Clinical trial NCT04068181
Conditions: Melanoma
Keywords: Melanoma Talimogene Laherparepvec Pembrolizumab Oncolytic immunotherapy Anti-PD-1 Checkpoint inhibitor MASTERKEY-115
Sponsor: Amgen
Start date: 2020-01-22; Completion date: 2024-02-26
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

Detailed description:

Arms: arm 1: Includes participants who received anti-PD1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles. arm 2: Includes participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles. arm 3: Includes participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles. arm 4: Includes participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Interventions: intervention 1: Talimogene laherparepvec intervention 2: Pembrolizumab
Intervention descriptions: intervention 1: Intralesional injection into injectable cutaneous, subcutaneous and nodal legions. intervention 2: Intravenous (IV) infusion.

Protocol documents:
Prot_000.pdf: 
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Product:  Talimogene Laherparepvec
Protocol Number:  20180115
Date:  10 March 2020
Page 1 of 27
CONFIDENTIAL
Amendment 2
Protocol Title:  Phase 2 Study of Talimogene Laherparepvec in Combination With 
Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d 
Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy
Amgen Protocol Number (talimogene laherparepvec) 20180115
EudraCT number 2019-001906-61
NCT number:  NCT04068181
Amendment Date:
10 March 2020
Rationale:
This protocol is being amended to:
!
Add new exclusion criterion to exclude subjects who experience disease progression 
on more than 1 line of prior anti-programmed cell death-1 (PD-1) therapy.
!
Align contraception requirements with Amgen Global Protocol template, including 
updates to and addition of new exclusion criterion for male subjects
!
Align with the program level frequency of follow-up for patients who achieve a 
complete response. 
!
Add a Per Protocol Analysis Set (PPAS), which is a subset of the Full Analysis Set 
(FAS) in the efficacy analysis
!
Update Table 7-2 – Dose Modification and Toxicity Management Guidelines for 
Immune-related Adverse Events Associated with Pembrolizumab to align with the 
Keytruda∀European Union (EU) Summary of Product Characteristics (SmPC).
!
Clarify Tumor Response Assessments:
#
Correct administrative/grammatical errors
!
Administrative, typographical, and formatting changes were made throughout the 
protocol.
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SAP_001.pdf: 
Product: Talimogene Laherparepvec (T-VEC) 
Protocol Number:  20180115 
Date:  12 August 2021 
Page 1 of 36 
CONFIDENTIAL  
FORM-008180 v. 17.0, 29 April 2020 
 
Statistical Analysis Plan 
Protocol Title: 
Phase 2 Study of Talimogene Laherparepvec in 
Combination With Pembrolizumab in Subjects With 
Unresectable/Metastatic Stage IIIB-IVM1d Melanoma 
Who Have Progressed on Prior Anti-PD-1 Based Therapy 
Short Protocol Title: 
MASTERKEY-115 
Protocol Number: 
20180115 
NCT Number: 
NCT04068181 
Authors: 
Sponsor: 
Amgen Inc. 
One Amgen Center Drive, Thousand Oaks, CA, 91320, 
USA 
SAP Date: 
Document Version 
Date 
Original (v1.0) 
20 March 2020 
Amendment 1 (v2.0) 
12 August 2021 
 


Product: Talimogene Laherparepvec (T-VEC) 
Protocol Number:  20180115 
Date:  12 August 2021 
Page 2 of 36 
CONFIDENTIAL  
FORM-008180 v. 17.0, 29 April 2020 
 
Version Number 
Date 
(DDMMMYYYY) 
Summary of Changes,  
including rationale for changes 
Original (v1.0) 
20MAR2020 
 
Amendment 1 (v2.0) 
12AUG2021 
 
Updated the date for this SAP 
amendment 
 
Updated the List of Abbreviations 
 
Updated the Introduction 
 
Updated the Section 3.2 Sample size 
a total of 72 subjects were enrolled in 
the study (instead of N = 100 subjects 
planned at the beginning of the 
study). 
 
Updated the Section 5. Definition  
Best overall response (iBOR) per 
modified irRC-RECIST 
From: 
… For the derivation of iBOR, the 
overall visit response will be 
considered iSD if it is an unconfirmed 
iCR or iPR, and iUE if it is either iSD 
earlier than 84 days after the date of 
first dose or an unconfirmed iPD 
when confirmation of iPD is required 
(ie, initial iPD without clinical 
instability). … 
To: 
… For the derivation of iBOR, the 
overall visit response will be 
considered iSD if it is an unconfirmed 
iCR or iPR, and iUE if it is either iSD 
earlier than 77 days after the date of 
first dose or an unconfirmed iPD 
when confirmation of iPD is required 
(ie, initial iPD without clinical 
instability). … 
And the corresponding Table 5-1.  
Matrix of Determining iBOR per 
Modified irRC-RECIST 
 
Updated the Section 5. Definition  
Best overall response (iBOR) per 
modified irRC-RECIST 
 
Updated the Section 5. Definition  
Best overall response (BOR) per 
modified RECIST 1.1 
From: 


Product: Talimogene Laherparepvec (T-VEC) 
Protocol Number:  20180115 
Date:  12 August 2021 
Page 3 of 36 
CONFIDENTIAL  
FORM-008180 v. 17.0, 29 April 2020 
 
… For the derivation of BOR, the 
overall visit response will be 
considered UE if it is SD earlier than 
84 days after the date of first dose. … 
To: 
… For the derivation of BOR, the 
overall visit response will be 
considered UE if it is SD earlier than 
77 days after the date of first dose. … 
 
Updated the Section 5. Definition  
Lesion-level 
From: 
Lesion-level endpoints will be 
censored on or after the earliest 
event of the start of the first 
subsequent anticancer therapy, 
merger with another lesion, or 
resection (except if pathology result 
indicates absence of melanoma). … 
To: 
Lesion-level endpoints will be 
censored at the earliest event of after 
the start of the first subsequent 
anticancer therapy, on or after 
merger with another lesion, or on or 
after resection (except if pathology 
result indicates absence of 
melanoma). … 
 
Updated the Section 5. Definition  
PD-L1 Status 
From: 
PD-L1 expression from tumor biopsy 
tissue samples will be reported as 
positive or negative. PD-L1 
expression is said to have positive 
status if the tumor performance 
score (TPS) is ≥ 1%, and negative 
status if TPS is <1%. 
To: 
PD-L1 expression is said to have 
positive status if the combined 
positive score (CPS) is ≥ 1%, and 
negative status if CPS is <1%. 
 
Updated the Section 9.6.1 Adverse 
Events  
From “A listing of all AEs, EOIs for 
talimogene laherparepvec and 
pembrolizumab ECI will be provided. 
Listing of SAEs reported with event 
onset 90 days after the last dose of 
study therapy or 30 days after last 


Product: Talimogene Laherparepvec (T-VEC) 
Protocol Number:  20180115 
Date:  12 August 2021 
Page 4 of 36 
CONFIDENTIAL  
FORM-008180 v. 17.0, 29 April 2020 
 
dose of study therapy if the subject 
initiates new anticancer therapy, 
whichever is earlier, will be provided.” 
To: 
“A Listing will be provided for 
treatment-emergent adverse events 
and treatment-emergent serious 
adverse events. In addition, death on 
study will be listed.” 
 


Product: Talimogene Laherparepvec (T-VEC) 
Protocol Number:  20180115 
Date:  12 August 2021 
Page 5 of 36 
CONFIDENTIAL  
FORM-008180 v. 17.0, 29 April 2020 
 
Table of Contents 
1. 
Introduction ............................................................................................................. 9 
2. 
Objectives, Endpoints and Hypotheses ................................................................... 9 
2.1 
Objectives and Endpoints/Estimands .......................................................... 9 
2.2 
Hypotheses and/or Estimations ................................................................. 11 
3. 
Study Overview .................................................................................................... 11 
3.1 
Study Design ............................................................................................. 11 
3.2 
Sample Size .............................................................................................. 12 
3.3 
Adaptive Design ........................................................................................ 12 
4. 
Covariates and Subgroups ................................................................................... 12 
4.1 
Planned Covariates ................................................................................... 12 
4.2 
Subgroups ................................................................................................. 13 
5. 
Definitions ............................................................................................................. 13 
6. 
Analysis Sets ........................................................................................................ 21 
6.1 
Full Analysis Set........................................................................................ 21 
6.2 
Safety Analysis Set ................................................................................... 21 
6.3 
Per Protocol Set(s) .................................................................................... 22 
6.4 
Study-specific Analysis Sets...................................................................... 22 
6.4.1 
qPCR Suspicious Lesion Swab Analysis Set ............................. 22 
....... 23 
....... 23 
....... 23 
....... 23 
....... 23 
....... 23 
7. 
Planned Analyses ................................................................................................. 23 
7.1 
Interim Analysis and Early Stopping Guidelines ........................................ 23 
7.2 
Primary Analysis ....................................................................................... 25 
7.3 
Final Analysis ............................................................................................ 25 
8. 
Data Screening and Acceptance ........................................................................... 25 
8.1 
General Principles ..................................................................................... 25 
8.2 
Data Handling and Electronic Transfer of Data ......................................... 25 
8.3 
Handling of Missing and Incomplete Data ................................................. 25 
8.4 
Detection of Bias ....................................................................................... 26 
8.5 
Outliers ..................................................................................................... 26 
8.6 
Distributional Characteristics ..................................................................... 26 
8.7 
Validation of Statistical Analyses ............................................................... 26 


Product: Talimogene Laherparepvec (T-VEC) 
Protocol Number:  20180115 
Date:  12 August 2021 
Page 6 of 36 
CONFIDENTIAL  
FORM-008180 v. 17.0, 29 April 2020 
 
9. 
Statistical Methods of Analysis.............................................................................. 26 
9.1 
General Considerations ............................................................................. 26 
9.2 
Subject Accountability ............................................................................... 27 
9.3 
Important Protocol Deviations ................................................................... 27 
9.4 
Demographic and Baseline Characteristics ............................................... 27 
9.5 
Efficacy Analyses ...................................................................................... 28 
9.5.1 
Analyses of Primary Efficacy Endpoint(s)/Estimand(s) .............. 28 
9.5.2 
Analyses of Secondary Efficacy Endpoint(s).............................. 28 
9.5.3 
Analyses of Exploratory Efficacy Endpoint(s) ............................. 29 
...... 29 
...... 29 
9.6 
Safety Analyses ........................................................................................ 29 
9.6.1 
Adverse Events ......................................................................... 29 
9.6.2 
Laboratory Test Results ............................................................ 30 
9.6.3 
Vital Signs ................................................................................. 30 
9.6.4 
Physical Measurements ............................................................ 30 
9.6.5 
Electrocardiogram ..................................................................... 31 
9.6.6 
Antibody Formation ................................................................... 31 
9.6.7 
Exposure to Investigational Product .......................................... 31 
9.6.8 
Exposure to Concomitant Medication ........................................ 31 
9.7 
Other Analyses ......................................................................................... 31 
............................................ 32 
10. 
Changes From Protocol-specified Analyses.......................................................... 32 
11. 
Literature Citations / References ........................................................................... 32 
12. 
Appendices ........................................................................................................... 33 
 
List of Table 
Table 5-1.  Matrix of Determining iBOR per Modified irRC-RECIST ............................... 14 
 
List of Appendices 
Appendix A.  Reference Values/Toxicity Grades ........................................................... 34 
Appendix B.  Technical Detail and Supplemental Information Regarding 
Statistical Procedures and Programs ...................................................... 36 
 


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List of Abbreviations 
 
Abbreviation 
Explanation 
AE 
Adverse Event 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BOR 
best overall response 
BRAFv600 
serine/threonine protein kinase B-Raf V600 
CI 
confidence interval 
CIF 
CRF 
Cumulative Incidence Function 
case report form 
CPS 
combined positive score 
CR 
complete response (by modified RECIST 1.1) 
CRR 
complete response rate (by modified RECIST 1.1) 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCR 
disease control rate (by modified RECIST 1.1) 
DOR 
duration of response (by modified RECIST 1.1) 
DRR 
durable response rate (by modified RECIST 1.1) 
DRT 
data review team 
ECG 
electrocardiogram 
ECI 
events of clinical interest 
ECOG PS 
Eastern Cooperative Oncology Group Performance Status 
FAS 
Full Analysis Set 
HSV 
herpes simplex virus 
iCR 
complete response (by modified irRC-RECIST) 
iCRR 
complete response rate (by modified irRC-RECIST) 
iDCR 
disease control rate (by modified irRC-RECIST) 
iDRR 
durable response rate (by modified irRC-RECIST) 
iDOR 
duration of response (by modified irRC-RECIST) 
iORR 
objective response rate (by modified irRC-RECIST) 
iPD 
iPR 
progressive disease (by modified irRC-RECIST) 
partial response (by modified irRC-RECIST) 
iPFS 
progression free survival (by modified irRC-RECIST) 
irRC-RECIST 
immune-related Response Criteria simulating Response 
Evaluation Criteria in Solid Tumors 
iSD 
stable disease (by modified irRC-RECIST) 
KM 
Kaplan-Meier 


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LDH 
lactate dehydrogenase 
NCT 
ND 
National Clinical Trials 
Not done 
ORR 
objective response rate (by modified RECIST 1.1) 
OS 
overall survival (by modified RECIST 1.1) 
PD 
Progressive disease (by modified RECIST 1.1) 
PD-1 
programmed cell death-1  
PD-L1 
programmed cell death-1 ligand 1 
PFS 
progression free survival (by modified RECIST 1.1) 
PR 
partial response (by modified RECIST 1.1) 
qPCR 
real-time polymerase chain reaction 
RECIST 
Response Evaluation Criteria in Solid Tumor 
SAS 
Safety Analysis Set 
SD 
Stable disease (by modified RECIST 1.1) 
TEAE 
Treatment Emergent Adverse Event 
UE 
Unevaluable 
ULN 
upper limit of normal 
 


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1. 
Introduction 
The purpose of this Statistical Analysis Plan (SAP) is to provide details of the statistical 
analyses that have been outlined within the protocol for study 20180115, Talimogene 
Laherparepvec (T-VEC), Amendment 3 dated 09 June 2021.  The scope of this plan 
includes the futility analysis, the primary analysis and the final analysis that are planned 
and will be executed by the Amgen Global Biostatistical Science department unless 
otherwise specified. 
2. 
Objectives, Endpoints and Hypotheses 
2.1 
Objectives and Endpoints 
 
Objectives 
Endpoints 
Primary 
 
To evaluate the efficacy of 
talimogene laherparepvec in 
combination with pembrolizumab as 
assessed by objective response rate 
(ORR) in subjects with 
unresectable/metastatic stage IIIB-
IVM1d melanoma who have 
progressed on prior anti-PD-1 therapy 
 
Overall response (complete 
response [CR]+partial response [PR]) 
(by investigator assessment using 
modified RECIST v1.1) 
Key Secondary 
 
To evaluate the efficacy of 
talimogene laherparepvec in 
combination with pembrolizumab, 
as assessed by: 
o Complete response rate (CRR), 
best overall response (BOR), 
durable response rate (DRR), 
duration of response (DOR), and 
disease control rate (DCR) 
o ORR using modified 
irRC-RECIST 
o Progression free survival (PFS)  
o Overall survival (OS) 
 
Complete response, BOR, durable 
response, DOR and disease 
control, (investigator assessment 
using modified RECIST 1.1 and 
modified irRC-RECIST) and 
overall response using modified 
irRC-RECIST by investigator 
assessment  
 
PFS (by investigator assessment 
using modified RECIST 1.1 and 
modified irRC-RECIST)  
 
OS 
 
To evaluate the safety of 
talimogene laherparepvec in 
combination with pembrolizumab as 
assessed by incidence of 
treatment-emergent and treatment-
related adverse events, and abnormal 
laboratory tests in patients who have 
progressed on prior anti-PD-1 therapy 
 
Incidence of treatment-emergent 
and treatment-related adverse events 
(all adverse events, grade ≥ 3 adverse 
events, serious adverse events, fatal 
adverse events, adverse events 
defined as events of interest), and 
abnormal laboratory tests 


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 
To evaluate time to subsequent 
anticancer therapy 
 
Time to subsequent anticancer 
therapy 
 
Exploratory 
 
 


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2.2 
Hypotheses and/or Estimations 
No formal hypothesis testing will be performed.  All analyses will be descriptive in nature. 
3. 
Study Overview 
3.1 
Study Design 
This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate 
the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab 
following disease progression on prior anti-PD-1 therapy in unresectable/metastatic 
melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting.   
Subject must have received prior anti-PD-1 therapy for at least 2 to 3 consecutive cycles 
within an 8-week period (based on administration schedule) and have disease 
progression as defined by RECIST 1.1 criteria.  The initial evidence of disease 
progression must have been confirmed by a second assessment no less than 4 weeks 
from the first documented disease progression, in the absence of rapid clinical 
progression.  The anti-PD-1 therapy must be the immediate prior line of therapy before 
enrollment and subjects with disease progression on more than 1 line of anti-PD-1 
therapy are not eligible. 
Subjects will be enrolled into 1 of 4 cohorts based on prior anti-PD-1 experience: 
 
Cohort 1 – Locally Recurrent/Metastatic - Primary Resistance  
Subjects who received anti-PD1 therapy in the locally recurrent/metastatic setting 
and experienced a best overall response of disease progression or stable 
disease prior to confirmed disease progression.  The initial date of disease 
progression must be within 12 weeks of the last dose of a PD-1 inhibitor.   
 
Cohort 2 – Locally Recurrent/Metastatic - Acquired Resistance 
Subjects who received anti-PD-1 therapy in the locally recurrent/metastatic 
setting and experienced confirmed disease progression following a complete or 
partial response on anti-PD-1 therapy.  The disease progression must occur 
within 12 weeks of the last dose of a PD-1 inhibitor.  
 
Cohort 3 – Adjuvant Setting – Disease Free Interval < 6 months 
Subjects who received anti-PD-1 therapy in the adjuvant setting and experienced 
confirmed disease progression following a disease free interval of < 6 months 
after starting the adjuvant anti-PD-1 therapy. 
 
Cohort 4 – Adjuvant Setting – Disease Free Interval ≥ 6 months 


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Subjects who received anti PD-1 therapy in the adjuvant setting and experienced 
confirmed disease progression following a disease free interval of ≥ 6 months 
after starting the adjuvant PD-1 inhibitor. 
3.2 
Sample Size 
This is a single-arm estimation study.  It is assumed that if the ORR using modified 
RECIST v1.1 is at least 25%, for this study (N = 100) the lower bound of the 
95% confidence interval for an objective response is > 15%. 
The 95% CIs for different sample sizes with an assumed ORR of 25% are presented 
below: 
Subjects Enrolled 
N 
Assumed ORR 
N (%) 
95% CI 
% 
Width 
% 
15 
4 (26.7) 
7.8, 55.1 
47.3 
30 
8 (26.7) 
12.3, 45.9 
33.6 
40 
10 (25) 
12.7, 41.2 
28.5 
70 
18 (25.7) 
16.0, 37.6 
21.6 
72 
18 (25.0) 
15.5, 36.6 
21.0 
100 
25 (25) 
16.9, 34.7 
17.8 
Actual number of subjects enrolled in the study: a total of 72 subjects were 
enrolled in the study (instead of N = 100 subjects planned at the beginning of the 
study). Twenty-seven subjects were enrolled into cohort 1 and 15 subjects were 
enrolled into cohorts 2, 3, and 4.   
3.3 
Adaptive Design 
Futility analyses are planned for each of cohorts 1 and 2, separately.  The futility criteria 
are detailed in Section 7.1. 
4. 
Covariates and Subgroups 
4.1 
Planned Covariates 
No covariate analyses will be performed. 


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4.2 
Subgroups 
Efficacy analyses on ORR and DCR will be repeated within the following 
subgroups, overall with cohorts pooled and separately for each cohort: 
 
Sex (female, male) 
 
Age at enrolment (<50, ≥50; < 65, ≥ 65; < 75, ≥ 75 years) 
 
Region (Europe, Non-Europe) 
 
PD-L1 status (positive, negative, missing/unknown) at baseline 
 
Disease stage (stage IVM1a or lower, stage IVM1b/c/d) at baseline 
 
Disease stage (stage IVM1b or lower, stage IVM1c/d) at baseline 
 
BRAFV600 mutation at baseline (yes, no) 
 
LDH (≤ ULN, > ULN; ≤ 2 x ULN, > 2 x ULN) 
 
ECOG PS (0, 1) 
 
HSV-1 serostatus at baseline (positive, negative, missing/unknown) 
 
In-transit disease at baseline (yes, no) 
 
Prior PD-1 therapy (nivolumab, ipilimumab/nivolumab, pembrolizumab, other) 
 
Prior anti-cancer therapy and line of therapy for current malignancy 
 
Prior surgery for current malignancy 
 
Prior radiotherapy for current malignancy 
5. 
Definitions 
 
Baseline 
Baseline in general refers to study day 1. The baseline value of a parameter (eg, vital 
signs, laboratory tests, and tumor measurement) is considered to be the latest value prior 
to receiving any study drug (i.e., on or prior to the first date of dosing). Parameters that 
are obtained on the same day as the first date of dosing are assuming to be pre-dose if 
the exact time of the baseline parameter relative to the first dose of any study drug is 
unknown. For subjects who are not dosed, the baseline value of a parameter is considered 
to be the latest value prior to the enrollment date.  BRAF mutational status, which is not 
sensitive to treatment, will be considered baseline regardless of the timing of 
ascertainment.  
 
Best overall response (iBOR) per modified irRC-RECIST 
iBOR of complete response (iCR), partial response (iPR), stable disease (iSD), 
progressive disease (iPD) or unevaluable (iUE) will be derived per modified irRC-RECIST 
based on investigator assessment. Overall visit response assessments occurring after the 
start of the first subsequent anticancer therapy will not be included. With the exception of 
a PD observation, overall visit response assessments occurring on or after a complete or 


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partial removal/reduction of any target lesion which contained melanoma on pathology 
evaluation or pathology results were unknown will not be included. The timepoint 
responses after initial confirmed iPD will not be used to derive BOR. Confirmation of iCR, 
iPR, and iPD is required as noted in the individual definitions for iCR, iPR and iPD per 
modified irRC-RECIST (refer to protocol Appendix 10). For the derivation of iBOR, the 
overall visit response will be considered iSD if it is an unconfirmed iCR or iPR, and iUE if 
it is either iSD earlier than 77 days after the date of first dose or an unconfirmed iPD when 
confirmation of iPD is required (ie, initial iPD without clinical instability). As indicated in 
Table 5.1, iBOR is defined as the best overall visit response in the following order: iCR, 
iPR, iSD, iPD, or iUE. 
Table 5.1  Matrix of Determining iBOR per Modified irRC-RECIST 
Visit Overall 
Response 
Sequence 
Examples 
Best 
Overall 
Response 
Specifications 
*, iCR, iCR,* 
iPR, iCR, iCR 
iCR, iCR, iPD 
iCR 
A confirmatory iCR must be at least 4 
weeks (28 days) later; a subsequent iCR 
within 28 days will not be valid for 
confirmation and will be ignored; the 
iCR will also not be confirmed if there is 
a subsequent iPR/iSD/iPD at any time 
prior to the next iCR. 
:*, iPR, iPR, * 
*, iPR, iCR/iPR, 
non-iCR, * 
iPR, iPR, iPD 
iPR, iCR, iPD 
iCR, iPR, iPD 
iPR 
Criteria for iBOR=iCR not met. 
A confirmatory iPR/iCR must be no less 
than 4 weeks (28 days) later; a 
subsequent iPR/iCR within 28 days will 
not be valid for confirmation and will be 
ignored; the iPR will also not be 
confirmed if there is a 
subsequent iSD/iPD at any time prior to 
the next iPR/iCR. 
*, iSD, * 
*,iCR, non-
iPR/iCR, 
* 
*,iPR, non-iPR/iCR, 
* 
iCR 
iPD, iCR 
iPR 
iPD, iPR, iSD 
iSD 
iPD,iSD,iPD 
iSD 
Criteria for iBOR=iCR or iPR not met. 
iSD must be ≥ 77 days from date of 
first dose; however, this is not 
required for an unconfirmed iCR/iPR. 


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*,iPD, iPD, * 
*, iPDci, * 
iPD, iPD 
iPD, iSD, iPD, 
iPD 
iPD, iUE, iPD 
iPDci 
iPD 
Criteria for iBOR= iCR, iPR, or iSD not 
met. 
A consecutive confirmatory iPD must be 
no less than 4 weeks (28 days) later 
unless the initial progression qualified 
for iPDci.; 
iPDci = the last available iPD 
“Nonconfirmed Disease 
Progression with Clinical Instability” as 
the reason for ending radiographic 
follow-up. 
*, iSD, * 
iPD 
iSD 
iUE, iSD 
iPD 
iUE, iPD 
iUE 
Criteria for iBOR=iCR, iPR, iSD, or iPD 
not met. 
iSD must be < 77 days from date of 
first dose. 
 
Best overall response (BOR) per modified RECIST 1.1 
BORs will be derived based on investigator assessment using modified RECIST 1.1 
(Eisenhauer et al. 2009). Per RECIST 1.1, a confirmation of CR or PR by a consecutive 
subsequent tumor assessment will not be required for the derivation of BOR. Overall visit 
response assessments occurring after the start of the first subsequent anticancer therapy 
will not be included. With the exception of a PD observation, overall visit response 
assessments occurring on or after a complete or partial removal/reduction of any target 
lesion which contained melanoma on pathology evaluation or pathology results were 
unknown will not be included. The timepoint responses after initial PD will not be used to 
derive BOR. For the derivation of BOR, the overall visit response will be considered UE if 
it is SD earlier than 77 days after the date of first dose. BOR is defined as the best overall 
visit response up to and including the first overall visit response of PD in the following 
order: CR, PR, SD, PD or UE.  
 
Complete response rate (iCRR) per modified irRC-RECIST 
Complete response rate (iCRR) per modified irRC-RECIST is defined as the incidence of 
an iBOR of iCR per modified irRC-RECIST. 
 
Complete response rate (CRR) per modified RECIST 1.1 
Complete response rate (CRR) per modified RECIST 1.1 is defined as the incidence of a 
BOR of CR per modified RECIST 1.1. 


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 
Disease control rate (iDCR) per modified irRC-RECIST 
Disease control rate (iDCR) per modified irRC-RECIST is defined as the incidence of an 
iBOR of iCR, iPR or iSD.  
 
Disease control rate (DCR) per modified RECIST 1.1 
Disease control rate (DCR) per modified RECIST 1.1 is defined as the incidence of a BOR 
of CR, PR or SD.  
 
Duration of response (iDOR) per modified irRC-RECIST 
Duration of response (iDOR) is defined as the time from the date of an initial response 
that is subsequently confirmed to the earlier of iPD (see definition of iBOR per modified 
irRC-RECIST) or death. Subjects who have not ended their response at the time of 
analysis will be censored at their last evaluable tumor assessment before the start of the 
first subsequent anticancer therapy. 
 
Duration of response (DOR) per modified RECIST 1.1  
Duration of response (DOR) is defined as the time from the date of an initial response of 
CR or PR to the earlier of PD (see definition of BOR per modified RECIST 1.1) or death. 
Subjects who have not ended their response at the time of analysis will be censored at 
their last evaluable tumor assessment date before start of the first subsequent anticancer 
therapy.  
 
Durable response rate (iDRR) per modified irRC-RECIST 
iDRR is defined as the percent of subjects with an iCR or iPR per modified irRC-RECIST 
with an iDOR ≥ 6 months. One month will be calculated based on 365.25 days per year.  
 
Durable response rate (DRR) per modified RECIST 1.1 
DRR is defined as the percent of subjects with a CR or PR per modified RECIST 1.1 with 
a DOR ≥ 6 months. One month will be calculated based on 365.25 days per year.  
 
End of study (trial) date 
The end of study date is defined as the date when the last subject across all sites is 
assessed or receives an intervention for evaluation in the study (i.e., last subject last visit), 
following any additional parts in the study (e.g., long-term follow-up), as applicable. 
 
Evaluable tumor assessment 
An overall visit response other than unevaluable (UE or iUE). 
 
Events of clinical interest pembrolizumab 


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Selected non-serious and serious adverse events known as pembrolizumab events of 
clinical interest (ECI) that occur after the first dose of pembrolizumab through 
90 (+7) days after the last dose of pembrolizumab, or 30 (+7) days after initiation of a 
new anticancer therapy, whichever is earlier must be reported to Amgen within 24 hours. 
 
Events of interest (EOI) for talimogene laherparepvec 
EOIs for talimogene laherparepvec are defined in the version-controlled EOI search 
strategies maintained by Global Regulatory Affairs and Safety (GRAAS) at Amgen for 
talimogene laherparepvec 
 
Investigational product (IP) 
Investigational product (IP) refers to Amgen IP talimogene laherparepvec and non-Amgen 
IP pembrolizumab in this study. IP is also referred as study drug or study therapy. 
 
Last date known to be alive 
For subjects not known to have died, their last date known to be alive will be determined 
as the latest date associated with clinic visits before data cutoff date including, for 
example, but not limited to the following: 
1. Survival status: Last subject status date if status of subject is “Alive”  
2. End of study date if the subject’s primary reason for ending study is not “Lost to 
follow-up” 
3. Any subsequent anti‐tumor therapy initialization date 
4. AE start or end date 
5. Procedure and concomitant medication start/end date  
6. Date of lesion assessments 
7. Date of herpetic lesion swabbing 
8. Visit date of vital signs; physical exam; ECOG; sample collection for local lab and 
central lab parameters including HSV‐1 
9. Date of last investigational product administration 


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 
Objective response rate (ORR) per modified RECIST 1.1 


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ORR is defined as the incidence of a BOR of CR or PR per modified RECIST 1.1. Subjects 
who do not have any post-baseline tumor assessments will be regarded as non-
responders. 
 
Objective response rate (iORR) per modified irRC-RECIST 
iORR is defined as the incidence of an iBOR of iCR or iPR per modified irRC-RECIST. 
Subjects who do not have any post-baseline tumor assessments will be regarded as non-
responders. 
 
Overall survival (OS)  
Overall survival is defined as the interval from first dose to death from any cause. Subjects 
without an event will be censored at the last date known to be alive. 
 
PD-L1 Status  
PD-L1 expression from tumor biopsy tissue samples will be reported as positive or 
negative. PD-L1 expression is said to have positive status if the combined positive score 
(CPS) is ≥ 1%, and negative status if CPS is <1%. 
 
Primary completion date 
The primary completion date is defined as the date when the last subject is assessed or 
receives an intervention for the final collection of data for the primary endpoints for the 
purpose of conducting the primary analysis, whether the study concluded as planned in 
the protocol or was terminated early. 
The primary completion date is the date when the last subject has completed the 
assessments for week 24. 
 
Progression-free survival (iPFS) per modified irRC-RECIST  
iPFS per modified irRC-RECIST is defined as the interval from first dose to the earlier 
event of iPD (per modified irRC-RECIST) or death from any cause. Subjects without an 
event will be censored at their last evaluable post-baseline tumor assessment if available, 
otherwise will be censored on study day 1. 
 
Progression-free survival (PFS) per modified RECIST 1.1 
PFS per modified RECIST 1.1 is defined as the interval from first dose to the earlier event 
of PD (per modified RECIST 1.1) or death from any cause. Subjects without an event will 
be censored at their last evaluable post-baseline tumor assessment if available, otherwise 
will be censored on study day 1.  


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 
Safety follow-up visit  
Safety follow-up visit will be performed approximately 30 (+7) days after the last dose of 
IP. If an end of treatment decision occurs > 30 (+7) days after the last treatment date, then 
safety follow-up will be performed as soon as possible (eg, within a week of end of 
treatment decision). 
 
Serious adverse event (SAE) 
Serious adverse events (SAE) are defined as any adverse event categorized as serious 
as determined by investigator per protocol defined criteria. 
 
Study day 
Study day is calculated from the first day IP is administered (i.e. non-zero dosing).   
If visit date is on or after first dose date then: 
                                      Study day = visit date – first dose date + 1 
if visit date is before first dose date then: 
                                      Study day = visit date – first dose date 
 
Study week 0 
The start of IP administration (i.e. non-zero dosing) to the subject is study week 0.  Study 
day 1 is corresponding to study week 0. 
 
Time to subsequent anticancer therapy 
Time to subsequent anticancer therapy is defined as the time from enrollment to the start 
of subsequent anticancer therapy.  Subjects who have not started subsequent 
anticancer therapy will be censored on their last visit date.  
 
Treatment-emergent adverse events (TEAE) 
Treatment-emergent adverse events are defined as any adverse event occurring after 
initiation of the first dose of study therapy through 30 days after the last administration of 
study therapy. Adverse events that occur on the same day as the first dose date of study 
therapy will be treated as treatment-emergent events unless indicated otherwise (for 
example, if an event occurs on the same date as the first administration of study therapy 
and the check box indicating prior to the first dose of study therapy is checked on eCRF, 
then the event will not be counted as a treatment-emergent AE).  
 
Treatment-emergent serious adverse events (TESAE) 


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Treatment-emergent serious adverse events are defined as any SAE occurring after 
initiation of the first dose of study therapy through 90 days after the last administration of 
study therapy or 30 days after the last administration of study therapy if the subject 
initiates new anti-cancer therapy, whichever is earlier.  
SAEs that occur on the same day as the first dose date of study therapy will be treated 
as treatment-emergent SAEs unless indicated otherwise (for example, if an event occurs 
on the same date as the first administration of study therapy and the check box 
indicating prior to the first dose of study therapy is checked on eCRF, then the event will 
not be counted as a treatment-emergent SAE). 
 
Treatment period 
Treatment period is defined as the period between the first date of study therapy 
administration and 30 days after the last study therapy administration. 
6. 
Analysis Set 
6.1 
Full Analysis Set 
The Full Analysis Set (FAS) is defined as all enrolled subjects who have received at least 
1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. The 
FAS will be used in the analysis of the efficacy endpoints.  
6.2 
Safety Analysis Set 
The Safety Analysis Set (SAS), defined as all enrolled subjects who received at least 
1 dose of talimogene laherparepvec or pembrolizumab, will be used in the analysis of 
the safety endpoints. 


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6.3 
Per Protocol Set(s) 
The Per Protocol Analysis Set (PPAS) is a subset of the FAS which includes subjects 
who do not have important protocol deviations that are considered to have an impact on 
efficacy outcomes. 
Subjects with any of the following eligibility criteria for important protocol deviations will 
be removed from the PPAS: 
 
Subject does not have histologically confirmed diagnosis of melanoma  
 
Subject does not have unresectable or metastatic melanoma, defined as either  
 
Stage IIIB, IIIC, IIID, IVM1a, IVM1b, or IVM1c; 
OR 
 
Stage IVM1d with up to 3 cerebral metastases, provided that all lesions have 
been adequately treated with stereotactic radiation therapy, craniotomy, or 
gamma knife therapy, with no evidence of progression and not requiring steroids 
for at least 2 months prior to enrollment. 
 
Subject is not a candidate for intralesional therapy, and a candidate is defined as 
either one of the following: 
 
At least one injectable cutaneous, subcutaneous, or nodal melanoma lesion 
equal to or greater than 10 mm in longest diameter; 
OR 
 
Multiple injectable melanoma lesions which in aggregate have a longest diameter 
of equal to or greater than 10 mm 
Additionally, the subjects with any of the following important protocol deviations related 
to prior PD-1 inhibitor use will be removed from the PPAS:  
 
Subject has not received prior treatment with a PD-1 inhibitor in the adjuvant or 
metastatic setting (monotherapy or in combination with anti-CTLA-4).  Combinations 
other than anti-PD-1 plus anti-CTLA-4 must have been reviewed with the medical 
monitor for approval. 
 
Subject has not received prior anti-PD-1 therapy for at least 2 to 3 consecutive 
cycles within an 8-week period (based on administration schedule). 
 
Subject for whom the anti-PD-1 therapy is not the immediate prior line of therapy 
before enrollment. 
The PPAS will be used in the analysis of the select efficacy endpoints. 
6.4 
Study-specific Analysis Sets 
6.4.1 
qPCR Suspicious Lesion Swab Analysis Set 
The qPCR Suspicious Lesion Swab Analysis Set will include subjects who are in the 
FAS, receive at least one dose of talimogene laherparepvec, and have at least one swab 
sample evaluable result from lesions suspicious to be herpetic in origin during the study. 


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Evaluable samples are sample with either positive, below quantification limit (BQL), or 
not detected results. 
7. 
Planned Analyses 
7.1 
Interim Analysis and Early Stopping Guidelines 
Futility analyses are not planned for cohorts 3 and 4. In cohorts 1 and 2, if there is at 
least 1 unconfirmed responder (PR/CR as per modified RECIST 1.1) in the first 10 


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subjects of a cohort, enrollment will continue in that cohort without a futility analysis. 
Otherwise, the DRT will oversee a futility analysis of unconfirmed response for cohorts 1 
and 2, performed separately and only once for each cohort, when 15 subjects within a 
cohort are evaluable for response (i.e. when 15 subjects have been treated and have 
had the opportunity to be followed for at least 12 weeks for tumor assessment). 
Screening in the respective cohort will be paused during the futility analysis. The below 
table presents the futility criteria: 
Number of Evaluable 
Subjects* at Futility Analysis 
Minimum Number of Subjects 
with an unconfirmed CR/PR 
to Continue 
Probability of Futility (%) 
True ORR = 25% 
15 
1 
< 5% 
* number of subjects treated and who have had the opportunity to be followed for at least 12 weeks for 
tumor assessment. 
When the true response is 25%, the probability of futility is < 5% with at least 
1 responder among 15 evaluable subjects.   
 
A data review team (DRT) will review safety data approximately every 3 months until the 
data snapshot for the primary analysis to ensure no avoidable increased risk for harm to 
subjects.  In addition, the DRT will oversee the futility analysis for each of cohorts 1 and 
2.  The DRT may request ad hoc meetings at any time.  The DRT also has a 
responsibility to review and evaluate study conduct to determine whether the study 
integrity may affect the ability of the DRT to fulfill its primary responsibility.  Therefore, 


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the DRT will review and evaluate eligibility/recruitment/retention of participants, 
management of participants, and adherence to protocol-specified criteria.  The DRT will 
make recommendations concerning the continuation or alteration of the study on the 
basis of its review of the data. 
The DRT will be comprised of an Amgen clinical research medical director, Amgen 
safety officer, and Amgen biostatistician who are external to the talimogene 
laherparepvec product team. 
Membership, procedures, and meeting timing will be described in the study DRT charter. 
7.2 
Primary Analysis 
The primary analysis will occur when all subjects treated with at least 1 dose of 
talimogene laherparepvec or pembrolizumab have had the opportunity to be followed for 
at least 24 weeks for tumor assessment. The database will be cleaned and a locked 
database will be used for this analysis. 
Before the primary analysis, ad hoc analyses may be conducted to support program 
level activities. 
7.3 
Final Analysis 
The final analysis will occur when all subjects have completed the study. The database 
will be cleaned and a locked database will be used for this analysis. 
8. 
Data Screening and Acceptance 
8.1 
General Principles 
The objective of the data screening is to assess the quantity, quality, and statistical 
characteristics of the data relative to the requirements of the planned analyses. 
8.2 
Data Handling and Electronic Transfer of Data 
The Amgen Global Study Operations-Data Management (GSO-DM) department will 
provide all data to be used in the planned analyses.  This study will use the RAVE 
database. 
8.3 
Handling of Missing and Incomplete Data 
Every effort will be made to obtain complete data in the clinical study. Partial or missing 
dates of adverse events and concomitant medications will be imputed. Adverse events 
with missing IP relatedness, seriousness, or CTCAE severity grades are included in 
TEAE as long as the events qualify for the reporting period. Events with missing 
relatedness, seriousness, and severity grades will be excluded from treatment-related, 
serious, and with a CTCAE grade of 3 or higher AE analysis, respectively.
 


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8.4 
Detection of Bias 
Lack of protocol compliance may introduce potential bias in the estimation of protocol 
endpoints. All important protocol deviations (IPDs) will be reported, documented and 
stored in eClinical (a clinical trial management system). IPD reports will be produced 
 by the study manager and will be regularly reviewed in the study team’s 
IPD review meetings as well as before analysis. 
8.5 
Outliers 
Descriptive statistics will be used to identify potential outliers in key variables. Suspected 
outliers will be included in all analyses unless there is sufficient scientific justification to 
exclude them. 
8.6 
Distributional Characteristics 
All binary endpoints will follow a binomial distribution. The KM estimates for the 
probability of time-to endpoints are based on non-parametric methods 
8.7 
Validation of Statistical Analyses 
Programs will be developed and maintained, and output will be verified in accordance 
with current risk-based quality control procedures.   
Tables, figures, and listings will be produced with validated standard macro programs 
where standard macros can produce the specified outputs.   
The production environment for statistical analyses consists of Amgen-supported 
versions of statistical analysis software; for example, the SAS System version 9.4 or 
later and qualified R. 
9. 
Statistical Methods of Analysis 
9.1 
General Considerations 
Unless otherwise specified, all safety analysis will be performed on the SAS and all 
efficacy analysis on the FAS. All analyses will be descriptive with no formal hypothesis 
testing. Analyses will be performed separately for each cohort. In addition, analyses with 
cohorts pooled together (all cohorts pooled, cohorts 1 and 2 pooled, and cohorts 3 and 4 
pooled) will be performed. Cohorts stopped for futility will not be pooled with other 
cohorts. Cohort data collected on the CRF will be used in the analysis. Cohort data will 
be checked and reviewed during the study to ensure that subjects are recorded in the 
correct cohort for analyses prior to database lock.  


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Continuous variables will be summarized by the non-missing sample size (n), mean, 
standard deviation, median, first and third quartiles, minimum, and maximum. 
Categorical variables will be summarized by the n and percentage in each category. 
Proportions and the corresponding 95% exact CIs will be provided (Clopper and 
Pearson, 1934). 
, time to event endpoints will be summarized 
with Kaplan-Meier (KM) (Kaplan and Meier, 1958) curves, KM estimates at selected time 
points, KM quartiles (when estimable), the number of subjects with events and the 
number of subjects censored. Accompanying 2-sided 95% CI for KM quartiles 
(Brookmeyer and Crowley, 1982) and KM estimates will be provided. 
9.2 
Subject Accountability 
The number of subjects enrolled will be tabulated by country and investigator site overall 
and by cohort. Subject disposition (including the number enrolled, treated, ended 
treatment, ended radiographic follow-up and that completed the safety follow-up visit and 
the study) will be summarized for all enrolled subjects overall and by cohort. Reasons for 
ending treatment, ending radiographic follow-up and not completing the 30-day safety 
follow-up visit will be provided overall and by cohort as well.  
Key study dates for the first subject enrolled, last subject enrolled, first subject treated, 
and last subject’s end of study will be presented. 
9.3 
Important Protocol Deviations 
Important Protocol Deviations (IPDs) categories are defined by the study team before 
the first subject’s initial visit and updated during the IPD reviews throughout the study 
prior to database lock.  These definitions of IPD categories, subcategory codes, and 
descriptions will be used during the course of the study.  Eligibility deviations are defined 
in the protocol. Eligibility deviations that are defined as IPDs will be summarized in both 
the IPD and Eligibility Deviation table and IPD and Eligibility Deviation listings. 
9.4 
Demographic and Baseline Characteristics 
Summary statistics of the following demographic and baseline disease characteristics 
will be tabulated using the Safety Analysis Set for the following:  
 
Sex (female, male) 
 
Age at enrolment (<50, ≥50; < 65, ≥ 65; < 75, ≥ 75 years) 
 
Region (Europe, Non-Europe) 
 
PD-L1 status (positive, negative, missing/unknown) at baseline 
 
Disease stage (stage IVM1a or lower, stage IVM1b/c/d) at baseline 
 
Disease stage (stage IVM1b or lower, stage IVM1c/d) at baseline 


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 
BRAFV600 mutation at baseline (yes, no) 
 
LDH (≤ ULN, > ULN; ≤ 2 x ULN, > 2 x ULN) 
 
ECOG PS (0, 1) 
 
HSV-1 serostatus at baseline (positive, negative, missing/unknown) 
 
In-transit disease at baseline (yes, no) 
 
Prior PD-1 therapy (nivolumab, ipilimumab/nivolumab, pembrolizumab, other) 
 
Prior anti-cancer therapy and line of therapy for current malignancy 
 
Prior surgery for current malignancy 
 
Prior radiotherapy for current malignancy 
9.5 
Efficacy Analyses 
Efficacy analysis will be performed on Full Analysis Set (FAS). Primary analysis for the 
primary efficacy endpoint as well as the key secondary efficacy endpoints will be 
repeated for the Per Protocol Analysis Set to assess the impact of IPDs. For key efficacy 
endpoints, sensitivity analyses excluding subjects who received more than one prior line 
of anti-PD-1 therapy may be performed.  The following sections describe analyses of 
efficacy endpoints. 
9.5.1 
Analyses of Primary Efficacy Endpoint(s)  
Descriptive statistics for the ORR (CR+PR) will be provided where tumor response 
evaluations are based on investigator assessments using modified RECIST 1.1. 
ORR (CR+PR) will be summarized with associated exact 95% confidence intervals (CIs) 
for binomial proportions (Clopper & Pearson 1934) (see code fragment in Appendix B). 
9.5.2 
Analyses of Secondary Efficacy Endpoint(s) 
CRR, BOR, DRR and DCR by investigator assessment using modified RECIST 1.1 and 
iORR, iCRR, iBOR, iDRR and iDCR by investigator assessment using modified irRC-
RECIST will be summarized with associated exact 95% CIs for binomial proportions 
(Clopper & Pearson 1934) (see code fragment in Appendix B). 
KM estimates and quartiles for DOR, iDOR, PFS , iPFS, OS and Time to subsequent 
anti-cancer therapy will be provided (Kaplan and Meier, 1958).  KM time to event curves 
will be presented. 
The impact of subsequent anti-cancer therapy on PFS, iPFS and OS will be assessed by 
censoring at the last evaluable tumor assessment prior to the start of the first 
subsequent anti-cancer therapy. 


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9.5.3 
Analyses of Exploratory Efficacy Endpoint(s) 
9.6 
Safety Analyses 
9.6.1 
Adverse Events 
Safety analyses will be conducted separately for each cohort on Safety Analysis Set 
(SAS). The Medical Dictionary for Regulatory Activities (MedDRA) version 21.1 or later 
will be used to code all adverse events (AE). The CTCAE version 5.0 or later will be 
used to grade severity of adverse events. 
The subject incidence of AEs will be summarized for all treatment-emergent AEs, 
serious AEs, AEs leading to withdrawal of investigational product, grade 3 or 4 AEs, fatal 
AEs, events of interests (EOIs) for talimogene laherparepvec and pembrolizumab events 
of clinical interest (ECI). Subject incidence of EOI/ECIs will be summarized by the 
EOI/ECI categories. Preferred terms within each EOI/ECI category will also be 
summarized. 


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The subject incidence of all treatment-related AEs, serious AEs, AEs leading to 
withdrawal of investigational product, grade ≥ 3 AEs, fatal AEs, and EOIs for talimogene 
laherparepvec will be tabulated by system organ class and preferred term in descending 
order of frequency. 
Summaries of treatment-emergent and serious AEs occurring in at least 5% of the 
subjects by preferred term will be provided in descending order of frequency. 
A Listing will be provided for treatment-emergent adverse events and treatment-
emergent serious adverse events. In addition, death on study will be listed. 
Potential or known unintended exposure to talimogene laherparepvec, related suspected 
signs or symptoms, and detection of talimogene laherparepvec in a subject’s household 
member, caregiver, or healthcare provider will be summarized. 
9.6.2 
Laboratory Test Results 
Laboratory results will be summarized for each cohort with descriptive statistics at 
baseline and selected time points for selected laboratory parameters. Shifts in grades of 
selected safety laboratory values between the baseline and the worst on-study value will 
be tabulated by cohort. 
The number and proportion of subjects in each cohort with positive qPCR for talimogene 
laherparepvec DNA detection in any swab of a lesion suspected to be herpetic in origin 
will be calculated based on the qPCR Suspicious Lesion Swab Analysis Set.  
Individual subjects having a positive qPCR results for talimogene laherparepvec DNA 
detection will be reviewed. 
A listing will be provided for subjects by assessed time point of qPCR analysis results 
(positive, and numeric value if quantifiable) for talimogene laherparepvec DNA in swab 
samples taken from cold sore, vesicles, and other lesions suspected to be herpetic in 
origin. 
9.6.3 
Vital Signs 
Descriptive statistics will be presented for systolic/diastolic blood pressure, heart rate, 
respiratory rate, and temperature for baseline, each post-baseline visit, change from 
baseline, and percent change from baseline for each cohort. 
9.6.4 
Physical Measurements 
Physical measurements will not be analyzed. 


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9.6.5 
Electrocardiogram 
The electrocardiogram (ECG) measurements from this clinical study were performed as 
per standard of care for routine safety monitoring, rather than for purposes of 
assessment of potential QT interval corrected (QTc) effect.  Because these evaluations 
may not necessarily be performed under the rigorous conditions expected to lead to 
meaningful evaluation of QTc data; neither summaries nor statistical analyses will be 
provided, and these data would not be expected to be useful for meta-analysis with data 
from other trials. 
9.6.6 
Antibody Formation 
Baseline HSV-1 serostatus will be summarized. The incidence of HSV-1 seroconversion 
will be summarized for subjects that are baseline seronegative. 
9.6.7 
Exposure to Investigational Product 
Summary statistics for exposure to talimogene laherparepvec, including total doses 
administered, total volume administered, duration from the first to the last administration 
of talimogene laherparepvec, and the average volume received by subject per visit will 
be provided and will be separated by the first (concentration of 106 PFU/ml) and 
subsequent doses (concentration of 108 PFU/ml). Subject incidence rate and reasons for 
IP delay and dose change/withheld will be tabulated.  
Exposure to pembrolizumab including total doses (in mg) administered, relative dose 
intensity, duration from the first to the last administration, and the average dose received 
by subject per visit will be provided. Subject incidence rate and reasons for IP delay, IP 
interruption and dose change/withheld will be examined. 
9.6.8 
Exposure to Concomitant Medication 
The number and proportion of subjects receiving therapies of interest will be 
summarized by preferred term or category for each cohort as coded by the World Health 
Organization Drug (WHO DRUG) dictionary.   
The number and proportion of subjects receiving subsequent anti-cancer therapies will 
be summarized by preferred term or category for each cohort as coded by the World 
Health Organization Drug (WHO DRUG) dictionary. 
9.7 
Other Analyses 
ECOG performance status scores will be summarized at each time point. Changes in 
scores for ECOG performance status scores from baseline will also be tabulated. 


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Spider plots for subject-level percent change from baseline in tumor burden by BOR per 
modified RECIST 1.1 and iBOR per modified irRC-RECIST and disease stage at 
baseline will be provided. Waterfall plots for subject-level maximum overall tumor burden 
reduction by BOR per modified RECIST 1.1 and iBOR per modified irRC-RECIST will 
also be summarized. Tumor assessments occurring after the start of the first subsequent 
anti-cancer therapy will be excluded from the analysis of tumor burden.  With the 
exception of tumor assessments with an increase of tumor burden ≥ 20% and also 
demonstrate ≥ 5 mm increase from nadir, tumor assessments occurring on or after the 
complete or partial removal/reduction of any target lesion with melanoma on pathology 
evaluation or unknown pathology results will also be excluded from the analysis of tumor 
burden. 
10. 
Changes From Protocol-specified Analyses 
Not applicable. 
11. 
Literature Citations / References 
Brookmeyer R and Crowley J. A confidence interval for the median survival time. 
Biometrics. 1982;38:29-41. 
Clopper, C. and Pearson, E. (1934) “The Use of Confidence or Fiducial Limits Illustrated 
in the Case of the Binomial,” Biometrika, 26, 404–413  
Eisenhauer, A., et al (2009) “New Response Evaluation in Solid Tumors: Revised 
RECIST Guideline (version 1.1)”, EJC, 45, 228-247.  
Kaplan EL, Meier P. Nonparametric Estimation from Incomplete Observations. J Am 
Stat Assoc. 1958;53:457-481. 
Lin, Guixian, Ying So, and Gordon Johnston. “Analyzing survival data with competing 
risks using SAS software.” SAS Global Forum. Vol. 2102. 2012. 
Pintilie, M. (2006) Competing Risks: A Practical Perspective. Wiley. 
http://dx.doi.org/10.1002/9780470870709 


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12. 
Appendices 


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Appendix A.  Reference Values/Toxicity Grades 


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Appendix B.  Technical Detail and Supplemental Information Regarding Statistical 
Procedures and Programs 
B.1  Clopper-Pearson Exact Confidence Interval 
proc freq data=data1;  
tables var1/ binomial(exact);  
run; 
 
B.2  Non-parametric cumulative incidence function (CIF) 
proc lifetest data=event_data outcif=cif plots=cif(test); 
time timevar*cnsr(1)/eventcode=0; 
ods output; 
run; 
 
Variable cnsr: 
Value 0 = 
 progression event 
1 = censored 
2 = competing risk event