day 8 or Day 15 chemotherapy will have 
chemotherapy on that day delayed for up to a week. Should the condition persist past a week, chemotherapy will then be omitted and not 
replaced.   
g 
To be conducted after eligibility confirmation, before venesection 
h 
To be conducted only if last CT or MRI scan is not done within 4 weeks of C1D1 
i 
Tests include Urea, Serum creatinine, Sodium, Potassium, Chloride, Bicarbonate, Glucose, Bilirubin, Albumin, ALT, AST, ALP, Total protein. 
Calcium and Magnesium to be performed only at Screening Visit.   
j 
The method of assessment and the same technique (e.g. CT or MRI) should be used to characterize each identified and reported lesion shall be 
determined at baseline and remained throughout the study period.  
k 
To be conducted before starting treatment.  
 
Note: FBC, differential counts and Serum Chemistry within 3 days before the start of each chemotherapy cycle. FBC and differential counts 
within 3 days before dosing of Day 8 and Day 15 of each chemotherapy. FBC, differential counts, Serum Chemistry and research blood within 3 
days before the start of each immunotherapy cycle. ECG will be performed before each cycle of immunotherapy 
m To be conducted after completion of every 2 cycles of chemotherapy (end of cycle 2 & 4). End of cycle 4 must be a separate timepoint from 1st 
cycle of immunotherapy. 
n 
FBC and differential counts, Serum Chemistry (results must be within 7 days from date of venesection of peripheral blood for preparation of EBV-
LCL and subsequent cytotoxic T lymphocytes (CTL) generation) 
o 
To be conducted after 2nd cycle of immunotherapy and before 3rd cycle of immunotherapy, and after 4th cycle of immunotherapy and before 5th 
cycle of immunotherapy 
 
q AE/SAE review will be initiated upon ICF obtained. AEs will be identified and collected from time of informed consent to EOT visit. 
       The investigator should follow up until the event is resolved or when the subject exits the trial. 
s   Chemotherapy involving 4 cycles of gemcitabine (1000 mg/m2) and carboplatin (AUC2), with the option of an additional 1 to 2 cycles (ie: up to a 
total of 6 cycles) if the autologous EBV-specific CTLs are not ready in time for infusion 
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Protocol No: FF01
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10. APPENDIX 2 
SCHEDULE OF ASSESSMENT (ARM B)  
 
Pre-Treatment 
Chemotherapy 
End of 
Treatment 
(EOT)  
Follow-up ^ 
Screening  
(Baseline) 
Cycle 1 to 6 
Even 
Cycles  
(2, 4, 6) 
-28 days 
Day 1 
Day 8 
Day 15 
 
 
 
Time- Window 
4 weeks from 
signing informed 
consent form to 1st 
chemotherapy dose 
1. For Cycle 1 Day 1- within 4 weeks of 
obtaining informed consent 
2. Subsequent cycles Day 1 - ±3 days 
3. All cycles Day 8 and 15 - ±3 days 
4. Total duration of each cycle should within 
25 to 31 days from that cycle day 1 dosing, 
unless due to treatment delay as per allowed 
by protocol 
After Day 15, 
before dosing 
of next cycle 
EOT to be done 
at 30 days (± 5 
days) after last 
dose 
 Survival status will be 
followed up every 12 
weeks (± 5 days) 
Informed Consent 
X ## 
 
 
 
 
 
 
Randomization 
(after 
eligibility 
confirmation, before 1st chemotherapy 
dose) 
X f 
 
 
 
 
 
 
Pre-Medication  
 
X c 
X c 
X c 
 
 
 
Chemotherapy 
(Gemcitabine 
+ 
Carboplatin) 
 
X d 
X e 
X e 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical History and Medication History 
X 
 
 
 
 
 
 
Physical Examination ++ 
X 
X b 
 
 
 
X 
 
Vital signs (BP, PR) 
X 
X b 
 
 
 
X 
 
Height 
X 
 
 
 
 
 
 
Weight 
X 
X b 
 
 
 
X 
 
ECOG Performance Status 
X 
X b 
 
 
 
X 
 
Urine Pregnancy Test 
X 
 
 
 
 
 
 
FBC + 
X l 
X j 
X j 
X j 
 
X 
 
Serum chemistry h  
X l 
X j 
 
 
 
X 
 
HBsAg 
/ 
HIV 
Antibody 
or 
Other 
Confirmatory Test m 
X 
 
 
 
 
 
 
ECG  
X 
 
 
 
 
 
 
Research blood (At least 10 Arm B patients 
from sites in Taipei and Taoyuan only) 
 
Xc 
 
 
Xn 
X 
 
Concomitant Medication / Therapy 
X 
X 
X 
X 
X 
X 
 
AE/SAE evaluation a 
X 
X 
X 
X 
X 
X 
 
CT or MRI for Tumor Response i 
X g 
 
 
 
X 
X 
 
QoL 
 
X c 
 
 
X 
X 
 
Survival Status  
 
X 
X 
X 
X 
X 
X 
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Abbreviated Clinical Study Report
Protocol No: FF01
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+ 
FBC: Hemoglobin, Hematocrit, RBC count, Platelets, Total Leukocyte Count, Neutrophils, Eosinophils, Basophils, Monocytes, Absolute 
Neutrophil count.   
++ 
Includes, but not limited to the following systems: Head, Eye, Ear, Nose and Throat / Lymph Nodes / Cardiovascular / Thorax / Abdomen / 
Extremities / Skin and Mucosae / Musculoskeletal / Neurological 
##  
Written informed consent to be obtained after study has been fully explained to each subject prior to the conduct of any screening procedures 
or assessments 
^ 
Patients who completed EOT will be followed up on the assessments listed for Follow-up. Patients who commence salvage therapy will exit 
the study treatment.  These patients will be followed up on survival status and initiation of subsequent antineoplastic therapies (medications, 
surgeries, radiotherapies) since discontinuation of study treatment.   
a 
AE/SAE review will be initiated upon ICF obtained. AEs will be identified and collected from time of informed consent to EOT visit. 
        The investigator should follow up until the event is resolved or when the subject exits the trial. 
b 
To be conducted before the start of each treatment cycle  
c 
To be conducted before initiating chemotherapy treatment 
d 
Patients with ANC <1000/mm3 or Platelet count <100,000/mm3 or Grade 3 and above AEs, on the first day of a new cycle will delay 
chemotherapy until recovery.  They will have their FBC repeated at weekly intervals until recovery.  Patients who experience delays of more 
than 28 days because of low neutrophil or platelet counts or Grade 3 and above AEs, will be taken off the study treatment.  They will undergo 
EOT visit and followed up on survival status and initiation of subsequent antineoplastic therapies (medications, surgeries, radiotherapies) 
since discontinuation of study treatment. 
e 
Patients with ANC <1000/mm3 or Platelet count <100,000/mm3 or Grade 3 and above AEs, during Day 8 or Day 15 chemotherapy will have 
chemotherapy on that day delayed for up to a week. Should the condition persist past a week, chemotherapy will then be omitted and not 
replaced.  
f 
To be conducted prior to first dose of chemotherapy premedication and chemotherapy 
g 
To be conducted only if last CT or MRI scan is not done within 4 weeks of C1D1 
h 
Tests include Urea, Serum creatinine, Sodium, Potassium, Chloride, Bicarbonate, Glucose, Bilirubin, Albumin, ALT, AST, ALP, Total protein. 
Calcium and Magnesium to be performed only at Screening Visit.   
i 
The method of assessment and the same technique (e.g. CT or MRI) should be used to characterize each identified and reported lesion 
shall be determined at baseline and remained throughout the study period.  
j 
To be conducted before starting treatment. 
 
Note: FBC, differential counts, Serum Chemistry and research blood within 3 days before the start of each chemotherapy cycle. 
 
FBC and differential counts within 3 days before dosing of Day 8 and Day 15 of each chemotherapy 
 
l 
FBC and differential counts, Serum Chemistry (results must be within 3 days before starting the 1st chemotherapy for Arm B subject)  
m 
Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests available within 4 weeks of screening  
n       To be conducted after completion of chemotherapy cycle 2, cycle 4, cycle 5 and cycle 6. 
 
. 
 
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Abbreviated Clinical Study Report
Protocol No: FF01
Final, 22 August 2022
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11. APPENDIX 3 
CANDIDATE BIOMARKER LIST 
S/N 
Biomarker (measure) 
Method of 
ascertainment 
Rationale 
1 
Absolute Lymphocyte 
Count (ALC) 
Blood count 
To assess if there are potential pre-
chemotherapy simple blood-based 
biomarkers representing the patient’s 
global immune profile that can predict 
for a better survival outcome in either 
arm. In addition, this data can help 
better understand the impact of 
chemotherapy on the expansion of 
EBV-specific CTLs. For example, 
after four cycles of chemotherapy, will 
a high (or low) absolute lymphocyte 
count predict for better survival in 
either Arm A or Arm B. Can a high 
NLR or AMC predict for poorer 
survival as it does in a series of 
immune-oncology clinical trials across 
different cancers.  
2 
Absolute Eosinophil 
Count (AEC) 
Blood count 
3 
Absolute Monocyte 
Count (AMC) 
Blood count 
4 
Monocyte-Lymphocyte 
Ratio (MLR)  
Blood count 
5 
Neutrophil-Lymphocyte 
Ratio (NLR)  
Blood count 
6 
Lactate Dehydrogenase 
(LDH) 
Serum test 
Patient serum LDH is a surrogate 
biomarker for tumor burden and a 
prognostic marker for patient response 
in some cancers, most notably in 
lymphoma. There is data for 
prognostication of LDH in NPC. 
7 
Circulating EBV DNA 
load (copies per ml) 
Real-time PCR 
(Technically a 
test from 
serum/plasma) 
High baseline circulating EBV DNA 
has been correlated with poor 
outcomes in many NPC studies both 
for locoregional disease and advanced 
disease. This is reported also in a 
meta-analysis study. It also serves as a 
surrogate biomarker of response to 
treatment. 
8 
Reactivity to LMP2 
peptides 
ELISpot 
This only applies to Arm A. In the 
single arm Phase 2 trial where 4 cycles 
of gemcitabine + carboplatin were 
followed by 6 cycles of EBV CTL, a 
positive LMP2 specific ELISpot in the 
CTL product predicted for improved 
overall survival. In addition, the EBV 
pepmix will also be studied to see if 
positive ELISpot assay against pooled 
peptides can predict for better overall 
survival. 
9 
Reactivity to EBV 
pepmix  
ELISpot  
 
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Protocol No: FF01
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12. REFERENCES 
1. ASA. (1999) Ethical Guidelines for Statistical Practice. Prepared by the Committee 
on Professional Ethics, August 7, 1999.  
2. The Royal Statistical Society: Code of Conduct (2014). 
3. ICH E8. General Considerations for Clinical Trials 1997. 
4. ICH E3, Structure and Content of Clinical Study Reports, 1996. 
5. ICH E9 Statistical Principles for Clinical Trials 1998 
6. Christopher Jennison, and Bruce W. Turnbull. “Jennison C and Turnbull BW 
(2000), Group Sequential Methods with Applications to Clinical Trials”  
 
7. Fayers P, Aaronson N, Bjordal K, et al. EORTC QLQ-C30 Scoring Manual (ed 3). 
Brussels, Belgium, EORTC Publications, 2001 
8. Public Workshop: Oncology Clinical Trials in the Presence of Non-Proportional 
Hazards. Workshop convened on Feb 5, 2018 by the Duke-Robert J. Margolis, 
MD, Center for Health Policy and Duke University and supported by a 
cooperative agreement with the FDA (https://healthpolicy.duke.edu/events/public-
workshop-oncology-clinical-trials-presence-non-proportional-hazards) 
9. Freidlin B, Jiang W, Simon R. ‘The Cross-Validated Adaptive Signature Design’, 
Clin Cancer Res; 16(2) January 15, 2010 
10. A. Giobbie-Hurder, R. Gelber, M. Regan. ‘Challenges of Guarantee-Time Bias’, 
Journal of Clinical Oncology, 23 (2013): 2963-2969. 
11. Chia, WK. et. al. “Adoptive T-cell Transfer and Chemotherapy in the First-line 
Treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma” 
Mol. Ther. Vol. 22 No. 1, 132–139 Jan. 2014 
12. Liao LJ. et. al., ‘Prognostic impact of pre-treatment neutrophil-to-lymphocyte ratio 
(NLR) in nasopharyngeal carcinoma: A retrospective study of 180 Taiwanese 
patients’, Clin Otolaryngol. 2018 Apr;43(2):463-469 
13. Jiang W. et. al., ‘Systemic immune-inflammation index predicts the clinical 
outcome in patients with nasopharyngeal carcinoma: a propensity score-matched 
analysis’, Oncotarget. 2017 Sep 12; 8(39): 66075–66086. 
14. Lau KM. et. al., ‘Increase in circulating Foxp3+CD4+CD25high regulatory T cells 
in nasopharyngeal carcinoma patients’, Br J Cancer. 2007 Feb 26; 96(4): 617–622. 
15. Kilbi J. et. al., ‘Blood diffusion and Th1-suppressive effects of galectin-9-
containing exosomes released by Epstein-Barr virus-infected nasopharyngeal 
carcinoma cells’, Blood. 2009 Feb 26;113(9):1957-66 
16. Fang Y. et. al., ‘Prognostic role of C-reactive protein in patients with 
nasopharyngeal carcinoma: A meta-analysis and literature review’, Medicine 
(Baltimore). 2017 Nov; 96(45): e8463 
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17. Zhou, G.-Q. et al., ‘Prognostic implications of dynamic serum lactate 
dehydrogenase assessments in nasopharyngeal carcinoma patients treated with 
intensity-modulated radiotherapy.’ Sci. Rep. 6, 22326; doi: 10.1038/srep22326 
(2016) 
 
13. CHANGE HISTORY 
Changes incorporated into Version 2.0 of this document. 
1. Section 7.5: Rules and processes for IA Decisions 
Change: Ceiling for increasing sample size was specified 
Rationale: In response to statistical question 1 of FDA comments sent January 11, 2017  
2. Section 5.1, 5.2: ITT and MITT population.  
Change: MITT population was re-defined.  
Rationale: In response to statistical question 2 of FDA comments in January 11, 2017.  
3. Section 6.4.2: Handling of missing data for overall survival.  
Change: Detailed procedures to minimize the number of subjects with unknown survival 
status were added. Sample SAS code for Multiple Imputation was added. 
Rationale: In response to statistical question 3 of FDA comments in January 11, 2017.  
 
Changes incorporated into Version 3.0 of this document. 
1. Section 5.1, Section 5.2: Intent to Treat (ITT) Population and Modified Intent to Treat 
(MITT) Population  
Change: Clarified ITT would be the primary analysis population for efficacy 
analysis and MITT will be used for supportive analysis 
Rationale: In response to FDA’s recommendation provided in letter dated 15 
February 2017  
2. Section 7.2: Interim Efficacy Analysis. 
Change: Updated the cutoff for efficacy interim analysis from 50% of subjects 
accrued for 6 months to 67% of events. 
Rationale: To align the original sample size for this event driven study with the 
plan for the efficacy interim analysis for the sample size re-assessment and to allow 
more observations to be used for the decision making regarding sample size 
adjustment by the IDMC at the time of the interim analysis.  
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Protocol No: FF01
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3. Section 7.5: Rules and processes for IA Decisions 
Change: Ceiling for increasing sample size is clarified and associated effect size 
intended to be detected is clarified.  
Rationale: In response to FDA’s comments provided in letter dated 15 February 2017 
4. Section 7.6 and 7.7: Data and Metrices Provided to IDMC and Information Provided to 
Sponsor by IDMC 
Change and rationale: New sections added to provide more clarity on the rules of 
the IA  
5. Other editorial and clarifying content changes as needed. 
 
Changes incorporated into Version 4.0 of this document. 
1. Section 6.4.2: Handling of Missing Data for Overall Survival 
Change: Clarified that subjects with unknown survival status will be censored, 
instead of having their survival status determined using multiple imputation. 
 
Rationale: In response to FDA’s comments provided via email dated 19 October 
2017 
Changes incorporated into Version 5.0 of this document. 
1. Section 2.2: Protocol Objective(s), Section 2.5.2: Secondary Efficacy Endpoints 
Change: Inclusion of new secondary objective of “Milestone 2, 3 and 5-year 
Overall Survival rates”. 
Rationale: To allow for an alternative assessment of treatment effect in a scenario 
of non-proportional hazards 
2. Section 2.2: Protocol Objective(s) 
Change: Inclusion of new secondary objective “Assess the safety and tolerability 
of both treatments”. 
Rationale: To align the study objectives with the planned analyses to assess 
safety. 
3. Section 2.2: Protocol Objective(s) 
Change: Inclusion of new exploratory objective “Develop a predictive biomarker 
classifier”. 
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Protocol No: FF01
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Rationale: To aid in identification of subjects who are more likely to respond to 
therapy. 
4. Section 3: Sample Size Determination, Statistical Power, and Significance level 
Change: Change in target hazard ratio that study aims to detect, together with 
corresponding updates in the accrual and follow-up times, and explicit statement 
of trigger for final analysis. 
 
 Rationale: Update of sponsor’s study plan. 
5. Section 3: Sample Size Determination, Statistical Power, and Significance level 
Change: Deletion of 2nd paragraph “A sample size re-estimation will be 
performed during the interim analysis as detailed in Section 7.2 of this statistical 
analysis plan.”  
Rationale: The Interim Analysis has been removed for this study, because the 
survival data observed at the interim are not considered to be sufficiently mature 
to provide a robust assessment of the probability of success at the final analysis.  
The target number of events has been increased from 195 to 280 as the expected 
delay in separation of the survival curves will result in a reduction of power based 
on the current design to collect 195 events in 330 patients. Optimization of study 
power in a situation of non-proportional hazards can be accomplished with a 
longer follow-up time compared to collecting the same number of events from a 
bigger pool of patients.  
6. Section 6.4.3: Handling of Missing Data for other Efficacy Evaluations other than 
Overall Survival 
Change: Clarified that primary analysis for endpoints of ORR and CBR will be 
based on the observed data; while a sensitivity analysis will be performed using 
Non-Responder Imputation. 
 
 Rationale: Other editorial and clarifying content changes as needed. 
7. Section 6.4.3: Handling of Missing Data for other Efficacy Evaluations other than 
Overall Survival 
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Change: Clarified that subjects with unknown status regarding tumor progression 
will be censored, instead of having tumor progression status determined using 
multiple imputation. 
 
 Rationale: To align the analysis approach with that of the primary endpoint. 
8. Section 6.5.1: Max Combo test 
Change: Deletion of previous analyses based on the MITT population, with new 
sensitivity analysis taking into consideration the scenario of non-proportional 
hazards included as a replacement. 
Rationale: To allow recovery of power loss which is implied by design through 
the application of new techniques that have been proposed to the FDA by other 
pharmaceutical companies which have conducted immunotherapy trials. 
9. Section 6.5.2: Analyses to assess the impact of differential withdrawal of study 
treatment between arms 
Change: Deletion of previous analyses based on Tipping Point Analysis, with 2 
new sensitivity analyses based on looking at prognostic factors of subjects who 
progressed after 4 cycles of chemotherapy, and censoring of subjects with 
progressive disease after 4 cycles of chemotherapy proposed. 
Rationale: To address previous comments from the FDA regarding bias arising 
from differential treatment after 4 cycles of chemotherapy. 
10.  Section 6.5.3: Association between the number of CTL infusions received and OS 
Change: New analyses to explore whether the efficacy of CTL therapy in Arm A 
subjects is dependent on the number of infusions received, while adjusting for the 
possibility of immortal-time bias. 
Rationale: It is of interest to know the extent to which CTL efficacy is dependent 
on the number of infusions received.  
11. Section 6.7: Multiple Testing and Comparisons 
Change: Change in the ordering of the secondary endpoints for closed-testing, 
taking into consideration the new secondary endpoint proposed.   
Rationale: Based on sponsor’s consideration of the relative strengths of each data 
point. 
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12. Section 6.8: Covariates 
Change: Clarified that the efficacy analysis of the primary endpoint will be 
performed with only treatment as a covariate, while covariate-adjusted analysis 
will be performed as supportive analyses.   
Rationale: Other editorial and clarifying content changes as needed. 
13. Section 8.2.1: Analysis of the Primary Endpoint 
Change: Revision of the measures to assess the proportional hazards assumption, 
as well as additional analyses in-case the proportional hazards assumption is 
violated. 
Rationale: Based on the recommendations put forth by the cross-pharma working 
group. 
14. Section 8.3: Analysis of Exploratory Objectives 
Change: New section added in to elaborate on analyses that will be undertaken to 
assess the exploratory objectives. This will include the use of the Cross Validated 
Adaptive Signature Design (CVASD) in development of a predictive biomarker 
classifier, as well as other exploratory analyses. 
Rationale: Other editorial and clarifying content changes as needed. 
15. Other editorial and clarifying content changes as needed. 
 
Changes incorporated into Version 6.0 of this document. 
1. Section 3: Sample Size Determination, Statistical Power, and Significance Level 
Change: Change in target hazard ratio that study aims to detect, together with 
corresponding updates in the power, accrual and follow-up times. 
Rationale: Update of sponsor’s study plan, as communicated to the FDA in 
response dated 2Feb2019. 
 
2. Section 3: Sample Size Determination, Statistical Power, and Significance Level 
Change: Change in trigger for final analysis to allow for earlier analysis. 
Rationale: Update of sponsor’s study plan. 
 
3. Section 5: Analysis Populations 
Change: Deletion of the Modified Intent to Treat (MITT) and Per Protocol analysis 
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populations in Section 5.2 and 5.3 respectively. 
Rationale: Beyond the scope of the planned abbreviated CSR. 
4. Section 6.3: Outliers 
Change: Deletion of section from v5.0. 
Rationale: Update of sponsor’s study plan 
5. Section 6.4: Handling of Missing Data 
Change: Deletion of Sections 6.4.1 Handling of Missing Data for Adverse Events 
and 6.4.3 Handling of Missing Data for other Efficacy Evaluations other than 
Overall Survival from v5.0 
Rationale: No imputation will be performed for missing data.  
6. Section 6.5.1: Max Combo test 
Change: Deletion of sensitivity analysis. 
Rationale: Beyond the scope of the planned abbreviated CSR. 
7. Section 6.3.1: Handling of Missing data for Overall Survival 
Change: Added rule for determination of death date for patients with unknown 
death date. 
Rationale: In anticipation of such situations given the extended follow-up time. 
8. Section 6.4: Definitions of Efficacy and Other Endpoints 
Change: Update in calculations and added text to elaborate on time-to-event 
endpoints. 
Rationale: Additional clarity in definition of endpoints. 
9. Section 7: Summarizing and Tabulating the Collected Data 
Change: ITT and Safety populations to be the basis for analyses of efficacy 
endpoints.  
Rationale: Update of sponsor’s study plan. 
10. Section 7.1.11: Treatment Exposure and Compliance 
Change: Additional metrics for analysis of treatment exposure. 
Rationale: Update of sponsor’s study plan. 
11. Section 7.2.1: Analysis of the Primary Endpoint 
Change: Further details regarding analysis methods to be used. 
Rationale: Additional clarity. 
12. Section 7.3: Analysis of Safety Data 
Change: Update in definition of Treatment-emergent adverse events to 8 weeks 
(56 calendar days) after the last dose of study treatment, inclusive. 
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Rationale: For consistency with the timing of the End-of-Treatment assessment. 
13. Section 8.4.1: Exploratory Analyses using the Cross Validated Adaptive Signature 
Design 
Change: Section deleted from v5.0. 
Rationale: Analysis approach will be written up in a separate document. 
Furthermore, this exploratory analysis is beyond the scope of the planned 
abbreviated CSR. 
14. Appendix 3: Candidate Biomarker List 
Change: Revision in list of biomarkers. 
Rationale: Update of sponsor’s study plan. 
15.  
Other editorial and clarifying content changes as needed. 
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Protocol No: FF01
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Protocol No: FF01
Final, 22 August 2022
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