Conditions: Solid Tumors
Keywords: MSB0011359C
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 114
Healthy volunteers: no

Brief summary:
The main purpose of this study was to assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in participants with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy had failed.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: MSB0011359C
Intervention descriptions: intervention 1: Subjects with metastatic or locally advanced solid tumors received intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.

Protocol document:
Prot_000.pdf: 




M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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Section # and Name
Description of Change
Brief Rationale
7.1.3 Rechallenge
Re-initiation period corrected for 
constancy in the protocol text.
Text in Section 7.1.3 updated to state 
re-initiation course of 12 months is 
allowed to maintain constancy in the 
protocol text.
7.7.1 Anti-drug antibody 
Analysis
Included details for anti-drug 
antibody testing.
Text included describing the anti-drug 
antibody testing and that confirmed 
positive antibodies may be tested for 
the presence of neutralizing antibodies.
Minor editorial and document 
formatting updates have been made 
throughout the protocol.
- Confidential -
This document is the property of Merck KGaA, Darmstadt, Germany, or one of its subsidiaries.  It is 
intended for restricted use only and may not – in full or part – be passed on, reproduced, published or 
used without express permission of Merck KGaA, Darmstadt, Germany, or its subsidiary.  
Copyright © 2020 by Merck KGaA, Darmstadt, Germany, or its subsidiary.  All rights reserved.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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Protocol Table of Contents
Protocol Table of Contents ..................................................................................................4
Table of In-text Tables.........................................................................................................9
Table of In-text Figures .......................................................................................................9
List of Abbreviations .........................................................................................................10
1
Synopsis..............................................................................................15
2
Sponsor, Investigators and Trial Administrative Structure ................39
2.1
Investigational Sites............................................................................39
2.2
Trial Coordination/Monitoring...........................................................39
2.2.1
Safety Monitoring Committee............................................................40
2.2.2
Central Reader and Independent Endpoint Review Committee.........40
3
Background Information.....................................................................41
3.1
Investigational Medicinal Product......................................................41
3.2
3.2.1
3.2.2
Pharmacokinetics/
.....................................47
3.2.3
3.3
3.3.1
3.3.2
3.3.3
Disease Background ...........................................................................53
3.4
Summary of the Overall Benefit and Risk..........................................54
3.4.1
Infusion-related Reactions/Hypersensitivity ......................................55
3.4.2
Immune-related Adverse Events/Autoimmune Disorders..................56
3.4.3
Anemia................................................................................................57
3.4.4
Alterations in Wound Healing or Repair of Tissue Damage..............57
3.4.5
Rash with Hyperkeratosis/Keratoacanthoma/Squamous Cell 
Carcinoma of the Skin ........................................................................58
3.4.6
Embryofetal Toxicity..........................................................................58
3.4.7
Mild to Moderate Mucosal Bleeding Events......................................58
3.4.8
Potential Benefit .................................................................................58
4
Trial Objectives ..................................................................................59
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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4.1
Primary Objective...............................................................................59
4.2
Secondary Objectives .........................................................................59
4.3
5
Investigational Plan ............................................................................60
5.1
Overall Trial Design and Plan ............................................................60
5.1.1
Overall Study Design..........................................................................60
5.1.2
Trial Medication Administration and Schedule..................................64
5.1.3
MSB0011359C Dose Escalation ........................................................64
5.1.4
Expansion Cohorts..............................................................................66
5.1.5
Planned Number of Subjects ..............................................................67
5.1.6
Planned Treatment Duration...............................................................67
5.1.7
Dose Modification and Adverse Drug Reactions Requiring 
Treatment Discontinuation .................................................................68
5.1.8
Analysis Cut-Off Dates.......................................................................70
5.2
Discussion of Trial Design .................................................................70
5.2.1
Inclusion of Special Populations ........................................................71
5.3
Selection of Trial Population..............................................................71
5.3.1
Inclusion Criteria ................................................................................72
5.3.2
Exclusion Criteria...............................................................................74
5.4
Criteria for Initiation of Trial Treatment ............................................77
5.5
Criteria for Subject Withdrawal..........................................................77
5.5.1
Withdrawal from Trial Treatment ......................................................77
5.5.2
Withdrawal from the Trial..................................................................78
5.6
Premature Discontinuation of the Trial ..............................................79
5.7
Definition of End of Trial...................................................................79
6
Investigational Medicinal Product and Other Drugs Used in the 
Trial.....................................................................................................80
6.1
Description of Investigational Medicinal Product..............................80
6.2
Dosage and Administration ................................................................81
6.3
Assignment to Treatment Groups.......................................................82
6.4
Non-investigational Medicinal Products to be Used ..........................82
6.5
Concomitant Medications and Therapies ...........................................82
6.5.1
Permitted Medicines...........................................................................83
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
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6.5.2
Prohibited Medicines..........................................................................83
6.5.3
Other Interventions.............................................................................84
6.5.4
Special Precautions.............................................................................84
6.6
Packaging and Labeling of the Investigational Medicinal Product....93
6.7
6.8
Investigational Medicinal Product Accountability.............................94
6.9
Assessment of Investigational Medicinal Product Compliance .........96
6.10
Method of Blinding.............................................................................96
6.11
Emergency Unblinding.......................................................................96
6.12
Treatment of Overdose .......................................................................96
6.13
Medical Care of Subjects after End of Trial.......................................97
7
Trial Procedures and Assessments......................................................97
7.1
Schedule of Assessments....................................................................97
7.1.1
Screening and Baseline Procedures and Assessments........................97
7.1.2
Treatment Period ................................................................................98
7.1.3
Rechallenge.......................................................................................102
7.1.4
End-of-Treatment .............................................................................103
7.1.5
Post-Treatment Follow-up................................................................104
7.1.6
Blood Consumption for Clinical Assessments .................................105
7.2
Demographic and Other Baseline Characteristics ............................106
7.2.1
Demographic Data............................................................................106
7.2.2
Diagnosis of Tumor..........................................................................106
7.2.3
Medical History ................................................................................106
7.2.4
Vital Signs and Physical Examination..............................................107
7.2.5
Computed Tomography or Magnetic Resonance Imaging Scans 
for Tumor Assessment at Baseline ...................................................107
7.2.6
Cardiac Assessments ........................................................................107
7.2.7
Clinical Laboratory Tests .................................................................108
7.3
Efficacy Assessments .......................................................................108
7.3.1
Modified Immune-related Response Criteria, Derived from 
RECIST 1.1.......................................................................................110
7.3.2
Modified Response Evaluation Criteria in Solid Tumors for 
Hepatocellular Carcinoma ................................................................111
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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8.5.4
8.5.5
Analysis of Safety.............................................................................139
8.6
Interim Analyses...............................................................................140
9
Ethical and Regulatory Aspects........................................................141
9.1
Responsibilities of the Investigator ..................................................141
9.2
Subject Information and Informed Consent .....................................141
9.3
Subject Identification and Privacy....................................................142
9.4
Emergency Medical Support and Subject Card................................143
9.5
Clinical Trial Insurance and Compensation to Subjects...................143
9.6
Independent Ethics Committee or Institutional Review Board........144
9.7
Health Authorities.............................................................................144
10
Trial Management.............................................................................144
10.1
Case Report Form Handling.............................................................144
10.2
Source Data and Subject Files..........................................................145
10.3
Investigator Site File and Archiving.................................................146
10.4
Monitoring, Quality Assurance and Inspection by Health 
Authorities ........................................................................................146
10.5
Changes to the Clinical Trial Protocol..............................................146
10.6
Clinical Trial Report and Publication Policy....................................147
10.6.1
Clinical Trial Report.........................................................................147
10.6.2
Publication........................................................................................147
11
References.........................................................................................147
12
Appendices .......................................................................................152
Appendix 1
Eastern Cooperative Oncology Group Performance Status..............153
Appendix 2
Guidance on Contraception ..............................................................154
Appendix 3
Protocol Amendments History .........................................................155
Appendix 4
Signature Pages and Responsible Persons for the Trial....................162
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
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List of Abbreviations
ACTH
adrenocorticotropic hormone
ADA
anti-drug antibody
ADR
adverse drug reaction
AE
adverse event
AESI
adverse events of special interest
AFP
alpha-fetoprotein
ALT
alanine aminotransferase
ANA
antinuclear antibody
ANC
absolute neutrophil count
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AUC0-∞
area under the concentration-time curve from the time of dosing 
extrapolated to infinity
AUC0-t
area under the concentration-time curve from the time of dosing to the 
time of the last observation
β-HCG
β-human chorionic gonadotropin
BOR
best overall response
BTC
biliary tract cancer
CC 
cholangio cell carcinoma
CI
confidence interval
CNS
central nervous system
Cmax
maximum serum concentration observed postdose
Cmin
minimum serum concentration observed postdose
CR
complete response
CRO
Contract Research Organization
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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CT 
computed tomography 
CTCAE
Common Terminology Criteria for Adverse Events
CTLA-4
cytotoxic T lymphocyte antigen-4
DLT
dose-limiting toxicity
EC
esophageal cancer
ECG
electrocardiogram
ECOG PS
Eastern Cooperative Oncology Group Performance Status
eCRF
electronic case report form
EORTC 
QLQ-BIL21
European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire Cholangiocarcinoma and Gallbladder Cancer 
Module
EORTC 
QLQ-C30
European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire Core instrument
EORTC 
QLQ-HCC18
European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire Hepatocellular Carcinoma Module
EORTC 
QLQ-OES18
European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire Esophageal Module
EORTC 
QLQ-STO22
European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire Gastric Module
ESCC
esophageal squamous cell cancer
FDA
Food and Drug Administration
FSH
follicle stimulating hormone
GBC
gallbladder cancer
GC
gastric cancer
GCP
Good Clinical Practice
HAHA
human antihuman antibody
HBV
hepatitis B virus
HCC
hepatocellular carcinoma
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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HCV
hepatitis C virus
HDV
hepatitis D virus
Hgb
hemoglobin
HIV
human immunodeficiency virus
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Council for Harmonisation
IEC
Independent Ethics Committee
IMP
Investigational Medicinal Product
INR
international normalized ratio
irAE
immune-related adverse event
IRB
Institutional Review Board
IRC
Independent Endpoint Review Committee
irSD
immune-related stable disease
LDH
lactate dehydrogenase
MAHA
mouse antibody against human antibody
MedDRA
Medical Dictionary for Regulatory Activities
MoA
mechanism of action
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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mRECIST
modified Response Evaluation Criteria in Solid Tumors
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
NCI
National Cancer Institute 
NK
natural killer
NOAEL
no-observed-adverse-effect level
NSAID
nonsteroidal anti-inflammatory drugs
ORR
objective response rate
OS
overall survival 
PBMC(s)
peripheral blood mononuclear cell(s)
PD
progressive disease
PD-1
programmed death 1
PD-L1
programmed death ligand 1
PFS
progression-free survival
Ph Eur
European Pharmacopeia 
PGIS
Patient Global Impression of Severity
PK
pharmacokinetics
PR
partial response
RECIST
Response Evaluation Criteria in Solid Tumors
RF
rheumatoid factor
SAE
serious adverse event
SAP
statistical analysis plan
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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SMC
Safety Monitoring Committee
SpO2
Oxygen saturation 
t1/2
terminal half-life
T4
thyroxine
TEAE
treatment-emergent adverse event
TGFβ
transforming growth factor-beta 
TGFβRII
transforming growth factor-beta receptor II
Treg
regulatory T cells
TSH
thyroid stimulating hormone
ULN
upper limit of normal
USP
United States Pharmacopeia
VAC
carcinoma of Vater’s ampular 
WBC
white blood cell
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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1
Synopsis
Trial title
A Phase I, open-label, multiple-ascending dose trial to 
investigate the safety, tolerability, pharmacokinetics, 
biological and clinical activity of MSB0011359C in 
subjects with metastatic or locally advanced solid tumors 
with expansion to selected indications in Asia
Trial number
MS200647-0008
Sponsor
For sites in Japan:
Merck Biopharma Co., Ltd.
(Affiliate of Merck KGaA, Darmstadt, Germany)
For all countries except Japan:
Merck KGaA, Frankfurter Str. 250
64293 Darmstadt, Germany
Phase
I
Trial under IND
yes
no
FDA "covered trial"
yes
no
Trial center(s)/country(ies)
Dose Escalation Part:  Up to 2 sites in Japan.
Expansion Part:  Up to 30 sites in Japan, Korea and 
Taiwan.
Planned trial period
(first enrollment-last subject out)
Dose Escalation Part:
First subject in:  First quarter (Q1) 2016
Last subject out:  Q4 2020
Expansion Part:
First subject in: Q4 2016 (Q2 2016 for hepatocellular 
carcinoma [HCC])
Last subject out: Q4 2020
End of Trial:
If the trial is not terminated prematurely, the end of the 
trial is defined as 1 year after the last subject receives the 
last dose of MSB0011359C.
Analysis cut-off dates:  The primary data cut-off date for 
the dose escalation part is 3 months after the last subject 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
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Trial design and plan
This Phase I, open-label trial consists of 2 parts:  a dose escalation part (Part A) and an expansion 
part (Part B).  This trial will be conducted to investigate the safety and tolerability of 
MSB0011359C in subjects with metastatic or locally advanced solid tumors in Asia.  This trial 
also has an expansion part to investigate the safety and efficacy of MSB0011359C in Asian 
patients with gastric cancer (GC), esophageal squamous cell cancer (ESCC) and biliary tract 
cancer (BTC), and in Japanese patients with HCC.
Dose escalation (Part A):
The dose escalation part will use a standard 3+3 scheme with the planned doses of 3 mg/kg, 
10 mg/kg, and 20 mg/kg administered once every 2 weeks.  For each dose level, DLTs are 
assessed during the first 3 weeks (21 days after administration of MSB0011359C).  The criteria 
for moving from one dose level to another do not allow escalation to the next cohort in cases 
where more than 1 subject in a cohort experiences a DLT.  If 1 of 3 subjects in a cohort 
experiences a DLT, this cohort will be automatically expanded to 6 subjects.  The MTD is 
defined as the highest dose where no more than 1 subject out of 6 subjects experiences a DLT.  
Thus, the MTD cohort should accrue at a total of 6 subjects.  After the cohort with the dose
selected for the expansion part has completed the DLT evaluation period, an additional 
3 subjects may be enrolled if a total of 6 subjects have not yet been treated at the dose level for 
the purpose of additional safety evaluation.
A DLT is defined as any Grade ≥3 adverse event (AE) (with certain exceptions as described in 
the protocol) suspected to be related to MSB0011359C by the Investigator and/or Sponsor
occurring during the DLT evaluation period (defined as 21 days after administration of 
MSB0011359C) and confirmed by the Safety Monitoring Committee (SMC) to be relevant for 
the IMP treatment.
At each dose level, subjects will receive MSB0011359C as a 1-hour intravenous infusion once 
every 2 weeks until progressive disease (PD) has been confirmed by a subsequent scan, 
unacceptable toxicity, or occurrence of any criterion for withdrawal from the trial or the IMP as 
outlined in this protocol.  In order to mitigate potential infusion-related reactions, premedication 
with an antihistamine and with paracetamol (acetaminophen) (eg, 25 to 50 mg diphenhydramine 
and 500 to 650 mg paracetamol [acetaminophen] intravenous or oral equivalent) approximately 
30 to 60 minutes prior to each dose of MSB0011359C is mandatory for the first 2 infusions.  
Premedication is optional and at the discretion of the Investigator after the second infusion.  If 
Grade 2 infusion reactions are seen during the first two infusions, then premedication should not 
be stopped.  Steroids as premedication are not permitted.
Expansion (Part B):
The expansion part consists of an HCC cohort and other cohort indications including GC, ESCC,
and BTC.
For the HCC cohort, 3 subjects will be enrolled at 3 mg/kg once the 3 mg/kg dose level in the 
dose escalation part of the trial has been cleared by the SMC.  Six subjects will be enrolled at 
10 mg/kg once the 10 mg/kg dose level in the dose escalation part of the trial has been cleared 
by the SMC.  The purpose of the HCC cohort is to further assess the safety of MSB0011359C 
in subjects with HCC.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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After confirmation of tolerability at 20 mg/kg in the dose escalation part, the MSB0011359C
dose for further investigation is 1200 mg and enrollment of GC, ESCC, and BTC subjects into 
the expansion cohorts will begin to determine the safety and clinical activity of MSB0011359C.  
These indications were chosen as they offer the potential for transformative treatment with 
ability to establish an initial proof of concept of antitumor activity of MSB0011359C with good 
feasibility.
Subjects in the expansion cohorts will receive MSB0011359C as a 1-hour intravenous infusion 
once every 2 weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, 
or occurrence of any criterion for withdrawal from the trial or the IMP as outlined in this 
protocol.
Subjects will be monitored and assessed for safety and efficacy parameters at regular intervals 
throughout the trial.
Planned number of subjects
Dose escalation part:  Up to 18 subjects with metastatic or locally advanced solid tumors.
Expansion part:  Up to 169 subjects (30, 30, up to 100, and 9 subjects in the GC, ESCC, BTC,
and HCC cohorts, respectively).
The total sample size at the end of the trial (based on the dose escalation part and the 
expansion part) is expected to be up to approximately 187 subjects.
Diagnosis and key inclusion and exclusion criteria
Key inclusion criteria for the dose escalation include:
1. Able and willing to give written informed consent and has signed the appropriate written 
informed consent form (ICF), prior to performance of any trial activities.
2. Eligible male and female subjects aged ≥20 years.
3. Histologically or cytologically proven metastatic or locally advanced solid tumors, for 
which no effective standard therapy exists or standard therapy has failed.
4. ECOG performance status of 0 to 1 at trial entry.
5. Life expectancy ≥12 weeks as judged by the Investigator.
6. Adequate hematological function defined by white blood cell (WBC) count ≥3 × 109/L 
with absolute neutrophil count (ANC) ≥1.5 × 109/L, lymphocyte count ≥0.5 × 109/L, 
platelet count ≥75 × 109/L, and Hgb ≥9 g/dL (in absence of blood transfusion).
7. Adequate hepatic function defined by a total bilirubin level ≤1.5 × ULN, an AST level 
≤2.5 × ULN, and an ALT level ≤2.5 × ULN. For subjects with liver involvement in 
their tumor, AST ≤5.0 × ULN, ALT ≤5.0 × ULN, and bilirubin ≤3.0 is acceptable.
8. Adequate renal function defined by an estimated creatinine clearance > 50 mL/min 
according to the Cockcroft-Gault formula or by measure of creatinine clearance from 
24-hour urine collection.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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4. Anticancer treatment within 21 days before the start of trial treatment, eg, cytoreductive 
therapy, radiotherapy (with the exception of palliative bone-directed radiotherapy), 
immune therapy, or cytokine therapy.
5. Anticancer treatment with antibody within 28 days before the start of trial treatment.
6. Major surgery within 28 days before the start of trial treatment (excluding prior 
diagnostic biopsy).
7. Systemic therapy with immunosuppressive agents within 7 days before the start of trial
treatment; or use of any investigational drug within 28 days before the start of trial
treatment.
Investigational Medicinal Product
Dose/mode of administration/dosing schedule:
For the dose-escalation cohorts and the HCC cohort, the dose of MSB0011359C will be 
calculated based on the weight of the subject determined on the day prior to or the day of each 
drug administration.  A flat dose of 1200 mg MSB0011359C will be used for all subjects in the 
expansion cohort (except for the HCC cohort) after confirming the tolerability of 
MSB0011359C at 20 mg/kg.
MSB0011359C will be administered once every 2 weeks as a 1-hour (-10/+20 minutes, ie, over 
50 to 80 minutes) intravenous infusion. 
In order to mitigate potential infusion-related reactions, premedication with an antihistamine 
and with paracetamol (acetaminophen) (eg, 25 to 50 mg diphenhydramine and 500 to 650 mg 
paracetamol [acetaminophen] intravenous or oral equivalent) approximately 30 to 60 minutes 
prior to each dose of MSB0011359C is mandatory for the first 2 infusions.  Premedication is 
optional and at the discretion of the Investigator after the second infusion.  If Grade 2 infusion 
reactions are seen during the first two infusions, then premedication should not be stopped.  
Steroids as premedication are not permitted.
Reference therapy
Dose/mode of administration/dosing schedule:
Not applicable
Planned trial and treatment duration per subject
Subjects will receive MSB0011359C until progression has been confirmed by a subsequent 
scan, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs as 
outlined in this protocol. 
In the case of complete response (CR), partial response (PR) or stable disease (SD), subjects 
should continue treatment through the end of 12 months at the discretion of the Investigator and 
in consultation with the Medical Monitor.  If the Investigator believes that a subject may benefit 
from treatment beyond 12 months, it may be permissible after discussion with the Medical 
Monitor. For subjects who achieve a CR, PR, or SD on MSB0011359C therapy and then 
subsequently develop disease progression after stopping therapy, but prior to the end of the trial, 
1 re-initiation course of treatment at the same dose and schedule and treatment duration up to 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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12 months is allowed at the discretion of the Investigator and agreement of the trial Medical 
Monitor.  In order to be eligible for retreatment, the subject must not have experienced any 
toxicity that led to treatment discontinuation of the initial MSB0011359C therapy. In the case 
of PD, subjects should continue treatment through their next tumor assessment, if they meet the 
criteria described in this protocol. If there is further evidence of PD thereafter, trial treatment 
should be discontinued; however continued treatment is possible in consultation with the 
Medical Monitor.
Primary endpoints:
The primary endpoints for the dose escalation part of the trial are:
!
Occurrence of DLTs during the first 3 weeks (21 days) of treatment in the dose 
escalation part
!
Number, severity and duration of treatment-emergent AEs (TEAEs) according to the 
National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events 
version 4.03 (CTCAE v4.03)
!
Number, severity, and duration of treatment-related AEs for all dose groups/indications 
according to CTCAE v4.03.
Secondary endpoints:
The secondary endpoints for the dose escalation part of the trial are:
!
MSB0011359C PK profile
(for dose escalation), including area under the 
concentration-time curve (AUC), maximum serum concentration observed postdose 
(Cmax), minimum serum concentration observed postdose (Cmin) and terminal half-life 
(t1/2)
!
Serum titers of anti-MSB0011359C antibodies
!
BOR according to RECIST 1.1 per investigator assessments.
The secondary endpoints for the expansion part of the trial are:
!
BOR according to RECIST 1.1 as adjudicated by the Independent Review Committee 
(IRC)
!
BOR according to RECIST 1.1 per investigator assessments
!
Duration of response according to RECIST as adjudicated by the IRC
!
Disease control rate according to RECIST 1.1 as adjudicated by the IRC
!
PFS time according to RECIST 1.1 as adjudicated by the IRC
!
OS time.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
24/167
  Descriptive statistics will be examined for indications of 
dose-related toxicity.
Listings will be produced upon completion of each dose escalation cohort of subjects and the 
decision as to whether to proceed with dose escalation, dose reduction or to enroll another cohort 
at the same dose level will be determined by reviewing these data.  Full details of the planned 
analyses will be described in the trial Statistical Analysis Plan, separately for the dose escalation 
part and the expansion part.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
25/167
Schedule of Assessments
Table 1
Schedule of Assessments:  Dose Escalation Part
Measure
Screening 
Assessments
Treatment Part
(-3 / +1 days)a
Discontinuation/
End-of-
Treatment Visitsw
Safety 
Follow-up 
Visit w
Long-Term
Follow-up b
Day -28 to
First 
Treatment
V1
V2
V3
V4
V5
V6
V7
V7
V8
V9
V10
Until 
Progression
Up to 7/28 Days 
(+/- 5 days) after 
Decision of 
Discontinuation/
Last Treatment
c, d
10 Weeks 
(+/- 2 weeks) 
after Last 
Treatment
Every 12 weeks 
(+/- 2 weeks)
W1
W1
W2
W3
W4
W5
W7
W7
W9
W11 W13
D1
D2
D8
D15 D22 D29
D43
D43-50
D57
D71
D85
Written informed consent
X
X
Inclusion/exclusion 
criteria
X
X 
Medical history
X
Cancer disease history
X
Prior anticancer 
drug/radiotherapy/
procedures
X
Other prior medications
X
Demographic data
X
HBV, HCV, and HIV 
testing 
X
Ophthalmology 
examination including 
slit lamp evaluation 
inclusive of the anterior 
segment and with visual 
acuity
X
Physical examinationt,x
X
X
X
X
X
X
X
X
X
X
X
6-weeklyu
x/X
X
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
26/167
Table 1
Schedule of Assessments:  Dose Escalation Part
Measure
Screening 
Assessments
Treatment Part
(-3 / +1 days)a
Discontinuation/
End-of-
Treatment Visitsw
Safety 
Follow-up 
Visit w
Long-Term
Follow-up b
Day -28 to
First 
Treatment
V1
V2
V3
V4
V5
V6
V7
V7
V8
V9
V10
Until 
Progression
Up to 7/28 Days 
(+/- 5 days) after 
Decision of 
Discontinuation/
Last Treatment
c, d
10 Weeks 
(+/- 2 weeks) 
after Last 
Treatment
Every 12 weeks 
(+/- 2 weeks)
W1
W1
W2
W3
W4
W5
W7
W7
W9
W11 W13
D1
D2
D8
D15 D22 D29
D43
D43-50
D57
D71
D85
Dermatological 
assessmente
X
X
X
X
X
X
X
6-weekly up 
to/including 
Week 25, 
then every 
12 weeks
x/X
X
SpO2
X
X
X
X
X
X
X
X
2-weekly
X
X
12 lead ECGf
X
X/X
X 
X
X/X
X
X
X
6-weekly 
normal 
ECGsu
-/X
X
Vital signs including 
weight and height 
(height at screening 
only)g
X
X
X
X
X
X
X
X
X
X
X
X
2-weekly
x/X
X
ECOG PSh
X 
X
X
X
X
X
X
X
X
X
2-weekly
x/X
X
Enrollment (if eligible)i
X
Hematology/
hemostaseologyj
X
X
X
X
X
X
X
X
X
X
X
2-weekly
x/X
X
Core serum chemistryk
X
X
X
X
X
X
X
2-weekly
Full serum chemistryk
X
X
X
X
6-weekly
x/X
X
Serum electrophoresis
X
X
-/X
Urinalysisl
X
X
X
X
6-weeklyu
x/X
X
β-HCG pregnancy test
(if applicable)m
X
X
X
X
X
4-weekly
-/X
X
FSH (if applicable)
X
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
28/167
Table 1
Schedule of Assessments:  Dose Escalation Part
Measure
Screening 
Assessments
Treatment Part
(-3 / +1 days)a
Discontinuation/
End-of-
Treatment Visitsw
Safety 
Follow-up 
Visit w
Long-Term
Follow-up b
Day -28 to
First 
Treatment
V1
V2
V3
V4
V5
V6
V7
V7
V8
V9
V10
Until 
Progression
Up to 7/28 Days 
(+/- 5 days) after 
Decision of 
Discontinuation/
Last Treatment
c, d
10 Weeks 
(+/- 2 weeks) 
after Last 
Treatment
Every 12 weeks 
(+/- 2 weeks)
W1
W1
W2
W3
W4
W5
W7
W7
W9
W11 W13
D1
D2
D8
D15 D22 D29
D43
D43-50
D57
D71
D85
Hospitalization on first 
2 dosesr
X
X
DLT assessments
X
X
X
X
X
Survival follow-up
X
ACTH=adrenocorticotropic hormone; ADA=anti-drug antibody; AE=adverse events; ANA=antinuclear antibody; β-HCG=β-human chorionic gonadotropin; CT=computer 
tomography; DLT=dose-limiting toxicity; ECG=electrocardiogram; ECOG PS=Eastern Cooperative Oncology Group Performance Status; FSH=follicle stimulating hormone; 
HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human immunodeficiency virus; IMP=investigational medicinal product; MRI=magnetic resonance imaging; 
PD=progressive disease; PK=pharmacokinetics; RF=rheumatoid factor; SpO2=Oxygen saturation; TGFβ=transforming growth factor beta; TSH=thyroid stimulating hormone, 
T4=thyroxine.
Unless stated otherwise in a footnote, all procedures and samples should occur prior to trial drug administration.
a
A time window of up to 3 days before or 1 day after the scheduled visit day (-3/+1 days) will be permitted for all procedures (except Day 2 and the Day 43-50 visit). The 
biweekly 14-day schedule should be strictly adhered to, returning to the target date even if the previous visit was off schedule. The Day 43-50 visit is to accommodate collection 
of tumor biopsy material and associated PK and 
 (see Table 3).
b
Subjects without progressive disease at End-of-Treatment visit will be followed up for disease progression (CT/MRI scans every 12 weeks) until PD. In addition, subjects will 
be followed every 12 weeks for survival (including assessment of any further tumor therapy). The survival follow-up will continue until 1 year after the last subject receives 
the last dose of trial drug. After completion of the Follow-up period the appropriate electronic Case Report Form section for Trial Termination must be completed.
c
Any subject who experiences an AE that mandates discontinuation of trial treatment should have a discontinuation visit within 7 days after the decision to discontinue trial 
treatment.
d
Tumor evaluation at the End-of-Treatment visit should only be performed if no disease progression has been documented previously.  If another antineoplastic therapy is 
administered before the end of the 28-day period, the End-of-Treatment visit should be conducted before the start of new therapy if possible. 
e
Assessments for skin lesions or rash with biopsy of suspicious lesions. Dermatological consults should be requested as needed. 
f
ECG to be taken before dosing and as soon as possible after completion of the infusion. If only a single “X”, then only ECG before dosing is required. All ECGs will be 
conducted according to local procedure and will NOT be digitally uploaded.
g
Vital signs should be assessed predose (within 15 minutes of start of infusion), then every 15 (±2) minutes after the start of infusion, and 15 (±5), 30 (±5), 60 (±5), 120 (±10), 
and 360 (±150) minutes after the end of infusion for the first 2 infusions. If there were no clinically significant changes in vital signs during the first 2 infusions, then the vital 
signs schedule for subsequent infusions will be predose (within 15 minutes of start of infusion), 30 (±5) and 60 (-5/+15) minutes after the start of infusions. For re-initiated 
subjects, vital signs should be assessed predose (within 15 minutes of start of the infusion), 30 (±5) and 60 (-5/+15) minutes after the start of infusion, and 30 (±5), 60 (±10), 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
29/167
and 120 (±10) minutes after the end of the infusion.  If the re-initiated subject does not have an infusion-related reaction during the first infusion the vital sign assessments at 
30 (±5), 60 (±10), and 120 minutes after the end of the infusion may be waived for subsequent infusions.
h
If the Screening ECOG PS was performed within 3 days prior to Cycle 1 Day 1, it does not have to be repeated at Cycle 1 Day 1.
i
Enrollment will be done after the confirmation of fulfilling all Screening inclusion criteria without matching any exclusion criterion. In the case of new clinical laboratory 
abnormalities detected prior to the first dose, the eligibility of the subject should be reconsidered with the guidance of Medical Monitor.
j
Hematology (including complete blood count) and hemostaseology assessments are detailed in Table 8. Follicle-stimulating hormone at Screening, if applicable. Complete 
blood count results must also be drawn and reviewed within 48 hours prior to dose administration. For subjects experiencing signs of anemia including, but not limited to, a 
significant drop in Hgb value (especially Hgb < 8 g/dL), routine monitoring of Hgb, red blood cells, and hematocrit should be performed weekly.
k
Full chemistry (which includes core chemistry) and core serum chemistry samples are detailed in Table 8. Samples for core chemistry results must be drawn and reviewed 
within 48 hours prior to dose administration.
l
A full urinalysis is required at Screening and the End-of-Treatment visit and basic urinalysis at each visit indicated prior to administration of study drug. If urinalysis (full or 
basic) is positive for protein, sediment will be evaluated.
m
β-HCG must be determined from serum at Screening and from either urine or serum sample thereafter. Results of the most recent pregnancy test should be available prior to 
next dosing. Pregnancy testing is applied for women of childbearing potential. Woman are considered of childbearing potential unless they are postmenopausal (defined by 
continuous amenorrhea excluding the amenorrhea caused by the administration of anticancer therapy) for at least 12 months, are surgically sterile or have increased FSH levels 
indicating menopause.
n
Tumor evaluations during Screening must be performed within 28 days prior to Cycle 1 Day 1 in order to document the baseline status of the tumor disease using RECIST 1.1 
target and nontarget lesions. The subsequent tumor evaluations have a time window of 5 days prior to dosing (-5 days). In case a tumor response according to RECIST 1.1 is 
documented during the course of the trial, confirmation of the response should be performed according to RECIST 1.1 after 6 weeks.
o
Brain CT/MRI scan (either, with contrast preferred) is required at Screening if not performed within the previous 6 weeks. Thereafter, brain CT/MRI scan should be done if 
clinically indicated by development of new specific symptoms. A bone scan should be done at Screening and beyond as clinically indicated. Bone metastases detected at 
Screening need to be followed at the subsequent tumor evaluation visits.
q
In order to mitigate potential infusion-related reactions, all subjects must receive premedication with an antihistamine and with paracetamol (acetaminophen) approximately 
30 to 60 minutes prior to each dose of MSB0011359C (eg, 25-50 mg diphenhydramine and 500-650 mg paracetamol [acetaminophen] intravenous or oral equivalent) for the 
first 2 infusions. Premedication is optional and at the discretion of the Investigator after the second infusion. If Grade 2 infusion reactions are seen during the first two infusions,
then premedication should not be stopped.  Steroids as premedication are not permitted.  MSB0011359C should be administered at the cohort prescribed dose by intravenous 
infusion over 1 hour (-10 minutes/+20 minutes, ie, over 50 to 80 minutes). The first 2 doses of MSB0011359C for any subject will be accompanied by overnight evaluation of 
at least 24 hours in an in-patient setting.
r
In-patient admission with periodic ECG and vital sign monitoring for a minimum of 24 hours. After 24 hours, investigator will decide the discharge of the subject based on the 
monitoring results and the results of in-person examination.
s
The observation period for DLTs refers to the first 21 days of IMP treatment in the dose escalation part for all subjects with data used for implementing the dose-escalation 
algorithm for determination of the MTD. 
t
At each visit, eye signs and symptoms should be checked.  If clinically relevant findings, then an appropriate ophthalmology examination including slit lamp evaluation inclusive 
of the anterior segment and with visual acuity should be obtained within 2 days.
u
After 6 months, this will be assessed every 12 weeks and after a year, this will be assessed every 6 months.
v
Tumor evaluation will be assessed every 12 weeks after 12 months.
w
See Section 7.4.1.3 for definition of the AE reporting period and Section 7.4.1.6 for monitoring of subjects with AEs.
x
After Day 1, the physical examination will be a directed physical examination indicated by subject’s symptoms.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
30/167
Table 2
Schedule of Assessments: Expansion Part
Measure
Screening 
Assessments
Treatment Part
(-3 / +1 days)a
Discontinuation/
End-of-Treatment
Visits w
Safety 
Follow-up 
Visit w
Long-Term 
Follow-up b
Day -28 to
First 
Treatment
V1x
V2
V3
V4
V5
V6
V7
V7
V8
V9
V10
Until 
Progression
Up to 7/28 Days 
(+/- 5 days) after 
Decision of 
Discontinuation/ 
Last Treatmentc, d
10 Weeks 
(+/- 2 weeks)  
after Last 
Treatment
Every 12 weeks 
(+/- 2 weeks)
W1
W1
W2
W3
W4
W5
W7
W7
W9 W11 W13
D1
D2cc D8cc D15 D22cc D29 D43
D43-
50cc
D57 D71 D85
Written informed consent
X
Inclusion/exclusion 
criteria
X
X 
Medical history
X
Cancer disease history
X
Prior anticancer drug/
radiotherapy/procedures
X
Other prior medications
X
Demographic data
X
HBV, HCV, and HIV
testing 
X
Ophthalmology 
examination including slit 
lamp evaluation inclusive 
of the anterior segment 
and with visual acuity
X
Physical examination s,u
X
X
X
X
X
X
X
X
X
X
X
6-weeklyt
x/X
X
Dermatological 
assessmente
X
X
X
X
X
X
X
6-weekly up 
to/including 
Week 25, then 
every 12 
weeks
x/X
X
SpO2
X
X
X
X
X
X
X
X
2-weekly
X
X
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
33/167
Table 2
Schedule of Assessments: Expansion Part
Measure
Screening 
Assessments
Treatment Part
(-3 / +1 days)a
Discontinuation/
End-of-Treatment
Visits w
Safety 
Follow-up 
Visit w
Long-Term 
Follow-up b
Day -28 to
First 
Treatment
V1x
V2
V3
V4
V5
V6
V7
V7
V8
V9
V10
Until 
Progression
Up to 7/28 Days 
(+/- 5 days) after 
Decision of 
Discontinuation/ 
Last Treatmentc, d
10 Weeks 
(+/- 2 weeks)  
after Last 
Treatment
Every 12 weeks 
(+/- 2 weeks)
W1
W1
W2
W3
W4
W5
W7
W7
W9 W11 W13
D1
D2cc D8cc D15 D22cc D29 D43
D43-
50cc
D57 D71 D85
ACTH=adrenocorticotropic hormone; ADA=anti-drug antibody; AE=adverse events; ANA=anti-nuclear antibody; β-HCG=β-human chorionic gonadotropin; CT=computer 
tomography; DLT=dose-limiting toxicity; EBV=epstein barr virus; ECG=electrocardiogram; ECOG PS=Eastern Cooperative Oncology Group Performance Status; EORTC QLQ-
C30=European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core instrument; EORTC QLQ-STO22=stomach cancer module; EORTC QLQ-
OES18=esophageal cancer module; EORTC QLQ-BIL21=cholangiocarcinoma and gallbladder cancer module; EORTC QLQ-HCC18= hepatocellular carcinoma module; 
FSH=follicle stimulating hormone; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human immunodeficiency virus; IMP=investigational medicinal product; MRI=magnetic 
resonance imaging; PD=progressive disease; PGIS=Patient Global Impression of Severity; PK=pharmacokinetics; RF=rheumatoid factor; SpO2=Oxygen saturation; 
TGFβ=transforming growth factor beta; TSH=thyroid stimulating hormone, T4=thyroxine.
Unless stated otherwise in a footnote, all procedures and samples should occur prior to trial drug administration.
a
A time window of up to 3 days before or 1 day after the scheduled visit day (-3 / +1 days) will be permitted for all procedures (except Day 2 and the Day 43-50 visit). The 
bi-weekly 14-day schedule should be strictly adhered to, returning to the target date even if the previous visit was off schedule. The Day 43-50 visit is to accommodate collection 
of tumor biopsy material and associated PK and 
 (see Table 3).
b
Subjects without progressive disease at End-of-Treatment visit will be followed up for disease progression (CT/MRI scans every 12 weeks) until PD. In addition, subjects will 
be followed every 12 weeks for survival (including assessment of any further tumor therapy). The survival follow-up will continue until 1 year after the last subject receives 
the last dose of trial drug. After completion of the Follow-up period, the appropriate electronic Case Report Form section for Trial Termination must be completed. 
c
Any subject who experiences an AE that mandates discontinuation of trial treatment should have a discontinuation visit within 7 days after the decision to discontinue trial 
treatment. 
d
Tumor evaluation at the End-of-Treatment visit should only be performed if no disease progression has been documented previously.  If another antineoplastic therapy is 
administered before the end of this 28-day period, the End-of-Treatment visit should be conducted, if possible, prior to the start of this new therapy.
e
Assessments for skin lesions or rash with biopsy of suspicious lesions. Dermatological consults should be requested as needed.
f
ECG to be taken before dosing and as soon as possible after completion of the infusion. If only a single “X”, then only ECG before dosing is required. All ECGs will be 
conducted according to local procedure and will NOT be digitally uploaded.
g
Vital signs should be assessed predose (within 15 minutes of start of infusion), then every 15 (±2) minutes after the start of infusion, and 15 (±5), 30 (±5), 60 (±5), 120 (±10), 
and 360 (±150) minutes after the end of infusion for the first 2 infusions. If there were no clinically significant changes in vital signs during the first 2 infusions, then the vital 
signs schedule for subsequent infusions will be predose (within 15 minutes of start of infusion), 30 (±5) and 60 (-5/+15) minutes after the start of infusion. For re-initiated 
subjects, vital signs should be assessed predose (within 15 minutes of start of the infusion), 30 (±5) and 60 (-5/+15) minutes after the start of infusion, and 30 (±5), 60 (±10), 
and 120 (±10) minutes after the end of the infusion.  If the re-initiated subject does not have an infusion-related reaction during the first infusion the vital sign assessments at 
30 (±5), 60 (±10), and 120 minutes after the end of the infusion may be waived for subsequent infusions.
h
If the Screening ECOG PS was performed within 3 days prior to Cycle 1 Day 1, it does not have to be repeated at Cycle 1 Day 1.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
40/167
The department of Global Biostatistics will supervise the statistical analyses (with the exception 
of the PK data analyses) which will be outsourced to a CRO.
The Coordinating Investigator, 
represents all investigators for decisions 
and discussions regarding this trial, consistent with the International Council for Harmonisation 
(ICH) Topic E6 Good Clinical Practice (GCP), hereafter referred to as ICH GCP. 
The 
Coordinating Investigator will provide expert medical input and advice relating to trial design and 
execution and is responsible for the review and signoff of the clinical trial report. 
Signature pages for the Protocol Lead and the Coordinating Investigator, as well as a list of 
Sponsor responsible persons, are in Appendix 4.
2.2.1
Safety Monitoring Committee
To ensure subjects’ safety during the dose escalation and expansion parts of the trial, a Safety 
Monitoring Committee (SMC) will review the safety data on a regular basis.  The SMC consists 
of permanent members from the Sponsor and/or CRO (at least the Medical Responsible, the Global 
Drug Safety Product Leader, and the Biostatistician for the expansion part), the Coordinating 
Investigator, and an external expert with expertise in the management of cancer patients.  The 
SMC will evaluate the safety data from the dose levels 1 and 3 mg/kg and PK data from the dose 
level 1 mg/kg of EMR200647-001 as well before Study EMR200647-008 will be started at the 
3 mg/kg dose level. During the dose escalation part of the trial, the SMC will evaluate the safety 
information of all the treated subjects, including those who started the treatment but did not 
complete the dose-limiting toxicity (DLT) evaluation period, and available PK data and will decide 
on the DLTs relevant for the treatment and will decide by consensus on dose escalation or 
suspension of enrollment and/or declaration of the maximum tolerated dose (MTD), with the final 
adjudication being a Sponsor prerogative.  Treatment-related adverse events leading to a delay in 
dosing will be considered as well for the decision to go to the next dose level.
The SMC will recommend an MSB0011359C dose for the expansion part of the trial and may 
consider the MTD plus overall AEs, PK and any supporting information such as biomarker data.  
During the expansion part of the trial, the SMC will monitor on an ongoing basis (eg, when 
15 subjects have been enrolled and treated for at least 4 weeks), all safety information of the 
participating subjects and will decide by consensus on continuation, modification, or suspension 
of the trial or of a particular expansion cohort.  The SMC may modify the frequency of meetings 
as deemed appropriate by the SMC during the course of the trial.  The specific working procedures 
will be described in an SMC charter, which will be established prior to the start of recruitment.
2.2.2
Central 
Reader 
and 
Independent 
Endpoint 
Review 
Committee
A central facility will read and interpret all radiographic scans for subjects enrolled in the 
expansion cohorts (for dose escalation, radiographic scans will be read locally).  The data for all 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
53/167
3.3.3
Disease Background
3.3.3.1
Gastric Cancer
Gastric cancer (GC) remains the third leading cause of cancer-related deaths worldwide and is 
especially frequent in East Asia, including Japan (Ferlay 2015).  Patients with advanced disease at 
diagnosis still remain with poor prognosis despite improvements in treatment.  The relative 5-year 
survival rate of GC was reported to be around 60% in Japan (Matsuda 2011).  Ramucirumab, an 
anti-epidermal growth factor receptor antibody was recently approved in Japan.  The combination 
of ramucirumab with paclitaxel significantly increases overall survival compared with placebo 
plus paclitaxel.  Recent progression of the treatment strategy with immune-checkpoint inhibitors 
showed antitumor activities in many kinds of tumors.
PD-1 plays an important role as an 
immune-checkpoint molecule. Some clinical trials of anti-PD-1/PD-L1 monoclonal antibody are 
under investigation for GC.  Pembrolizumab, a monoclonal antibody against PD-1 showed
favorable antitumor effects in advanced GC (Bang 2015).  The TGFβ1 is also considered a target 
of anticancer therapy.  The association between expression of TGFβ and prognosis in GC has been 
reported.  Patients with TGFβ1 expression had worse prognosis after surgical therapy compared 
to those without expression of TGF-β1 in the tumor (median survival of 16.1 months of patients 
with TGFβ1 expression versus 37.1 months of patients without TGFβ1 expression, p = 0.034) 
(Ananiev 2011).  GC is considered to be a good target indication of MSB0011359C.
3.3.3.2
Esophageal Squamous Cell Cancer
Esophageal cancer (EC) is one of the common cancers in the world (Zhang 2013). The incidence 
of EC appears to be increasing due to the increase of adenocarcinoma in the Western countries.  
Globally, the most prevalent form of EC is esophageal squamous cell carcinoma (ESCC) 
(Arnold 2015). ESCC is the most common histological type in Asian countries, including Japan 
with over 95% of EC. In 2014, mortality was estimated at 11,700 in Japan (Matsuda 2014). 
Esophageal cancer continues to have a poor prognosis with a relative 5-year survival of 30% 
(Matsuda 2011). 
PD-L1, the ligand of PD-1, is known to frequently overexpress in EC. 
Pembrolizumab, a monoclonal antibody against PD-1 has demonstrated antitumor effects in 
advanced EC (Doi 2015). One ESCC patient was also observed to have a durable response on 
avelumab (internal data).  Association between serum TGFβ1 level and the prognosis in patients 
with ESCC was also reported (Sun 2007). In patients with decreased serum TGFβ1 levels after 
radiotherapy, the 1-year survival rate was 61.02% compared with 17.86% in patients with 
increased serum TGFβ1 levels (p < 0.01). ESCC is also considered to be a good target indication 
of MSB0011359C.
3.3.3.3
Biliary Tract Cancer
Biliary tract cancer (BTC) is more common in East Asia and Latin America than in other 
continents.  The incidence of BTC in 2011 was reported to be 23,606 (male: 12,250, female: 
11,356) in Japan (Doi 2015).  Biliary tract cancer includes gallbladder cancer (GBC), cholangio 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
56/167
Risk mitigation measures for potential infusion-related reactions/hypersensitivity include:
!
Premedication with an antihistamine and with paracetamol (acetaminophen) approximately 
30 to 60 minutes prior to each dose of MSB0011359C is mandatory (eg, 25 to 50 mg 
diphenhydramine and 500 to 650 mg paracetamol [acetaminophen] intravenous or oral 
equivalent) for the first 2 infusions.  Premedication is optional and at the discretion of the 
Investigator after the second infusion.  If Grade 2 infusion reactions are seen during the 
first two infusions, then premedication should not be stopped.  Steroids as premedication 
are not permitted.
!
Special precautions for monitoring of subjects and management of infusion-related 
reactions/hypersensitivity as described in Section 6.5.4.1 and Section 6.5.4.2.
!
Infusion-related reactions/hypersensitivity (any grade) are considered as important 
identified risks and adverse events of special interest (AESI) requiring expedited reporting 
from the Investigator to the Sponsor.  For nonserious AESIs, an AESI Report Form has to 
be completed; for serious events, an SAE Report Form has to be used (see Section 7.4.1.4).
3.4.2
Immune-related Adverse Events/Autoimmune Disorders
Immune-related AEs/autoimmune disorders are events that are related to the pharmacology of 
checkpoint inhibitors and can be explained by an immune-phenomenon after other etiologies have 
been ruled out.  Relevant clinical safety experience has been generated with the parent anti-PD-L1 
avelumab antibody.
!
As of 05 November 2014, a cumulative review revealed 56 cases of potential irAEs out of 
480 subjects (11.7%) treated in the expansion part of trial EMR100070-001 and 4 cases 
out of 50 subjects (8.0%) treated in the dose-escalation part of trial EMR100070-001.  A 
customized Medical Dictionary for Regulatory Activities (MedDRA) query was used for 
data retrieval from the clinical database with predefined preferred terms of potential irAEs.
!
Of 69 potential irAEs reported, 13 were SAEs (18.8%) and 56 were nonserious AEs 
(81.1%).  In the majority of the cases, there was a plausible temporal association between 
the event onset and the drug administration.  Of these 69 events, 46 events (66.7%) were 
assessed as treatment-related by the Investigator and 23 events (33.3%) were assessed as 
not treatment-related by the Investigator.
!
Twenty-six events were assessed as Grade 1, 29 events as Grade 2, 11 events as Grade 3, 
2 events as Grade 4, and 1 event (pneumonitis) as Grade 5 (note:  2 more events of 
autoimmune hepatitis had a fatal outcome; however, they were assessed as Grade 3 with a 
subsequent fatal liver failure).
!
Based on the irAE cases that have been observed with avelumab, all trial investigators will 
be trained to be made aware of the frequency and severity of the observed events and to 
proactively administer steroid treatment for any suspicion of irAEs.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
60/167
5
Investigational Plan
5.1
Overall Trial Design and Plan
This is a Phase I, open-label, dose escalation trial to investigate the safety, tolerability, PK, 
biological and clinical activity of MSB0011359C (M7824) in subjects with metastatic or locally 
advanced solid tumors with expansion cohorts in selected indications (GC, ESCC, BTC and HCC) 
in Asia (see Figure 1).
5.1.1
Overall Study Design
5.1.1.1
Dose Escalation
The dose escalation part of this trial will investigate the safety and tolerability of MSB0011359C.  
It is composed of a standard “3+3” dose escalation design for which 3 to 6 subjects will be enrolled 
at each dose level depending on the occurrence of DLTs (see Section 5.1.3.3), followed by 
expansion in cohorts of subjects with GC, ESCC, BTC and HCC (see Figure 1). The dose 
escalation part and the HCC expansion part of the trial will be conducted in Japan only. 
Cohorts of 3 to 6 subjects with metastatic or locally advanced solid tumors, for which no standard 
effective therapy exists or a standard therapy has failed, will receive MSB0011359C at escalating 
dose levels (3 mg/kg, 10 mg/kg and 20 mg/kg) once every 2 weeks (see Section 5.1.3.2).  The dose 
range and schedule for this trial were developed based on safety considerations as well as on 
 and experience with the parent avelumab antibody.  Up to 
18 subjects with metastatic or locally advanced solid tumors are planned for the dose escalation 
part.
At each dose level, subjects will receive MSB0011359C as a 1-hour (-10 minutes/+20 minutes, ie, 
over 50 to 80 minutes) intravenous infusion once every 2 weeks until PD has been confirmed by a 
subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the trial 
or the investigation medicinal product (IMP; see Section 5.5). 
Subjects who have experienced CR, PR or SD should be treated through the end of 12 months, 
although additional treatment is possible.  If the Investigator believes that a subject may benefit 
from treatment beyond 12 months, it may be permissible after discussion with the Medical 
Monitor.  For subjects who achieve CR, PR, or SD on MSB0011359C therapy and then 
subsequently develop disease progression after stopping therapy, but prior to the end of the study, 
1 re-initiation course of treatment at the same dose and schedule and treatment duration up to 
12 months is allowed at the discretion of the Investigator and agreement of the trial Medical 
Monitor (see Section 5.1.6).
Assessment of safety parameters will focus on potential acute side effects that include allergic 
reactions/hypersensitivities during and immediately following infusion, in the worst case 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
61/167
anaphylaxis, which could develop as consequence of an immunogenicity response and might be 
pronounced due to the immunostimulatory properties of MSB0011359C, promoting an immune 
response against itself.
Evaluation of safety will also include the incidence and severity of potential irAEs, which may 
manifest after weeks of treatment (Attia 2005; Calabro 2010; Di Giacomo 2010; Kaehler 2010;
Phan 2003; Wolchok 2010).  Such immune-mediated AEs may include pneumonitis, colitis, 
hepatitis, hypophysitis, nephritis, and thyroiditis (hypo- or hyperthyroidism).  The spectrum of 
hypothetical irAEs also includes formation of auto-antibodies such as antinuclear antibodies
(ANAs).
Other important
risks of the compound include anemia, rash with hyperkeratosis, 
keratoacanthoma, and squamous cell carcinoma of the skin, as well as alterations in wound healing 
or repair of tissue damage.
All DLTs will be monitored centrally, and the decision to escalate to the next dose level will be 
determined by the SMC as outlined in Section 2.2.1.
5.1.1.2
Expansion Cohorts
After determination of the MTD in the dose escalation part, an MSB0011359C dose for further 
investigation will be selected and enrollment in the expansion cohorts of GC, ESCC and BTC will 
begin (Figure 1).
After completion of DLT evaluation at 3 mg/kg and 10 mg/kg in the dose escalation part, 
enrollment in the HCC expansion cohort will start at 3 mg/kg and 10 mg/kg, respectively.  Three 
subjects will be enrolled at 3 mg/kg once the 3 mg/kg dose level in the dose escalation part of the 
trial has been cleared by the SMC.  Six subjects will be enrolled at 10 mg/kg once the 10 mg/kg 
dose level in the dose escalation part of the trial has been cleared by the SMC.  The purpose of the 
HCC cohort is to further assess the safety of MSB0011359C in subjects with HCC.
Subjects in the expansion cohorts will receive MSB0011359C as a 1-hour intravenous infusion 
once every 2 weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity or 
occurrence of any criterion for withdrawal from the trial or the IMP (see Section 5.5).
Subjects who have experienced CR, PR or SD should continue treatment through the end of 
12 months after confirmation, although additional treatment is possible.  If the Investigator
believes that a subject may benefit from treatment beyond 12 months, it may be permissible after 
discussion with the Medical Monitor.  In the case of PD, subjects should continue treatment 
through their next tumor assessment, if they meet the criteria described in Section 5.5.1.  If there 
is further evidence of PD thereafter, trial treatment should be discontinued; however, continued 
treatment is possible in consultation with the Medical Monitor.  For subjects who achieve a CR,
PR, or SD on MSB0011359C therapy and then subsequently develop disease progression after 
stopping therapy, but prior to the end of the study, 1 re-initiation course of treatment at the same 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
62/167
dose and schedule and treatment duration up to 12 months is allowed at the discretion of the 
Investigator and agreement of the trial Medical Monitor (see Section 5.1.6).
For subjects in the GC expansion cohort only, symptom severity will be assessed using 
3 patient-reported outcomes questionnaires:
!
Patient Global Impression of Severity (PGIS)
!
Select items from the European Organisation for Research and Treatment of Cancer 
Quality of Life Questionnaire Core instrument (EORTC QLQ-C30)
!
Select items from the EORTC QLQ-STO22 (stomach cancer module)
For subjects in the ESCC cohort only, symptom severity will be assessed using 3 patient-reported 
outcomes questionnaires:
!
PGIS
!
Select items from the EORTC QLQ-C30
!
Select items from the EORTC QLQ-OES18 (esophageal cancer module)
For subjects in the BTC cohort only, symptom severity will be assessed using 4 patient-reported 
outcomes questionnaires:
!
PGIS
!
Select items from the EORTC QLQ-C30
!
Select items from the EORTC QLQ-BIL21 (cholangiocarcinoma and gallbladder cancer 
module)
!
Select items from the EORTC QLQ-HCC18 (hepatocellular carcinoma module)
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
64/167
Figure 2
Dose Escalation Schematic
DLT=dose-limiting toxicity; max=maximum; MTD=maximum tolerated dose
5.1.2
Trial Medication Administration and Schedule
Subjects 
will 
receive 
intravenous 
infusion 
of 
MSB0011359C
over 
1 
hour 
(- 10 minutes/+20 minutes, ie, over 50 to 80 minutes) once every 2 weeks.  In order to mitigate 
potential infusion-related reactions, premedication with an antihistamine and with paracetamol 
(acetaminophen) (eg, 25 to 50 mg diphenhydramine and 500 to 650 mg paracetamol 
[acetaminophen] intravenous or oral equivalent) approximately 30 to 60 minutes prior to each dose 
of MSB0011359C is mandatory for the first 2 infusions.  Premedication is optional and at the 
discretion of the Investigator after the second infusion.  If Grade 2 infusion reactions are seen 
during the first two infusions, then premedication should not be stopped.  Steroids as premedication 
are not permitted.
The trial treatment schedules are provided in the Schedules of Assessments (see Table 1 and 
Table 2).
The formulation and packaging information of MSB0011359C is provided in Section 6.1 and
Section 6.6.
5.1.3
MSB0011359C Dose Escalation
The dose escalation part of the study is expected to enroll up to 18 subjects.  Eligible subjects will 
be patients with metastatic or locally advanced solid tumors who have failed standard therapies or 
who have no standard effective therapy available.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
65/167
5.1.3.1
Starting Dose
The starting dose of MSB0011359C will be 3 mg/kg.
5.1.3.2
Dose Escalation
The dose escalation will use a standard 3+3 scheme with the following planned doses:
!
3 mg/kg
!
10 mg/kg
!
20 mg/kg
The DLT period is defined as 21 days after the start of therapy.  The first subject of each cohort 
will be observed for at least 5 days before the second subject can be treated.  Thereafter, within 
each cohort, 48 hours must pass before a new subject can initiate dosing.  Once the 3 or 6 subjects 
have passed the 21-day DLT evaluation period, the SMC will review the safety and available PK 
data to decide upon further dose escalation.  Pharmacokinetics data from the previous cohort will 
be required for SMC review (eg, when the SMC is reviewing safety data from the 10 mg/kg cohort, 
available PK data from the 3 mg/kg cohort); however, PK data from the cohort under review will 
not be required).
For each dose level, DLTs are assessed during the first 3 weeks (Figure 1).  The criteria for moving 
from one dose level to another do not allow escalation to the next cohort in cases where more than 
1 subject in a cohort experience a DLT.  If 1 of 3 subjects in a cohort experiences a DLT, this 
cohort will be expanded to 6 subjects with the SMC meeting after the 6th subject completes the 
DLT evaluation period. 
The MTD is defined as the highest dose where no more than 1 subject out of 6 subjects experiences
a DLT.  Thus, the MTD cohort should accrue a total of 6 subjects (Figure 2).
After completion of the DLT evaluation at 3 and 10 mg/kg in the dose escalation part, enrollment 
in the HCC expansion cohort will start at 3 and 10 mg/kg, respectively. 
After determination of the MTD in the dose escalation part, an MSB0011359C dose for further 
investigation will be selected and enrollment in the expansion cohorts of subjects with GC, ESCC, 
and BTC will begin (Figure 1).
The DLT criteria will not apply to any of the expansion cohorts.
5.1.3.3
Dose-Limiting Toxicity
A DLT is defined as any Grade ≥3 AE, with the exceptions described hereafter, assessed as related 
to IMP by the Investigator and/or Sponsor (ie, Grade ≥3 adverse drug reaction [ADR]; grading 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
66/167
according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse 
Events Version 4.03 [CTCAE v4.03]) occurring in the DLT evaluation period (21 days after first
administration of MSB0011359C) confirmed by the SMC to be relevant for the IMP treatment.  
The SMC recognizes that in the absence of prior human experience with MSB0011359C, a 
conservative approach will be adopted in ascribing the relevance of the treatment-related toxicity 
to IMP.  Treatment-related SAEs will be ascribed as related to drug except where a clear 
relationship to the underlying disease or recognized comorbidities is evident.
A DLT is defined as the following:
Any Grade ≥3 AE that is related to MSB0011359C, occurring during the DLT evaluation period 
(21 days after administration of MSB0011359C), except for those listed below.  Also, elevated 
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of 
normal (ULN) and a concomitant elevation of bilirubin 2 times the ULN attributable to study drug 
constitutes a DLT.
!
Grade 3 infusion-related reactions resolving within 6 hours from the end of infusion and 
controlled with medical management.
!
Transient (≤6 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical 
management.
!
Transient (≤24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that 
resolves to Grade ≤1.
!
Any Grade ≥3 drug-related amylase or lipase abnormality that is not associated with 
symptoms or clinical manifestations of pancreatitis.
!
Grade 3 Hgb decrease (< 8.0 g/dL) that resolves to at least 9 g/dL within 14 days or the 
changes in the associated RBC parameters resolve within 14 days without blood 
transfusion or erythroid growth factor use.
!
Malignant skin lesion that is local and can be resected with negative resection margin.
Dose-limiting toxicities that require treatment discontinuation are described in Section 5.1.7.2.
Subjects who do not complete the DLT observation period for reasons other than a DLT will be 
replaced.
5.1.4
Expansion Cohorts
After completion of DLT evaluation at 3 and 10 mg/kg in the dose escalation part, enrollment in 
the HCC expansion cohort will start at 3 and 10 mg/kg, respectively. 
After confirmation of tolerability at 20 mg/kg in the dose escalation part, the MSB0011359C dose 
for further investigation is 1200 mg in the expansion cohorts of subjects with GC, ESCC, and BTC 
after confirmation by the SMC. 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
68/167
For subjects who achieve a CR, PR, or SD on MSB0011359C therapy and then subsequently 
develop disease progression after stopping therapy, but prior to the end of the trial, 1 re-initiation 
course of treatment at the same dose and schedule and treatment duration up to 12 months is 
allowed at the discretion of the Investigator and agreement of the trial Medical Monitor.  In order 
to be eligible for retreatment, the subject must not have experienced any toxicity that led to 
treatment discontinuation of the initial MSB0011359C therapy.  Prior to re-initiation of the trial 
treatment, malignant disease needs to be radiologically re-staged to assess all known sites of the 
disease and to establish a new baseline for subsequent tumor measurements.  Relevant safety 
laboratory results must be available and verified prior to re-initiating of treatment.  Subjects who 
re-initiate treatment will stay on trial and will be treated and monitored according to the Schedule 
of Assessments for the expansion part of the trial starting at Week 1, Day 1 (see Table 2).
Moreover, any ADRs should be followed until they resolve, return to Baseline, or stabilization or 
are irreversible, or when the subject starts a new anticancer therapy (see Section 7.1.5 for details).
5.1.7
Dose Modification and Adverse Drug Reactions Requiring 
Treatment Discontinuation
5.1.7.1
Dose Modification
The dose of MSB0011359C will be calculated based on the weight of the subject determined on 
the day prior to or the day of each drug administration.
Each subject will stay on the MSB0011359C dose level assigned in the trial unless treatment needs 
to be stopped.  Dosing modifications (changes in infusion rate) and dose delays are described in 
Section 5.1.7.2 and Section 6.5.4 and subsections.  There are no dose reductions.
5.1.7.2
Adverse 
Drug 
Reactions 
Requiring 
Treatment 
Discontinuation
Certain ADRs, defined in this trial as any AE assessed as related to MSB0011359C by the 
Investigator and/or Sponsor, may require permanent treatment discontinuation of MSB0011359C
(listed below).  For certain ADRs assessed to be immune-related, Table 5 criteria may supersede 
this section.  These criteria may allow the subject to continue on study if medically indicated after 
consultation with Medical Monitor.
Any Grade 4 ADRs require permanent treatment discontinuation except for single laboratory 
values out of normal range that do not have any clinical correlate, and resolve to Grade ≤1 within 
7 days with adequate medical management.
Any Grade 3 ADRs require treatment discontinuation except for any of the following:
!
Transient (≤6 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical 
management.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
69/167
!
Transient (≤24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that 
resolves to ≤Grade 1.
!
Tumor flare phenomenon defined as local pain, irritation, or rash localized at sites of known 
or suspected tumor.
!
Any Grade ≥3 drug-related amylase or lipase abnormality that is not associated with
symptoms or clinical manifestations of pancreatitis. The trial Medical Monitor should be 
consulted for such Grade ≥3 amylase or lipase abnormalities.  If the amylase or lipase 
abnormality not associated with symptoms or clinical manifestations of pancreatitis has not 
resolved to Grade ≤1 within the subsequent 2 cycles (28 days), the subject should 
permanently discontinue treatment with MSB0011359C.
!
Grade 3 Hgb decrease (< 8.0 g/dL) that is clinically manageable with blood transfusions or 
erythroid growth factor use does not require treatment discontinuation.  During the 21-Day 
DLT period, a Grade 3 Hgb decrease (< 8.0 g/dL) will require treatment discontinuation, 
unless it resolves to at least 9 g/dL within 14 days or the changes in the associated RBC 
parameters resolve within 14 days without blood transfusion or erythroid growth factor 
use.
!
Increases in Eastern Cooperative Oncology Group performance status (ECOG PS) ≥3 that 
resolves to ∃2 by cycle Day 1 of the next cycle (infusions should not be given if the ECOG 
PS is ≥3 on the day of IMP administration and should be delayed until ECOG PS ≤2).
!
Keratoacanthoma and squamous cell carcinoma of the skin.  Any suspicious skin lesion 
should be biopsied and be surgically removed.  The Study Medical Monitor should be 
consulted.
!
Grade 3 or 4 dematological irAEs, treatment should be delayed and treatment started 
according to Table 5, if condition improves to Grade 1, treatment may be resumed.  If 
≥2 consecutive doses are missed, the Medical Monitor should be consulted. 
!
Grade 3 or 4 symptomatic endocrinopathies (eg, thyroiditis or hypophysitis), treatment 
should be delayed and treatment started according to Table 5, if condition improves to 
Grade 1, treatment may be resumed.  If ≥ 2 consecutive doses are missed, the Medical 
Monitor should be consulted 
!
Other immune-related ADRs, see Table 5.
Any Grade 2 ADR should be managed as follows:
!
If a Grade 2 ADR resolves to Grade ≤1 by the last day of the current cycle, treatment may 
continue.
!
If a Grade 2 ADR does not resolve to Grade ≤1 by the last day of the current cycle but is 
manageable and/or not clinically relevant, the ADR should be discussed with the medical 
monitor.  Based on the discussion, it is possible that the infusion will be given on the 
following cycle.  If at the end of the following cycle, the event has not resolved to Grade 1, 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
70/167
another discussion should occur with Medical Monitor to consider permanently 
discontinuing treatment with MSB0011359C.
!
Upon the second occurrence of the same Grade 2 ADR in the same subject (except for 
fatigue and hormone insufficiencies that can be managed by replacement therapy), 
continuation of treatment with MSB0011359C has to be discussed with the medical 
monitor and may lead to permanently discontinuation.
!
Infusion-related reactions and hypersensitivity reactions (Grades 1 to 4) should be handled 
according to the guidelines provided in Section 6.5.4.1 and Section 6.5.4.2, respectively.
!
Anemia should be handled according to the guidelines provided in Section 6.5.4.4.
!
If immune-related ADRs, see Table 5.
5.1.8
Analysis Cut-Off Dates
After the end of the dose escalation part of the trial, a full analysis for safety and PK/
 
data will be made.  The primary data cut-off date for the dose escalation part is 3 months after the 
last subject in the dose escalation part received the first dose of MSB0011359C.
The primary data cut-off for the analysis of each expansion cohort separately will be 6 months 
after the last subject in that cohort started treatment.
The final data cut-off is 1 year after the last subject has received the last dose of MSB0011359C.
5.2
Discussion of Trial Design
This is a Phase I, open-label, dose escalation trial with an expansion part in cohorts of subjects 
with GC, ESCC, BTC and HCC.
An open-label, unblinded design is appropriate for a dose
escalation trial with expansion cohorts in advanced cancer subjects since subjects have exhausted 
treatment options.
In this trial, the assessment of the safety and tolerability of the IMP with the determination of the 
MTD (in the dose escalation part only) is set to be the primary objective.  The determination of the 
MTD is one of the first major steps in the development of a compound entering early clinical 
development because it might be determined that the highest tolerable dose is important in future 
clinical development in order to achieve the best efficacy to risk ratio for subjects.  The MTD will 
be determined using a standard “3+3 subjects” dose-escalation design based on DLT assessments, 
which is commonly used in first-in-man oncology trials (Crowley 2006).  The aim of this design 
is to maximize the protection to subjects and reduce the chances of more subjects to be exposed to 
possible drug toxicities; however, at the end of the dose-escalation part, it is intended to fill cohorts
as described in Section 5.1.1 to identify a reasonable dose for the expansion part.  All these 
assessments will be correlated to PK
 parameters to potentially aid selection of the most 
meaningful dose for the expansion cohorts or future studies.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
72/167
5.3.1
Inclusion Criteria
For inclusion in the trial, all of the following inclusion criteria must be fulfilled.
5.3.1.1
Inclusion Criteria for Dose Escalation
1. Able and willing to give written informed consent and has signed the appropriate written 
informed consent form (ICF), prior to performance of any trial activities.
2. Eligible male or female subjects aged ≥20 years.
3. Histologically or cytologically proven metastatic or locally advanced solid tumors, for which 
no effective standard therapy exists or standard therapy has failed.
4. ECOG PS of 0 to 1 at trial entry.
5. Life expectancy ≥12 weeks as judged by the Investigator.
6. Adequate hematological function defined by white blood cell (WBC) count ≥3 × 109/L with 
absolute neutrophil count (ANC) ≥1.5 × 109/L, lymphocyte count ≥0.5 × 109/L, platelet 
count ≥75 × 109/L, and Hgb ≥9 g/dL (in absence of blood transfusion).
7. Adequate hepatic function defined by a total bilirubin level ≤1.5 × ULN, an AST level 
≤2.5 × ULN, and an ALT level ≤2.5 × ULN. For subjects with liver involvement in their 
tumor, AST ≤5.0 × ULN, ALT ≤5.0 × ULN, and bilirubin ≤3.0 is acceptable.
8. Adequate renal function defined by an estimated creatinine clearance > 50 mL/min according 
to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine 
collection.
9. Highly effective contraception (that is, methods with a failure rate of less than 1% per year) 
for both male and female subjects if the risk of conception exists (Note: The effects of the trial 
treatment on the developing human fetus are unknown; thus, women of childbearing potential 
and men must agree to use highly effective contraception, defined in Appendix 2 or as 
stipulated in national or local guidelines).  Highly effective contraception must be used 30 days 
prior to first trial treatment administration, for the duration of trial treatment, and at least for 
4 months after stopping trial treatment. Should a woman become pregnant or suspect she is 
pregnant while she or her partner is participating in this trial, the treating physician should be 
informed immediately.
10. Woman of childbearing potential must have a negative serum pregnancy test at screening visit 
and a negative serum or urine pregnancy test at Day 1 before dosing, if applicable.
5.3.1.2
Inclusion Criteria for Expansion Cohorts
1. Able and willing to give written informed consent and has signed the appropriate written ICF, 
prior to performance of any trial activities.
2. Eligible male or female subjects aged ≥20 years.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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3. Subjects must have one of the following:
!
GC:  Histologically or cytologically confirmed recurrent or refractory unresectable stage 
IV gastric or gastro-esophageal junctional adenocarcinoma (according to American Joint 
Committee on Cancer/Union Internationale Contre le Cancer 7th edition) for which no 
standard therapy exists or standard therapy has failed.
!
ESCC:  Histologically or cytologically confirmed esophageal squamous cell cancer for 
which no standard therapy exists or standard therapy has failed.
!
BTC, second line:  Histologically or cytologically confirmed biliary tract cancer.  Must 
have failed or are intolerant to one line of systemic treatment.  Patients who received 
adjuvant chemotherapy and had evidence of disease recurrence within 6 months of 
completion of the adjuvant treatment are also eligible.
!
HCC, second line or later, or sorafenib intolerant:  Histologically confirmed HCC.  Must 
be unresectable or advanced disease not amenable to curative resection.  Must have had 
progression following at least 1 line of prior sorafenib therapy (must have received at least 
14 days of sorafenib at least 400 mg per day) or previously considered to be sorafenib 
intolerant.
Uninfected, HCV and HBV infected subjects are eligible.  Subjects infected with HBV 
must be treated and on a stable dose of entecavir, tenofovir, or lamivudine (adefovir or 
interferon not allowed) at study entry and with planned monitoring and management 
according to appropriate labeling guidance.  Any prior HCV therapy for curative intent
must be completed prior to entry; if subjects reach stable disease, CR or PR of at least 
3 months duration and are considered medically stable, then HCV small molecule 
treatments are allowable in the judgement of the Investigator and in consultation with the 
Medical Monitor and following appropriate labeling guidance for initiation, monitoring, 
and management. 
Additional inclusion criteria for HCC subjects include:
o
Child-Pugh A or B7
o
Albumin ≥2.8 g/dL
o
International normalized ratio (INR) < 1.7
o
Prothrombin time < 4 seconds over control
o
Hepatic function defined by a total bilirubin level ≤3 mg/dL and AST and ALT levels 
≤5 × ULN
o
Adequate hematological function defined by WBC count ≥2.5 × 109/L with 
ANC ≥1.5 × 109/L, lymphocyte count ≥0.5 × 109/L, platelet count ≥50 × 109/L, and 
hemoglobin ≥9 g/dL (in absence of blood transfusion)
o
Subjects with no allergies to contrast and able to tolerate CT or MRI contrast in the 
opinion of the Investigator.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
74/167
4. Availability of tumor (primary or metastatic) archival material or fresh biopsies within 28 days 
before first administration of IMP is mandatory.  If no archival material is available and only 
one lesion is amenable for biopsy and it is the only target lesion, the Medical Monitor should 
be consulted for subject eligibility). Tumor biopsies and tumor archival material must be 
suitable for 
as described in the Laboratory Manual.
5. Disease must be measurable with at least 1 unidimensionally measurable lesion by 
RECIST 1.1.
6. ECOG PS of 0 to 1 at trial entry.
7. Life expectancy ≥12 weeks as judged by the Investigator.
8. For subjects with GC, ESCC, or BTC, adequate hematological function defined by WBC count 
≥3 × 109/L with ANC ≥1.5 × 109/L, lymphocyte count ≥0.5 × 109/L, platelet count ≥75 × 
109/L, and Hgb ≥9 g/dL (in absence of blood transfusion).
9. For subjects with GC, ESCC, or BTC, adequate hepatic function defined by a total bilirubin 
level ≤1.5 × ULN, an AST level ≤2.5 × ULN, and an ALT level ≤2.5 × ULN.
10. Adequate renal function defined by an estimated creatinine clearance > 50 mL/min according 
to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine 
collection.
11. Highly effective contraception (that is, methods with a failure rate of less than 1% per year) 
for both male and female subjects if the risk of conception exists (Note: The effects of the trial 
treatment on the developing human fetus are unknown; thus, women of childbearing potential 
and men must agree to use highly effective contraception, defined in Appendix 2 or as 
stipulated in national or local guidelines).  Highly effective contraception must be used 30 days 
prior to first trial treatment administration, for the duration of trial treatment, and at least for 
4 months after stopping trial treatment. Should a woman become pregnant or suspect she is 
pregnant while she or her partner is participating in this trial, the treating physician should be 
informed immediately.
12. Woman of childbearing potential must have a negative serum pregnancy test at screening visit 
and a negative serum or urine pregnancy test at Day 1 before dosing, if applicable.
5.3.2
Exclusion Criteria
Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria:
1. Concurrent treatment with non-permitted drugs (see Section 6.5.2).
2. Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune 
checkpoints) such as anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody (consult Medical Monitor 
if necessary), or anti-4-1BB antibody is not allowed, inclusive of intrahepatic, localized 
administration of such agents.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
75/167
3. Prior therapy with any antibody/drug targeting TGFβ/TGFβ receptor.
4. Anticancer treatment within 21 days before the start of trial treatment, eg, cytoreductive 
therapy, radiotherapy involving more than 30% of the bone marrow (with the exception of 
palliative bone directed radiotherapy), immune therapy, or cytokine therapy.
5.
Anticancer treatment with antibody within 28 days before the start of trial treatment.
6. Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic 
biopsy).
7. Systemic therapy with immunosuppressive agents within 7 days before the start of trial
treatment; or use of any investigational drug within 28 days before the start of trial treatment.
8. Previous malignant disease other than the target malignancy to be investigated in this trial with 
the exception of cervical carcinoma in situ and superficial or non-invasive bladder cancer 
(treated with curative intent) within the last 5 years or basal cell or squamous cell carcinoma 
in situ within the last 3 years.
9. Rapidly progressive disease which, in the opinion of the Investigator, may predispose to 
inability to tolerate treatment or trial procedures.
10. Subjects with active central nervous system (CNS) metastases causing clinical symptoms or 
metastases that require therapeutic intervention are excluded.  Subjects with a history of treated 
CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully 
recovered from treatment, demonstrated no progression for at least 2 months, and do not 
require continued steroid therapy.  Subjects with CNS metastases incidentally detected during 
Screening which do not cause clinical symptoms and where no therapeutic intervention is 
needed should be discussed with the Sponsor.
11. Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with 
the exception of transplants that do not require immunosuppression (eg, corneal transplant, 
hair transplant).
12. Significant acute or chronic infections including, among others:
! Positive test for human immunodeficiency virus (HIV) or known acquired 
immunodeficiency syndrome
! Except for the HCC cohort, HBV infection (HBV surface antigen positive or HBV core 
antibody positive with reflex to positive HBV DNA) or HCV infection (positive HCV 
antibody with reflex to positive HCV RNA)
! Subjects with active tuberculosis (history of exposure or history of positive tuberculosis test; 
plus presence of clinical symptoms, physical or radiographic findings)
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
76/167
13. Active autoimmune disease that might deteriorate when receiving an immunostimulatory 
agent:
!
Subjects with diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease 
not requiring immunosuppressive treatment are eligible.
!
Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are 
administered only for the purpose of hormonal replacement and at doses ≤10 mg of 
prednisone or equivalent per day.
!
Administration of steroids for other conditions through a route known to result in a minimal 
systemic exposure (topical, intranasal, intro-ocular, or inhalation) is acceptable.
14. Interstitial lung disease or its history.
15. Known history of hypersensitivity reactions to MSB0011359C or its products, or known severe 
hypersensitivity reactions to monoclonal antibodies (Grade ≥3 NCI-CTCAE v4.03), any 
history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.
16. Persisting toxicity (except alopecia and vitiligo) related to prior therapy Grade > 1 
NCI-CTCAE v4.03; however, sensory neuropathy Grade ≤2 is acceptable.
17. Pregnancy or currently in lactation. Subject is not eligible even if lactation is suspended.
18. Known alcohol or drug abuse.
19. Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular 
accident / stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to 
enrollment), unstable angina, congestive heart failure (≥ New York Heart Association 
Classification Class II), or serious cardiac arrhythmia. 
20. Clinically relevant diseases (eg, inflammatory bowel disease) and/or uncontrolled medical 
conditions, which, in the opinion of the Investigator, might impair the subject’s tolerance or 
ability to participate in the trial.
21. Any psychiatric condition that would prohibit the understanding or rendering of informed 
consent.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
77/167
22. Legal incapacity or limited legal capacity.
23. Vaccine administration within 4 weeks of IMP administration.  Vaccination with live vaccines 
while on trial is prohibited.  Administration of inactivated vaccines is allowed (eg, inactivated 
influenza vaccines).
Additional exclusion criteria for subjects in the HCC cohort include:
24. Any prior or current ascites that requires paracentesis for control; or history of variceal 
bleeding; or history of hepatic encephalopathy; or history of obstructive jaundice.
25. Hepatitis D virus (HDV) co-infection with HBV (if HBV surface antigen or HBV DNA 
positivity at Screening, then must check for HDV status).
26. Chemoembolization or radioembolization within 28 days prior to IMP administration.
5.4
Criteria for Initiation of Trial Treatment
The inclusion and exclusion criteria will be checked at the Screening visit.  Eligible subjects will 
be enrolled before treatment start after verification of fulfilling all inclusion criteria without 
matching any exclusion criterion.
5.5
Criteria for Subject Withdrawal
5.5.1
Withdrawal from Trial Treatment
Subjects will be withdrawn from trial treatment for any of the following reasons:
!
Confirmed PD per RECIST 1.1: Subjects should continue treatment beyond the initial 
determination of PD, through their next tumor assessment, provided:
a. There are no new Grade 2 or greater symptoms or significant worsening of existing symptoms.
b. There is no decrease in ECOG PS.
c. In the opinion of the Investigator, the subject does not require new anticancer therapy.
!
Subjects should be discontinued from treatment thereafter if further evidence of PD; 
however, continued treatment is possible in consultation with the Medical Monitor.
!
Occurrence of an exclusion criterion, which is clinically relevant and affects the subject’s 
safety, if discontinuation is considered necessary by the Investigator and/or Sponsor.
!
Therapeutic failure requiring urgent additional cancer therapy.
!
Occurrence of any Grade ≥3 ADRs or repetitive Grade 2 ADRs as defined in
Section 5.1.7.2.
!
Occurrence of AEs, at the Investigator’s discretion.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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!
Pregnancy.
!
Use of prohibited concomitant drug, as defined in Section 6.5.2, where the predefined 
consequence is withdrawal from the IMP.
!
Non-adherence/noncompliance to the trial protocol or trial requirements (see Section 6.9).
!
Withdrawal of consent.
!
Participation in any other trial.
For subjects who miss ≥2 consecutive doses for medical reasons, the Medical Monitor should be 
consulted.
Subject Replacement
For the dose escalation part, subjects with the following events during the DLT observation period 
(see Section 5.1.3.3 and Section 5.5.2) will be considered non-completers and have to be replaced:
!
Deviation in MSB0011359C administration of greater than -3 days or +1 day due to reasons 
other than DLT.
!
Other condition that DLT is not evaluable (eg, use of non-permitted medicines as detailed 
in Section 6.5.2).
5.5.2
Withdrawal from the Trial
Subjects may withdraw from the trial at any time without giving a reason.  Withdrawal of consent 
will be considered withdrawal from the trial.
A subject must be withdrawn in the event of any of the following:
!
Withdrawal of the subject’s consent.
!
Participation in any other therapeutic trial during the treatment duration of this trial; 
however, subjects will continue to be followed for survival.
If a subject has failed to attend scheduled trial assessments, the Investigator must determine and 
record the reasons and the circumstances as completely and accurately as possible.
In case of withdrawal from the trial, the assessments scheduled for the last visit (End-of-Treatment 
visit) should be performed (see Section 7.1.4), if possible, with focus on the most relevant 
assessments.  In any case, the appropriate End-of-Treatment electronic case report form (eCRF) 
visit must be completed. In case of withdrawal, subjects will be asked to continue safety and 
survival follow-up, which includes the collection of data on survival and subsequent anticancer 
therapy.  After completion of the Follow-up period or after the End-of-Treatment visit, whatever 
is applicable, the appropriate eCRF section for Trial Termination must be completed.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
79/167
If a subject is withdrawn prior to disease progression for any reason in the expansion part of the 
trial, the subject will not be replaced.  For the dose escalation part, subjects with the following 
events during the DLT observation period will be considered non-completers and have to be 
replaced: 1) deviation in MSB0011359C administration of greater than -3 days or +1 day due to 
reasons other than DLT; or 2) other condition that DLT is not evaluable (eg, use of non-permitted 
medicines).
5.6
Premature Discontinuation of the Trial
The whole trial may be discontinued prematurely in the event of any of the following:
!
New information leading to unfavorable risk-benefit judgment of the IMP(s), eg, due to:
o
Evidence of inefficacy of the IMP(s),
o
Occurrence of significant previously unknown adverse reactions or unexpectedly high 
intensity or incidence of known adverse reactions, or
o
Other unfavorable safety findings.
(Note: evidence of inefficacy may arise from this trial or from other trials; unfavorable 
safety findings may arise from clinical or nonclinical examinations, eg, toxicology.)
!
Sponsor’s decision that continuation of the trial is unjustifiable for medical or ethical 
reasons.
!
Poor enrollment of subjects making completion of the trial within an acceptable time frame 
unlikely.
!
Discontinuation of development of the Sponsor’s IMP(s).
!
Withdrawal of the IMP(s) from the market for safety reasons (applicable to trials with 
marketed products only).
After primary analyses are completed, subjects may be offered to enroll into a roll-over trial before 
planned end of the trial.
The Health Authorities and Independent Ethics Committee (IEC)/Institutional Review Boards 
(IRBs) will be informed about the discontinuation of the trial in accordance with applicable 
regulations.
The whole trial may be terminated or suspended upon request of the Health Authorities.
5.7
Definition of End of Trial
If the trial is not terminated for any reason given in Section 5.6, the end of the trial is defined as 
1 year after the last subject receives the last dose of MSB0011359C.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
81/167
6.2
Dosage and Administration
Subjects 
will 
receive 
intravenous 
infusion 
of 
MSB0011359C 
over 
1 
hour 
(- 10 minutes/+20 minutes, ie, over 50 to 80 minutes) once every 2 weeks as detailed in the 
Schedules of Assessments (see Table 1 and Table 2).  Modifications of the infusion rate due to 
infusion-related reactions are described in Section 6.5.4.1.  In order to mitigate potential 
infusion-related reactions, premedication with an antihistamine and with paracetamol 
(acetaminophen) (eg, 25 to 50 mg diphenhydramine and 500 to 650 mg paracetamol 
[acetaminophen] intravenous or oral equivalent) approximately 30 to 60 minutes prior to each dose 
of MSB0011359C is mandatory for the first 2 infusions.  Premedication is optional and at the 
discretion of the Investigator after the second infusion.  If Grade 2 infusion reactions are seen 
during the first two infusions, then premedication should not be stopped.  Steroids as premedication 
are not permitted.  Special precautions for monitoring of subjects and management of 
infusion-related reactions/hypersensitivity including modifications of the infusion rate and 
stopping of trial drug are described in Section 6.5.4 and subsections.
The starting dose of MSB0011359C in the dose escalation part is 3 mg/kg (dose escalation 
according to 3+3 design up to 20 mg/kg is intended) and the treatment cycle will be 2 weeks 
(14 days).  The first subject of each cohort will be observed for at least 5 days before the second 
subject can be treated.  Within each cohort, 48 hours must pass before a new subject can initiate 
dosing.
During the dose escalation part and for the HCC cohort, the dose of MSB0011359C will be 
calculated based on the weight of the subject determined on the day prior to or the day of each 
drug administration.  For subsequent administrations, the dose will only be changed in case of 
weight gain or loss of ≥10%. 
A flat dose of 1200 mg MSB0011359C will be used for all subjects in the expansion cohort (except 
for the HCC cohort) after confirming the tolerability of MSB0011359C at 20 mg/kg.  Subjects will 
receive MSB0011359C once every 2 weeks until confirmed progression, unacceptable toxicity, or 
any criterion for withdrawal from the trial or IMP occurs (see Section 5.5).  Subjects who have 
experienced a CR, PR or SD should continue treatment through the end of 12 months at the 
discretion of the Investigator and in consultation with the Medical Monitor.  If the Investigator 
believes that a subject may benefit from treatment beyond 12 months, it may be permissible after 
discussion with the Medical Monitor.
For subjects who achieve a CR, PR, or SD on MSB0011359C therapy and then subsequently 
develop disease progression after stopping therapy, but prior to the end of the trial, 1 re-initiation 
course of treatment at the same dose and schedule and treatment duration up to 12 months is 
allowed at the discretion of the Investigator and agreement of the trial Medical Monitor.  Subjects 
re-initiating treatment should be assessed according to the Schedule of Assessments for the 
expansion part of the trial (see Table 2).
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
82/167
6.3
Assignment to Treatment Groups
The Investigator or delegate will assign a unique subject identifier number to eligible subjects in 
chronological order at the time of informed consent signature.  Subject identifiers will be 
comprised of digits representing the trial number, the site number, and the subject number, which 
is allocated sequentially.  Enrollment in the dose escalation and expansion parts will utilize an 
interactive web response system.
6.4
Non-investigational Medicinal Products to be Used
In order to mitigate potential infusion-related reactions premedication with an antihistamine and 
with paracetamol (acetaminophen) (eg, 25 to 50 mg diphenhydramine and 500 to 650 mg 
paracetamol [acetaminophen] intravenous or oral equivalent) approximately 30 to 60 minutes prior 
to each dose of MSB0011359C is mandatory for the first 2 infusions.  Premedication is optional 
and at the discretion of the Investigator after the second infusion.  If Grade 2 infusion reactions are 
seen during the first two infusions, then premedication should not be stopped.  This regimen may 
be modified based on local treatment standards and guidelines as appropriate. Steroids as 
premedication are not permitted.
As with all monoclonal antibody therapies, there is a risk of allergic reaction including 
anaphylactic shock. MSB0011359C should be administered in a setting that allows for immediate 
access to an intensive care unit or equivalent environment and administration of therapy for 
anaphylaxis, such as the ability to implement immediate resuscitation measures.  Steroids 
(dexamethasone 10 mg), epinephrine (1:1,000 dilution), allergy medications (intravenous 
antihistamines), bronchodilators, or equivalents, and oxygen should be available for immediate 
access.  Infusion of MSB0011359C will be stopped in case of Grade ≥2 infusion-related, allergic, 
or anaphylactic reactions.  Following MSB0011359C infusions, during the first 2 doses in the 
escalation phase there will be a minimum 24-hour in-patient observation.  Please see the guidelines 
for handling of infusion-related reaction in Section 6.5.4.1.
If an allergic reaction occurs, the subject must be treated according to the best available medical 
practice.  Guidelines for management of infusion-related reactions and severe hypersensitivity 
reaction according to the NCI are found in Section 6.5.4. 
Further precautions are provided in Section 6.5.4.  For prophylaxis of flu-like symptoms, a 
nonsteroidal anti-inflammatory drug (NSAID), eg, ibuprofen 400 mg or comparable NSAID dose, 
may be administered 2 hours before and 8 hours after the start of each dose of MSB0011359C 
intravenous infusion.
6.5
Concomitant Medications and Therapies
All concomitant medications taken by the subject during the trial, from the date of signature of 
informed consent are to be recorded in the appropriate section of the eCRF, noting the name, dose, 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
83/167
duration and indication of each drug.  Nondrug interventions (other than vitamins) and any changes 
to a concomitant medication or other intervention should also be recorded in the eCRF.
6.5.1
Permitted Medicines
Any medications (other than those excluded by the clinical trial protocol) that are considered 
necessary to protect subject welfare and will not interfere with the trial medication may be given 
at the Investigator’s discretion.
Other drugs to be used for prophylaxis, treatment of anaphylactic reactions, infusion-related 
reactions, and severe hypersensitivity reactions/flu-like symptoms and irAEs are described in 
Sections 5.1.7.2, 6.4, and 6.5.4.
Palliative bone directed radiotherapy may be administered during the trial.  The assessment of PD 
will be made according to RECIST 1.1 (Eisenhauer 2009) and not based on the necessity for 
palliative bone-directed radiotherapy.
6.5.2
Prohibited Medicines
As stated for the exclusion criteria in Section 5.3.2, subjects must not have had chemotherapy, 
radiotherapy involving more than 30% of the bone marrow (other than palliative bone directed 
radiotherapy as described in Section 6.5.1) within 21 days before the start of trial treatment, and 
anticancer treatment with antibody, major surgery, or received another investigational agent within 
28 days before the start of trial treatment.
The following treatments must not be administered during the trial:
!
Immunotherapy, immunosuppressive drugs (eg, chemotherapy or systemic corticosteroids 
except for short-term treatment of allergic reactions, endocrine replacement therapy at low 
dose prednisone [≤10 mg daily] or equivalent, or for the treatment of irAEs or other 
appropriate short-term steroid use), or other experimental pharmaceutical products.  
Short-term administration of systemic steroid or other immunosuppressant such as 
infliximab or mycophenolate (ie, for allergic reactions or the management of irAEs) is 
allowed.  Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
!
Adefovir.
!
Prophylactic use of corticosteroids for infusion-related reactions is prohibited.
!
Any live vaccine therapies for the prevention of infectious disease.  Administration of 
inactivated vaccines is allowed (eg, inactivated influenza vaccines).
!
Blood transfusions and erythroid growth factors are not allowed during the 21-day DLT 
window during the escalation part.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
84/167
If the administration of a non-permitted concomitant drug becomes necessary during the trial, the 
subject will be withdrawn from trial treatment (the Medical Monitor may be contacted to discuss 
whether the IMP must be discontinued).
Medications other than those specifically excluded in this trial (as outlined in this section) may be 
administered for the management of symptoms associated with the administration of 
MSB0011359C as required.  These might include analgesics, antiemetics, antihistamines, 
diuretics, anti-anxiety medications, and medication for pain management, including narcotic 
agents.
Any additional concomitant therapy that becomes necessary during the trial and any change to 
concomitant drugs must be recorded in the corresponding section of the eCRF, noting the name, 
dose, duration, and indication of each drug.
6.5.3
Other Interventions
The following nondrug therapies must not be administered during the trial (and within 28 days 
before the start of trial treatment):
!
Major surgery (excluding prior diagnostic biopsy).
!
Herbal remedies with immunostimulating properties (eg, mistletoe extract) or 
known to potentially interfere with major organ function (eg, hypericin).
!
Subjects should not abuse alcohol or other drugs during the trial.
6.5.4
Special Precautions
For subjects enrolled in the dose escalation part of the trial, in-house observation in a hospitalized 
setting for at least 24 hours will occur for the first 2 doses administered to each subject.  To 
facilitate PK and 
, subjects may remain in-house through an additional 
24 hours if necessary.  A nurse or physician will communicate with the first subject of each cohort 
after the first treatment to assess for any side effects on or after Day 5 but before enrolling a 
subsequent subject.  Thereafter, within each cohort, 48 hours must pass before a new subject can 
initiate dosing.
In the expansion part of the trial, there is no in-house observation and no waiting period between 
subjects.
At all times during MSB0011359C treatment, immediate emergency treatment of an 
infusion-related reaction or a severe hypersensitivity reaction according to institutional standards 
must be assured. In order to treat possible anaphylactic reactions, for instance, dexamethasone 
10 mg and epinephrine in a 1:1000 dilution or equivalents should always be available along with 
equipment for assisted ventilation.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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Infusion of MSB0011359C will be stopped in case of Grade ≥2 hypersensitivity, inflammatory 
response, or anaphylactic reaction.  The treatment recommendations for infusion-related reactions 
and severe hypersensitivity reactions according to the NCI are outlined in Sections 6.5.4.1 and 
6.5.4.2, respectively.
Investigators should also monitor subjects closely for potential irAEs, which may become manifest 
after several weeks of treatment.  Such events may consist of persistent rash, diarrhea and colitis, 
autoimmune hepatitis, arthritis, glomerulonephritis, cardiomyopathy, or uveitis and other 
inflammatory eye conditions.  The spectrum of hypothetical irAEs also includes formation of 
auto-antibodies like ANAs.
6.5.4.1
Infusion-related Reactions
A. Symptoms:
!
Fever
!
Chills
!
Rigors
!
Diaphoresis
!
Headache.
B. Management (see Table 4)
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
86/167
Table 4
Treatment Modification for Symptoms of Infusion-related Reactions 
Caused by MSB0011359C
NCI-CTCAE Grade 
Treatment Modification for MSB0011359C
Grade 1 – mild
! Mild transient reaction; infusion interruption not 
indicated; intervention not indicated.
! Decrease the MSB0011359C infusion rate by 50% and 
monitor closely for any worsening.
! The total infusion time for MSB0011359C should not 
exceed 120 minutes.
Grade 2 – moderate
! Therapy or infusion interruption indicated but responds 
promptly to symptomatic treatment (eg, antihistamines, 
NSAIDs, narcotics, IV fluids); prophylactic medications 
indicated for ∃24 hours.
! Stop MSB0011359C infusion.
! Resume infusion at 50% of previous rate once infusion-
related reaction has resolved or decreased to at least 
Grade 1 in severity, and monitor closely for any
worsening.
Grade 3 or Grade 4 – severe or life-threatening
! Grade 3: Prolonged (eg, not rapidly responsive to 
symptomatic medication and/or brief interruption of 
infusion); recurrence of symptoms following initial 
improvement; hospitalization indicated for clinical 
sequelae.
! Grade 4: Life-threatening consequences; urgent 
intervention indicated.
! Stop the MSB0011359C infusion immediately and 
disconnect infusion tubing from the subject.
! Subjects have to be withdrawn immediately from 
MSB0011359C treatment and must not receive any 
further MSB0011359C treatment.
IV=intravenous; NCI-CTCAE=National Cancer Institute-Common Terminology Criteria for Adverse Event; 
NSAIDs=nonsteroidal anti-inflammatory drugs.
Additional Modifications for Subjects with Grade 2 Infusion-related Reactions
If, in the event of a Grade 2 infusion-related reaction that does not improve or worsens after 
implementation of the modifications indicated in Table 4 (including reducing the infusion rate by 
50%), the Investigator may consider treatment with corticosteroids and the infusion of IMP should 
be stopped for that day.  At the next infusion, the Investigator may consider the addition of 
H2-blocker antihistamines (eg, famotidine or ranitidine), in addition to premedication, for select 
subjects.  However, prophylactic steroids are NOT permitted.  If the subject has a second 
infusion-related reaction Grade ≥2 on the slower infusion rate, with or without the addition of 
further medication to premedication, the infusion should be stopped and the subject removed from 
MSB0011359C treatment.
6.5.4.2
Severe Hypersensitivity Reactions and Flu-like Symptoms
If a hypersensitivity reaction occurs, the subject must be treated according to the best available 
medical practice.  A complete guideline for the emergency treatment of anaphylactic reactions 
according to the Working Group of the Resuscitation Council (United Kingdom) and can be found 
at https://www.resus.org.uk/pages/reaction.pdf.  Subjects should be instructed to report any 
delayed reactions to the Investigator immediately.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
87/167
A. Symptoms
!
Impaired airway
!
Decreased oxygen saturation (< 92%)
!
Confusion
!
Lethargy
!
Hypotension
!
Pale/clammy skin
!
Cyanosis.
B. Management
1. Epinephrine injection and intravenous dexamethasone.
2. Patient should be placed on cardiac, blood pressure, heart rate, and oxygen saturation 
monitor immediately.
3. Alert intensive care unit for possible transfer if required.
For prophylaxis of flu-like symptoms, an NSAID, eg, ibuprofen 400 mg or comparable NSAID 
dose, may be administered 2 hours before and 8 hours after the start of each dose of MSB0011359C 
IV infusion except for the DLT period (for subjects who experienced a flu-like syndrome in the 
DLT assessment period, prophylactic use of an NSAID at the next dose is allowed).
6.5.4.3
Immune-related Adverse Events
Since inhibition of PD-L1 stimulates the immune system, irAEs may occur.  Treatment of irAEs 
is mainly dependent upon severity (NCI-CTCAE grade):
!
Grade 1 to 2:  Treat symptomatically or with moderate dose steroids, more frequent 
monitoring.
!
Grade 1 to 2 (persistent):  Manage similar to high grade AE (Grade 3 to 4).
!
Grade 3 to 4:  Treat with high dose corticosteroids.
Treatment of irAEs should follow guidelines set forth in Table 5.
Table 5
Management of Immune-Related Adverse Events
Gastrointestinal irAEs
Severity of Diarrhea/Colitis
(NCI-CTCAE v4.03)
Management
Follow-up
Grade 1
Diarrhea: < 4 stools/day over Baseline
Continue MSB0011359C 
therapy
Close monitoring for worsening symptoms
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
88/167
Colitis: asymptomatic 
Symptomatic treatment (eg, 
loperamide)
Educate subject to report worsening 
immediately
If worsens:
Treat as Grade 2 or 3/4 
Grade 2
Diarrhea: 4 to 6 stools per day over 
Baseline; IV fluids indicated < 24 hours; 
not interfering with ADL
Colitis: abdominal pain; blood in stool 
Delay MSB0011359C therapy
Symptomatic treatment
If improves to Grade 1:
Resume MSB0011359C therapy
If persists > 5 to 7 days or recur:
0.5 to 1 mg/kg/day methylprednisolone or 
equivalent
When symptoms improve to Grade 1, taper 
steroids over at least 1 month, consider 
prophylactic antibiotics for opportunistic 
infections, and resume MSB0011359C therapy 
per protocol.
If worsens or persists > 3 to 5 days with oral 
steroids:
Treat as Grade 3 to 4
Grade 3 to 4
Diarrhea (Grade 3): ≥7 stools per day 
over Baseline; incontinence; IV fluids 
≥24 hours; interfering with ADL
Colitis (Grade 3):  severe abdominal pain, 
medical intervention indicated, peritoneal 
signs
Grade 4: life-threatening, perforation
Discontinue MSB0011359C 
therapy per protocol
1 to 2 mg/kg/day 
methylprednisolone IV or  
equivalent
Add prophylactic antibiotics for 
opportunistic infections
Consider lower endoscopy 
If improves:
Continue steroids until Grade 1, then taper 
over at least 1 month
If persists > 3 to 5 days, or recurs after 
improvement:
Add infliximab 5 mg/kg (if no 
contraindication), Note: Infliximab should not 
be used in cases of perforation or sepsis
Permanently discontinue IMP
Dermatological irAEs
Grade of Rash
(NCI-CTCAE v4.03)
Management
Follow-up
Grade 1 to 2
Covering ≤30% body surface area 
Symptomatic therapy (eg, 
antihistamines, topical steroids)
Continue MSB0011359C 
therapy
If persists > 1 to 2 weeks or recurs:
Consider skin biopsy
Delay MSB0011359C therapy
Consider 0.5 to 1 mg/kg/day 
methylprednisolone IV or oral equivalent. 
Once improving, taper steroids over at least 
1 month, consider prophylactic antibiotics for 
opportunistic infections, and resume 
MSB0011359C therapy
If worsens:
Treat as Grade 3 to 4 
Grade 3 to 4
Covering > 30% body surface area; life 
threatening consequences 
Delay or discontinue  
MSB0011359C  therapy
Consider skin biopsy
Dermatology consult
If improves to Grade 1:
Taper steroids over at least 1 month and add 
prophylactic antibiotics for opportunistic 
infections
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
89/167
1 to 2 mg/kg/day 
methylprednisolone IV or IV 
equivalent 
Resume MSB0011359C therapy (except in 
cases of Toxic Epidermal Necrolysis or 
Stevens-Johnson Syndrome)
Pulmonary irAEs
Grade of Pneumonitis
(NCI-CTCAE v4.03)
Management
Follow-up
Grade 1
Radiographic changes only 
Consider delay of 
MSB0011359C therapy
Monitor for symptoms every 
2 to 3 days
Consider Pulmonary and 
Infectious Disease consults 
Re-image at least every 3 weeks
If worsens:
Treat as Grade 2 or Grade 3 to 4 
Grade 2
Mild to moderate new symptoms 
Delay MSB0011359C therapy
Pulmonary and Infectious 
Disease consults
Monitor symptoms daily, 
consider hospitalization
1 mg/kg/day 
methyl-prednisolone IV or oral 
equivalent
Consider bronchoscopy, lung 
biopsy 
Re-image every 1 to 3 days
If improves:
When symptoms return to near Baseline, taper 
steroids over at least 1 month and then resume 
MSB0011359C therapy and consider 
prophylactic antibiotics
If not improving after 2 weeks or worsening:
Treat as Grade 3 to 4
Permanently discontinue IMP
Grade 3 to 4
Severe new symptoms; New/worsening 
hypoxia; life-threatening 
Discontinue MSB0011359C 
therapy
Hospitalize
Pulmonary and Infectious 
Disease consults
2 to 4 mg/kg/day 
methylprednisolone IV or IV 
equivalent
Add prophylactic antibiotics for 
opportunistic infections
Consider bronchoscopy, lung 
biopsy 
If improves to Baseline:
Taper steroids over at least 6 weeks
If not improving after 48 hours or worsening:
Add additional immunosuppression (eg, 
infliximab, cyclophosphamide, IV 
immunoglobulin, or mycophenolate mofetil)
Permanently discontinue IMP
Hepatic irAEs
Grade of Liver Test Elevation
(NCI-CTCAE v4.03)
Management
Follow-up
Grade 1
Grade 1 AST or ALT > ULN to 3.0 x 
ULN and/or total bilirubin > ULN to 1.5 
x ULN
Continue MSB0011359C 
therapy
Continue liver function monitoring
If worsens:
Treat as Grade 2 or 3 to 4 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
91/167
Immune-mediated myocarditis
Permanently discontinue 
MSB0011359C.
Guideline based supportive 
treatment as appropriate as per 
cardiology consult.a
Methylprednisolone 1 to 
2 mg/kg/day.
Once improving, taper steroids over at least 
1 month and add prophylactic antibiotics for 
opportunistic infections.
If no improvement or worsening, consider 
additional immunosuppressants (eg,
azathioprine, cyclosporine A).
a Local guidelines, or eg. European Society of Cardiology or American Heart Association guidelines
European Society of Cardiology guidelines website: https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines
American Heart Association guidelines website:
http://professional heart.org/professional/GuidelinesStatements/searchresults.jsp?q=&y=&t=1001
Endocrine irAEs
Endocrine Disorder
Management
Follow-up
Asymptomatic TSH abnormality 
Continue MSB0011359C therapy
If TSH < 0.5 x LLN, or TSH > 2 x ULN, or consistently out of range in 
2 subsequent measurements: include free T4 at subsequent cycles as clinically 
indicated; consider endocrinology consult 
Symptomatic endocrinopathy 
Evaluate endocrine function
Consider pituitary scan
Symptomatic with abnormal 
laboratory/pituitary scan:
Delay MSB0011359C therapy
1 to 2 mg/kg/day 
methylprednisolone IV or by 
mouth equivalent
Initiate appropriate hormone 
therapy
No abnormal laboratory/
pituitary MRI scan but 
symptoms persist:
Repeat laboratories in 1 to 
3 weeks/MRI in 1 month 
If improves (with or without hormone 
replacement):
Taper steroids over at least 1 month and 
consider prophylactic antibiotics for 
opportunistic infections
Resume MSB0011359C therapy
Subjects with adrenal insufficiency may need 
to continue steroids with mineralocorticoid 
component 
Suspicion of adrenal crisis (eg, severe 
dehydration, hypotension, shock out of 
proportion to current illness) 
Delay or discontinue MSB0011359C therapy
Rule out sepsis
Stress dose of IV steroids with mineralocorticoid activity
IV fluids
Consult endocrinologist
If adrenal crisis ruled out, then treat as above for symptomatic endocrinopathy 
ADL=activities of daily living; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CT=computed tomography; 
irAE=immune-related adverse event; IMP=investigational medicinal product; IV=intravenous; LFT=liver function test; 
LLN=lower limit of normal; MRI=magnetic resonance imaging; NCI-CTCAE=National Cancer Institute-Common Terminology 
Criteria for Adverse Events; T4=thyroxine; TSH=thyroid stimulating hormone; ULN=upper limit of normal.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
92/167
6.5.4.4
Anemia
Risk management measures in addition to routine laboratory tests will include:
!
Subjects must enter the trial with Hgb values at least 9 g/dL
!
Routine monitoring of Hgb, red blood cells, and hematocrit will be performed every week 
up to Week 5 and then every 2 weeks thereafter (prior to treatment)
!
RBC morphology will be assessed in the case of anemia onset caused by hemolysis, or 
other unknown causes 
!
Instructions for trial treatment discontinuation or modification in case of anemia will be 
provided, briefly described here:
o If decreased Hgb below 8 g/dL does not return to 9 g/dL (the entry criterion at screening) or 
changes in associated red blood cell parameters during such a Hgb decrease that do not resolve 
within 14 days without blood transfusion or erythroid growth factor use, the subject is 
permanently withdrawn from trial treatment (pertains only to the 21-day DLT period).  
Furthermore, the subject may require additional treatment for anemia.
o Especially if Hgb < 7 g/dL, the Investigator should consider blood transfusion.
o In case of any Hgb < 8 g/dL, the Investigator should use discretion to initiate anemia work up, 
including Coombs, haptoglobin, indirect bilirubin and peripheral smear, and prothrombin time, 
activated partial thromboplastin time, INR; Hgb, red blood cells, and hematocrit are to be 
closely monitored.
!
If a subject experiences significant anemia, then the amount of blood to be drawn may be 
reduced by not taking blood at selected time points for soluble factors and TGFβ.  The 
decision to reduce the time points for these biomarkers will be taken by the Investigator in 
consultation with the Medical Monitor.  This will be documented.  Blood will continue to 
be taken as scheduled for safety analyses, PK, anti-drug antibodies (ADAs).
6.5.4.5
Rash with Hyperkeratosis/Keratoacanthoma/Squamous Cell 
Carcinoma of the Skin
Monitoring will include skin assessments as defined in the Schedules of Assessments (Table 1 and 
Table 2), with biopsy of suspicious lesions.  Management should be discussed with the Medical 
Monitor on a case-by-case basis.  Dermatological consults should be requested as needed. 
Hyperkeratotic rash/keratoacanthoma/squamous cell carcinoma will be considered as AESI 
requiring expedited reporting from the Investigator to the Sponsor.
6.5.4.6
Alterations in Wound Healing or Tissue Damage Repair
Management should be discussed with the Medical Monitor on a case-by-case basis.  
Dermatological consults should be requested as needed.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
93/167
6.5.4.7
Dose Interruptions for Adverse Events No Related to Study 
Drug
In the case of Grade 3 and Grade 4 AEs that are not considered to be related to the study drug, the 
study treatment may be interrupted based on the Investigator assessment.  The subject will be 
medically treated for the event.
If the AE reduces to a lower tolerable grade, the study treatment may be resumed in the subsequent 
cycle.  If the AE remains the same in spite of medical treatment until the next treatment (second 
cycle after the AE occurred), the event should be discussed with the Medical Monitor to consider 
either a possible extension of the dose interruption for up to 1 additional cycle or a permanent 
withdrawal from the study treatment.
If upon resuming study treatment, the subject experiences the same AE again, this should be 
discussed again with the medical monitor to assess permanent withdrawal from the study 
treatment.
Grade 3 and 4 laboratory abnormalities that do not have clinical significance do not require dose 
interruption.
6.6
Packaging and Labeling of the Investigational Medicinal 
Product
MSB0011359C freeze-dried formulation is presented at a concentration of 45 mg/vial in USP / Ph 
Eur type I glass vial closed with a rubber stopper and sealed with an aluminum crimping cap.  
MSB0011359C liquid formulation is presented at a 10 mg/mL concentration in a USP / Ph Eur 
type I 50R vial closed with a rubber stopper and sealed with an aluminum crimp seal closure.  The 
stopper is made of elastomer complying with USP and Ph Eur.  Vials are filled with 61.2 mL of 
drug product solution in order to allow an extractable volume of 60 mL.
Packaging and labeling will be in accordance with applicable local regulatory requirements and 
applicable Good Manufacturing Practice guidelines.  MSB0011359C will be packed in boxes 
containing a suitable number of vials.  The information on the medication will be in accordance 
with approved submission documents.
MSB0011359C will be shipped in transport cool containers (2°C to 8°C) that are monitored with 
temperature control devices.
Packaging and labeling will be in accordance with applicable local regulatory requirements and 
applicable GMP Guidelines.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
95/167
!
The dispensing of the IMP will be carefully recorded on the appropriate drug accountability 
forms provided by the Sponsor and an accurate accounting will be available for verification 
by the Sponsor’s Medical Monitor at each monitoring visit.
!
Trial site IMP accountability records will include the following:
! Confirmation of IMP receipt, in good condition and in the defined temperature range.
! The inventory of IMP provided by the Sponsor and prepared at the site.
! The use of each dose by each subject.
! The return to the Sponsor or alternative disposition of unused trial drug.
! Dates, quantities, batch numbers, expiry dates, formulation (for IMP prepared at the site), and 
the subjects’ trial numbers.
!
The Investigator should maintain records that adequately document the following:
!
The subjects received the doses specified by the clinical trial protocol/amendment(s); and
!
The head of the trial site should maintain records that adequately document that all IMP 
provided by the Sponsor were fully reconciled.
The unused IMP must not be discarded or used for any purpose other than the present trial.  Any 
IMP that has been dispensed to a subject must not be re-dispensed to a different subject.
The Sponsor’s Monitor will periodically collect and review the IMP accountability forms and 
where applicable, will check all returns (both unused and used containers) before arranging for 
their return or authorizing their destruction by the trial site.
At the conclusion or termination of this trial, trial site personnel and the Clinical Trial Monitor will 
conduct a final product supply inventory on the Investigational Drug Accountability Forms and all 
unused containers will be destroyed.  Instructions for destruction of product will be provided to 
the site.  The Clinical Trial Monitor will be supplied with a copy for filing of the Investigational 
Drug Accountability Forms.  This documentation must contain a record of clinical supplies used, 
unused, and destroyed and shall include information on:
!
all administered units,
!
all unused units,
!
all destroyed units (during the trial),
!
all destroyed units at the end of the trial,
!
date of destruction(s),
!
name and signature of the head of the trial site or the investigational product storage 
manager
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
96/167
It must be ensured at each trial site that the IMP is not used
!
after the expiry date, and
!
after the retest date unless the IMP is reanalyzed and its retest date extended.
This is to be closely monitored by the Clinical Trial Monitor.
6.9
Assessment of Investigational Medicinal Product Compliance
In this trial, subjects will receive IMP (MSB0011359C intravenous infusions) at the investigational 
site.  Well-trained medical staff will monitor and perform the IMP administration.  The information 
of each IMP administration including the date, time, and dose of IMP will be recorded on the 
eCRF. The Investigator will make sure that the information entered into the eCRF regarding IMP 
administration is accurate for each subject.  Any reason for noncompliance should be documented.
Noncompliance is defined as a subject missing > 1 administration of trial treatment for nonmedical 
reasons. If 1 treatment administration was missed and the interval between the subsequent 
treatment and the last administered treatment is longer than 4 weeks for nonmedical reasons, the 
criteria of insufficient compliance are met as well.  Continuation of treatment should be discussed 
with the Medical Monitor.
6.10
Method of Blinding
Not applicable.
6.11
Emergency Unblinding
Not applicable.
6.12
Treatment of Overdose
An overdose is defined as any dose 5% greater than the highest dose included in the clinical trial 
protocol.  Any overdose must be recorded in the trial medication section of the eCRF.
For monitoring purposes, any case of overdose – whether or not associated with an AE (serious or 
nonserious) – must be reported to the Sponsor’s Global Drug Safety department in an expedited 
manner using the appropriate reporting form (see Section 7.4.1.4).
There are no known symptoms of MSB0011359C overdose to date.  The Investigator should 
monitor closely for AEs should an overdose occur and use his or her clinical judgment in providing 
symptomatic/supportive care as medically indicated.  There is no known antidote for 
MSB0011359C.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
97/167
6.13
Medical Care of Subjects after End of Trial
After a subject has completed the trial or has withdrawn early, usual treatment will be 
administered, if required, in accordance with the trial site’s standard of care and generally accepted 
medical practice and depending on the subject’s individual medical needs.
Upon withdrawal from the trial, subjects may receive whatever care they and their physicians agree 
upon.  Subjects will be followed for survival and AEs as specified in Section 7.1.5.
7
Trial Procedures and Assessments
7.1
Schedule of Assessments
A complete schedule of assessments for the dose escalation part of the trial is provided in Table 1
and for the expansion part in Table 2.  Sample collection for PK, 
 
, and 
changes in 
 are provided in Table 3.
Prior to performing any study assessments not part of the subject’s routine medical care, the 
Investigator will ensure that the subject or the subject’s legal representative has provided written 
informed consent according to the procedure described in Section 9.2.
7.1.1
Screening and Baseline Procedures and Assessments
There is a 21-day washout/recovery period for prior anticancer treatment (eg, cytoreductive 
therapy, radiotherapy involving more than 30% of the bone marrow [with the exception of 
palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for 
erythropoietin) and 28 days for prior anticancer treatment with antibody, major surgery before the 
start of trial treatment (Section 5.3.2).  Hematology, hemostaseology and chemistry laboratory 
samples must be drawn and reviewed within 48 hours prior to dose administration.
During the Screening period and before any trial-related investigations and assessments are started, 
the subjects will be asked to sign the relevant ICFs.  The subjects’ information that will be 
documented during Screening includes the demographic information (birth date, sex, ethnicity, 
and race) and the complete medical history, including the history of the tumor disease and prior 
anticancer therapies, previous medications (prior 30 days to signing of ICF), concomitant 
medications, and baseline medical condition (the information of concomitant medications and AEs 
will be monitored throughout the trial treatment period). Moreover, an Emergency Medical 
Support card will be handed out at the baseline assessments visit.
During Screening, subjects will undergo a complete physical examination, recording vital signs, 
including body weight and height (height only at Screening), 12-lead electrocardiogram (ECG), 
dermatological assessment, ophthalmology examination including slit lamp inclusive of the 
anterior segment and including visual acuity, and a determination of the ECOG PS (Appendix 1).
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
99/167
For subjects who achieve CR, PR, or SD on MSB0011359C therapy and then subsequently 
develop disease progression after stopping therapy, but prior to the end of the trial, 1 re-initiation 
course of treatment at the same dose and schedule and treatment duration up to 12 months is 
allowed at the discretion of the Investigator and agreement of the trial Medical Monitor. In order 
to be eligible for retreatment, the subject must not have experienced any toxicity that led to 
treatment discontinuation of the initial MSB0011359C therapy.  Prior to re-initiation of the trial
treatment, malignant disease needs to be radiologically re-staged to assess all known sites of the 
disease and to establish a new baseline for subsequent tumor measurements.  Relevant safety 
laboratory samples must be drawn and results available and verified prior to re-initiating of 
treatment.  Subjects who re-initiate treatment will stay on trial and will be treated and monitored 
according to the Schedule of Assessments for the expansion part of the trial (see Table 2).
Subjects will be asked to visit the investigational site according to the Schedules of Assessments 
(see Table 1 and Table 2).  A time window of up to 3 days before or 1 day after the scheduled visit 
day (-3/+1 days) will be permitted for all trial procedures (except on Day 2 and the Day 43 to 50 
visit).  In addition, the tumor evaluation (see Section 7.3) has a tumor assessment visiting time 
window of 5 days prior to dosing (-5 days).  Furthermore, if any Screening procedures are 
conducted within 3 days prior to Day 1 of trial treatment (Week 1, Day 1), the assessments 
scheduled on Week 1, Day 1 do not need to be repeated except for the evaluation of AEs and 
concomitant medications.
7.1.2.1
Dose Escalation Part Treatment Period
For the dose escalation part, in-house observation in a hospitalized setting with periodic ECG and 
vital sign monitoring for at least 24 hours will occur for the first 2 MSB0011359C doses 
administered to each subject.  After 24 hours, investigator will decide the discharge of the subject 
based on the monitoring results and the results of in-person examination.  The first subject of each 
cohort will be observed for at least 5 days before the second subject can be treated.  Subsequent 
subjects may receive first dosing at no less than 48 hour intervals between subjects.
During the treatment period, the following assessments will be performed (see Table 1 and Table 3
for the detailed schedule):
!
DLTs will be assessed during the first 21 days of trial treatment for each dose level of the 
dose-escalation part (see Section 5.1.3.2).
!
For subjects who wish to continue participation following the completion of their DLT 
period, another written consent is required.
!
AEs and concomitant medications will be documented at each trial visit.
!
ECOG PS will be assessed prior to trial treatment on Day 1 (unless the Screening ECOG 
PS was performed within 3 days prior to Day 1) and according to Table 1 thereafter.
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MS200647-0008
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!
Physical examination will be performed prior to trial treatment on Day 1 (Week 1).  After 
Day 1, a directed physical examination indicated by subject’s symptoms will be performed
according to Table 1.
!
At each visit, eye signs and symptoms should be checked.  If clinically relevant findings, 
then an appropriate ophthalmology examination (including slit lamp evaluation inclusive 
of the anterior segment and with visual acuity) should be obtained within 2 days.
!
Dermatological assessment.
!
Oxygen saturation (SpO2) will be measured. 
!
Vital signs including body weight, will be assessed prior to trial treatment according to
Table 1.
!
12-lead ECG will be assessed prior to and as soon as possible after infusion according to
Table 1.
!
The laboratory hematology and hemostaseology tests will be assessed according to Table 1.  
Complete blood count results must be drawn and reviewed within 48 hours prior to dose 
administration.
!
Full serum chemistry (includes core chemistry) and core serum chemistry will be assessed 
prior to trial treatment according to Table 1.  Samples for core chemistry results must be 
drawn and reviewed within 48 hours prior to dose administration.
!
Serum electrophoresis at Week 13 (Visit 10).
!
A basic urinalysis will be performed prior to trial treatment as detailed in Table 1.
!
A serum β-HCG pregnancy test will be required at Screening, urine or serum β-HCG 
pregnancy test will be performed prior to each administration of the study drug every 
4 weeks (if applicable). If necessary to confirm postmenopausal status, an FSH will be 
drawn at Screening.
!
The tumor evaluation (see Section 7.3) will be performed at Week 7, and then once every 
6 weeks, with a tumor assessment visiting time window of 5 days prior to dosing.
!
PK samples will be drawn as detailed in Table 3. 
!
Free T4 and TSH will be measured prior to trial treatment according to Table 1.
!
ADA samples will be drawn as detailed in Table 3.  The term for ADA on the CRF is 
human antihuman antibodies (HAHA)
!
Soluble factors will be drawn as detailed in Table 3 and as described in Section 7.6.1.2.
!
Samples for TGFβ determination will be drawn as detailed in Table 3.
!
Blood samples for gene expression evaluation will be collected according to Table 3 (prior 
to IMP administration where applicable).
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
101/167
!
For subjects undergoing the optional Week 7 biopsy, the biopsy should be performed 
within 7 days after the Week 7 IMP administration (Table 3).
7.1.2.2
Expansion Part Treatment Period
During the treatment period, the following assessments will be performed (see Table 2 and Table 3
for the detailed schedule):
!
For subjects in the GC, ESCC, and BTC expansion cohorts only, patient-reported outcome 
questionnaires (PGIS, EORTC QLQ-C30, EORTC QLQ-BIL21, EORTC QLQ-HCC18, 
EORTC QLQ-OES18, and EORTC QLQ-STO22) will be completed prior to any 
study-related procedures as indicated in Table 2.
!
AEs and concomitant medications will be documented in each study visit.
!
ECOG PS will be assessed prior to trial treatment on Day 1 (unless the Screening ECOG 
PS was performed within 3 days prior to Day 1) and according to Table 2 thereafter.
!
Any new concomitant procedures will be documented in each study visit. For any biopsies 
or other procedures resulting in tissue acquisition, official pathology reports must be filed 
and available for review if requested.
!
Physical examination will be performed prior to trial treatment on Day 1 (Week 1).  After 
Day 1, a directed physical examination indicated by subject’s symptoms will be performed
according to Table 2.
!
At each visit, eye signs and symptoms should be checked.  If clinically relevant findings, 
then an appropriate ophthalmology examination (including slit lamp evaluation inclusive 
of the anterior segment and with visual acuity) should be obtained within 2 days.
!
Dermatological assessment.
!
SpO2 will be measured.
!
Vital signs, including body weight, will be assessed prior to trial treatment according to
Table 2.
!
12-lead ECG will be assessed prior to and as soon as possible after infusion according to 
Table 2.
!
The laboratory hematology and hemostaseology tests will be assessed according to Table 2.  
Complete blood count results must be drawn and reviewed within 48 hours prior to dose 
administration. For subjects experiencing signs of anemia including, but not limited to, a 
significant drop in Hgb value (especially Hgb < 8 g/dL), routine monitoring of Hgb, red 
blood cells, and hematocrit should be performed weekly.  
!
Full serum chemistry (includes core chemistry) and core serum chemistry will be assessed 
prior to trial treatment according to Table 2.  Samples for core chemistry results must be 
drawn and reviewed within 48 hours prior to dose administration. 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
102/167
!
A basic urinalysis will be performed prior to trial treatment as detailed in Table 2.
!
A serum β-HCG pregnancy test will be required at Screening, urine or serum β-HCG 
pregnancy test will be performed prior to each administration of the study drug every 
4 weeks (if applicable).  If necessary to confirm postmenopausal status, an FSH will be 
drawn at Screening.
!
The tumor evaluation (see Section 7.3) will be performed at Week 7, and then once every 
6 weeks, with a tumor assessment visiting time window of 5 days prior to dosing.
!
Tumor biopsies at Week 7 (Days 43 to 50, see Table 3).
!
PK samples will be drawn as detailed in Table 3.
!
Free T4 and TSH will be measured prior to trial treatment according to Table 2.
!
ADA samples will be drawn as detailed in Table 3.  The term for ADA on the CRF is 
human antihuman antibodies (HAHA).
!
Soluble factors will be drawn as detailed in Table 3 and as described in Section 7.6.1.2.
!
Samples for TGFβ determination will be drawn as detailed in Table 3.
!
Samples will be collected for viral load testing (HBV, HCV) and AFP from subjects in the 
HCC cohort as detailed in Table 3.
!
Blood samples for gene expression evaluation will be collected according to Table 3 (prior 
to study drug administration where applicable).
7.1.3
Rechallenge
One re-initiation course of treatment at the same dose and schedule and treatment duration up to 
12 months is allowed at the discretion of the Investigator and agreement of the Medical 
Responsible for the following:
!
Participants who are experiencing stable disease, a PR, or CR at the time of discontinuation, 
and then subsequently develop disease progression after stopping therapy, but prior to the 
end of the study.
OR
!
Participants who are discontinued due to an AE that are subsequently well managed or
resolved after stopping therapy, but prior to the end of the study.
Prior to re-initiation, the Investigator will need to confirm that the benefit of re-initiating treatment 
outweighs any risk involved, such as that which led to initial treatment discontinuation. For 
participants with only stable disease at the time of discontinuation, the Investigator should confirm 
that no other reasonable treatment options are available. In addition, to be eligible for re-initiation, 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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the participant must not have previously withdrawn consent for this trial and should have been 
followed up with regular eCRF documented evaluation scans up to re-initiation of treatment.
Prior to re-initiation of the study intervention, malignant disease must be radiologically restaged 
within 28 days of dosing to assess all known disease sites. Additionally, relevant safety laboratory 
assessments, including both full hematology and full chemistry results within 2 weeks, must be 
available and verified. The clinical Investigator will determine whether additional evaluation and 
work up are required on a case-by-case basis.
Participants who re-initiate treatment should stay on study and should be treated and monitored 
according the Schedule of Activities for the rest of the study.
7.1.4
End-of-Treatment
7.1.4.1
Discontinuation Visit
Any subject who experiences an AE that mandates discontinuation of trial treatment should have 
a discontinuation visit within 7 days after the decision to discontinue trial treatment (see Table 1
and Table 2).  For all these subjects, the discontinuation visit consists of:
!
Documentation of AEs and concomitant medications.
!
Physical examination including vital signs and body weight.
!
Dermatological assessment.
!
SpO2 will be measured.
!
Laboratory hematology, hemostaseology, full serum chemistry, and basic urinalysis.
!
ECOG PS will be assessed.
7.1.4.2
End-of-Treatment Visit
The End-of-Treatment visit is scheduled 4 weeks (28±5 days) after the last administration of 
MSB0011359C but before any new therapy is started, if possible, whichever occurs earlier.  The 
End-of-Treatment visit will comprise a full assessment for safety, immunogenicity, and tumor 
response as appropriate, which will include the following (refer to Table 1, Table 2, and Table 3):
! For subjects in the GC, ESCC, and BTC expansion cohorts only, patient-reported outcome 
questionnaires (PGIS, EORTC QLQ-C30, EORTC QLQ-BIL21, EORTC QLQ-HCC18, 
EORTC QLQ-OES18, and EORTC QLQ-STO22) will be completed prior to any study-related 
procedures as indicated in Table 2.
! AEs, concomitant medications.
! Vital signs and body weight.
! Physical examinations.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
104/167
! Dermatological assessment.
! SpO2 will be measured.
! 12-lead ECG will be assessed.
! The laboratory hematology, hemostaseology, full serum chemistry, serum electrophoresis tests
(for dose escalation part only), and full urinalysis.
! ECOG PS will be assessed.
! Urine β-HCG pregnancy test (in females of childbearing potential).
! Tumor evaluation (only to be performed, if no disease progression was documented previously).
! Free T4 and TSH.
! PK sample.
!
ADA sample (see Section 7.7.1).  The term for ADA on the CRF is human antihuman 
antibodies (HAHA)
!
Soluble factors will be drawn as described in Section 7.6.1.2 and Table 3.
!
Samples for TGFβ determination as described in Table 3.
!
Blood samples for gene expression evaluation for subjects with PD.
!
Samples for viral load testing (HBV, HCV) and AFP (for HCC cohort only).
!
If the therapy is discontinued due to regrowth of the tumor, then a repeat biopsy at the end 
of treatment is advisable (optional). A PK sample should be collected as close as possible 
to the time of the biopsy (ie, same day).
7.1.5
Post-Treatment Follow-up
7.1.5.1
Safety Follow-up Visit
All subjects will have a subsequent visit scheduled 10 weeks (±2 weeks) after the last 
administration of MSB0011359C.  The visit will include the following full assessment of safety 
parameters (refer to Table 1, Table 2, and Table 3):
! For subjects in the GC, ESCC, and BTC expansion cohorts only, patient-reported outcome 
questionnaires (PGIS, EORTC QLQ-C30, EORTC QLQ-BIL21, EORTC QLQ-HCC18, 
EORTC QLQ-OES18, and EORTC QLQ-STO22) will be completed prior to any study-related 
procedures as indicated in Table 2.
! AEs that are deemed attributable to trial drug by the Investigator and concomitant medications 
(including further anticancer therapy) will be documented.
! Vital signs and body weight will be measured.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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! Physical examination will be performed.
! Dermatological assessment.
! SpO2 will be measured.
! ECOG PS will be assessed.
! 12-lead ECG will be assessed.
! Laboratory testing consisting of the following will be assessed:
o Hematology, hemostaseology, full serum chemistry, and full urinalysis
o Free T4, and TSH levels.
!
PK sample will be collected.
!
ADA sample.  The term for ADA on the CRF is human antihuman antibodies (HAHA)
!
Samples for viral load testing (HBV, HCV; HCC cohort only).
! A urine β-HCG pregnancy test (in women of child bearing potential) will be conducted.
7.1.5.2
Long-term Follow-up/Trial Termination
All SAEs ongoing at the End-of-Treatment visit must be monitored and followed up by the 
Investigator until stabilization or until the outcome is known, unless the subject is documented as 
“lost to follow-up” or started a new anticancer therapy. In addition, all trial drug-related SAEs 
occurring after End-of-Treatment visit and ongoing at the Safety Follow-up visit have to be 
followed up in the same manner.
Subjects without PD at the End-of-Treatment visit will be followed up for disease progression 
(CT/MRI scans every 12 weeks) until PD. 
After the End-of-Treatment visit, subjects will be followed quarterly (±14 days) for survival 
(including assessment of any further tumor therapy).  The survival follow-up will continue until 
1 year after the last subject receives the last dose of MSB0011359C.
After completion of the Follow-up period or at discontinuation of the trial, whatever is 
applicable / comes first, the appropriate eCRF section for Trial Termination must be completed.
7.1.6
Blood Consumption for Clinical Assessments
The overall amount of blood to be drawn from a single subject must not exceed 60 mL/day and 
300 mL in an 8-week period for safety laboratory testing, pregnancy testing, PK analyses, 
 and antibody evaluation.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
106/167
7.2
Demographic and Other Baseline Characteristics
The assessments and procedures described in this section must be performed during the Screening 
period.
7.2.1
Demographic Data
The following demographic data will be recoded:
!
Subject identifier
!
Date of birth
!
Sex
!
Ethnicity
!
Race.
7.2.2
Diagnosis of Tumor
The tumor disease information that will be documented and verified at the Screening visit for each 
subject includes:
!
Detailed history of the tumor, including histopathological diagnosis, grading and staging 
in accordance with the Union Internationale Contre le Cancer Tumor Node Metastasis 
Classification at diagnosis.
!
All therapy used for prior treatment of the tumor (including surgery, radiotherapy and 
chemotherapy, immunotherapy, etc).
!
Any other conditions that were treated with chemotherapy, radiation therapy, or 
immunotherapy.
!
Current cancer signs and symptoms and side effects from current and/or previous 
anticancer treatments.
!
Current cancer disease status.
7.2.3
Medical History
In order to determine the subject’s eligibility to the trial, a complete medical history of each subject 
will be collected and documented during Screening, which will include, but may not be limited to, 
the following:
!
Past and concomitant non-malignant diseases and treatments.
!
All medications taken and procedures carried out within 30 days prior to Screening.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
107/167
For the trial entry, all the subjects must fulfill all inclusion criteria described in Section 5.3.1, and 
none of the subjects should have any exclusion criterion from the list described in Section 5.3.2.
7.2.4
Vital Signs and Physical Examination
Vital signs including body temperature, respiratory rate, heart rate (after 5-minute rest), and arterial 
blood pressure (after 5-minute rest), body weight and height will be recorded at study entry.
A complete physical examination will be performed.  Oxygen saturation will be measured.  An 
ophthalmology examination including slit lamp evaluation inclusive of the anterior segment and 
with visual acuity should be conducted.
The ECOG PS will be documented during the Screening period.
7.2.5
Computed Tomography or Magnetic Resonance Imaging
Scans for Tumor Assessment at Baseline
A CT scan or MRI (if MRI is used, CT of chest is mandatory) of the chest, abdomen, and pelvis 
(at a minimum and other established assessments of tumor burden if CT/MRI imaging is not 
sufficient for the individual subject; other regions as specifically required for specific tumor 
indications) will be performed within 28 days prior to trial treatment start in order to document the 
baseline status of the tumor disease using RECIST 1.1 target and nontarget lesions and secondarily 
using mRECIST for subjects in the HCC cohort (see vendor manual).  However, if the results of a 
CT scan or MRI performed within 4 weeks prior to first treatment are available, the Screening 
CT/MRI does not need to be performed.
A brain CT/MRI scan (either, contrast preferred) is required at Screening if not performed within 
the previous 6 weeks.  Thereafter, brain CT/MRI scan should be done if clinically indicated by 
development of new specific symptoms.
A bone scan should be done at Screening as clinically indicated.
7.2.6
Cardiac Assessments
A 12-lead ECG will be recorded at Screening.  The ECG will be recorded under institution’s 
guidance after the subject has been in a supine position breathing quietly for 5 minutes.  The ECG 
results will be used to evaluate the heart rate, atrial-ventricular conduction, QR, QT, RR duration
and corrected QT intervals, and possible arrhythmias.
The ECGs will be documented by recording date and time of collection.  All ECG results must be 
reviewed at the site by the Investigator or a medically qualified designee for clinical management 
of the subject. 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
108/167
The Investigator will judge the overall interpretation as normal or abnormal.  If abnormal, it will 
be decided if the abnormality is clinically significant or not clinically significant and the reason 
for the abnormality will be recorded on the eCRF.  Abnormal values will not be recorded as AEs 
unless they are the reason for discontinuation of the trial IMP due to AEs or are SAEs.
7.2.7
Clinical Laboratory Tests
Blood samples will be collected at Screening for clinical laboratory parameter evaluations.  These 
clinical laboratory test results will serve not only as the baseline values for subsequent safety 
clinical laboratory evaluations during the trial, but also help to make sure that each enrolled subject 
fulfills all the trial entry criteria as listed in Section 5.3.1 and does not meet any of the trial 
exclusion criteria for laboratory parameters as listed in Section 5.3.2.  Detailed description of 
laboratory assessments is provided in Section 7.4.3.
7.3
Efficacy Assessments
For all subjects in all cohorts, tumor response assessment will be performed by CT scan or MRI 
(if MRI is used, CT of chest is mandatory; for subjects in the HCC cohort, contrast is mandatory) 
imaging of the chest/abdomen/pelvis (plus other regions as specifically required for specific tumor 
types) and other established assessments of tumor burden if CT/MRI imaging is insufficient for 
the individual subject.  All the scans performed at Baseline and other imaging performed as 
clinically required (other supportive imaging) need to be repeated at subsequent visits.  In general, 
lesions detected at Baseline need to be followed using the same imaging methodology and 
preferably the same imaging equipment at subsequent tumor evaluation visits.
A brain CT/MRI scan (either, with contrast preferred) is required at Screening if not performed 
within the previous 6 weeks.  Thereafter brain CT/MRI scan should be performed, if clinically 
indicated by development of new specific symptoms.  A bone scan should be performed at 
Screening and beyond as clinically indicated.  Skin metastasis can be used as target lesions 
according to RECIST 1.1 using measurements by caliper, if they fulfill RECIST 1.1 for target 
lesions as described below.  The presence of new cutaneous lesions will be considered diagnostic 
of progression for RECIST 1.1, even if not imaged.  For each subject, the Investigator will 
designate 1 or more of the following measures of tumor status to follow for determining response:  
CT or MRI images of primary and/or metastatic tumor masses, physical examination findings, and 
the results of other assessments.  All available images collected during the trial period will be 
considered.  The most appropriate measures to evaluate the tumor status of a subject should be 
used.  The measure(s) to be chosen for sequential evaluation during the trial have to correspond to 
the measures used to document the progressive tumor status that qualifies the subject for 
enrollment.  The tumor response assessment will be assessed and listed according to the Schedule 
of Assessments (refer to Table 1 and Table 2).
The foreseen treatment duration is until disease progression verified by a scan subsequent to the 
initial documentation of PD, unacceptable toxicity, or any criterion for withdrawal from the trial 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
109/167
or IMP occurs (see Section 5.5). Before stopping the treatment, PD should be confirmed by 
imaging 4 to 6 weeks (preferably 6 weeks, but not later) after progression has been diagnosed 
according to RECIST 1.1.  If progression is based on the occurrence of a new lesion in an area not 
scanned at Baseline, a further on-study scan 6 weeks later should be considered before performing 
the End-of-Treatment visit.  Treatment may be continued despite progression according to 
RECIST 1.1 at any time if:
!
There are no new symptoms or worsening of existing symptoms.
!
There is no decrease in ECOG PS.
!
The Investigator does not consider it necessary to administer a salvage therapy.
The treatment should be stopped immediately, if the subject does not tolerate MSB0011359C 
anymore or if therapeutic failure occurs, which requires urgent treatment with an additional drug 
or results in clinically significant progression/deterioration.
Tumor responses to treatment will be assigned based on the evaluation of the response of target, 
nontarget, and new lesions according to RECIST 1.1 (all measurements should be recorded in 
metric notation) and secondarily using mRECIST for subjects in the HCC cohort.
!
To assess objective response, the tumor burden at baseline will be estimated and used for 
comparison with subsequent measurements. At baseline, tumor lesions will be categorized 
in target and nontarget lesions according to RECIST 1.1 and secondarily using mRECIST 
for subjects in the HCC cohort.
Results for these evaluations will be recorded with as much specificity as possible so that pre- and 
post-treatment results will provide the best opportunity for evaluating tumor response.
Any CR or PR should be confirmed according to RECIST 1.1.  In the case of a PR or CR, a 
confirmatory CT or MRI scan must be done no sooner than 4 weeks (preferably at the scheduled 
6-week interval).
The Investigator may perform scans in addition to a scheduled trial scan for medical reasons or if 
the Investigator suspects PD.
As outlined in Section 5.1, treatment should continue with the investigational drug and the subject 
may remain on study according to the Investigator’s decision and in agreement with the subject in 
case of PD according to RECIST 1.1.  Following PD on RECIST 1.1, modified “immune-related 
response criteria” (irRC; see below and Nishino 2013) should be used as guidance for further 
clinical care.
Subjects who have experienced a CR, PR or SD should continue treatment through the end of 
12 months after confirmation, although additional treatment is possible.  If the Investigator
believes that a subject may benefit from treatment beyond 12 months, it may be permissible after 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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discussion with the Medical Monitor.  Subjects re-initiating treatment should be assessed 
according to the Schedule of Assessments (Table 1 and Table 2).
7.3.1
Modified Immune-related Response Criteria, Derived from 
RECIST 1.1
This new classification is based on the recent learning from clinical studies with cancer 
immunotherapies that even if some new lesions appear at the beginning of a treatment or if the 
total tumor burden does not increase substantially, tumor regressions or stabilizations might still 
occur later.  For this trial, the concepts of the irRC (Nishino 2013) are combined with RECIST 1.1 
to come up with the modified irRC, which uses unidimensional measurements.
For modified irRC, only target and measurable lesions are taken into account.  In contrast to the 
RECIST 1.1, the modified irRC criteria
a) require confirmation of both progression and response by imaging at 4 to 6 weeks (preferably 
6 weeks) after initial imaging, and
b) do not necessarily score the appearance of new lesions as PD if the sum of lesion diameters of 
target lesions (minimum of 10 mm per lesion, maximum of 5 target lesions, maximum of 2 per 
organ) and measurable new lesions does not increase by ≥20%.
The same method of assessment and the same technique should be used to characterize each 
identified and reported target lesion(s) at Baseline, during the trial, and at the End-of-Treatment 
visit.  All measurements should be recorded in metric notation.  The modified irRC based on 
RECIST 1.1 are displayed below.
Modified irRC are defined as follows:
!
New measurable lesions:  Incorporated into tumor burden.
!
New non-measurable lesions:  Do not define progression but precludes immune-related 
complete response (irCR).
Overall irCR:  Complete disappearance of all lesions (whether measurable or not) and no new 
lesions.  All measurable lymph nodes also must have a reduction in short axis to 10 mm or less.
Overall immune-related partial response (irPR):  Sum of the longest diameters of target and 
new measurable lesions decreases ≥30%.
Overall immune-related stable disease (irSD):  Sum of the longest diameters of target and new 
measurable lesions neither irCR, irPR, (compared to baseline) or immune-related progressive 
disease (irPD; compared to nadir).
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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Overall immune-related progressive disease (irPD):  Sum of the longest diameters of target and 
new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive 
observations at least 4 weeks (normally it should be done at 6 weeks) from the date first 
documented.
Documentation of irPD (based on modified irRC) does not mandate discontinuation of the trial 
treatment, even after irPD is confirmed with CT scan 6 weeks after the initial observation of irPD.  
Please refer to Section 5.5.1 (Withdrawal from the Trial Treatment) to determine when it is 
appropriate to discontinue treatment with the study drug.
Overall responses derived from changes in index, non-index, and new lesions are shown in Table 6.
Table 6
Overall Responses Derived from Changes in Index, Non-Index, and New 
Lesions
Measurable Response
Non-Measurable Response
Overall Response 
Using Modified irRC
Index and New, Measurable 
Lesions (Tumor Burden) 
Non-Index Lesions
New, Non-Measurable 
Lesions
Decrease 100%
Absent
Absent
irCRa
Decrease 100%
Stable
Any
irPRa
Decrease 100%
Unequivocal progression
Any
irPRa
Decrease ≥30%
Absent/Stable
Any
irPRa
Decrease ≥30%
Unequivocal progression
Any
irPRa
Decrease < 30% increase < 20%
Absent/Stable
Any
irSD
Decrease < 30% to increase < 20%
Unequivocal progression
Any
irSD
Increase ≥20%
Any
Any
irPD
irCR=immune-related complete response; irPD=immune-related progressive disease; irPR=immune-related partial 
response; irSD=immune-related stable disease.
a
Assuming that the response (irCR and irPR) and progression (irPD) are confirmed by a second, consecutive assessment at least 
4 weeks apart (normally it should be done 6 weeks apart).
7.3.2
Modified Response Evaluation Criteria in Solid Tumors for 
Hepatocellular Carcinoma
The text below was obtained from Lencioni 2010.
SUMMARY OF THE mRECIST ASSESSMENT OF RESPONSE: STANDARDIZING 
RESPONSE ASSESSMENT
1. Image Acquisition
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The administration of intravenous contrast is recommended for all CT or MRI studies if not 
medically contraindicated.  In contrast-enhanced studies, it is mandatory to obtain a dual-phase 
imaging of the liver.  Every effort should be made to time the contrast administration so that 
high-quality arterial-phase imaging is obtained throughout the liver on the first run, and 
high quality portal venous-phase imaging is obtained throughout the liver on the second run.
2. Image Interpretation
To properly use the proposed mRECIST for HCC to assess response rates and time to progression 
in HCC clinical trials and to ensure comparability across studies, uniform image acquisition 
parameters, rigorous quality control, and independent blinded multireader assessments are 
mandatory.
3. Assessment of Tumor Lesion at Baseline
To be selected as a target lesion using mRECIST, a HCC lesion should meet all the following 
criteria:
!
The lesion can be classified as a RECIST measurable lesion (that is, the lesion can be 
accurately measured in at least one dimension as 1 cm or more).
!
The lesion is suitable for repeat measurement.
!
The lesion shows intratumoral arterial enhancement on contrast-enhanced CT or MRI.
It is important to point out that only well-delineated, arterially enhancing lesions can be selected 
as target lesions for mRECIST.
DEFINING TREATMENT RESPONSE AND TUMOR PROGRESSION
1. Target Lesion Response
The mRECIST for HCC has introduced the following amendments to RECIST in the determination 
of tumor response for target lesions, which are summarized in Table 7.
Table 7
Assessment of Target Lesion Response: 
Conventional RECIST and 
mRECIST Assessment for Hepatocellular Carcinoma Following the American 
Association for the Study of Liver Disease-Journal of the National Cancer 
Institute Guideline
Assessment 
RECIST 
mRECIST for HCC
Complete response
Disappearance of all target lesions
Disappearance of any intratumoral arterial 
enhancement in all target lesions
Partial response
At least a 30% decrease in the sum of 
diameters of target lesions, taking as 
reference the baseline sum of the diameters 
At least a 30% decrease in the sum of 
diameters of viable (enhancement in the 
arterial phase) target lesions, taking as 
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Assessment 
RECIST 
mRECIST for HCC
of target lesions
reference the baseline sum of the 
diameters of target lesions
Stable disease
Any cases that do not qualify for either 
partial response or progressive disease
Any cases that do not qualify for either 
partial response or progressive disease
Progressive disease
An increase of at least 20% in the sum of the 
diameters of target lesions, taking as 
reference the smallest sum of the diameters 
of target lesions recorded since treatment 
started
An increase of at least 20% in the sum of 
the diameters of viable (enhancing) target 
lesions, taking as reference the smallest 
sum of the diameters of viable 
(enhancing) target lesions recorded since 
treatment started
HCC=hepatocellular carcinoma; mRECIST=modified Response Evaluation Criteria in Solid Tumors.
2. Nontarget Lesion Response
According to mRECIST for HCC, tumor necrosis should be taken into account when assessing the 
response of nontarget lesions. 
The disappearance of intratumoral arterial enhancement in 
nontarget lesions should be considered equivalent to the disappearance of nontarget lesions, and 
therefore, should declare complete response of nontarget lesions. The persistence of intratumoral 
arterial enhancement in one or more nontarget lesions should be considered equivalent to 
persistence of one or more nontarget lesions, and therefore, should declare incomplete 
response/stable disease. 
The appearance of one or more new lesions and/or unequivocal 
progression of existing nontarget lesions should declare progressive disease.
Special recommendations for the assessment of tumor response in nontarget lesions in patients 
with HCC and cirrhosis can be made regarding the following points:
!
Portal vein thrombosis: 
Malignant portal vein thrombosis should be considered a 
non-measurable lesion due to the difficulty in performing consistent measurements of the 
malignant thrombus during the course of the treatment.
!
Porta hepatis lymph node: Lymph nodes detected at the porta hepatis can be considered as 
malignant if the lymph node short axis is at least 20 mm.
!
Pleural effusion and ascites: The mRECIST for HCC emphasizes that cytopathologic 
confirmation of the neoplastic nature of any effusion (particularly ascites) that appears or 
worsens during treatment is required when the measurable tumor has met criteria for 
response or stable disease.
3. New Lesions
In the assessment of tumor progression, these concepts have been adopted by the mRECIST 
assessment proposal, considering some specificities for the frame of progression mode:
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!
A newly detected hepatic nodule will be classified as HCC – and therefore will be declared 
as evidence of progression – when its longest diameter is at least 1 cm and the nodule 
shows the typical vascular pattern of HCC on dynamic imaging, that is, 
hypervascularization in the arterial phase with washout in the portal venous or late venous 
phase.
!
Liver lesions larger than 1 cm that do not show a typical vascular pattern can be diagnosed 
as HCC by evidence of at least 1-cm-interval growth in subsequent scans.
!
An individual radiologic event will be adjudicated in retrospect as progression at the time 
it was first detected by imaging techniques, even if strict criteria were fulfilled only on 
subsequent radiologic testing.
OVERALL RESPONSE ASSESSMENT
Any newly detected focal liver lesion that does not meet the criteria reported above should be 
considered equivocal and not conclusive for disease progression.
7.4
Assessment of Safety
The safety profile of the IMP will be assessed through the recording, reporting and analyzing of 
baseline medical conditions, AEs, physical examination findings including vital signs and eyes 
signs and symptoms, and laboratory tests.
Comprehensive assessment of any apparent toxicity experienced by each subject will be performed 
from the time of giving informed consent and throughout the trial.  The Investigator will report 
any AEs, whether observed by the Investigator or reported by the subject (see Section 7.4.1.2).  
Given the intended MoA, particular attention will be given to AEs that may follow the enhanced 
T-cell activation such as persistent rash, diarrhea and colitis, autoimmune hepatitis, arthritis, 
glomerulonephritis, cardiomyopathy, uveitis and other inflammatory eye conditions, or other 
immune-related reactions.  Ophthalmologic examinations should be considered, when clinically 
indicated, for signs or symptoms of uveitis.  Furthermore, due to the anti-TGFβ activity, particular 
attention will also be given to events associated with, anemia, and
rash with 
hyperkeratosis/keratoacanthoma and squamous cell carcinoma of the skin.
The reporting period for AEs is described in Section 7.4.1.3.
The safety assessments will be performed according to the Schedules of Assessments (see Table 1
and Table 2).
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7.4.1
Adverse Events
7.4.1.1
Adverse Event Definitions
Adverse Event
An AE is any untoward medical occurrence in a subject or clinical investigation subject 
administered a pharmaceutical product, regardless of causal relationship with this treatment.  An 
AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal product, whether 
or not considered related to the medicinal product.
For surgical or diagnostic procedures, the condition/illness leading to such a procedure is 
considered as the AE rather than the procedure itself.
In case of a fatality, the cause of death is considered as an AE, and the death is considered as its 
OUTCOME.
The Investigator is required to grade the severity or toxicity of each AE.
Investigators will reference the NCI-CTCAE v4.03 (publication date: 14 June 2010), a descriptive 
terminology that can be used for AE reporting.
A general grading (severity/intensity; hereafter referred to as severity) scale is provided at the 
beginning of the above referenced document, and specific event Grades are also provided.
If a particular AE’s severity is not specifically graded by the guidance document, the Investigator
is to use the general NCI-CTCAE definitions of Grade 1 through Grade 5 following his or her best 
medical judgment.
Grade 1:
Mild
Grade 2:
Moderate
Grade 3:
Severe
Grade 4:
Life-threatening or disabling
Grade 5:
Death related to AE*
According to the Sponsor’s convention, any clinical AE with severity of Grade 4 or 5 must also 
be reported as an SAE as per Section 7.4.1.4; however, a laboratory abnormality of Grade 4, such 
as anemia or neutropenia, is considered serious only if the condition meets one of the serious 
criteria described below.
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*Note:  Death (Grade 5 as defined by NCI-CTCAE Version 4.0) is mainly regarded as an outcome, 
to be documented as described below.
If death occurs, the primary cause of death or the event leading to death should be recorded and 
reported as an SAE.  “Fatal” will be recorded as the outcome of this specific event and death will 
not be recorded as separate event.  Only, if no cause of death can be reported (eg, sudden death, 
unexplained death), the death per se might then be reported as an SAE.
Investigators must also systematically assess the causal relationship of AEs to the IMP using the 
following definitions.  Decisive factors for the assessment of causal relationship of an AE to the 
MSB0011359C include, but may not be limited to, temporal relationship between the AE and the 
MSB0011359C, the known safety profile of MSB0011359C, medical history, concomitant 
medication, course of the underlying disease, trial procedures.
Unrelated:
Not suspected to be reasonably related to the IMP.  The AE could not medically 
(pharmacologically/clinically) be attributed to the IMP under study in this clinical 
trial protocol.  A reasonable alternative explanation must be available.
Related:
Suspected to be reasonably related to the IMP.  The AE could medically 
(pharmacologically/clinically) be attributed to the IMP under study in this clinical 
trial protocol. 
Abnormal Laboratory Findings and Other Abnormal Investigational Findings
Abnormal laboratory findings and other abnormal investigational findings (eg, on an ECG trace) 
should not be reported as AEs unless they are associated with clinical signs and symptoms, lead to 
treatment discontinuation or are considered otherwise medically important by the Investigator.  If 
a laboratory abnormality fulfills these criteria, the identified medical condition (eg, anemia, 
increased ALT) must be reported as the AE rather than the abnormal value itself.
7.4.1.1.1
Adverse Drug Reaction
An ADR is defined in this trial as any AE assessed as related to MSB0011359C by the Investigator
and/or Sponsor.
7.4.1.1.2
Serious Adverse Event
An SAE is any untoward medical occurrence that at any dose:
!
Results in death.
!
Is life-threatening (NOTE: The term “life-threatening” in this definition refers to an event 
in which the subject is at risk of death at the time of the event; it does not refer to an event 
that hypothetically might cause death if it were more severe).
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!
Requires inpatient hospitalization or prolongation of existing hospitalization.
!
Results in persistent or significant disability/incapacity.
!
Is a congenital anomaly/birth defect.
!
Is otherwise considered as medically important.
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered as SAEs when, based upon appropriate medical judgment, they may jeopardize 
the subject or may require medical or surgical intervention to prevent one of the outcomes listed 
in this definition. Examples of such events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse.  Any type of new 
(secondary) cancer including squamous cell cancer of the skin should be considered as medically 
important condition.
For the purposes of reporting, any suspected transmission of an infectious agent via the IMP is 
also considered an SAE, and all such cases should be reported in an expedited manner as described 
in Section 7.4.1.4.
Events that Do Not Meet the Definition of an SAE
Elective hospitalizations to administer, or to simplify trial treatment or trial procedures (eg, an 
overnight stay to facilitate chemotherapy and related hydration therapy application) are not 
considered SAEs. However, all events leading to unplanned hospitalizations or unplanned 
prolongation of an elective hospitalization (eg, undesirable effects of any administered treatment) 
must be documented and reported as SAEs.
7.4.1.1.3
Events Not to Be Considered as AEs/SAEs
Medical conditions present at the initial trial visit that do not worsen in severity or frequency during 
the study are defined as Baseline Medical Conditions, and are NOT to be considered AEs.
AE/SAEs Observed in Association with Disease Progression
Disease progression recorded in the course of efficacy assessments only, but without any adverse 
signs or symptoms should not be reported as AEs.
However, if adverse signs or symptoms occur in association with disease progression then these 
should be recorded as AEs or reported as SAEs, if they meet criteria for seriousness.
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MS200647-0008
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7.4.1.1.4
Pre-defined AEs of Special Interest (AESI) for Safety 
Monitoring
Any AE that is suspicious to be a potential irAE (see Section 6.5.4.3), including ophthalmologic 
findings, has to be reported in an expeditious manner and will be considered an AESI.
Infusion-related reactions/hypersensitivity, regardless of grade, must be reported as AESIs.
In addition, rash with hyperkeratosis/keratoacanthoma/squamous cell cancer of the skin are 
regarded as AESIs.  Please note that squamous cell cancer of the skin should be considered as 
medically important condition and thus as a serious AESI, which has to be reported in an expedited 
manner as a SAE.
Anemia suspected by the Investigator to be drug related should also be reported as an AESI.
The reporting of AESI is defined in Section 7.4.1.4.
7.4.1.2
Methods of Recording and Assessing Adverse Events
At each trial visit, the subject will be queried on changes in his or her condition.  During the 
reporting period, any unfavorable changes in the subject’s condition will be recorded as AEs, 
whether reported by the subject or observed by the Investigator.
Complete, accurate, and consistent data on all AEs experienced for the duration of the reporting 
period (defined below) will be reported on an ongoing basis in the appropriate section of the eCRF.  
All SAEs and all nonserious AEs of special interest must be additionally documented and reported 
using the appropriate SAE Report Form or the AESI Report Form, respectively as described in 
Section 7.4.1.4.
It is important that each AE report include a description of the event, its duration (onset and 
resolution dates and times to be completed when it is important to assess the time of AE onset 
relative to the recorded treatment administration time), its severity, its causal relationship with the 
trial treatment, any other potential causal factors, any treatment given or other action taken, 
including dose modification or discontinuation of the IMP, and its outcome.  In addition, serious 
cases should be identified and the appropriate seriousness criteria documented.  If an AE 
constitutes a DLT, this has to be documented accordingly.
Specific guidance can be found in the eCRF Completion and Monitoring Conventions.
7.4.1.3
Definition of the Adverse Event Reporting Period
The AE reporting period for safety surveillance begins when the subject is included into the trial 
(date and time of first signature of informed consent) and continues through the trial’s 
End-of-Treatment visit, defined as 28 days (±5 days)  after last trial drug administration.  After the 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
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End-of-Treatment visit, only AEs that are deemed attributable to trial drug by the Investigator
should be documented until the Safety Follow-up visit, defined as 10 weeks (± 2 weeks) after the 
last trial drug administration. 
Any SAE assessed as related to MSB0011359C must be reported whenever it occurs, irrespective 
of the time elapsed since the last administration of MSB0011359C.
7.4.1.4
Procedure for Reporting Serious Adverse Events, Adverse 
Events of Special Interest
Serious Adverse Events
In the event of any new SAE occurring during the reporting period, the Investigator must 
immediately (within a maximum 24 hours after becoming aware of the event) inform the Sponsor 
or its designee using the SAE Report Form following specific completion instructions.
In exceptional circumstances, a SAE (or follow-up information) may be reported by telephone; in 
these cases, SAE Report Form must be provided immediately thereafter.
Reporting procedures and timelines are the same for any new information on a previously reported 
SAE (= follow-up).
Relevant pages from the eCRF may be provided in parallel (eg, medical history, concomitant 
drugs).  Additional documents may be provided by the Investigator, if available (eg, laboratory 
results, hospital report, and autopsy report).  In all cases, the information provided on the SAE 
Report Form must be consistent with the data about the event recorded in the eCRF.
The Investigator/reporter must respond to any request for follow-up information (eg, additional 
information, outcome, final evaluation, other records where needed) or to any question the Sponsor 
may have on the AE within the same timelines as initial reports.  This is necessary to ensure a 
prompt assessment of the event by the Sponsor or designee and, where applicable, to allow the 
Sponsor to meet strict regulatory timelines associated with expedited safety reporting obligations.
Requests for follow-up will usually be made by the responsible Medical Monitor. In exceptional 
cases where a particularly critical event occurs, the Global Drug Safety department may contact 
the Investigator directly to obtain further information or to discuss the event.
Adverse Events of Special Interest
In the event of a nonserious AESI, the Investigator must complete the AESI Report Form and 
provide it to the Sponsor/designee immediately (within 24 hours) following the specific 
completion instructions.  Serious AESIs have to be reported in an expedited manner as SAEs as 
outlined above.
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Dose-Limiting Toxicities
Each event meeting the criteria of a DLT (see Section 5.1.3.3) has to be recorded in the eCRF 
within 24 hours after becoming aware of the event.  Serious DLTs have to be reported in an 
expedited manner as SAEs as outlined above.
7.4.1.5
Safety Reporting to Health Authorities, Institutional Review 
Boards and Investigators
The Sponsor will send appropriate safety notifications to Health Authorities in accordance with 
applicable laws and regulations.
The Investigator must report SAEs in accordance with applicable site-specific requirements to the 
IRB that approved the trial.
In accordance with the ICH GCP guidelines and the Japanese ministerial ordinance on GCP, the 
Sponsor or designee will immediately inform all the trial investigators and the Heads of the trial
sites of “findings that could adversely affect the safety of subjects, impact the conduct of the trial 
or alter the IRB’s approval/favorable opinion to continue the trial.” In particular and in line with 
respective applicable regulations, the Sponsor/designee will immediately inform all the trial 
investigators and the Heads of the trial sites of AEs that are both serious and unexpected and are 
considered to be related to the administered product (“suspected unexpected serious adverse 
reactions” or SUSARs). In addition, according to applicable regulations, the Sponsor/designee
will inform the trial investigators and the Heads of the trial sites of all SAEs which were reported 
to the health authorities. In accordance with the Japanese regulatory requirements concerning 
safety reporting, the Investigator should place copies of the safety reports in the Investigator Site 
File. The Head of the trial site should also maintain copies of safety reports appropriately.
National regulations with regard to safety report notifications to investigators will be taken into 
account.
When specifically required by regulations and guidelines, the Sponsor or designee will provide 
appropriate safety reports directly to the concerned lead IRB and will maintain records of these 
notifications. When direct reporting by the Sponsor is not clearly defined by national or 
site-specific regulations, the Investigator will be responsible for promptly notifying the concerned 
IRB of any safety reports provided by the Sponsor or designee and for filing copies of all related 
correspondence in the Investigator Site File.
For trials covered by the European Directive 2001/20/EC, the Sponsor’s responsibilities regarding 
the reporting of SAEs/SUSARs/safety issues will be carried out in accordance with that Directive 
and with the related Detailed Guidances.
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7.4.1.6
Monitoring of Subjects with Adverse Events
Adverse events are recorded and assessed continuously throughout the trial (see Section 7.4.1.3) 
and are assessed for final outcome at the End-of-Treatment visit.  After the End-of-Treatment visit,
only AEs that are deemed attributable to trial drug by the Investigator should be documented until 
the Safety Follow-up visit.
All SAEs ongoing at the End-of-Treatment visit must be monitored and followed up by the 
Investigator until stabilization or until the outcome is known, unless the subject is documented as 
“lost to follow-up”.  In addition, all trial drug related SAEs occurring after End-of-Treatment visit 
and ongoing at the Safety Follow-up visit must be followed up in the same manner.  Reasonable 
attempts to obtain this information must be made and documented.  It is also the responsibility of 
the Investigator to ensure that any necessary additional therapeutic measures and follow-up 
procedures are performed.
7.4.2
Pregnancy and In Utero Drug Exposure
Only pregnancies considered by the Investigator to be related to trial treatment (eg, resulting from 
a drug interaction with a contraceptive medication) are considered to be AEs. However, all 
pregnancies with an estimated conception date during the period defined in Section 7.4.1.3 must 
be recorded by convention in the AE page/section of the eCRF. The same rule applies to 
pregnancies in female subjects and in female partners of male subjects. The Investigator must 
notify the Sponsor or designee in an expedited manner of any pregnancy using the Pregnancy 
Report Form, which must be transmitted according to the same process as described for SAE 
reporting in Section 7.4.1.4.
Investigators must actively follow up, document and report on the outcome of all these 
pregnancies, even if the subjects are withdrawn from the study.
The Investigator must notify the Sponsor or designee of these outcomes using the Pregnancy 
Report Form.  If an abnormal outcome occurs, the SAE Safety Report Form will be used if the 
subject sustains an event and the Parent-Child/Fetus AE Report Form if the child/fetus sustains an 
event.
Any abnormal outcome must be reported in an expedited manner as described in Section 7.4.1.4, 
while normal outcomes must be reported within 45 days from delivery.
In the event of a pregnancy in a subject occurring during the course of the trial, the subject must 
be discontinued from trial medication immediately. The Sponsor must be notified without delay 
and the subject must be followed as mentioned above.
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7.4.3
Clinical Laboratory Assessments
It is essential that the Sponsor be provided with a list of laboratory normal ranges before shipment 
of IMP.  Any change in laboratory normal ranges during the trial will additionally be forwarded to 
the CRO and the Sponsor.
All routine laboratory analyses will be performed at a laboratory facility local to the investigational 
site and relevant results must be drawn and checked before administration of MSB0011359C.  The 
report of the results must be retained as a part of the subject’s medical record or source documents.
However, an assessment for albumin for the HCC cohort at Screening should be performed 
centrally. Blood samples for the tests listed in Table 8 will be taken from non-fasted subjects 
during the Screening period, at the End-of-Treatment visit, and during the treatment period as 
specified in the Schedules of Assessments (Table 1 and Table 2).  Complete blood count and core 
serum chemistry must be checked within 48 hours prior to each dose administration.
Serum electrophoresis (for dose escalation part only), ACTH, ANA, RF, free T4, TSH, and 
urinalysis will be assessed at the time points defined in the Schedules of Assessments (Table 1 and
Table 2).  If confirmation of a subject’s postmenopausal status is necessary, an FSH level will also 
be performed at Screening, see Section 7.1.1.
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Table 8
Required Laboratory Panel Tests
Full Chemistry
Hematology
AFP (HCC cohort only)
Absolute lymphocyte count
Albumin
ANC
Alkaline phosphatase*
Hematocrit
ALT*
Hemoglobin
Amylase
Platelet count
AST*
RBC count
GGT
WBC count and differential count
BUN/total urea*
RBC morphology**
Calcium*
Reticulocytes
Chloride*
MCH
Cholesterol
Mean corpuscular volume
Creatine kinase
MCHC
Creatinine*
CRP
Hemostaseology
Glucose*
aPTT
LDH
Prothrombin time/INR
Lipase
Phosphorus/phosphates*
Basic Urinalysis (dipstick, including macroscopic appearance, 
bilirubin, blood, color, glucose, ketones, leukocyte esterase, 
nitrite, pH, protein, specific gravity, urobilinogen)
Full urinalysis (dipstick plus microscopic evaluation) to be 
performed only at the Screening and End-of-Treatment visits 
and a basic urinalysis prior to each administration of the IMP.
Magnesium*
Potassium*
Sodium*
Total bilirubin/indirect bilirubin*
Total protein
Totality of binding ADAs
Uric acid
Triglycerides
ACTH, ANA, RF, TSH, and free T4
Hormone
FSH (if applicable)
ACTH=adrenocorticotropic hormone; ADA=anti-drug antibody; AFP=alpha-fetoprotein; ALT=alanine 
aminotransferase; ANA=antinuclear antibody; ANC=absolute neutrophil count; aPTT=activated partial 
thromboplastin time; AST=aspartate aminotransferase; BUN=blood urea nitrogen; CRP=C-reactive protein; 
FSH=follicle stimulating hormone; GGT=gamma-glutamyltransferase; IMP=Investigational Medicinal 
Product; INR=international normalized ratio; LDH=lactate dehydrogenase; MCH=mean corpuscular 
hemoglobin; MCHC=mean corpuscular hemoglobin concentration; RBC=red blood cell; RF=rheumatoid 
factor; TSH=thyroid stimulating hormone; T4=thyroxine; WBC=white blood cell.
* Core serum chemistries.  ** This test will be conducted in cases that a patient has anemia due to hemolysis 
or anemia of unknown etiology.
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MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
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If a subject has a clinically significant abnormal laboratory test value that is not present at Baseline, 
the test will be repeated weekly and the subject will be followed until the test value has returned 
to the normal range or the Investigator has determined that the abnormality is chronic or stable. In 
addition, RBC morphology will be assessed in case of anemia onset caused by hemolysis, or other 
unknown causes.
7.4.4
Vital Signs, Physical Examinations, and Other Assessments
The ECOG PS will be assessed at Screening and at subsequent visits as indicated in the Schedules 
of Assessments (Table 1 and Table 2) and documented in the eCRF.
Body weight will be measured at Screening and at subsequent visits as indicated in the Schedules 
of Assessments (Table 1 and Table 2) and documented in the eCRF.  Body height will be measured 
at Screening only.
A physical examination will be conducted and SpO2 measured at Screening and at subsequent 
visits as indicated in the Schedules of Assessments (Table 1 and Table 2) and documented in the 
eCRF (detailed description in Section 7.1).  Any abnormalities arising or worsening after the 
signing of the ICF should be documented in the eCRF Adverse Event section (see Section 7.4.1).  
Abnormal findings are to be reassessed at subsequent visits.
An ophthalmology examination including slit lamp evaluation inclusive of the anterior segment 
and with visual acuity should be conducted at Screening.  At subsequent visits, eye signs and 
symptoms should be checked.  If there are any clinically relevant findings, then an appropriate 
ophthalmology examination including slit lamp evaluation inclusive of the anterior segment and 
with visual acuity should be obtained within 2 days.
Digital 12-lead ECGs will be recorded at Screening and at trial visits as indicated in the Schedules 
of Assessments (Table 1 and Table 2) until Week 13 (Visit 10). 
All newly diagnosed or worsening conditions, signs and symptoms observed since Screening, 
whether related to trial treatment or not, are to be reported as AEs.
For female subjects of childbearing potential, serum β-HCG pregnancy test will be carried out 
during the Screening period.  A urine or serum β-HCG test will be performed once a month during 
the treatment period as indicated in the Schedules of Assessments (Table 1 and Table 2), at the 
End-of-Treatment visit, and at the Safety Follow-up visit.  Results of the most recent pregnancy 
test should be available prior to the next dosing of IMP.  Subjects who are postmenopausal 
(age-related amenorrhea ≥12 consecutive months and if needed FSH > 40 mIU/mL [in the 
postmenopausal range] as outlined in Section 7.1.1), or who have undergone hysterectomy or 
bilateral oophorectomy are exempt from pregnancy testing.  If necessary to confirm 
postmenopausal status, an FSH will be drawn at Screening.
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M7824 (MSB0011359C)
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MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
135/167
Qualitative variables will be summarized by counts and percentages.  The uncertainty of estimates 
will be assessed by CIs.  Unless otherwise specified, the calculation of proportions will be based 
on the sample size of the population of interest.  Counts of missing observations will be included 
in the denominator and presented as a separate category if not otherwise specified in the SAP.
The DLT analysis set is the underlying data set for the MTD determination.  Safety analyses will 
be performed on the safety analysis set.  Baseline summaries and efficacy analyses will be 
performed on the full analysis set.  Analyses of PK variables will be performed on the PK analysis 
set.
The estimation of PK parameters will be performed using WinNonlin® Version 5.0 or higher.  All 
other statistical analyses will be performed using SAS® Version 9.1.3 or higher, or 
R, Version 2.10.1 or higher.
Unless otherwise specified, the endpoint analyses described in the following will be performed 
separately for both the dose escalation part and the expansion part of the trial.
8.5.2
Analysis of Primary Endpoints
8.5.2.1
Maximum Tolerated Dose Determination
For determination of the MTD, individual subject data from the dose escalation part will be 
reported.
In addition, for the final statistical analysis, the following will be analyzed for the escalation part:
!
At each dose level, the number and proportion of subjects in the DLT analysis set who 
experience a DLT during the DLT evaluation period.
!
At each dose level, the number and proportion of TEAEs experienced by subjects by 
overall and the worst severity in the safety analysis set and duration of TEAEs.
!
At each dose level, the number and proportion of treatment related TEAEs experienced by 
subjects by overall and the worst severity in the safety analysis se and duration of treatment 
related TEAEs.
The MTD will be determined according to the dose escalation plan described in Section 5.1.3.2. 
The MTD is defined as the highest dose level at which no more than 1 subject out of 6 subjects 
treated in a cohort and evaluable for DLT determination experiences a DLT.
8.5.3
Analysis of Secondary Endpoints
8.5.3.1
Efficacy Parameters
Clinical efficacy parameters will be analyzed descriptively in the full analysis set. 
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Does escalation
For the dose escalation part of the trial, the secondary efficacy endpoint is BOR according to 
RECIST 1.1 per investigator assessment. For a BOR of PR or CR, confirmation of the response 
according to RECIST 1.1 (Eisenhauer 2009) will be required. The response at each scheduled 
tumor assessment and the BOR will be listed for each subject. The ORR, defined as the proportion 
of subjects with BOR of PR or CR, will be tabulated by dose level.
Dose expansion
For the dose expansion part of the trial, the primary secondary efficacy endpoint is confirmed BOR 
according to RECIST 1.1 as adjudicated by the IRC (Section 2.2.2) for the GC, ESCC and BTC 
cohorts. 
For a BOR of PR or CR, confirmation of the response according to RECIST 1.1 (Eisenhauer 2009) 
will be required for the final analysis for both escalation and expansion parts.  The response at 
each scheduled tumor assessment and the BOR will be listed for each subject.  The ORR and 
associated 95% CIs will be tabulated for each cohort.
The following secondary endpoints will also be reported:
!
Duration of response according to RECIST 1.1 as adjudicated by the IRC will be defined as 
the time from first confirmed response until the first documented disease progression that is 
subsequently confirmed. It will be analyzed using Kaplan-Meier method. Subjects without 
an event at the analysis cut-off date will be censored on the date of the last tumor assessment.
!
Disease control rate, defined as the proportion of subjects with BOR of CR, PR, or SD with 
minimum duration of 12 weeks according to RECIST 1.1 as adjudicated by the IRC, will 
be tabulated within each expansion cohort.
!
PFS time according to RECIST 1.1 as adjudicated by the IRC
o
The PFS time is defined as the time (months) from first administration of trial drug 
to the first observation of radiological PD (as assessed by the IRC) or occurrence 
of death due to any cause.  PFS will be presented in listings and analyzed using the 
Kaplan-Meier method in GC, ESCC and BTC cohorts separately if the cohort 
enrolls the full planned number of subjects. The detailed censoring rules will be 
provided in the SAP.
o
OS, defined as the time between the first dose date and death. If a patient has not 
died, the patient will be censored at the time of last contact (last known alive date). 
OS will be presented in listings and analyzed using the Kaplan-Meier method in 
GC, ESCC and BTC cohorts separately if the cohort enrolls the full planned number 
of subjects.
! OS time.
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M7824 (MSB0011359C)
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MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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8.5.3.2
Pharmacokinetics Profile
Serum concentrations of MSB0011359C will be determined by a validated method at the times 
listed in the Schedule of Assessments (refer to Table 3).
The following PK parameters will be estimated and reported:
!
AUC0-t (dose escalation part only):  Area under the concentration-time curve from the time 
of dosing to the time of the last observation (calculated by linear trapezoidal summation).
!
AUC0-∞ (dose escalation part only):  Area under the concentration-time curve from the time 
of dosing extrapolated to infinity (calculated by the linear trapezoidal summation and 
extrapolated to infinity using Clast/λz [terminal elimination rate constant]).
!
Cmax :  Maximum serum concentration observed postdose (for the expansion phase, 
2 postdose samples in 3 cycles).
!
Cmin :  Minimum serum concentration observed postdose.
!
t½ (dose escalation part only):  Elimination half-life, determined as 0.693/λz (terminal 
elimination rate constant).
The PK parameters will be summarized using descriptive statistics.  Individual as well as mean 
concentration-time plots will be depicted.
Unresolved missing data may be imputed when the analysis integrity is affected.  The conservative 
principle will be used for data imputation.
8.5.3.3
Serum Titers of Anti-MSB0011359C Antibodies (ADA)
Immunogenicity testing strategy will be implemented and conducted in line with:
!
Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins 
(April 2008. EMEA/CHMP/BMWP/14327/2006).
!
Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo 
clinical use (24 May 2012. EMA/CHMP/BMWP/86289/2010).
!
Food and Drug Administration (December 2009, draft) Guidance for Industry: Assay 
Development for Immunogenicity Testing of Therapeutic Proteins.
A qualified method that uses an acid dissociation step to detect ADAs in the presence of excess 
drug in human serum will be applied.  Removal of drug after acid treatment is not required.  The 
ADA titers of positive samples will be determined.
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M7824 (MSB0011359C)
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MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
140/167
8.5.5.2
Laboratory Variables
Laboratory results will be classified by grade according to NCI-CTCAE v4.03.  The worst on-trial 
grades after the first trial treatment will be summarized.  Shifts in toxicity grading from first 
treatment to highest grade will be displayed.  Results for variables that are not part of NCI-CTCAE 
will be presented as within or above normal limits.  Only subjects with post-Baseline laboratory 
values will be included in these analyses.
8.5.5.3
Physical Examination, Including Vital Signs and 12-lead 
Electrocardiogram
Clinically significant, abnormal findings from the physical examination are to be reported as AEs. 
Separate summaries of the physical examination will therefore not be provided.
Vital signs (including body temperature, respiratory rate, heart rate, and blood pressure), and 
12-lead ECG recorded according to the Schedules of Assessments (refer to Table 1 and Table 2) 
will be descriptively presented.
Further details on the safety analyses will be provided in the SAP.
8.6
Interim Analyses
Enrollment of expansion cohorts will not be stopped for the purpose of conducting their respective 
interim analyses but will stop if futility is met as specified.
Dose Escalation Part
In the dose escalation part, the trial data will be evaluated before decision is made to go to the next 
dose level or to start with treatment in the expansion part.
BTC Cohort
One interim analysis is planned for this cohort 12 weeks after the 20th subject in the cohort started 
treatment. The endpoint in this interim analysis is BOR (confirmation is not required). No 
multiplicity adjusted is applied to the interim analysis.
Additional Interim Analyses
In general, interim analyses at time points that are not specified in the protocol may be performed 
for internal planning purposes.
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MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
141/167
9
Ethical and Regulatory Aspects
9.1
Responsibilities of the Investigator
The Investigator is responsible for the conduct of the trial at his/her site. Throughout this clinical 
trial protocol, Investigator refers to both the principal investigator and any subinvestigators.  
He/she will ensure that the trial is performed in accordance with the clinical trial protocol, the 
ethical principles that have their origin in the Declaration of Helsinki, and with the standards 
stipulated in Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law; and 
“Ministerial Ordinance on Standards for the Implementation of Clinical Studies on Pharmaceutical 
Product (GCP). In particular, the Investigator must ensure that only subjects who have given their 
informed consent are included in the trial.
In 1998, the United States’ FDA introduced a regulation (21 CFR, Part 54) entitled “Financial 
Disclosure by Clinical Investigators”. For studies conducted in any country that could result in a 
product submission to the FDA for marketing approval and could contribute significantly to the 
demonstration of efficacy and safety of the IMP(s) (named “covered studies” by the FDA), the 
Investigator and all sub-Investigators are obliged to disclose any financial interest which they, their 
spouses or their dependent children may have in the Sponsor or the Sponsor’s product under study. 
This information is required during the trial and for 12 months following completion of the trial.
9.2
Subject Information and Informed Consent
An unconditional prerequisite for a subject’s participation in the study is his/her written informed 
consent. The subject’s written informed consent to participate in the trial must be given before 
any trial-related activities are carried out.
Adequate information must therefore be given to the subject by the Investigator before informed 
consent is obtained (a person designated by the Investigator may give the information, if permitted 
by local regulations). With the cooperation of the Sponsor, and in accordance with the Note for 
Guidance on GCP (ICH Topic E6, 1996), the Japanese ministerial ordinance on GCP, and the 
ethical principles that have their origin in the Declaration of Helsinki, the Investigator or designee 
will prepare the ICF and other written information to be used in obtaining informed consent from 
the trial subjects. 
The Sponsor should provide the Investigator
or designee with 
documents/information necessary for preparing the aforementioned written information and 
cooperate with the Investigator to prepare it. In addition to providing this written information to a 
potential subject, the Investigator or his/her designate will inform the subject of all pertinent 
aspects of the trial orally as well as in writing. The language used in the aforementioned oral and 
written information about the trial must be fully and readily understandable to lay persons.
Before consent may be obtained, the Investigator should provide the prospective subject (the 
prospective subject’s legally acceptable representative in the case of obtaining the consent of the 
legally acceptable representative) with ample time and opportunity to inquire about details of the 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
144/167
9.6
Independent Ethics Committee or Institutional Review Board
Prior to commencement of the trial at a given site, the clinical trial protocol will be submitted, 
through the Head of the trial site, together with its associated documents (such as the ICF) to the 
responsible IEC/IRB for its favorable opinion/approval. The written favorable opinion/approval 
of the IEC/IRB will be filed in the Investigator Site File, and a copy will be filed in the Trial Master 
File at the CRO.
The Sponsor will initiate the trial at a site after obtaining written approval from the Head of the 
trial site based on favorable opinion/approval from the concerned IEC/IRB. The IEC/IRB will be 
asked to provide documentation of the date of the meeting at which the favorable opinion/approval 
was given, its membership list, and names of members who were present and voted at the meeting. 
Written favorable opinion/approval should clearly identify the trial, the clinical trial protocol 
version and the Subject Information and ICF version that were reviewed at the meeting. Where 
possible, copies of the meeting minutes should also be obtained.
Plans for any substantial amendments to the clinical trial will also be submitted to the concerned 
IEC/IRB before they are implemented (see Section 10.5). Relevant safety information will be 
submitted to the IEC/IRB during the course of the trial in accordance with national regulations and 
requirements.
9.7
Health Authorities
The clinical trial protocol and any applicable documentation (eg, IMP Dossier, Subject 
Information and ICF) will be submitted or notified to the Health Authorities in accordance with 
the regulations of the country involved in the trial.
10
Trial Management
10.1
Case Report Form Handling
Refer to the Manual of Operations for eCRF handling guidelines.
The Investigator or designee will be responsible for entering trial data in the eCRF provided by 
the CRO and follow the data standards of the Sponsor.  It is the Investigator’s responsibility to 
ensure the accuracy of the data entered in the eCRFs.
The data will be entered into a validated database. The CRO will be responsible for data review 
and processing, in accordance with the Sponsor’s data management procedures. Database lock 
will occur once quality control procedure, and quality assurance procedures (if applicable) have 
been completed. All PDF files of the eCRFs will be provided to the Investigators at the completion 
of the trial.
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I N F O R M A T I O N
145/167
10.2
Source Data and Subject Files
The Investigator must keep a subject file (medical file, original medical records) on paper or 
electronically for every subject included in the trial. 
This file will contain the available 
demographic and medical information for the subject, and should be as complete as possible. In 
particular, the following data should be available in this file: (adapt to trial as necessary)
!
Subject’s full name
!
Date of birth
!
Sex
!
Height
!
Weight
!
Medical history and concomitant diseases
!
Prior and concomitant therapies (including changes during the trial)
!
Trial identification (MS200647-0008)
!
Date of subject’s inclusion into the trial (ie, date of giving informed consent)
!
Subject number in the trial
!
Dates of the subject’s visits to the site
!
Any medical examinations and clinical findings predefined in the clinical trial protocol
!
All AEs observed in the subject
!
Date of subject’s end of trial
!
Date of and reason for early withdrawal of the subject from the trial or from the IMP, if 
applicable.
It must be possible to identify each subject by using this subject file.
Additionally, any other documents containing source data must be filed. This includes original 
printouts of data recorded or generated by automated instruments, photographic negatives, X-rays, 
CT or MRI scan images, ECG recordings, laboratory value listings, etc.  Such documents must 
bear at least the subject number and the date when the procedure was performed.  Information 
should be printed by the instrument used to perform the assessment or measurement, if possible. 
Information that cannot be printed by an automated instrument will be entered manually.  Medical 
evaluation of such records should be documented as necessary and the documentation signed and 
dated by the Investigator.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
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C O N F I D E N T I A L
I N F O R M A T I O N
146/167
10.3
Investigator Site File and Archiving
The Investigator will be provided with an Investigator Site File upon initiation of the trial. This 
file will contain all documents necessary for the conduct of the trial and will be updated and 
completed throughout the trial. It must be available for review by the Monitor, and must be ready 
for Sponsor audit as well as for inspection by Health Authorities during and after the trial, and 
must be safely archived for at least 15 years (or in accordance with the requirements of Japan GCP 
or as otherwise notified by the Sponsor) after the end of the trial. The documents to be thus 
archived include the Subject Identification List and the signed subject ICFs. If archiving of the 
Investigator Site File is no longer possible at the site, the Investigator must notify the Sponsor.
The Head of the trial site must retain all records, including documents and data, which relate to the 
clinical trial in accordance with GCP.  The Head of the trial site must retain the records for the 
longest possible time permitted by Japan GCP, and/or as per ICH GCP guidelines, whichever is 
longer. In any case, the Head of the trial site should ensure that no destruction of medical records 
is performed without the written approval of the Sponsor.  The principal investigator must retain 
records, including documents and data, which relate to the clinical trial in accordance with the 
instructions from the Head of the trial site.
10.4
Monitoring, Quality Assurance and Inspection by Health 
Authorities
This trial will be monitored in accordance with the ICH Note for Guidance on GCP (ICH Topic 
E6, 1996), the Japanese ministerial ordinance on GCP, and any other applicable regulations. The 
site Monitor will perform visits to the trial site at regular intervals.
Representatives of the Sponsor’s Quality Assurance unit or a designated organization, as well as 
Health Authorities, must be permitted to access all trial-related documents and other materials at 
the site, including the Investigator Site File, the completed eCRFs, the IMP, IMP accountability 
records, and the subjects’ original medical records/files.
The clinical trial protocol, each step of the data capture procedure, and the handling of the data, 
including the final clinical trial report, will be subject to independent Quality Assurance activities. 
Audits may be conducted at any time during or after the trial to ensure the validity and integrity of 
the trial data.
10.5
Changes to the Clinical Trial Protocol
Changes to the clinical trial protocol will be documented in written protocol amendments. Major 
(substantial, significant) amendments will usually require submission to the Health Authorities and 
to the relevant IRB through the Head of the trial site for approval or favorable opinion. In such 
cases, the amendment will be implemented only after written approval from the Head of the trial 
site based on favorable opinion/approval from the relevant IRB has been obtained.
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MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
147/167
Minor (nonsubstantial) protocol amendments, including administrative changes, will be filed by 
the Sponsor and at the site. They will be submitted to the relevant IRB or to Health Authorities 
only where requested by pertinent regulations.
Any amendment that could have an impact on the subject’s agreement to participate in the trial 
requires the subject’s informed consent prior to implementation (see Section 9.2).
10.6
Clinical Trial Report and Publication Policy
10.6.1
Clinical Trial Report
After completion of the trial, or completion of a particular cohort or cohorts if applicable, a clinical 
trial report according to ICH Topic E3 will be written by the Sponsor or the designated CRO in 
consultation with the Coordinating Investigator.
10.6.2
Publication
The first publication may be a publication of the results of the analysis of the primary endpoint(s) 
that will include data from all trial sites that participated in the dose escalation part of the trial.
The Investigator will inform the Sponsor in advance about any plans to publish or present data 
from the trial. Any publications and presentations of the results (abstracts in journals or 
newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their 
representatives will require pre-submission review by the Sponsor.
The Sponsor will not suppress or veto publications, but maintains the right to delay publication in 
order to protect intellectual property rights.
11
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measure quality of life in patients with cholangiocarcinoma and gallbladder cancer , the EORTC 
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http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
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antibodies in melanoma: 
identification of clinical and biological response patterns, 
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Lencioni, R, Llovet, JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. 
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Lonning S, Mannick J, McPherson JM.  Antibody targeting of TGF-β in cancer patients.  Curr 
Pharm Biotechnol 2011;12(12):2176-89.
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MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
150/167
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Suzuki E, Kapoor V, Cheung HK, et al. Soluble type II transforming growth factor-beta receptor 
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
152/167
12
Appendices
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
153/167
Appendix 1
Eastern Cooperative Oncology Group Performance Status
ECOG PS
Grade
ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, eg, light house work, office work
2
Ambulatory and capable of all self-care, but unable to carry out any work activities; up and about 
> 50% of waking hours
3
Capable of only limited self-care, confined to bed or chair > 50% of waking hours
4
Completely disabled; cannot carry on any self-care; totally confined to bed or chair
5
Dead
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
154/167
Appendix 2
Guidance on Contraception
Birth control methods considered as highly effective
Aligned with the Clinical Trials Facilitation Group (CTFG 2014) “Recommendations related to 
contraception and pregnancy testing in clinical trials” methods that can achieve a failure rate of 
less than 1% per year when used consistently and correctly are considered as highly effective birth 
control methods, such as:
!
combined (estrogen and progesterone containing) hormonal contraception associated with 
inhibition of ovulation1 (oral, intravaginal, transdermal)
!
progesterone-only hormonal contraception associated with inhibition of ovulation1 (oral, 
injectable, implantable2*)
!
intrauterine device (IUD)2
!
intrauterine hormone-releasing system (IUS)2
!
bilateral tubal occlusion2
!
vasectomized partner2,3
!
sexual abstinence4
1 Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the
contraception method
2
Contraception methods in the context of this guidance are considered to have low user dependency
3
Vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual 
partner of the woman of childbearing potential trial participant and that the vasectomized partner has received 
medical assessment of the surgical success
4
In the context of this guidance sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.  
Abstinence needs to be in line with the preferred and usual lifestyle of the subject.  Periodic abstinence (eg, 
calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of 
contraception
*not approved in Japan
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
156/167
Section # and Name
Description of Change
Brief Rationale
7.1.5.2 Long-term Follow-
up/Trial Termination
Amended follow up of serious
adverse events
To include serious adverse events 
could be followed up until start of 
new therapy
Changes from Version 4.0 to Version 5.0 Included in the Amendment
Section # and Name
Description of Change
Brief Rationale
Cover page, synopsis, and 
Appendix 4 Signature pages
Removed “M7824” from the title
To align title with other studies in this 
program for consistency.
Synopsis and Section 5.1.8 
Analysis Cut-Off Dates
Changed the analysis cut-off dates 
for dose escalation part 
To align the analysis cut-off dates for 
dose escalation part.
Synopsis and Sections 5.1.5 
Planned Number of Subjects 
and 8.1.2 Expansion Cohorts
Updated number of subjects to be 
enrolled in expansion part of the 
study
To account for the additional subjects 
in the BTC cohort.
Synopsis – Key inclusion 
criteria for the dose escalation 
5.3.1.1 Inclusion Criteria for 
Dose Escalation  
Added statement that subjects with 
liver involvement could have AST 
≤5.0 × ULN, ALT ≤5.0 × ULN, 
and bilirubin ≤3.0 is acceptable
To not exclude subjects who could 
benefit from treatment
Synopsis-Key inclusion criteria 
expansion cohort
Section 5.3.1.2 Inclusion criteria 
for expansion cohort
Added statement regarding biopsies 
of target lesions for subjects in the 
cohort
To provide additional guidance to 
Investigators.
Synopsis- Planned trial and 
treatment duration per subject
Added subjects with PR or SD as 
those to be treated through the end 
of 12 months
To provide treatment for subjects who 
may benefit
Synopsis- statistical methods
Added language for BTC analysis
Provide clarification for analysis of 
BTC cohort and update total sample 
size to account for this cohort.
Schedule of Assessments –
Table 1 – Footnote “f” and 
Table 2 – Footnote “f”
Revised footnote “f” on guidance 
on ECG assessment
Provide clarification for ECG 
assessment.
Schedule of Assessments –
Table 1 – Footnote “i” and 
Table 2 – Footnote “i”
Added to footnote “i” stipulating 
guidance from the Medical Monitor
For additional guidance for 
Investigators and additional oversight.
Schedule of Assessments –
Table 1 – Footnote “j” and 
Table 2 – Footnote “j”
Added statement that subjects with 
signs of anemia should be 
monitored on a weekly basis
To provide additional guidance for 
Investigators and ensure proper safety
monitoring
Table 2
Added Patient reported Outcomes 
assessment for discontinuation visit
To clarify that PROs should be 
assessed at discontinuation or EOT.
3.1 Investigational Medicinal 
Product
Added “M7824” as additional 
designation for MSB0011359C and 
deleted “proposed” from the INN of 
avelumab as the name is now 
accepted
Deleted “proposed”, as avelumab is 
now the accepted non-proprietary name 
and to align with other documents in 
the program.
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
159/167
Section
Change
Brief Rationale
Synopsis
Revised the definition for the BTC 
target population
Clarified the quality of tumor 
samples
To redefine the target population for 
Biliary Tract Cancer (BTC)
To clarify the quality of tumor samples 
needed
Synopsis
Clarified that a flat dose will be used 
in the expansion part.
Modified the premedication 
procedures
To reflect a flat dose of 1200 mg 
MSB0011359C administered during the 
expansion cohort
To clarify the use of premedications
Synopsis
Addition of patient-reported 
outcome measures
To add health-related Quality-of-Life 
assessments for the GC, ESCC, and 
BTC expansion cohorts
Section 3.3.2 (NEW)
Added rationale for the 
establishment of a flat dose in the 
expansion part.
To reflect a flat dose of 1200 mg 
MSB0011359C administered during the 
expansion cohort
Section 3.4.1
Modified the premedication 
procedures
To clarify the use of premedications
Section 4.3
Addition of patient-reported 
outcome measures
To add health-related Quality-of-Life 
assessments for the GC, ESCC, and 
BTC expansion cohorts
Section 5.1.1.2
Addition of patient-reported 
outcome measures
To add health-related Quality-of-Life 
assessments for the GC, ESCC, and 
BTC expansion cohorts
Section 5.1.2
Modified the premedication 
procedures
To clarify the use of premedications
Section 5.1.4
Clarified the flat dose to be used in 
the expansion part.
To reflect a flat dose of 1200 mg 
MSB0011359C administered during the 
expansion cohort
Section 5.1.7.2
To present guidance for dose 
interruptions in response to a 
nonrelated AE 
To clarify the dose interruption criteria 
for AEs not related to study drug
Section 5.3.1.2
Revised the definition for the BTC 
target population
Clarified the quality of tumor 
samples
To redefine the target population for 
Biliary Tract Cancer (BTC)
To clarify the quality of tumor samples 
needed
Section 6.2
Modified the premedication 
procedures
Clarified the flat dose to be used in 
the expansion part.
To clarify the use of premedications
To reflect a flat dose of 1200 mg 
MSB0011359C administered during the 
expansion cohort
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
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Section
Change
Brief Rationale
Section 8.1.2
Clarified that a flat dose will be used 
in the expansion part.
To reflect a flat dose of 1200 mg 
MSB0011359C administered during the 
expansion cohort
Section 8.3.3
Addition of patient-reported 
outcome measures
To add health-related Quality-of-Life 
assessments for the GC, ESCC, and BTC 
expansion cohorts
Section 8.5.4
Addition of patient-reported 
outcome measures
To add health-related Quality-of-Life 
assessments for the GC, ESCC, and BTC 
expansion cohorts
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
162/167
Appendix 4
Signature Pages and Responsible Persons for the Trial
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
165/167
Signature Page - Principal Investigator
Trial Title:
A Phase I, open-label, multiple-ascending dose trial 
to 
investigate 
the 
safety, 
tolerability, 
pharmacokinetics, biological and clinical activity of 
MSB0011359C in subjects with metastatic or 
locally advanced solid tumors with expansion to 
selected indications in Asia
Clinical Trial Protocol Date/Version:
03 March 2020/Version 7.0
Center Number:
Principal Investigator:
I, the undersigned, am responsible for the conduct of the trial at this site and affirm that:
!
I understand and will conduct the trial according to the clinical trial protocol, any approved 
protocol amendments, ICH Good Clinical Practice (ICH Topic E6 GCP) and all applicable 
Health Authority requirements and national laws.
!
I will not deviate from the clinical trial protocol without prior written permission from the 
Sponsor and prior review and written approval from the Institutional Review Board or 
Independent Ethics Committee, except where necessary to prevent immediate danger to 
the subject.
I understand that some Health Authorities require the Sponsors of clinical trials to obtain and 
supply, when required, details about the Investigators’ ownership interests in the Sponsor or 
Investigational Medicinal Product and information regarding any financial ties with the Sponsor. 
The Sponsor will use any such information that is collected solely for the purpose of complying 
with the regulatory requirements. I therefore agree to supply the Sponsor with any necessary 
information regarding ownership interest and financial ties (including those of my spouse and 
dependent children), and to provide updates as necessary.
_____________________________________
____________________________
Signature
Date of Signature
Name, academic degree:
Function/Title:
Institution:
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M7824 (MSB0011359C)
MSB0011359C in Metastatic or Locally Advanced Solid Tumors in Asia
MS200647-0008
C O N F I D E N T I A L
I N F O R M A T I O N
166/167
Address:
Telephone number:
Fax number:
E-mail address:
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