Clinical trial NCT03340766
Conditions: Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Keywords: DLBCL Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT) Antibodies Bispecific in combination with PD-1/PD-L1 inhibitor
Sponsor: Amgen
Start date: 2018-03-16; Completion date: 2023-08-14
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.

Detailed description:
The study was planned as 2 parts:

* Part 1 will test the safety of up to 3 different blinatumomab target dose levels in combination with pembrolizumab in a rolling 6 design. A Dose Level Review Team (DLRT) will review the safety data to evaluate possible drug effects and dose-limiting toxicities (DLTs).
* Part 2 will consist of an expansion cohort to assess pharmacokinetics (PK), safety, and preliminary efficacy data at the chosen target dose. The part 2 dose will be determined by the totality of the clinical data from part 1 as determined by the DLRT.

Based on the results from Part 1, a decision was made not to proceed with Part 2 of this study.

Secondary objectives of the study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of blinatumomab in combination with pembrolizumab. Tumor response will be evaluated according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al, 2007). With implementation of Protocol Amendment 5, response will also be assessed according to the Lugano Classification (Cheson et al, 2014). Only participants enrolled after implementation of Protocol Amendment 5 (03 December 2019) will have tumor assessments using the Lugano criteria.

Arms: arm 1: Participants received blinatumomab administered as a continuous intravenous infusion (CIVI) for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days then 28 µg/day for the remaining days of treatment.

Starting on Day 15 participants also received 200 mg pembrolizumab administered by intravenous (IV) infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles. arm 2: Participants received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 56 µg/day for the remaining days of treatment.

Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. arm 3: Participants received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment.

Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. arm 4: This cohort will test the maximum tolerated dose of blinatumomab in combination with pembrolizumab identified in Part 1 of the study.
Interventions: intervention 1: Blinatumomab intervention 2: Pembrolizumab
Intervention descriptions: intervention 1: Up to 2 cycles of blinatumomab may be given, where cycle 1 lasts 8 weeks, and cycle 2 lasts 28 days. The treatment is given as a continuous intravenous infusion. intervention 2: One cycle of pembrolizumab is a 200 mg IV injection lasting 30 minutes. One cycle will be given every 3 weeks until disease progression, or for a maximum of 35 cycles.

Protocol documents:
Prot_002.pdf: 
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Product:  Blinatumomab
Protocol Number:  20150290
Date:  08 March 2018
Page 1 of 70
CONFIDENTIAL
Amendment 2
Protocol Title:  A Phase 1b Open Label Study Investigating the Safety and Efficacy 
of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With 
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) 
Amgen Protocol Number Blinatumomab 20150290
Merck Protocol Number PN348
Eudra CT number 2016-002191-27
Amendment Date:
08 March 2018
Rationale:
This protocol is being amended to:
!
Update Merck investigational product background information (pembrolizumab) and
rationale for dose selection
!
Include language about addition of pembrolizumab to blinatumomab dosing per once
blinatumomab target dose has been reached.
!
Update End of Study language per new protocol template.
!
Update Exclusion Criteria #222 to indicate that subjects who have quantifiable
hepatitis b virus are excluded.
!
Add Exclusion Criteria #227 for history of solid organ transplant.
!
Update dose modification for pembrolizumab (text and table).
!
Update concomitant medication language per Merck text.
!
Add hepatitis antibody testing at screening and hepatitis virus testing throughout
study.
!
Add neurological exam to physical exam.
!
Clarify PK language for expansion cohort.
!
Add suspected unexpected serious adverse reaction (SUSAR) language to safety
section.
!
Clarify ± 3 day window for pembrolizumab-related assessments
!
Make administrative and editorial changes.
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SAP_003.pdf: 
Product:  Blinatumomab 
Statistical Analysis Plan:  20150290 
Date:  15 February 2021 
Page 1 
STATISTICAL ANALYSIS PLAN 
A Phase 1b Open Label Study Investigating the Safety and Efficacy of 
Blinatumomab in Combination With Pembrolizumab in Adult Subjects With 
Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) 
Protocol Number: 
20150290  
Version: 
2.0 
Date: 
February 15th, 2021  
Authors: 
 Global Biostatistics Science 
NCT Number: NCT03340766
This NCT number has been applied to the document for
purposes of posting on Clinicaltrials.gov


Product:  Blinatumomab 
Statistical Analysis Plan:  20150290 
Date:  15 February 2021 
Page 2 
 
Version Number 
Date 
(DDMMMYYYY) 
Summary of Changes,  
including rationale for changes 
Original (v1.0) 
02 OCT 2017 
 
Amendment 1 (v2.0) 
15 FEB 2021  
All text has been updated for conducting 
primary analysis based on the Protocol 
amendment 5 and the decision of not to 
proceed into part 2 phase of study. 
 


Product:  Blinatumomab 
Statistical Analysis Plan:  20150290 
Date:  15 February 2021 
Page 3 
 
Table of Contents 
Table of Abbreviations ..................................................................................................... 6 
1. 
Introduction ............................................................................................................. 8 
2. 
Objectives ............................................................................................................... 8 
2.1 
Primary ....................................................................................................... 8 
2.2 
Secondary ................................................................................................... 8 
2.3 
Exploratory .................................................................................................. 8 
3. 
Study Overview ...................................................................................................... 8 
3.1 
Study Design ............................................................................................... 8 
3.2 
Sample Size .............................................................................................. 13 
4. 
Study Endpoints and Covariates ........................................................................... 13 
4.1 
Study Endpoints ........................................................................................ 13 
4.1.1 
Primary Endpoints ..................................................................... 13 
4.1.2 
Secondary Endpoints ................................................................ 13 
4.1.3 
Safety Endpoints ....................................................................... 14 
4.1.4 
Exploratory Endpoints ............................................................... 14 
5. 
Hypotheses and/or Estimations ............................................................................ 14 
6. 
Definitions ............................................................................................................. 14 
6.1 
General Definitions .................................................................................... 14 
6.2 
Efficacy Endpoints ..................................................................................... 18 
6.3 
PRO Endpoint ........................................................................................... 20 
7. 
Analysis Subsets .................................................................................................. 20 
7.1 
Full Analysis Set........................................................................................ 20 
7.2 
Safety Analysis Set ................................................................................... 20 
7.3 
Responder Analysis Set ............................................................................ 21 
7.4 
DLT Analysis Set ....................................................................................... 21 
7.5 
Pharmacokinetic Analysis Set ................................................................... 21 
7.6 
Pharmacodynamic Analysis Set ................................................................ 21 
7.7 
Interim Analyses Set(s) ............................................................................. 21 
8. 
Interim Analysis and Early Stopping Guidelines .................................................... 21 
8.1 
Interim Analyses........................................................................................ 21 
8.2 
Dose Level Review Team (DLRT) and Data Review Team 
(DRT) ........................................................................................................ 23 
9. 
Data Screening and Acceptance ........................................................................... 24 
9.1 
General Principles ..................................................................................... 24 
9.2 
Data Handling and Electronic Transfer of Data ......................................... 24 
9.3 
Handling of Missing and Incomplete Data ................................................. 24 


Product:  Blinatumomab 
Statistical Analysis Plan:  20150290 
Date:  15 February 2021 
Page 4 
 
9.4 
Detection of Bias ....................................................................................... 24 
9.5 
Outliers ..................................................................................................... 24 
9.6 
Distributional Characteristics ..................................................................... 25 
9.7 
Validation of Statistical Analyses ............................................................... 25 
10. 
Statistical Methods of Analysis.............................................................................. 25 
10.1 
General Principles ..................................................................................... 25 
10.2 
Subject Accountability ............................................................................... 26 
10.3 
Important Protocol Deviations ................................................................... 26 
10.4 
Demographic and Baseline Characteristics ............................................... 26 
10.5 
Efficacy Analyses ...................................................................................... 27 
10.6 
Safety Analyses ........................................................................................ 28 
10.6.1 
DLT Summary ........................................................................... 28 
10.6.2 
Adverse Events and Disease Related Events ............................ 28 
10.6.3 
Laboratory Test Results ............................................................ 29 
10.6.4 
Vital Signs ................................................................................. 30 
10.6.5 
Physical Measurements ............................................................ 30 
10.6.6 
Electrocardiogram (ECG) .......................................................... 30 
10.6.7 
Antibody Formation ................................................................... 30 
10.6.8 
Exposure to Investigational Product .......................................... 30 
10.6.9 
Exposure to Concomitant Medication ........................................ 30 
10.6.10 
Pharmacokinetic Analysis of Blinatumomab .............................. 31 
10.6.11 
Pharmacokinetic Analysis of Pembrolizumab ............................ 31 
10.6.12 
Pharmacodynamic Analysis ....................................................... 32 
10.6.13 
Exposure Response Analysis .................................................... 32 
11. 
Changes From Protocol-specified Analyses.......................................................... 32 
12. 
Literature Citations / References ........................................................................... 34 
13. 
Prioritization of Analyses....................................................................................... 35 
14. 
Data Not Covered by This Plan............................................................................. 35 
15. 
Appendices ........................................................................................................... 36 
List of Tables 
Table 1.  Estimated 95  Confidence Interval for ORR ................................................. 13 
Table 2.  Efficacy Stopping Boundary With Batch Size of 10 Subjects, 
Posterior Probability of 80 and ORR of 50 ........................................ 22 
Table 3.  Operating Characteristics With Batch Size of 10 Subjects .............................. 22 
Table 4.  Safety Stopping Boundary With Batch Size of 10 Subjects, Posterior 
Probability of 90 and DLT Limit of 25 ................................................ 22 
Table 5.  Operating Characteristics With Batch Size of 10 Subjects .............................. 23 


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List of Figures 
Figure 1.  Study Design and Treatment Schema ........................................................... 11 
List of Appendices 
Appendix A.  Technical Detail and Supplemental Information Regarding 
Statistical Procedures and Programs ...................................................... 37 
Appendix B.  Reference Values/Toxicity Grades ........................................................... 39 


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Table of Abbreviations 
Abbreviation/Acronym 
Definition 
ADPC 
Analysis Dataset for PK Concentrations  
AE 
Adverse Event 
AMQs 
Amgen MedDRA Queries 
CDM 
Clinical Data Management  
CR 
Complete Response  
CPMS 
Clinical Pharmacology Modeling and Simulation  
CRF 
Case Report Form 
CSR 
Clinical Study Report  
CTCAE  
Common Terminology Criteria for Adverse Events 
DLBCL 
Diffuse Large B-Cell Lymphoma 
DLRT 
Dose Level Review Team 
DRT 
Data Review Team 
DLT 
Dose Limiting Toxicity  
DOR 
Duration of Response 
DRE 
Disease Related Events 
ECG 
Electrocardiogram 
ECI 
Event of Clinical Interest 
EOI 
Events of interest 
E-R analysis 
Exposure Response Analysis 
FAS 
Full Analysis Set 
GSO-DM 
Global Study Operations-Data Management  
HSCT  
Hematopoietic Stem Cell Transplantation 
IA 
Interim Analysis 
IP 
Investigational Product 
IPD 
Important Protocol Deviations  
IPI 
International Prognostic Index  
IVRS 
Interactive Voice Response System 
KM  
Kaplan-Meier  
MedDRA 
Medical Dictionary for Regulatory Activities  
MTD 
Maximum Tolerated Dose 
NGS 
next generation sequencing 
OR 
Objective Response 
ORR 
Objective Response Rate 
OS 
Overall Survival 


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Abbreviation/Acronym 
Definition 
PFS 
Progression Free Survival 
PK 
Pharmacokinetics 
PR 
Partial Remission 
SAP 
Statistical Analysis Plan 
SMQs 
Standard MedDRA Queries 
SSAP 
Supplemental Statistical Analysis Plan 
WHODRUG 
World Health Organization Drug 


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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 amendment 5 for the phase 1b 
blinatumomab in combination with pembrolizumab study 20150290, dated 
December 03, 2019. The scope of this plan includes the primary analysis and the final 
analysis that is planned and will be executed by the Global Biostatistics Science 
department unless otherwise specified. Pharmacokinetic, pharmacodynamic, 
exposure-response and biomarker analyses will be performed by Clinical Pharmacology 
Modeling and Simulation (CPMS) or biomarker group.  
2. 
Objectives 
2.1 
Primary 
To determine the maximum tolerated dose (MTD) of blinatumomab in combination with 
pembrolizumab in adult subjects with relapsed or refractory (r/r) diffuse large B-cell 
lymphoma (DLBCL). 
2.2 
Secondary 
To evaluate the safety, efficacy, and pharmacokinetics (PK) of blinatumomab in 
combination with pembrolizumab in adult subjects with r/r DLBCL 
2.3 
Exploratory 
 
To evaluate blood and tissue biomarkers 
 
To evaluate minimal residual disease (MRD) response by next generation 
sequencing (NGS) 
3. 
Study Overview 
3.1 
Study Design 
This is an open label, multicenter, phase 1b study testing the combination of 
blinatumomab with pembrolizumab in r/r DLBCL. 
The study will consist of 2 portions: 
 
Part 1 (n  6 – 30) will test the safety of up to 3 different blinatumomab target 
dose levels in combination with pembrolizumab in a rolling 6 design.  A Dose 
Level Review Team (DLRT) will review the safety data to evaluate possible drug 
effects and dose limiting toxicities (DLTs).  Subjects who are not on the dose 
ultimately selected for part 2 will remain on their initial dose throughout the study. 
 
Part 2 (n  40) will consist of an expansion cohort to assess PK, safety, and 
preliminary efficacy data at the chosen target dose.  The part 2 dose will be 
determined by the totality of the clinical data from part 1 as determined by the 
DLRT. 


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The study design includes: 
 
A 21-day screening period. 
 
A standard (core) treatment period of blinatumomab (first cycle) of 8 weeks 
 
A second (consolidation) cycle of blinatumomab of 28 days after a 28-day ( 3 days) 
blinatumomab treatment-free period that can be administered to subjects with stable 
disease (SD), partial remission (PR), or complete remission (CR). 
 
Pembrolizumab treatment until disease progression or relapse or up to 35 cycles in 
the absence of disease progression or relapse: 
 
To begin on study day 15 for subjects in cohort Ia 
OR 
 
To begin on study day 19 for subjects in cohort IIa and IIIa 
 
A safety follow-up visit after 30 days ( 7 days) of last dose of each protocol 
specified therapy.  
Follow-up for survival and collection of subsequent anticancer therapies will occur every 
12 weeks ( 28 days) following blinatumomab safety follow-up visit for until 
approximately 24 months from the last dose of pembrolizumab.   
Part 1 design and blinatumomab escalation/de-escalation rules 
For part 1, subject enrollment will start in cohort Ia as outlined in the schema in Figure 1.  
Blinatumomab will be dosed as a continuous intravenous infusion (CIVI) for 8 weeks.  
The initial dose will be 9 g/day and the dose will be escalated after 7 days to a target 
dose of 28 g/day.  Depending on tolerability, the target dose of blinatumomab will be 
increased to a maximum of 56 g/day in cohort IIa or to 112 g/day in cohort IIIa. 
Pembrolizumab will be dosed by intravenous (IV) infusion 200 mg at Q3W starting on 
study day 15 in cohort Ia, and on study day 19 in cohorts IIa and IIIa. Trial treatment of 
pembrolizumab may be administered up to 3 days before or after each scheduled day 1 
from pembrolizumab cycle 2 onwards.  
Subjects who do not meet the criteria for investigational product (IP) discontinuation  
(see below) are eligible for a second cycle of blinatumomab (consolidation) consisting of 
a CIVI of 28 days after a 28-day ( 3 days) blinatumomab treatment-free interval.  
Blinatumomab will be started at 9 g/day and escalated every 7 days to the maximum 
target dose of blinatumomab in the assigned cohort. 
Subjects will be enrolled to part 1 with up to 6 subjects being enrolled per cohort.  In any 
cohort, tolerability will be defined as  1 DLT out of 6 subjects). Expansion to 
10 subjects will be allowed in any cohort to ensure adequate safety and PK data is 


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collected.  The decision to expand a cohort will be made by the DLRT. In case of 
10 subjects enrolled, tolerability is defined as  2 DLTs out of 10 subjects. 
The MTD of blinatumomab will be defined as the highest dose level at which at most 1 
of 6 subjects or at most 2 subjects in 10 experiences a DLT.  The MTD defines the 
stopping rules for the study.  For further details on replacement of subjects is given in 
Section 3.4 of protocol. The DLT criteria are defined in the Appendix E of the protocol.  
The DLRT will meet to review the safety data when any of the following criteria are met: 
 
In two or more subjects out of 6, a DLT has been reported, or 3 or more 
subjects out of 10, a DLT has been reported in a cohort. 
 
Six subjects are enrolled in a cohort and all subjects have completed the DLT 
observation period. 
 
In the event that a cohort is expanded to 10, DLRT will also meet after all 
subjects have completed DLT observation period.  
The DLRT will review the available data in part 1 to determine if the combination of 
blinatumomab and pembrolizumab is safe and tolerable as defined by DLT criteria.  
Based on the totality of the data, the DLRT may recommend MTD, to escalate to the 
next dose level, or to expand a cohort to a maximum of 10 subjects if the collection of 
more data is deemed warranted, or to adjudicate DLT criteria (see Appendix E of 
protocol for details). At the end of Part 1, the cohort with recommended dose level 
requires to have at least 1 response out of 6 evaluable subjects or 2 responses out of 
10 evaluable subjects in order to proceed to Part 2. 
Part 2 
For part 2, the dosing will be determined based on the safety of the combination of 
blinatumomab and pembrolizumab and the MTD of blinatumomab established in part 1 
per DLRT. For part 2, the DLT observation period will be determined by cohort 
chosen in Part 1 and Part 2 expansion.  Part 2 will consist of an expansion cohort to 
collect further safety and PK data as well as provide a preliminary estimate of the 
efficacy of the combination of blinatumomab and pembrolizumab.  Dose limiting toxicities 
and efficacy will be monitored by Data Review Team (DRT) to ensure they do not 
reach a pre-defined threshold of 25.  If this threshold is reached, the DRT will have the 
discretion to change to another dose/schedule tested in phase 1b part 1, based on the 
totality of the available data.  The details of DLT boundaries are provided in Section 8.1.  
 


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Study Design and Treatment Schema 
Figure 1.  Study Design and Treatment Schema 
Consent, Screening
Enrollment
/________ /
Treatmenta
/ _______________________________________________________________________________________ /
Follow- up
/______________ /
SCREENING
ENROLLMENT
SAFETY  FOLLOW  UP
LONG TERM FOLLOW UP
COHORT Ia
Blinatumomab 
9→28 µg/day
+
Pembrolizumab
(day 15) 
EXPANSION
COHORTd
Part 1b
Part 2c
3-week period
Safety follow up to occur 30 (+7) 
days after last dose of protocol 
specified therapy and long term 
follow-up to occur every 12 weeks 
(±28 days) following blinatumomab 
safety follow-up visit for 
approximately 24 months from the 
last dose of each protocol specified 
therapy.
COHORT IIa
Blinatumomab 
9→28→56 µg/day
+
Pembrolizumab
(day 19)
≥ 2 DLTs in 6 subjects or ≥ 3 
DLTs in 10 subjects, MTD is not 
defined 
≤ 1 DLT in 6 
subjects or ≤ 2 
DLTs in 10 
subjects, move 
to next cohort
≥ 2 DLTs in 6 subjects or 
≥ 3 DLTs in 10 subjects, 
MTD = Cohort Ia dose 
≤ 1 DLT in 6 subjects or 
≤ 2 DLTs in 10 subjects, 
move to next cohort
COHORT IIIa
Blinatumomab 
9→28→112 µg/day
+
Pembrolizumab
(day 19)
≤ 1 DLT in 6 subjects or ≤ 2 DLTs 
in 10 subjects, this is MTD
≥ 2 DLTs in 6 subjects or ≥ 3 DLTs 
in 10 subjects, MTD =Cohort IIa
dose
 
Figure Legend present on next page 


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DLT  dose limiting toxicity; MTD  maximum tolerated dose. First cycle of blinatumomab will be 8 weeks in duration, followed by a 28-day ( 3 days) blinatumomab 
treatment-free interval.  A second consolidation cycle of blinatumomab will be 28 days in duration at the same dose as the first cycle, starting at 9 g/day with weekly 
dose escalations until the target dose is reached, if subject has stable disease or partial/complete remission after cycle 1.  Pembrolizumab will be started on study 
day 15 for cohort Ia, and study day 19 for cohorts IIa and IIIa, and administered Q3 weeks until disease progression for up to 35 cycles. The first dose of 
pembrolizumab must be delayed if blinatumomab is interrupted during the step dose period per protocol (see Table 6-1 of protocol). The first dose of 
pembrolizumab can only be given after the blinatumomab target dose is reached ( 4 days); also, before adding pembrolizumab, there should be no 
blinatumomab dose interruption due to adverse events and if blinatumomab was interrupted, no  grade 1 CRS and/or neurologic events. The cohort name 
has been updated to be in sequential order, retaining the historical “a” in the cohort name (ie, cohorts Ia, IIa, IIIa) from previous protocol naming 
convention. 
a For cohorts Ia, IIa and IIIa, the DLT observation period will begin on the same day as the first dose of pembrolizumab (day 15 for Ia and day 19 for IIa and IIIa) and 
will continue for 42 days. For part 2, the DLT observation period will be determined by cohort chosen in Part 1 and Part 2 expansion.  A dose level review team 
(DLRT) will review the available data to determine if blinatumomab is safe and tolerable as defined by DLT criteria and general clinical judgement.  Based on the 
totality of the data, the DLRT may recommend to declare MTD, to escalate to the next dose level, to expand a cohort to a maximum of 10 subjects if the 
collection of more data is deemed warranted, or to adjudicate the DLT criteria.  
b Part 1:  To determine maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab.  The MTD will be defined as the dose level at which 
 1 DLT in 6 subjects or  2 DLTs in 10 subjects experience a Dose limiting toxicity (DLT). 
c Part 2:  Expansion cohort to estimate the efficacy of the combination of blinatumomab and pembrolizumab.  Dosing will be determined based on the MTD of 
blinatumomab established in part 1.  Dose limiting toxicities and efficacy will be monitored by the Data Review Team to ensure they do not reach a 
pre-defined threshold of 25.  
d Dosing for the Part 2 expansion cohort will be based on the safety of the combination of blinatumomab and pembrolizumab and the MTD of blinatumomab in Part 1. 
 


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3.2 
Sample Size 
Part 1: 
A rolling 6 dose design will be used. An additional 4 subjects per cohort can be enrolled 
to further evaluate safety and PK data if needed.  There will be a minimum of 6 subjects 
and a maximum of 30 subjects enrolled.   
Part 2: 
Forty subjects will be enrolled in Part 2. With 40 subjects, the 95 exact 
confidence interval (Clopper and Pearson, 1934) for the estimate of ORR can be 
calculated. The 95 confidence intervals for some ORRs are shown in the table 
below.  
Table 1.  Estimated 95  Confidence Interval for ORR 
ORR 
95 Confidence Interval 
0.40 
(0.25, 0.57) 
0.45 
(0.29, 0.61) 
0.50 
(0.34, 0.71) 
0.55 
(0.38, 0.71) 
0.60 
(0.43, 0.75) 
4. 
Study Endpoints and Covariates 
4.1 
Study Endpoints 
4.1.1 
Primary Endpoints 
o Incidence of DLTs 
4.1.2 
Secondary Endpoints 
o Objective response (including CR and PR) by the Lugano Classification 
(Cheson et al, 2014) and Revised Response Criteria (Cheson et al, 2007) during 
the first 12 weeks since starting blinatumomab and during the treatment period.    
o Complete response by the Lugano Classification (Cheson et al, 2014) and 
Revised Response Criteria (Cheson et al, 2007) during the first 12 weeks since 
starting blinatumomab and during the treatment period. 
o PFS 
o OS 
o Duration of response (DOR) for subjects with OR, (ie, CR and PR) by the Lugano 
Classification (Cheson et al, 2014) and Revised Response Criteria 
(Cheson et al, 2007) during the first 12 weeks since starting blinatumomab 
o Blinatumomab PK parameters 
o Pembrolizumab PK parameters 


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4.1.3 
Safety Endpoints 
 
Incidence and severity of adverse events 
4.1.4 
Exploratory Endpoints 
 
Tumor PD-L1 expression will be assessed pre-treatment and on treatment to 
explore potential correlation with clinical outcomes 
 
Changes in Lymphocytes (B-cell, T-cell populations, NK cells) and leukocyte 
populations (leukocytes, lymphocytes, monocytes, and granulocytes) in 
peripheral blood 
 
Peripheral blood cytokine levels 
 
Minimal residual disease (MRD) by NGS after cycle 1 of blinatumomab 
5. 
Hypotheses and/or Estimations 
The overlying hypothesis is that blinatumomab in combination with 
pembrolizumab will be tolerable in r/r DLBCL. 
6. 
Definitions 
6.1 
General Definitions 
Age at Enrollment 
Subject age at enrollment will be collected in years in the clinical database. 
Baseline 
For the analysis of all endpoints, baseline will be defined as the value measured on day 
1 of the first cycle of blinatumomab. The protocol specifies that procedures and labs on 
day 1 should be completed before the initiation of any protocol-specified therapy which 
will be the assumption in the analysis unless the time of the assessment is recorded. If a 
day 1 value is not available, the most recent value before the day of the start of any 
protocol-specified therapy may be used. 
Cumulative Dose of Blinatumomab, Pembrolizumab 
Blinatumomab: The cumulative dose in μg is defined as the following with summation 
over infusions: 
(Duration of infusion (days) for each dose received x dose received [g]) 
Pembrolizumab: The cumulative dose in mg is defined as the following with summation 
over infusions: 
(Duration of infusion (days) for each dose received x dose received [mg]) 
Cumulative dose will be calculated within a cycle and across all cycles. 


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Death Date 
For subjects who die during the study, the death date will be recorded on the event, end 
of study and survival status CRF. The earliest date will be used if the dates are 
inconsistent among these CRF pages. For deaths collected after a subject has ended 
study (eg, through public records in countries where permitted), the death date will be 
recorded on the long term follow-up page. 
Dose limiting toxicity (DLT) 
The occurrence of any of the toxicities in the Appendix E of the protocol will be 
considered a DLT, if judged by the investigator to be possibly, probably or definitely 
related to study drug administration. 
DLT Evaluable 
To be DLT evaluable, subjects must meet one of the following criteria during DLT 
evaluation period: 
 
The subject experienced a DLT;  
OR 
 
The subject was removed from treatment for an adverse event/toxicity that is 
not a DLT, if the subject has been exposed to both investigational 
products for at least 12 days since pembrolizumab initiation with 
blinatumomab at the target dose; 
OR 
 
The subject was removed from treatment for reasons other than an adverse 
event/toxicity (ie, disease progression), and the subject has been exposed to 
both investigational products for at least 12 days since pembrolizumab 
initiation with blinatumomab at the target dose; 
OR 
 
The subject did not experience a DLT and completed the DLT evaluation 
period. 
Duration of Blinatumomab/Pembrolizumab 
Blinatumomab/ Pembrolizumab: For each infusion episode within a cycle, the duration of 
exposure will be calculated by subtracting the start date and time from the stop date and 
time. If either a start or stop time is missing, only the date portion will be used in 
calculating the duration of a specific infusion. For each cycle, the duration will be last 
date minus first date plus 1 of infusion. For the entire study, the duration will be the sum 
of the durations across cycles. The duration will be rounded to the nearest day. 


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Event of Clinical Interest (ECI) 
Selected non-serious and serious adverse events are known as ECI and must be 
reported within 24 hours to the sponsor. The ECI for this trial includes 
o An overdose of blinatumomab or pembrolizumab (see Protocol Section 6.2.1.1 
and Section 6.2.2.1) 
o Hepatic disorder (See protocol section 9.1.4) 
Events of interest (EOI) 
Events of interest (EOI) will be based on search strategies defined by Standard 
MedDRA Queries (SMQs) or Amgen MedDRA Queries (AMQs). 
End of Investigational Product (IP) Administration Date 
End of IP Administration for subjects who had blinatumomab or pembrolizumab is 
defined as the last infusion of blinatumomab/ pembrolizumab reported on the End of IP 
Administration CRF. 
Enrollment Date 
Enrollment Date is defined as the date of enrollment collected on the CRF. 
Investigational Product 
Amgen Investigational Product: refers to blinatumomab 
Non-Amgen Investigational Product: refers to pembrolizumab 
Last Dose Date of Blinatumomab/ Pembrolizumab  
This is the stop date of the last infusion of blinatumomab/pembrolizumab administration 
reported on the Investigational Product Administration CRF. 
Treatment period  
Treatment period will be from study day 1 to 30 days after last dose of either 
blinatumomab/ pembrolizumab administration reported on the Investigational Product 
Administration CRF. 
Prior Salvage Regimens  
Prior salvage regimens are those medications recorded on the prior anti-cancer 
therapies CRF where the line of therapy field indicates 2nd or higher line therapy. 


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Relative Dose Intensity at the Target Dose 
Relative dose intensity at the target dose is the actual exposure duration at target 
dose divided by planned duration of target dose, which is 49 days for cohort Ia, 
and 42 days for cohort IIa and IIIa in cycle 1; and 21 days for cohort Ia, and 
14 days for cohort IIa and IIIa in cycle 2. Subjects who didn’t reach the target dose 
are considered having actual exposure duration as 0. 
Study Day 
Study Day 1 is defined as the day of first dose of blinatumomab. 
And Study Day is defined as: 
Pre study day 1: study day (date – date of study day 1) 
Post study day 1: study day (date - date of study day 1)  1  
Subject Level End of Study (EOS) Date 
End of Study for each subject is defined as the date the subject last completed a 
protocol-specified procedure. The date will be recorded on the End of Study CRF page.  
Treatment Emergent Adverse Event (AE) 
Treatment emergent adverse event refers to an adverse event that starts on or after first 
dose of blinatumomab up to and including 30 days after the end of blinatumomab or 
pembrolizumab whichever is later. It is indicated by a flag whether an event start before 
first dose of blinatumomab on the Event CRF page. This reporting window also applies 
to treatment-emergent serious adverse events (SAEs). 
Treatment Emergent Disease-related Event (DRE) 
Treatment emergent disease-related event refers to a disease-related event that starts 
on or after first dose of blinatumomab up to and including 30 days after the end of 
blinatumomab or pembrolizumab whichever is later. It is indicated by a flag whether an 
event start before first dose of blinatumomab on the Event CRF page. 
Disease-related events assessed by the investigator to be more severe than 
expected and/or related to the investigational product(s)/study 
treatment/protocol-required therapies, and determined to be serious, must be 
reported on the Event CRF as serious adverse events. 


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Treatment Emergent Event of Clinical Interest (ECI) 
ECI is defined in Section 9.1.4 of the protocol. Treatment emergent ECI refers to an ECI 
that starts on or after first dose of blinatumomab up to and including 30 days after the 
end of blinatumomab or pembrolizumab whichever is later. 
Primary Completion:  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 endpoint(s), whether the study concluded as planned in the protocol or was 
terminated early. 
If the study concludes prior to the primary completion date originally planned in the 
protocol (ie, early termination of the study), then the primary completion will be the date 
when the last subject is assessed or receives an intervention for evaluation in the study 
(ie, last subject last visit). 
The primary completion date is the date when data for the primary endpoint are last 
collected for the purposes of conducting the primary analysis. 
End of Study:  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 (ie, last 
subject last visit), following any additional parts in the study (eg, long-term follow-up) as 
applicable. 
6.2 
Efficacy Endpoints 
Complete Response (CR) Rate by the Lugano Classification  
Complete response rate by the Lugano Classification is the proportion of subjects 
who have achieved complete response by the Lugano Classification 
(Cheson et al, 2014) during the first 12 weeks since starting blinatumomab and 
during the treatment period among all subjects in the respective analysis set.  
Complete Response (CR) Rate by the Revised Response Criteria  
Complete response rate by the Revised Response Criteria is the proportion of 
subjects who have achieved complete response by the Revised Response Criteria 
(Cheson et al, 2007) during the first 12 weeks since starting blinatumomab and 
during the treatment period among all subjects in the respective analysis set. 


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Duration of Response (DOR) by Lugano Classification 
Duration of response will be calculated only for subjects who achieve an OR (ie, CR or 
PR) by Lugano Classification (Cheson et al, 2014) criteria during the first 12 weeks 
since starting blinatumomab.  The duration will be calculated from the date a response, 
CR or PR, is first achieved until the earliest date of a disease assessment indicating a 
disease progression or death, whichever occurs first. For diagnosis of progression of 
lymphoma, the progression of radiographic assessment of PET-CT using Lugano 
Classification will be used.  Subjects who do not have a relapse event will be 
censored on their last radiological non-missing evaluable tumor assessment date. 
Duration of Response (DOR) by Revised Response Criteria (Cheson et al, 2007) 
Duration of response will be calculated only for subjects who achieve an OR (ie, 
CR or PR) by Revised Response Criteria (Cheson et al, 2007) criteria during the 
first 12 weeks since starting blinatumomab. The duration will be calculated from 
the date a response, CR or PR, is first achieved until the earliest date of a disease 
assessment indicating a disease progression or death, whichever occurs first. For 
diagnosis of progression of lymphoma, the progression of radiographic 
assessment of PET-CT using Revised Response Criteria (Cheson et al, 2007) will 
be used. Subjects who do not have a relapse event will be censored on their last 
radiological non-missing evaluable tumor assessment date. 
Objective Response by the Lugano Classification 
Objective response (including CR and PR) by the Lugano Classification is 
determined by the Lugano Classification (Cheson et al, 2014) during the first 
12 weeks since starting blinatumomab and during the treatment period. 
Objective Response by the Revised Response Criteria 
Objective response (including CR and PR) by the Revised Response Criteria is 
determined by the Revised Response Criteria (Cheson et al, 2007) during the first 
12 weeks since starting blinatumomab and during the treatment period. 
Objective Response Rate (ORR) by the Lugano Classification 
Objective response rate (ORR) by the Lugano Classification is the proportion of 
subjects who have achieved either a CR or a PR among subjects by the Lugano 
Classification (Cheson et al, 2014) during the first 12 weeks since starting 
blinatumomab and during the treatment period in the respective analysis set.  


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Objective Response Rate (ORR) by the Revised Response Criteria 
Objective response rate (ORR) by the Revised Response Criteria is the proportion of 
subjects who have achieved either a CR or a PR among subjects by the Revised 
Response Criteria (Cheson et al, 2007) during the first 12 weeks since starting 
blinatumomab and during the treatment period in the respective analysis set. 
Overall Survival (OS) 
The overall survival will be calculated as the time from the date of first dose of 
blinatumomab until death due to any cause. Subjects who are alive at the date that 
triggers the analysis will be censored at the date last known to be alive.  
Progression Free Survival (PFS) by Lugano Classification 
The PFS will be calculated as the time from the date of first dose of blinatumomab until 
the date of diagnosis of progression of lymphoma, or date of death, whichever is earliest. 
For diagnosis of progression of lymphoma, the progression of radiographic 
assessment of PET-CT using Lugano Classification will be used.  Subjects who are 
alive and did not have progression will be censored at the last radiological 
non-missing evaluable tumor assessment date.  
Progression Free Survival (PFS) by Revised Response Criteria 
The PFS will be calculated as the time from the date of first dose of blinatumomab 
until the date of diagnosis of progression of lymphoma, or date of death, 
whichever is earliest. For diagnosis of progression of lymphoma, the progression 
of radiographic assessment of PET-CT using Revised Response Criteria will be 
used.  Subjects who are alive and did not have progression will be censored at the 
last radiological non-missing evaluable tumor assessment date.  
6.3 
PRO Endpoint 
Not Applicable. 
7. 
Analysis Subsets 
7.1 
Full Analysis Set 
The full analysis set includes all subjects who received blinatumomab. 
7.2 
Safety Analysis Set 
Safety analysis set is same as the full analysis set. 


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7.3 
Responder Analysis Set  
The responder analysis set includes all subjects who had CR or PR within 12 weeks 
after starting blinatumomab. 
7.4 
DLT Analysis Set 
DLT analysis set includes all subjects who are DLT-evaluable. 
7.5 
Pharmacokinetic Analysis Set 
The pharmacokinetic analysis set for blinatumomab includes all subjects who received 
any infusion of blinatumomab or pembrolizumab and have at least 1 pharmacokinetic 
sample collected. 
7.6 
Pharmacodynamic Analysis Set 
The cytokine analysis set includes all subjects who receive any infusion of blinatumomab 
and have at least 1 pharmacodynamic sample collected. 
For other biomarker analysis set include all subjects who received blinatumomab and 
pembrolizumab and have at least one biomarker sample collected. 
7.7 
Interim Analyses Set(s)  
Interim analysis set will include all subjects at the interim analysis.  
8. 
Interim Analysis and Early Stopping Guidelines 
8.1 
Interim Analyses 
DRT will conduct evaluations of efficacy for ORR by the Lugano Classification 
(Cheson et al, 2014) during the first 12 weeks since starting blinatumomab and 
safety for DLT rate to assess if the threshold for early trial termination has been 
reached.   
Table 2 shows the efficacy stopping rules using a Bayesian approach to 
potentially terminate the study if the posterior probability that ORR is less than 
50 is  80.  The stopping boundaries assume a prior beta distribution (1, 1).  
The operating characteristics in Table 3 provide the probability of stopping the 
trial early for given hypothetical true ORR. 


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Table 2.  Efficacy Stopping Boundary With Batch Size of 10 Subjects, Posterior 
Probability of 80 and ORR of 50 
Number of evaluable subjects 
Stop study if observing these many 
responders 
10 
 3 
20 
 8 
30 
 12 
40 
Always stop 
Table 3.  Operating Characteristics With Batch Size of 10 Subjects 
True ORR 
Prob of Stopping Early 
Average Sample Size 
0.40 
70 
23 
0.45 
52 
27 
0.50 
34 
32 
0.55 
19 
19 
0.60 
9 
38 
Table 4 shows the safety stopping rules using a Bayesian approach to terminate the 
study if the posterior probability that the DLT rate is greater than 25 is  90.  The 
stopping boundaries assume a prior beta distribution (0.50, 1.50). The evaluations could 
occur more frequently if necessary, to address emerging safety concerns.  The operating 
characteristics in Table 5 provide the probability of stopping the trial early for given 
hypothetical true DLT rates. 
Table 4.  Safety Stopping Boundary With Batch Size of 10 Subjects, Posterior 
Probability of 90 and DLT Limit of 25 
Number of DLT evaluable subjects 
Stop study if observing these many DLTs 
10 
 5 
20 
 8 
30 
 11 
40 
Always stop 
DLT  dose limiting toxicity 


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Table 5.  Operating Characteristics With Batch Size of 10 Subjects 
True DLT Rate 
Prob. of Stopping Early 
Average Sample Size 
0.20 
6 
38 
0.25 
17 
36 
0.30 
36 
32 
0.35 
57 
27 
0.40 
76 
22 
DLT  dose limiting toxicity; prob  probability 
8.2 
Dose Level Review Team (DLRT) and Data Review Team (DRT) 
DLRT: 
The DLRT will review safety data from each cohort in part 1 to determine if the 
combination of blinatumomab and pembrolizumab is safe and tolerable as defined by 
DLT criteria and general clinical judgement, taking into account a general benefit risk 
assessment.  Pharmacokinetic data may be reviewed, if available. 
Based on the totality of the data, the DLRT may recommend to declare MTD, to escalate 
to the next dose level, to expand a cohort to a maximum of 10 subjects, if the collection 
of more data is deemed warranted, or to adjudicate the DLT criteria. 
The DLRT will meet to review the safety data, when any of the following criteria are met: 
 
In 2 or more out of 6 subjects, a DLT has been reported or in 3 or more   
out of 10 subjects, a DLT has been reported in a cohort 
 
6 subjects are enrolled in a cohort and all subjects have completed the DLT 
observation period 
 
In the event that a cohort is expanded to 10, DLRT will also meet after all 
subjects have completed DLT observation period 
The DLRT will consist of, at minimum, members from the Amgen study team including at 
least one clinician, one safety representative, members outside the Amgen study team 
including at least one representative of the Merck study team, and one investigator 
participating in the study who has recruited subjects into the cohort under review.  A 
cohort may be expanded by DLRT recommendation in the case that the data suggests a 
change to the anticipated risk/benefit profile, warranting collection of further data at the 
blinatumomab target dose. 
In part 2, DRT will meet after every set of 10 subjects who become DLT evaluable. 
A DRT is a group, internal to Amgen but external to the product team, that reviews 
accumulating data from the ongoing clinical trial to evaluate overall benefit and 


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risk. The DRT includes a clinician, a safety physician, and a biostatistician. 
Experts external to Amgen may be included if needed. Membership, procedures 
and meeting timing will be described in detail in the study DRT charter. 
9. 
Data Screening and Acceptance  
9.1 
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. The 
database will be subject to edit checks outlined in the data management plan by Amgen 
Clinical Data Management (CDM) department. Any outstanding data issues will be 
communicated to CDM for resolution before the database is locked. 
9.2 
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 
Clinical database. 
An Analysis Dataset for PK Concentrations (ADPC) will be provided to the appropriate 
Clinical Pharmacology Modeling and Simulation CPMS representative from Global 
Biostatistical Sciences. 
9.3 
Handling of Missing and Incomplete Data 
Subjects without tumor response assessments will be considered as non-responders. 
Otherwise, only non-missing data will be analyzed. No other missing value replacement 
procedure will be deployed for clinical data. The handling of incomplete and partial dates 
for adverse events and concomitant medications are described in Appendix A. Handling 
of missing or incomplete data for exposure-response analysis will be described in the 
E-R supplemental SAP (SSAP) or associated documents to support population PK/PD 
dataset generation and E-R analysis. 
9.4 
Detection of Bias 
If applicable, the methods to detect bias are described in the analyses of particular 
endpoints. 
9.5 
Outliers 
Any suspected outliers will be investigated by the study team and will be included in the 
database unless determined to be an error or there is supporting evidence or 
explanation to justify the exclusion. Any outliers excluded from the analysis will be 


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discussed in the Clinical Study Report (CSR), including the reasons for exclusion and 
the impact of their exclusion on the study.  
PK serum concentration data will be evaluated for outliers by visual inspection, and 
decisions to re-assay individual samples will be made in accordance with standard 
pharmacokinetic evaluation practice. 
9.6 
Distributional Characteristics 
The statistical assumptions for analysis methods will be assessed. If the assumptions for 
the distributional characteristics are not met, these will be described, and further 
analyses may be carried out using data transformations or alternative analysis methods. 
The use of transformations or alternative analysis methods will be justified in the final 
study report. 
9.7 
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. 
10. 
Statistical Methods of Analysis 
10.1 
General Principles 
The analysis will be performed by cohorts for part 1.  The analyses for part 2 will 
combine subjects in part 2 and the cohort in part 1 with selected dose for part 2 unless 
specified otherwise.  The analyses will be performed on the Full Analysis Set unless 
specified otherwise. 
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. 
Time to event endpoints will be summarized with hazard ratios, Kaplan-Meier (KM) 
curves, KM proportions at select time points, KM quartiles (when estimable), the number 
of subjects with events, the number of subjects censored, and the pattern of censoring. 
Point estimates for efficacy endpoints will be accompanied by 2-sided 95 confidence 
intervals including estimates of KM quartiles (Brookmeyer and Crowley, 1982), KM 


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proportions (Kalbfleisch and Prentice, 1980), and binomial proportions (Clopper and 
Pearson, 1934). Pharmacokinetics will be performed by noncompartmental analysis. 
Pharmacodynamic samples will be summarized by descriptive statistics.  
Relationships among drug exposures and efficacy, safety, and biomarkers may be 
explored if the data are sufficient. 
10.2 
Subject Accountability 
The number (and percent) of subjects who were screened, received blinatumomab and 
pembrolizumab and complete the study will be summarized. The number (and percent) 
of subjects who discontinue each treatment and the study and their reasons for 
discontinuation will be summarized.  
10.3 
Important Protocol Deviations 
Categories for Important Protocol Deviations (IPDs) are defined by the study team 
before the first subject’s visit and updated during the IPD reviews throughout the study 
prior to database lock. These definitions of IPD categories, sub-category codes, and 
descriptions will be used during the course of the study. Eligibility deviations are defined 
in the protocol. 
10.4 
Demographic and Baseline Characteristics 
Demographic (ie, age, age group, sex, race, and ethnicity) and baseline disease 
characteristics will be summarized using descriptive statistics. If multiple races have 
been reported for a subject, the subject will be categorized as multiple races as well as 
by combination of races. 
The baseline characteristics to be summarized include: 
 
Age 
 
age group:  65, 65-74,  75 
 
age as continuous variable 
 
Sex:  Male, Female 
 
Race 
 
American Indian or Alaska Native 
 
Asian 
 
Black (or African American) 
 
Native Hawaiian or other Pacific Islander 
 
White 
 
Other 


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 
Geographic region  
 
US/Canada 
 
Asia 
 
Europe 
 
Rest of the world 
 
aaIPI: Low (0), Low-Intermediate (1), High-Intermediate (2), High (3) 
 
Primary disease status: Relapsed, Refractory 
 
Prior HSCT: Yes, No 
 
Extranodal disease: Yes, No. 
 
Cell of Origin Determination: GCB, Non-GCB, ABC, Not done 
 
Bcl-2 rearrangement status: Normal, Rearranged, Overexpressed, Not 
Overexpressed, Not done 
 
Bcl-2 overexpression status: Normal, Rearranged, Overexpressed, Not 
Overexpressed, Not done 
 
Bcl-6 rearrangement: Normal, Rearranged, Overexpressed, Not Overexpressed, 
Not done.  
 
Bcl-6 overexpression: Normal, Rearranged, Overexpressed, Not Overexpressed, 
Not done.  
 
C-myc rearrangement status: Normal, Rearranged, Overexpressed, Not 
Overexpressed, Not done 
 
C-myc overexpression status: Normal, Rearranged, Overexpressed, Not 
Overexpressed, Not done  
 
Double hit: Yes, No (Yes is defined by both C-myc and Bcl-6 overexpression and 
rearrangement are Yes; otherwise No) 
 
Triple hit: Yes, No, (defined as 'Yes' if all of Bcl-2, Bcl-6 and C-myc 
rearrangement are 'Yes', else 'No'.) 
 
Double high expressor: Yes, No, (defined as 'Yes' if Two of Bcl-2, Bcl-6, C-myc 
overexpression are Yes', else 'No'.) 
 
Triple high expressor:  Yes, No, (defined as 'Yes' if all of Bcl-2, Bcl-6, C-myc 
overexpression are Yes', else 'No'.) 
10.5 
Efficacy Analyses 
The efficacy endpoints are ORR, CR, PFS, OS and DOR. 
The percentage of subjects with an objective response (CR/ PR) using the Lugano 
Classification; and an objective response (CR/ PR) using Revised Response 
Criteria during the first 12 weeks since starting blinatumomab (for part 2 and the 
cohort in part 1 with selected dose only) and during the treatment period will be 
summarized with an exact 2-sided binomial 95 confidence interval using Full 


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Analysis Set. Subjects missing post baseline disease assessments will be considered 
not to have achieved an objective response. 
The KM summaries will be performed for PFS and OS. K-M quartiles along with 2-sided 
95 CIs, the number of subjects censored and the number of subjects with events will 
be provided using FAS. The KM summaries of DOR will be performed using Responder 
Analysis Set.  
The exploratory endpoint minimal residual disease (MRD) by NGS after cycle 1 of 
blinatumomab will be summarized with descriptive statistics by treatment cohort using 
full analysis set. 
10.6 
Safety Analyses 
10.6.1 
DLT Summary 
The DLT criteria are defined in the Appendix E of the protocol. 
Incidence rates of DLTs and corresponding exact binomial 95 CIs will be summarized 
for DLT evaluable subjects.  
10.6.2 
Adverse Events and Disease Related Events 
The Medical Dictionary for Regulatory Activities (MedDRA) version 22.1 or later will be 
used to code all events categorized as adverse events (AEs) or disease-related events 
(DREs) to a system organ class and a preferred term. AEs of interest (EOI) categories 
will be based on search strategies defined by Medical Coding.  Treatment emergent 
adverse event refers to an adverse event that starts on or after first dose of 
blinatumomab up to and including 30 days after the end of blinatumomab or 
pembrolizumab whichever is later. 
Subject incidence of all, serious, grade 3 and above, leading to withdrawal of 
investigational product, leading to interruption of investigational product, fatal, 
treatment-related, treatment-related serious, and treatment-related grade 3 and 
above treatment-emergent adverse events (including DREs) will be tabulated by 
system organ class and preferred term in descending order of frequency for highest 
dose group. 
Treatment-emergent events of interest (EOIs) will be summarized by EOI category and 
preferred term.  In addition, for each EOI category, the subject incidence of all, serious, 
grade 3 and above, grade 4 and above, fatal, leading to withdrawal of investigational 
product, leading to interruption of investigational product will be summarized.  Time to 
onset, duration, number of selected EOIs will also be summarized.  


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Additionally, treatment emergent DREs and fatal DREs will be summarized by system 
organ class and preferred term in descending order of frequency for highest dose 
group. Subject incidence of ECIs will be summarized by ECI category and preferred 
term in descending order of frequency for highest dose group. 
Subgroup analyses of treatment-emergent adverse events will be presented for 
age-group ( 65, 65-74,  75), and gender by system organ glass and preferred 
term in descending order of frequency for highest dose group.  
Subject listings of Serious AEs, Fatal AEs and Deaths will be provided. Analyses 
will be performed based on Safety Analysis Set.  
10.6.3 
Laboratory Test Results 
Summary statistics over scheduled visits for actual values, changes from baseline of 
selected laboratory parameters below will be presented for subjects in the Safety 
Analysis Set. 
1. Corrected Calcium 
2. Magnesium 
3. Total bilirubin 
4. Direct bilirubin 
5. Alkaline phosphatase 
6. AST (SGOT) 
7. ALT (SGPT) 
8. Amylase 
9. Lipase 
10. Hemoglobin 
11. Platelets 
12. Neutrophils 
13. Lymphocytes 
14. LDH 
15. Immunoglobulins (IgG, IgA, IgM) 
16. Fibrinogen 
Shift tables between the worst post-baseline and baseline grades for selected laboratory 
parameters will be provided. 


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The subject incidence of potential cases of Hy’s Law will be summarized. 
10.6.4 
Vital Signs 
The number and percentage of subjects with abnormal changes in systolic blood 
pressure, diastolic blood pressure and heart rate will be summarized based on Safety 
Analysis Set. 
10.6.5 
Physical Measurements 
Not Applicable  
10.6.6 
Electrocardiogram (ECG)  
Not Applicable  
10.6.7 
Antibody Formation  
The incidence and percentage of subjects who develop anti blinatumomab antibodies 
(binding and if positive, neutralizing) and anti-pembrolizumab antibodies at any time will 
be tabulated. 
10.6.8 
Exposure to Investigational Product 
Descriptive statistics will be produced to describe the exposure to blinatumomab and 
pembrolizumab. The number of cycles initiated, completed, discontinued, and re-started 
of blinatumomab and pembrolizumab will be summarized. If a subject completed 85 
of planned days on target dose, he/she is considered as completing a cycle. In 
addition, the duration of therapy will be summarized by cycle and overall. Relative dose 
intensity at the target dose will be calculated. It is the actual exposure duration at 
target dose divided by planned duration of target dose, which is 49 days for 
cohort Ia, and 42 days for cohort IIa and IIIa in cycle 1; and 21 days for cohort Ia, 
and 14 days for cohort IIa and IIIa in cycle 2. Subjects who didn’t reach the target 
dose are considered having actual exposure duration as 0. Relative dose intensity 
at the target dose will be summarized by cycle. The number and percent of subjects 
with dose modifications (eg, dose changes, dose interruptions) and reasons for 
modification will be summarized. Analysis will be performed based on Safety 
Analysis Set. 
10.6.9 
Exposure to Concomitant Medication 
The number and percent of subjects receiving concomitant medications from study day 1 
through blinatumomab or pembrolizumab safety follow-up, whichever is later will be 
summarized by preferred term as coded by the World Health Organization Drug 
(WHODRUG) dictionary. In addition, the number and proportion of subjects receiving 


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anti-cancer therapies during long term follow-up will be summarized using Safety 
Analysis Set. 
10.6.10 
Pharmacokinetic Analysis of Blinatumomab 
Blinatumomab serum samples will be taken as listed in Schedule of Assessment of 
protocol. All data for PK analyses will be extracted from a secure folder and were 
mapped via the SAS_CDISC_v2 clinical connector into the Pharsight Knowledgebase 
Server (PKS) system version 4.0.3 (Pharsight, St. Louis, MO).  
Blinatumomab pharmacokinetic analysis will be performed using Phoenix WinNonlin 
v.6.4 software on Citrix (Pharsight, St. Louis, MO) as part of the validated PKS system 
on individual serum blinatumomab concentrations to estimate the following PK 
parameters: 
 
The steady state serum concentration (Css) of cycle 1 summarized as the 
observed concentrations collected during continuous IV infusion by dose 
levels.  
 
Systemic clearance (CL) calculated as CLR0/Css; where R0 is the 
infusion rate (g/hr) and Css is the dose normalized average Css.  
Nominal times were used for presenting data in tables. Blinatumomab concentrations 
below the lower limit of quantification (LLOQ, 50 pg/mL) were set to zero before data 
analysis. All individual PK parameters and descriptive statistics are presented to 
3 significant figures, except for CV, which was reported to 1 decimal place. 
PK parameters such as steady state concentration (Css) will be estimated for patients 
who have evaluable PK data. Summary statistics, including mean, standard deviation, 
CV, median, range (Minimal, Maximal), geometric mean and CV of geometric mean 
will be computed for each pharmacokinetic parameter and grouped by dose, and 
treatment Phase. Individual concentration-time data will be tabulated and presented in 
PK appendix. Mean concentration-time profiles for each cohort may be provided, if 
sufficient data are available. Analyses will be performed based on Pharmacokinetic 
Analysis Set. 
10.6.11 
Pharmacokinetic Analysis of Pembrolizumab  
Pembrolizumab serum samples will be taken as listed in Schedule of Assessment of 
protocol. Pembrolizumab exposure parameters (eg, concentrations at the end of IV 
infusion and steady state trough concentrations) will be estimated for subjects who have 
evaluable PK data. Summary statistics, including mean, standard deviation, CV, 
median, range (Minimal, Maximal), geometric mean and CV of geometric mean will be 


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computed for each pharmacokinetic parameter by treatment cycles. Individual 
concentration-time data will be tabulated and presented in PK appendix. Mean 
concentration-time profiles may be provided, if sufficient data are available. Analyses 
will be based on Pharmacokinetic Analysis Set  
10.6.12 
Pharmacodynamic Analysis 
Blood samples for biomarker analysis will be taken as described in the Schedule of 
Assessment of protocol. The cytokine levels over time will be analyzed with summary 
statistics by treatment period and treatment cohort. The changes in Lymphocytes (B-cell, 
T-cell populations, NK cells), leukocyte populations (leukocytes, lymphocytes, 
monocytes, and granulocytes) and Tumor PD-L1 expression over time will be 
summarized with descriptive statistics by treatment period and treatment cohort. Other 
analysis may be performed as appropriate. There will be a separate biomarker SSAP 
developed with a molecular scientist. 
Merck biomarker lead will define analysis related to pembrolizumab and PD-L1. 
Analyses will be based on Pharmacodynamic Analysis Set.  
10.6.13 
Exposure Response Analysis 
PK data of blinatumomab may be subjected to exploratory population PK analysis with 
data from multiple studies. Nonlinear mixed effects modeling will be used for the 
analysis. Effect of covariates on exposure will be determined. These may include, age, 
body weight, body surface area, renal function, liver function, sex and selected baseline 
lab values. Other covariates may be analyzed as needed. Individual blinatumomab 
concentration data at time of interest may be used for the exposure response analysis.  
Exposure-response relationships for selected efficacy and safety endpoints may be 
assessed as appropriate.  The objectives and methodology of the exposure-response 
analysis will be provided in an E-R SSAP. 
11. 
Changes From Protocol-specified Analyses 
Because the decision was made not to proceed with Part 2 of the study. The 
primary analysis will now occur after the last subject in Part 1 has had an 
opportunity to complete response assessment during first 12 weeks since starting 
blinatumomab. 


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Other changes include modifications of the definitions to the following endpoints. 
Secondary Endpoint (Per protocol):  
Duration of response (DOR) for subjects with OR, (ie, CR and PR) by the Lugano 
Classification (Cheson et al, 2014) during the first 12 weeks since starting 
blinatumomab. 
Changes from protocol:  
Duration of response (DOR) for subjects with OR, (ie, CR and PR) by the Lugano 
Classification (Cheson et al, 2014) and Revised Response Criteria 
(Cheson et al, 2007) during the first 12 weeks since starting blinatumomab. 
PFS definition (Per protocol):  
The PFS will be calculated as the time from the date of first dose of blinatumomab 
until the date of diagnosis of progression of lymphoma, or date of death, 
whichever is earliest. For diagnosis of progression of lymphoma, the progression 
of radiographic assessment of PET-CT using Lugano Classification will be used.  
Subjects who are alive and did not have progression will be censored at the last 
radiological non-missing evaluable tumor assessment date. Progression free 
survival for subjects who were enrolled in dose cohorts that were not selected for 
the extension cohort will not be calculated. 
Changes from protocol: 
Progression Free Survival (PFS) by Lugano Classification: 
The PFS will be calculated as the time from the date of first dose of blinatumomab 
until the date of diagnosis of progression of lymphoma, or date of death, 
whichever is earliest. For diagnosis of progression of lymphoma, the progression 
of radiographic assessment of PET-CT using Lugano Classification will be used.  
Subjects who are alive and did not have progression will be censored at the last 
radiological non-missing evaluable tumor assessment date.  
Progression Free Survival (PFS) by Revised Response Criteria: 
The PFS will be calculated as the time from the date of first dose of blinatumomab 
until the date of diagnosis of progression of lymphoma, or date of death, 
whichever is earliest. For diagnosis of progression of lymphoma, the progression 
of radiographic assessment of PET-CT using Revised Response Criteria will be 
used.  Subjects who are alive and did not have progression will be censored at the 
last radiological non-missing evaluable tumor assessment date.  


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12. 
Literature Citations / References 
Brookmeyer R and Crowly J. A confidence interval for the median survival time. 
Biometrics. 1982 ; 29-41. 
Cheson, Bruce D., et al. "Revised response criteria for malignant lymphoma." Journal of 
Clinical Oncology 25.5 (2007): 579-586. 
Cheson, Bruce D., et al. "Recommendations for initial evaluation, staging, and response 
assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification." Journal 
of clinical oncology 32.27 (2014): 3059-3067. 
Clopper CJ and Pearson EG. The use of confidence or fiducial limits illustrated in the 
case of the binomial. Biometrica 1934; 26(4): 404-413. 
Cui L, Hung HM, Wang SJ. Modification of Sample Size in Group Sequential Clinical 
Trials. Biometrics. 1999: 853-857. 
Gao, P, Ware, JH and Mehta, C Sample Size Re-estimation for Adaptive Sequential 
Design in Clinical Trials, Journal of Biopharmaceutical Statistics, 2008; 1184-1196 
Kalbfleisch JD and Prentice RL. The Statistical Analysis of Failure Time Data. John 
Wiley, New York Rev, 1980; 4(2): 25. 
Neuenschwander B, Branson M, Gsponer T. Critical aspects of the Bayesian approach 
to phase I cancer trials. Statistics in Medicine 2008; 27:2420-2439. 


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13. 
Prioritization of Analyses  
Not Applicable. 
14. 
Data Not Covered by This Plan  
Not Applicable. 


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15. 
Appendices 


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Appendix A.  Technical Detail and Supplemental Information Regarding Statistical 
Procedures and Programs 
Handling Incomplete Dates and Missing Dates for Adverse Events and Concomitant 
Medications. 
The following data will be imputed using the following algorithm: 
 
Adverse Events 
 
Concomitant Medications 
Imputation Rules for Partial or Missing Start Dates 
 Start Date 
Stop Date 
Complete: 
yyyymmdd 
Partial:  
yyyymm 
Partial:  
yyyy 
Missing 
 1st 
dose 
 1st 
dose 
 1st 
dose 
yyyymm 
 1st 
dose 
yyyymm 
 1st 
dose 
yyyy 
 1st 
dose 
yyyy 
Partial: 
yyyymm 
 1st dose 
yyyymm 
2 
1 
2 
1 
n/a 
1 
1 
 1st dose 
yyyymm 
2 
2 
2 
2 
2 
Partial: 
yyyy 
 1st dose 
yyyy 
3 
1 
3 
1 
n/a 
1 
1 
 1st dose 
yyyy 
3 
3 
3 
3 
3 
Missing 
4 
1 
4 
1 
4 
1 
1 
1  Impute the date of first dose 
2  Impute the first of the month 
3  Impute January 1 of the year 
4  Impute January 1 of the stop year 
Note: If the start date imputation leads to a start date that is after the stop date, then do 
not impute the start date. 
Imputation rules for partial or missing stop dates: 
Initial imputation 
 
For partial stop date mmyyyy, impute the last of the month. 
 
For partial stop date yyyy, impute December 31 of the year. 
 
For completely missing stop date, do not impute. 


Product:  Blinatumomab 
Statistical Analysis Plan:  20150290 
Date:  15 February 2021 
Page 38 
 
 
If the stop date imputation leads to a stop date that is after the death date, then 
impute the stop date as the death date. 
 
If the stop date imputation leads to a stop date that is before the start date, then 
there is a data error and do not impute the stop date. (ie. set the stop date as 
missing). 
Imputation rules for partial or missing death dates: 
 
If death year and month are available but day is missing: 
 
If mmyyyy for last contact date  mmyyyy for death date, set death date to the 
day after the last contact date. 
 
If mmyyyy for last contact date  mmyyyy for death date, set death date to the 
first day of the death month. 
 
If mmyyyy for last contact date  mmyyyy for death date, data error and do not 
impute. 
If both month and day are missing for death date or a death date is totally 
missing, do not impute. 


Product:  Blinatumomab 
Statistical Analysis Plan:  20150290 
Date:  15 February 2021 
Page 39 
 
Appendix B.  Reference Values/Toxicity Grades 
Laboratory Values 
Safety laboratory values below a distinct limit (eg, detection limit, documented as 
“ [limit]”) will be substituted by half of the limit and values above a distinct limit 
(documented as “ [limit]”) will be substituted by the limit itself for all analyses. A Grade 
(based on CTC AE version 4.0 [v4.03: June 14, 2010]) will be assigned to each 
laboratory result as detailed in Table 6. Depending on the toxicity definition, the same 
result may be assigned to two grading for deviations towards higher or lower values. In 
case no lower limit of normal is provided for the absolute lymphocyte, neutrophils or 
leukocyte counts it will not be differentiated between grade 1 and grade 0 results for 
these parameters. Values not meeting any of the criteria will be assigned a grade 0. 
Grading of Select Laboratory Parameters 
Laboratory 
Parameter [Unit] 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Lymphocytes 
[G/L] 
0.8 -  LLN 
0.5 -  0.8 
0.2 -  0.5 
 0.2 
Neutrophils 
[G/L] 
1.5 -  LLN 
1.0 -  1.5 
0.5 -  1.0 
 0.5 
Leukocytes 
[G/L] 
3.0 -  LLN 
2.0 -  3.0 
1.0 -  2.0 
 1.0 
Platelets [G/L] 
75 -  LLN 
50 -  75 
25 -  50 
 25 
Hemoglobin 
[g/L]* 
100 -  LLN  
80 -  100 
65 -  80 
 65 
Albumin [g/L] 
30 -  LLN 
20 -  30 
 20 
not defined 
AST* 
 ULN – 3*ULN 
 3*ULN – 
5*ULN 
 5*ULN – 20*ULN 
 20*ULN 
ALT * 
 ULN – 3*ULN 
 3*ULN – 
5*ULN 
 5*ULN – 20*ULN 
 20*ULN 
GGT  
 ULN – 
2.5*ULN 
2.5*ULN – 
5*ULN 
 5*ULN – 20*ULN 
 20*ULN 
Bilirubin 
 ULN – 
1.5*ULN 
1.5*ULN – 
3*ULN 
 3*ULN – 10*ULN 
 10*ULN 
Fibrinogen^ 
change of 
BL 25 or 
0.75*LLN -  
LLN 
25- 50 of 
BL 
  or  
 75*LLN – 
0.5*LLN 
50 - 75 of BL  
or 
 0.5* LLN – 
0.25*LLN 
 75 of BL 
or  50mg/dL 
or  
0.25*LLN 
Page 1 of 2 


Product:  Blinatumomab 
Statistical Analysis Plan:  20150290 
Date:  15 February 2021 
Page 40 
 
Laboratory 
Parameter [Unit] 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Calcium 
[mmol/L]* 
2.0 -  LLN 
1.75 -  2.0 
1.5 -  1.75 
 1.5 
Potassium 
[mmol/L]* 
not defined 
3.0 -  LLN 
2.5 -  3.0 
 2.5 
Lipase 
 ULN – 
1.5*ULN 
 1.5*ULN – 
2.0*ULN 
 2.0*ULN – 
5.0*ULN 
 5.0*ULN 
Amylase  
 ULN – 
1.5*ULN 
 1.5*ULN – 
2.0*ULN 
 2.0*ULN – 
5.0*ULN 
 5.0*ULN 
Page 2 of 2 
BL baseline value, LLN: Lower limit of normal, ULN: Upper limit of normal 
* Clinical criteria from CTC AE 4.0 grading were not considered in order to assign grades 
^ In case of conflicting criteria the higher grade will be assigned,  change only used when baseline 
is LLN