A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies
Phase: PHASE1
Conditions: Advanced Malignancies, Non-small-cell Lung Cancer
Sponsor: Pfizer

Sasanlimab (PF-06801591)
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Final Protocol, Amendment 2, 24 June 2020
PFIZER CONFIDENTIAL
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TITLE PAGE
Protocol Title: A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, 
Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 inhibitor) in Participants with 
Advanced Malignancies
Protocol Number: B8011007
Amendment Number: Amendment 2
Compound Number: Sasanlimab (PF-06801591)
Study Phase: Phase 1b/Phase 2
Short Title: A Phase 1b/2 Study of Sasanlimab (PF-06801591, PD-1 inhibitor) in 
Participants with Advanced Malignancies
Acronym: N/A
Sponsor Name: Pfizer Inc 
Legal Registered Address: 235 East 42nd Street, New York, NY 10017-5755, USA
Regulatory Agency Identifier Number(s)
Registry
ID
EudraCT
2019-003818-14
Approval Date: 24 June 2020
This document and accompanying materials contain confidential information belonging to Pfizer.  Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.

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Protocol Amendment Summary of Changes Table
DOCUMENT HISTORY
Document
Date 
Amendment 2
24-June-2020
Amendment 1
13 December 2019
Original Protocol
12 October 2019
Amendment 2 (24-June-2020)
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union because it 
significantly impacts the scientific value of the study.
Overall Rationale for the Amendment:
Section # and Name
Description of 
Change
Brief Rationale
Title page and Section 1.1 Synopsis
Sasanlimab has been 
added in the short title.
The short title has been 
aligned with the 
protocol title: “With” 
has been replaced by 
“with”. 
Sasanlimab is officially 
confirmed as the generic name for 
PF-06801591 in the newest 
recommended International 
Nonproprietary Names list.
Adjusted typo.
Section 1.1 Synopsis, Section 2.0 
Introduction, Section 2.1 Study Rationale, 
Section 3 Objectives, estimands and 
endpoints, Section 4.1 Overall Design and 
Section 4.2 Scientific Rationale for Study 
Design
The sections have been 
updated to extend the 
enrollment from only 
Japanese participants to 
also include Asian 
participants.
Therefore, the Phase 1b 
is composed of two 
parts, dose escalation 
part and dose expansion 
part.
Asian participants, in addition to 
Japanese participants, will be 
enrolled to further characterize 
safety profile in this population.
.
Section 1.1 Synopsis, Section 2.1 Study 
Rationale, Section 5.1 Inclusion Criteria, 
Section 6.3. Measures to Minimize Bias: 
Randomization and Blinding, Section 8.8.5 
Specified Gene Expression Protein Research
and Section 10.13 Appendix 13 Japan-
specific Requirements
“Patient” has been 
replaced by 
“participant”.
To be consistent with study
protocol template version.
Section 1.1 Synopsis, Section 2, 
Introduction, Headers, Title page 
“Sasanlimab” has been 
added in addition to  
“PF-06801591”.
Sasanlimab is officially 
confirmed as the generic name for 
PF-06801591 in the newest 

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Section # and Name
Description of 
Change
Brief Rationale
recommended International 
Nonproprietary Names list.
Section 1.1 Synopsis, 3. OBJECTIVES, 
ESTIMANDS AND ENDPOINTS Section 
9.1.1 Estimands and Section 9.3. Populations 
for Analyses
The DLT-Evaluable 
analysis set has been 
updated.
Further clarity was added 
reporting that in case participants
are non-evaluable for DLT, 
additional participants can be 
enrolled to ensure that target 
number of DLT evaluable 
participants is reached.
Section 1.3 Schedule of Activities
Reference to the study 
assessments and 
procedures section of 
the protocol for detailed 
information on each 
procedure and 
assessment required for 
compliance with the 
protocol has been 
added.
This sentence has been added for 
further clarity.
Schedule of Activities for Phase 1b and 
Phase 2 (Q4W) and (Q6W). 
The sentence related to 
the time frame between 
study treatment and 
randomization/treatment 
allocation has been 
added.. Moreover as per  
Section 10.1.3. 
Informed Consent 
Process, the Japanese 
participants enrolled in 
the Phase 1b of the trial 
will be asked to sign an 
additional consent 
document after 
completion of Cycle 1.
It has been clarified that 
the end of treatment: 
safety assessments are 
not required if 
completed in the prior 
week, except for tumor 
assessment, which need 
not to be repeated if 
performed within the 
prior 12 weeks.
The post-treatment 
period has been defined 
at 30, 90 and 180 days 
after last dose. The post 
treatment period ends at 
180 days or at the time 
To add clarity.

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Section # and Name
Description of 
Change
Brief Rationale
a new anticancer 
treatment starts 
whichever comes first.
Schedule of Activities for Pharmacokinetics, 
Pharmacodynamics and Immunogenicity 
Assessments for Q4W dosing (Phase 1b and 
Phase 2) and for Q6W dosing  (Phase 1b and 
Phase 2) and Section 8.8.1.2. Tumor Tissue 
at the End of Treatment
The sentence related to 
the collection of the 
study biopsy within “± 
14 days” after the end 
of treatment has been 
removed because not 
consistent with the time 
window for the EOT (+
7 days). Moreover, as 
per local regulations in 
China, sample 
collection for 
biobanking purpose is 
not allowed.
Adjusted typos and to add clarity.
Section 4.0 Overall design
It has been further 
clarified that the 
randomization will be 
stratified by line of 
therapy (1st line vs 2nd 
line).
To add further clarity
Section 4.1 Overall design and Section  
9.4.1. DLT rate assessment
The sections have been 
updated to clarify that 
the Phase 1b is 
composed of two parts, 
dose escalation part and 
dose expansion part.
A dose expansion part has been 
added in the current amendment 
to further evaluate the safety 
profile in Asian participants. 
Therefore, it has been clarified 
that the dose expansion part will 
be opened once the dose 
escalation part is completed and 
dose(s) safety is confirmed.
Section 1.1 Synopsis and Section 4.4 End of 
study definition
The end of study 
definition has been 
updated.
The expectation is that the 
participants may benefit from 
treatment and can remain on 
study longer than 1 year as 
previously reported. Therefore, 
the end of study has been updated 
up to 3 years after the last 
participant is randomized or if the 
Sponsor determines the study 
should end earlier.   
Moreover, the sentence related to 
options for continuing study 
treatment outside the study has 
been removed since the duration 
of the study has been extended up 
to 3 years.

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Section # and Name
Description of 
Change
Brief Rationale
Section 1.2 Schema 
The schema has been 
revised
The schema has been revised to 
add the dose expansion part in the 
Phase 1b.
Section 5.1 Inclusion Criteria
Inclusion Criteria N°1: 
“≥ 19 years of age in 
South Korea” has been 
added.
Inclusion Criteria N°2e: 
A neoadjuvant/adjuvant 
treatment will be 
counted as a line for 
advanced or metastatic 
disease if the 
development of 
recurrent or metastasis 
disease occurs during 
treatment or within 6 
months after last dose.
Inclusion Criteria N°10. 
As for participants 
using a highly effective 
method that is user 
dependent, this 
contraception method 
must be used together 
with a second effective 
method of 
contraception.
Since the age of consent in South 
Korea is 19 years, this sentence 
has been added for consistency.
A clear definition has been added 
regarding previous 
neoadjuvant/adjuvant treatment.
This sentence has been added to 
be aligned with study protocol 
template.
Section 5.2 Exclusion Criteria  
Exclusion Criteria N°5: 
“sero-positivity” has 
been added 
Exclusion Criteria N°6: 
This exclusion criteria 
has been streamlined.
Exclusion Criteria N°7:  
It has been clarified that 
the participants are not 
eligible if both systolic 
Exclusion Criteria N°5: Further 
clarity has been added to the 
exclusion criteria specifying that 
seropositive participants cannot 
be enrolled. 
Exclusion Criteria N°6: the 
exclusion criteria has been 
rephrased and is now more simple 
and understandable.
Exclusion Criteria N°7:  Further 
clarity has been added for 

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Section # and Name
Description of 
Change
Brief Rationale
and diastolic blood 
pressures are higher 
than 150 and 90 mmHg, 
respectively.
participants’ eligibility regarding 
blood pressure measurements.
Section 5.2 Exclusion Criteria 
Live attenuated 
vaccines have been 
reported as prohibited 
medication within 4 
weeks prior to study 
entry.
It has been clarified that live 
attenuated vaccines are not 
allowed within 4 weeks prior to 
study entry. 
Section 5.3. Lifestyle Considerations
This section has been 
updated reporting that a 
second method of 
contraception is needed 
in the event a highly 
effective methods that is 
user dependent is 
selected.  
Updated for consistency with 
appendix 4.
Section 6.1 Study Intervention(s)
Administered
One sentence has been 
rephrased for adding 
clarity.
To add further clarity.
Section 6.1.1. Medical Devices
The paragraph has been 
rephrased to be aligned 
with study protocol 
template.
Moreover, the sentence 
related to the medical 
device used to deliver 
PF-06801591 has been 
rephrased for further 
clarity.
To be aligned with study protocol 
template.
Section 6.2 
Preparation/Handling/Storage/Accountability
The sentence “and 
information the site 
should report for each 
excursion” has been 
removed because 
reported as duplication.
Adjusted typos.
Section 6.5.1. Other Anti tumor/Anti cancer 
or Experimental Drugs
Cancer vaccination 
therapy has been 
reported as prohibited 
medication during study 
conduction.
To add clarity 
Section 6.5.3. Hematopoietic Growth Factors
It has been clarified that 
for the countries, 
The paragraph has been rephrased 
to add further clarity.

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Section # and Name
Description of 
Change
Brief Rationale
including Japan, where 
the indication and 
dosage of G-CSF 
compounds may differ 
from ASCO guidelines, 
local package insert or 
clinical practice in their 
countries should be 
followed.  
“During screening
window (ie, within 28 
days prior to Day 1)” 
has been replaced by 
“during screening”
The participants can be screened 
at any time during the screening 
time window (within 28 days). 
Therefore, it has been clarified 
that granulocyte Colony-
Stimulating Factor (G-CSF) is not 
permitted to qualify a participant 
with low ANC counts during 
screening and not during 
screening window.
Section 6.5.7. Vaccines
Live attenuated 
vaccines within 4 weeks 
prior to the first dose of 
PF-06801591 and 
through 30 days 
following the last dose 
of PF 06801591 are not 
allowed.  
The paragraph has been added for 
further clarity.
Section 6.5.9 Rescue Medicine
The reference sections 
have been added. 
To add further clarity the 
reference sections have been 
added.
Section 7.1. Discontinuation of Study 
Intervention
This section has been 
updated regarding the 
reason of treatment 
discontinuation.
The sentence related to 
options for continuing 
study treatment outside 
the study has been 
removed.
There is no limitation in the 
treatment of patients in complete 
response. Therefore, this sentence 
has been removed.
Moreover the sentence related to 
options for continuing study 
treatment outside the study has 
been removed since the duration 
of the study has been extended up 
to 3 years.
Section 7.1.1. Treatment after Initial 
Evidence of Radiological Disease 
Progression
A sentence was added 
to clarify that 
participants should be 
considered for 
discontinuation from 
study treatment if the 
repeat imaging confirms 
To give the opportunity to
continue treatment beyond 
progressive disease if the 
participant is still experiencing 
clinical benefit.

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Section # and Name
Description of 
Change
Brief Rationale
progressive disease.  
However, if a 
participant with 
evidence of progressive 
disease is still 
experiencing clinical 
benefit, the participant 
may be eligible for 
continued treatment 
with PF-06801591.
Section 7.2. Participant 
Discontinuation/Withdrawal from the Study
The paragraph has been 
rephrased to be aligned 
with study protocol 
template.
To be aligned with study protocol 
template.
Section 7.2.1 Withdrawal of Consent
This section has been 
updated.
To be aligned with the mandatory 
language reported in the new 
version of the study protocol 
template.
Section 8.2.3. Electrocardiograms
The interval for the 3 
consecutive ECGs at 
baseline has been 
added.
Three consecutive ECGs will be 
performed at approximately [2-4] 
minutes apart to determine the 
mean QTc interval.   
Section 8.2.4. Clinical Safety Laboratory 
Assessments
Assessments performed 
on C2D1 and each 
subsequent cycle should 
be performed within 72 
hours prior to dosing. 
Moreover, the 
assessments to be 
reviewed prior to dosing 
have also been reported.
Changes has been made to be 
consistent with the time window 
reported in the Schedule of 
activities and to clarify the 
assessments to be reviewed prior 
to dosing.
Section 8.2.5. Pregnancy Testing
A sentence related to 
the pregnancy test has 
been added.
The protocol has been aligned 
with the new version of the study 
protocol template.
Section 8.3. Adverse Events and Serious 
Adverse Events and Subsections
This section and 
subsections have been 
updated. 
The protocol has been aligned 
with the new version of the study 
protocol template.
Section 8.3.9 Medical Device Deficiencies 
and Subsections 
This section and 
subsections have been 
updated. 
The protocol has been aligned 
with the new version of the study 
protocol template.
Section 8.3.10. Medication Errors
This section has been 
updated.
The protocol has been aligned 
with the new version of the study 
protocol template.
Section 8.4. Treatment of Overdose
This section has been 
updated.
Prefilled syringes are not 
graduated, and the percentage of 
the overdose cannot be 
calculated. Therefore, the 

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Section # and Name
Description of 
Change
Brief Rationale
definition of the overdose has 
been updated and defined as the 
dose higher than the assigned 
dose level.  Moreover, this 
section has been aligned with the 
new version of the study protocol 
template.
Section 8.5 Pharmacokinetic
It has been added that 
the PK samples for 
further analysis will be 
used unless prohibited 
by local regulations or 
ethics committee 
decision.
To add further clarity
Section 8.6.2. Collection of Samples for 
Pharmacodynamic Analysis
The total volume of 
samples has been 
updated. 
Moreover the sample 
for pharmacodynamics 
analysis will be used 
unless prohibited by 
local regulations or 
ethics committee 
decision.
Adjusted typos and to add further 
clarity.
Section 8.8 Biomarkers
The sample for 
pharmacodynamics 
analysis will be used 
unless prohibited by 
local regulations or 
ethics committee 
decision.
To add further clarity
Section 8.8.1.1 Baseline Tumor Tissue
It has been further 
clarified that the 
baseline tumor tissue is 
mandatory for Phase 2 
part of the study.
To add further clarity
Section 8.8.1.2. Tumor Tissue at the End of 
Treatment
The time frame of “± 14 
days” for the biopsy 
collection at the end of 
treatment has been 
removed because not 
consistent with the End 
of treatment visit 
window (+ 7 days).
Adjusted typo

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Section # and Name
Description of 
Change
Brief Rationale
Section 8.8.4. Specified Gene Expression 
(RNA) Research
It has been clarified that 
two blood samples will 
be collected for RNA 
analyses. 
This section has been updated as 
per consistency with the Schedule 
of Activities.
Section 9.2 Sample size and Section 9.2.1 
Phase 1b
Since the Phase 1b has 
been extended to Asian 
participant, in addition 
to Japanese participants, 
the sample size has been 
modified.
Asian participants, in addition to 
Japanese participants, will be 
treated to assess the safety profile 
in the Phase 1b part of the trial. 
Therefore, the total number of 
participants has been increased.
Section 9.4. Statistical Analyses
The primary analysis 
will include all data up 
to a clinical cut-off date 
corresponding to 12 
months after the last 
participant randomized 
in Phase 2. The final 
analysis of the data will 
be performed after last 
participant last visit 
(LPLV).
The end of study has been 
extended to 3 years after last 
participant is randomized. 
Therefore, it has been clarified 
that the primary analysis will be 
done prior to the end of study and 
will be performed 12 months after 
the last participant randomized in 
Phase 2.  
Section 10.1.5 Dissemination of Clinical 
Study Data
The appendix has been 
updated to be aligned 
with study protocol 
template.
The protocol has been aligned 
with the study protocol template.
Section 10.2. Appendix 2: Clinical 
Laboratory Tests
A sentence related to 
the urine test has been 
added in this section.
The protocol has been aligned 
with the new version of the study 
protocol template.
Section 10.3. Appendix 3: Adverse Events: 
Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
The appendix has been 
updated to be aligned 
with study protocol 
template.
The protocol has been aligned 
with the new version of the study 
protocol template.
Section 10.4. Appendix 4: Contraceptive 
Guidance 
The appendix has been 
updated to be aligned 
with study protocol 
template.
The protocol has been aligned 
with the new version of protocol 
template.
Section 10.7. Appendix 7: Medical Device 
Adverse Events, Adverse Device Effects, 
Serious Adverse Events, and Device 
Deficiencies: Definition and Procedures for 
Recording, Evaluating, Follow up, and 
Reporting
The appendix has been 
updated to be aligned 
with study protocol 
template.
The protocol has been aligned 
with the new version of protocol 
template
Section 10.10. Appendix 10
Non-target disease: 
Indeterminate has been 
replaced by inevaluable; 
present by present 
without unequivocal 
The evaluation of the non-target 
lesions has been updated 
consistently with the terms 
reported in the CRF. 

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Section # and Name
Description of 
Change
Brief Rationale
progression; increased 
by unequivocal 
progression.
Moreover, a table 
reporting the 
determination of tumor 
response at each 
assessment for 
participants with no-
measurable lesions has 
been added.
In the Phase 1b part participants 
can be enrolled without 
measurable lesions.
Section 10.12. Appendix 12 Management of 
Immune-related Adverse Event (irAEs)
Cardiac IRAE section 
has been updated: 
Troponin I has been 
specified and abatacept  
has been added 
To add clarity and to be aligned 
with program level decision.
10.13. Appendix 13 Japan-specific 
Requirements
A subsection 10.13.1 
has been added.
Definition of serious adverse 
event caused by medical device
was added. Japan requires this 
language to comply with their 
local GCP requirements for trials 
involving a medical device.
10.14. Appendix 14. Alternative Measures 
During Public Emergencies
This appendix was 
added to provide  
alternative study 
measures followed 
during public 
emergencies, including 
the COVID-19 
pandemic.
To add clarity and guidelines.
Section 10.15. Appendix 15 Abbreviations
PMAP (pharmacometric 
analysis plan) has been 
removed because 
reported twice. 
Moreover E/D (early 
discontinuation) has 
been removed because 
not applicable to this 
study.
Adjusted typo.
Section 11.0 References 
The section has been 
updated 
A reference is not applicable 
anymore and has been removed.
Amendment 1 (13-Dec-2019)

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This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union because it 
significantly impacts the scientific value of the study.
Overall Rationale for the Amendment:
Section # and Name
Description of 
Change
Brief Rationale
Section 1.1 Synopsis and 
Section 4.1 Overall design; 
DLT determination
Adjusted typos. 
Febrile neutropenia 
definition: the single 
temperature was changed 
from 38.5 °C (101.3°F) 
to 38.3°C (101 °F).
The single temperature of >38.5°C (101.3°F) 
was not consistent CTCAE version 5.0.
Schedule of Activities 
(Tables 1 and 3)
To add that re-consent is 
needed for Japan 
participants on Cycle 2 
Day 1 in Phase 1b 
The reconsent after DLT evaluation period 
(cycle 1) is a requirement in Japan.
Schedule of Activities 
(Tables 2, 3 and Section 
1.3.4)
Adjusted typos. 
The end of treatment 
time frame has been 
updated to + 7 days 
instead of ± 7 days 
previously reported.
The end of treatment visit can occur only + 7 
days.
Schedule of Activities 
(Tables 1, 2, 3 and Section 
1.3.4)
The time window has 
been updated from ± 5 
days to ± 3 days.
As per consistency with the other studies of this 
program, the time window has been updated to 
± 3 days.
Schedule of Activities 
(Tables 1 and 3) and 
Appendix 2 Clinical 
Laboratory Tests
The pulmonary function 
KL-6 and SpO2 tests 
have been added.
As per Pharmaceuticals and Medical Devices 
Agency (PMDA) request, KL-6 and SpO2 tests 
have been added to detect potential Interstitial 
Lung Disease (ILD)
Section 5.2 Exclusion 
Criteria
The exclusion criteria to 
not allow participants 
with ILD history or 
complication to be 
enrolled has been added.
As per PMDA request this exclusion criterion 
has been added.
Section 5.4 Screen Failures
The following sentence 
has been removed: 
“Rescreened participants 
should be assigned the 
same participant number 
as for the initial 
screening”
As per consistency with the last version of the 
protocol template the language that indicates 
rescreened participant should be assigned the 
same participant number has been removed.
Section 6.5.3 Hematopoietic
Growth Factors
Adjusted typos. To 
specify that the screening 
period is within 28 days 
prior cycle 1 Day 1.
In addition, it has also 
been clarified that 
A typo was adjusted and additional clarity was 
added about the use erythropoietin in Japan.

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Section # and Name
Description of 
Change
Brief Rationale
erythropoietin is not 
approved in Japan for 
anemia caused by cancer 
treatment.
Section 9.4.1. DLT rate 
assessment 
It has been clarified that 
evidence such as safety 
data beyond DLT, 
including safety data 
from treated participants 
who are not DLT 
evaluable, clinical 
activity, PK, and PD data 
will play an important 
role in the final decision.
As per PMDA requirement, it has been added 
that safety data from treated participants who 
are not DLT evaluable will play an important 
role in the final decision.
Section 9.4.4.3 Analysis of 
Immunogenicity Data
Adjusted typos. 
Avelumab has been 
replaced with PF-
06801591.
Avelumab was a leftover.
Appendix 2 Clinical 
Laboratory Tests
Amylase and lipase tests 
have been added.
As per PMDA request amylase and lipase tests 
have been added for the purpose of early 
detection of pancreatic disease (eg, pancreatitis) 
after treatment start.
Appendix 4 Contraceptive 
Guidance and Collection of 
Pregnancy Information
To add that the states of 
high FSH level should be 
confirmed if there is no 
other medical cause.
As per PMDA request, confirmation of high 
FSH level is needed if there is no other medical 
cause.
Appendix 4 Contraceptive 
Guidance and Collection of 
Pregnancy Information
An asterisk was added to 
“implantable 
progestogen-only 
hormone contraception 
associated with 
inhibition of ovulation” 
to clarify that is not 
commercially available 
in Japan 
Adjusted typo.
Appendix 13 Japan specific 
requirement
A Japan specific 
appendix has been added 
to report the management 
of the participants during 
the DLT observation 
period and the disclosure 
of biomarker tests results 
to participants.
As per PMDA request the management of the 
participant during the DLT observation period 
and the disclosure of biomarker tests results to 
participants are clarified.
Section 2.2.4 Clinical 
Overview
The acronym of 
vaccine-based 
Adjusted typo.

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Section # and Name
Description of 
Change
Brief Rationale
immunotherapy regimen  
has been adjusted.
Appendix 14 Abbreviations
The abbreviations of the 
terms Interstitial Lung 
Disease/Pharmaceuticals 
and Medical Devices 
Agency/ sialylated 
carbohydrate antigen/ 
arterial oxygen saturation
were added. The 
abbreviation of VBIR 
was updated.
Some abbreviations were added/updated to 
reflect the changes in the amendment.

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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................22
LIST OF FIGURES .................................................................................................................22
1. PROTOCOL SUMMARY...................................................................................................23
1.1. Synopsis ..................................................................................................................23
1.2. Schema ....................................................................................................................30
1.3. Schedule of Activities (SoA)...................................................................................32
1.3.1. SoA for Phase 1b and Phase 2 (Q4W)........................................................32
1.3.2. SoA for Pharmacokinetics, Pharmacodynamics and Immunogenicity 
Assessments for Q4W dosing (Phase 1b and Phase 2)....................................36
1.3.3. SoA for Phase 1b and 2 (Q6W)..................................................................39
1.3.4. SoA for Pharmacokinetics, Pharmacodynamics and Immunogenicity 
Assessments for Q6W dosing  (Phase 1b and Phase 2)...................................43
2. INTRODUCTION ...............................................................................................................45
2.1. Study Rationale .......................................................................................................45
2.2. Background .............................................................................................................46
2.2.1. Nonclinical Pharmacology..........................................................................46
2.2.2. Nonclinical Pharmacokinetics and Metabolism .........................................47
2.2.3. Nonclinical Safety ......................................................................................47
2.2.4. Clinical Overview.......................................................................................47
2.3. Benefit/Risk Assessment.........................................................................................50
3. OBJECTIVES, ESTIMANDS AND ENDPOINTS ............................................................51
4. STUDY DESIGN.................................................................................................................54
4.1. Overall Design.........................................................................................................54
4.2. Scientific Rationale for Study Design.....................................................................57
4.3. Justification for Dose ..............................................................................................58
4.4. End of Study Definition ..........................................................................................58
5. STUDY POPULATION......................................................................................................59
5.1. Inclusion Criteria.....................................................................................................59
5.2. Exclusion Criteria....................................................................................................62
5.3. Lifestyle Considerations..........................................................................................63

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5.3.1. Meals and Dietary Restrictions...................................................................64
5.4. Screen Failures ........................................................................................................64
6. STUDY INTERVENTION..................................................................................................65
6.1. Study Intervention(s) Administered........................................................................65
6.1.1. Medical Devices .........................................................................................66
6.2. Preparation/Handling/Storage/Accountability ........................................................66
6.2.1. Preparation and Dispensing........................................................................67
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................67
6.4. Study Intervention Compliance...............................................................................68
6.5. Concomitant Therapy..............................................................................................68
6.5.1. Other Anti-tumor/Anti-cancer or Experimental Drugs...............................68
6.5.2. Supportive Care ..........................................................................................69
6.5.3. Hematopoietic Growth Factors...................................................................69
6.5.4. Anti-Diarrheal, Anti-Emetic Therapy.........................................................69
6.5.5. Anti-Inflammatory Therapy........................................................................69
6.5.6. Corticosteroids............................................................................................69
6.5.7. Vaccines......................................................................................................70
6.5.8. Surgery........................................................................................................70
6.5.9. Rescue Medicine.........................................................................................70
6.5.10. Proton-Pump Inhibitors ............................................................................70
6.5.11. Antacids or H2-Receptor Antagonists......................................................70
6.6. Dose Modification...................................................................................................70
6.7. Intervention after the End of the Study...................................................................73
6.8. Management of Treatment Related Adverse Events...............................................73
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................74
7.1. Discontinuation of Study Intervention ....................................................................74
7.1.1. Treatment after Initial Evidence of Radiological Disease Progression......74
7.2. Participant Discontinuation/Withdrawal from the Study........................................75
7.2.1. Withdrawal of Consent...............................................................................76
7.3. Lost to Follow up ....................................................................................................76
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................76

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8.1. Efficacy Assessments..............................................................................................77
8.1.1. Tumor Response Assessment .....................................................................77
8.1.2. Tumor Markers...........................................................................................78
8.2. Safety Assessments .................................................................................................78
8.2.1. Physical Examinations................................................................................79
8.2.2. Vital Signs ..................................................................................................79
8.2.3. Electrocardiograms.....................................................................................79
8.2.4. Clinical Safety Laboratory Assessments ....................................................80
8.2.5. Pregnancy Testing ......................................................................................80
8.2.6. ECOG Performance Status .........................................................................81
8.2.7. Local Site Injection Tolerability Assessment.............................................81
8.3. Adverse Events and Serious Adverse Events..........................................................81
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......82
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................82
8.3.1.2. Recording Non-serious AEs and SAEs on the CRF .................83
8.3.2. Method of Detecting AEs and SAEs ..........................................................83
8.3.3. Follow-up of AEs and SAEs.......................................................................83
8.3.4. Regulatory Reporting Requirements for SAEs...........................................83
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ..........................................................................................................84
8.3.5.1. Exposure During Pregnancy......................................................84
8.3.5.2. Exposure During Breastfeeding ................................................86
8.3.5.3. Occupational Exposure .............................................................86
8.3.6. Cardiovascular and Death Events...............................................................86
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................86
8.3.8. Adverse Events of Special Interest.............................................................87
8.3.8.1. Lack of Efficacy........................................................................87
8.3.9. Medical Device Deficiencies......................................................................87
8.3.9.1. Time Period for Detecting Medical Device Deficiencies .........87
8.3.9.2. Follow-up of Medical Device Deficiencies...............................87
8.3.9.3. Prompt Reporting of  Device Deficiencies to Sponsor .............88

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8.3.9.4. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................88
8.3.10. Medication Errors.....................................................................................88
8.4. Treatment of Overdose............................................................................................89
8.5. Pharmacokinetics ....................................................................................................89
8.5.1. Blood for PK Analysis of PF-06801591.....................................................90
8.9. Medical Resource Utilization and Health Economics.............................................94
9. STATISTICAL CONSIDERATIONS ................................................................................95
9.1. Estimands and Statistical Hypotheses.....................................................................95
9.1.1. Estimands....................................................................................................95
9.2. Sample Size Determination.....................................................................................96
9.2.1. Phase 1b......................................................................................................96
9.2.2. Phase 2........................................................................................................96
9.3. Populations for Analyses.........................................................................................97
9.4. Statistical Analyses .................................................................................................97
9.4.1. DLT rate assessment...................................................................................98
9.4.2. Efficacy Analyses .......................................................................................98
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9.4.3. Safety Analyses ..........................................................................................99
9.4.3.1. Primary Safety Analyses ...........................................................99
9.4.3.2. Secondary Safety Analyses .......................................................99
9.4.3.3. ECG Analyses .........................................................................100
9.4.3.4. Adverse Events........................................................................100
9.4.3.5. Laboratory Test Abnormalities ...............................................100
9.4.4. Other Analyses..........................................................................................100
9.4.4.1. PK Analyses ............................................................................100
9.4.4.2. Population Pharmacokinetic Analysis or 
Pharmacokinetic/Pharmacodynamic (PK/Pharmacodynamic) 
Modeling..........................................................................................101
9.4.4.3. Analysis of Immunogenicity Data...........................................101
9.5. Interim Analyses ...................................................................................................102
9.5.1. Data Monitoring Committee (DMC)........................................................102
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS........................................................................................................103
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations.............103
10.1.1. Regulatory and Ethical Considerations ..................................................103
10.1.2. Financial Disclosure ...............................................................................104
10.1.3. Informed Consent Process ......................................................................104
10.1.4. Data Protection .......................................................................................105
10.1.5. Dissemination of Clinical Study Data ....................................................106
10.1.6. Data Quality Assurance ..........................................................................107
10.1.7. Source Documents..................................................................................108
10.1.8. Study and Site Closure............................................................................108
10.1.9. Publication Policy...................................................................................109
10.1.10. Sponsor’s Qualified Medical Personnel ...............................................109
10.2. Appendix 2: Clinical Laboratory Tests ...............................................................111
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ....................................................................113
10.3.1. Definition of AE .....................................................................................113
10.3.2. Definition of SAE...................................................................................114
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10.3.3. Recording/Reporting and Follow-Up of AE and/or SAE.......................116
10.3.4. Reporting of SAEs..................................................................................118
10.4. Appendix 4: Contraceptive Guidance ................................................................120
10.4.1. Male Participant Reproductive Inclusion Criteria..................................121
10.4.2. Female Participant Reproductive Inclusion Criteria...............................121
10.4.3. Contraception Methods...........................................................................122
10.5. Appendix 5: Genetics..........................................................................................124
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments ......125
10.7. Appendix 7: Medical Device Adverse Events, Adverse Device Effects, 
Serious Adverse Events, and Device Deficiencies: Definition and Procedures 
for Recording, Evaluating, Follow-up, and Reporting............................................127
10.7.1. Definition of AE and ADE .....................................................................127
10.7.2. Definition of SAE, SADE, and Unanticipated Serious Adverse 
Device Effect .................................................................................................127
10.7.3. Definition of Device Deficiency.............................................................128
10.7.4. Recording/Reporting and Follow-up of AEs and/or SAEs and 
Device Deficiencies .......................................................................................129
10.7.5. Reporting of SAEs..................................................................................131
10.7.6. Reporting of SADEs...............................................................................131
10.8. Appendix 8: ECG Findings of Potential Clinical Concern .................................132
10.9. Appendix 9: Detailed Dose Escalation/De-Escalation Scheme for mTPI 
design.......................................................................................................................134
10.10. Appendix 10: RECIST (Response Evaluation Criteria In Solid Tumors) 
version 1.1 Guidelines.............................................................................................137
10.11. Appendix 11: ECOG Performance Status.........................................................142
10.12. Appendix 12 Management of Immune-related Adverse Event (irAEs)............143
10.13. Appendix 13 Japan-specific Requirements.......................................................152
10.13.1. Definitions of serious adverse event, serious adverse event caused 
by medical device, and unanticipated serious adverse event caused by 
medical device ...............................................................................................152
10.14. Appendix 14. Alternative Measures During Public Emergencies.....................153
10.14.1. Eligibility..............................................................................................153
10.14.2. Telehealth Visits...................................................................................153
10.14.3. Alternative Facilities for Safety Assessments ......................................154

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10.14.3.1. Laboratory Testing ..............................................................154
10.14.3.2. Electrocardiograms..............................................................155
10.14.4. Study Intervention ................................................................................155
10.14.5. Adverse Events and Serious Adverse Events.......................................155
10.15. Appendix 15: Abbreviations .............................................................................156
11. REFERENCES ................................................................................................................160

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LIST OF TABLES
Table 1.
SoA for Phase 1b and Phase 2 for Q4W dosing.......................................32
Table 2.
SoA for Pharmacokinetics, Pharmacodynamics and 
Immunogenicity Assessments for Q4W dosing .......................................36
Table 3.
Schedule of Activities for Phase 1b and Phase 2 for Q6W dosing...........39
Table 4.
Treatment Modification for Related Events** .........................................72
Table 5.
Protocol-Required Safety Laboratory Assessments ...............................112
Table 6.
Dose finding Rules .................................................................................135
LIST OF FIGURES
Figure 1.
Study Schema ...........................................................................................31

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1. PROTOCOL SUMMARY
1.1. Synopsis
Protocol Title: A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, 
Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 inhibitor) in Participants with 
Advanced Malignancies
Short Title: A Phase 1b/2 Study of Sasanlimab (PF-06801591, PD-1 inhibitor) in 
Participants with Advanced Malignancies
Rationale:
This is a Phase 1b/2 protocol to evaluate pharmacokinetics (PK), safety, efficacy, and 
pharmacodynamics of sasanlimab (PF-06801591), a programmed death-1(PD-1) antagonist 
monoclonal antibody (mAb) in participants with advanced malignancies.  This study consists 
of 2 parts: Phase 1b for participants with advanced malignancies in Asia only and a global 
Phase 2 in participants with non-small cell lung cancer (NSCLC).
The primary purpose is to assess the safety and tolerability of PF-06801591 in Asian 
participants (Phase 1b) and to support modeling and simulation approaches for optimizing 
the dosing interval for PF-06801591. 
The treatments with PD-1/PD-L1 inhibitors have demonstrated significant survival benefit 
for multiple tumor types.  To date, all approved PD-1/PD-L1 inhibitors are administered 
intravenously (IV) 1-5.  As participants receiving these agents achieve durable responses and 
long-term survival, the subcutaneous (SC) treatment administration offers an innovative 
approach decreasing medical costs and making more efficient use of resources while 
simultaneously improving participant experience and satisfaction 6-8. 
In Study B8011001, an open-label, multi-center Phase 1 study, the safety, tolerability, 
pharmacokinetics (PK), immunogenicity, pharmacodynamics and efficacy of PF-06801591 
were evaluated after IV or SC administration in participants with locally advanced or 
metastatic solid tumors.  PF-06801591, a PD-1 inhibitor, has shown safety and efficacy in 
tumor types tested, regardless of route of administration (Section 2.2.4). Based on Study 
B8011001, the safety and tolerability of the PF-06801591, 300 mg Q4W, administered SC 
was selected for further evaluation in Phase 3 studies.
In the Phase 1b part of this study, 300 mg Q4W SC will be evaluated in Asian participants.  
Participants with advanced solid tumor will be enrolled for safety and PK evaluations.  Since 
no dose-limiting toxicities (DLTs) occurred in Study B8011001 and no ethnic differences 
have been identified for PF-06801591 or other PD-1 or PD-L1 inhibitors, no safety concerns 
are expected.
A second dose level with a longer dosing interval (600 mg Q6W) will be also investigated in 
Asian participants in Phase 1b to support potential future schedule optimization for Asian 
population.  The Asian Phase 1b and global Phase 2 will be conducted in parallel. 
Participants from Japan sites will be allowed to enter the global Phase 2 after Phase 1b meets 
safety criteria as defined by modified Toxicity Probability Interval (mTPI) design. Chinese 
participants will be enrolled only in the Phase 1b part of this study.

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Phase 1b is composed of two parts, a dose escalation part and a dose expansion part. Once 
the safety evaluation is completed in the dose escalation part, the expansion part will be 
opened for further safety and PK assessment in Asian participants.
In the global Phase 2 part of this study, the PK profile of PF-06801591 is planned to be 
characterized at 2 different dose levels and intervals (300 mg Q4W and 600 mg Q6W) to 
support further optimization of dosing schedule. Participants will be randomized in a 1:2 
ratio between 300 mg Q4W and 600 mg Q6W. The aim of the randomized Phase 2 is to 
explore and compare the PK exposure of PF-06801591 between those two regimens. The 
findings will support a modeling and simulation approach for extending the dosing interval 
from Q4W to Q6W and for enabling a flexible dosing interval for future combination 
programs. 
Recently, the PD-1 inhibitors, pembrolizumab and nivolumab, are also being evaluated at 
different dose intervals using a similar approach9,10. 
The study will enroll participants with NSCLC, a tumor with clinical evidence of response to 
PD-1/PD-L1 inhibitors 13,14, including PF-06801591.  The single tumor homogenous 
participant population is considered suitable for the collection of robust PK, safety and 
efficacy data.
In summary, the proposed dose of 600 mg Q6W will be investigated in addition to the 
previously studied dose 300 mg Q4W to support a modeling and simulation approach for 
extending the dosing interval from Q4W to Q6W. 
Objectives, Estimands and Endpoints
Objectives
Endpoints
Primary

Phase 1b: To assess DLT rate of 
PF-06801591 

Phase 2: To compare PF-06801591 
exposure of 600 mg SC Q6W to 
300 mg SC Q4W in terms of area 
under the concentration-time curve 
during the dosing interval (τ) 
(AUCτ) and Ctrough at steady state 

Phase 1b: DLTs observed in Cycle 1 
(28 days for Q4W and 42 days for 
Q6W)

Phase 2: PK parameters (AUCτ and 
Ctrough at steady state, at Week 12)
Secondary

To assess the overall safety 
and tolerability

Adverse events (AEs) (type, severity 
[as graded by National Cancer 
Institute (NCI) CTCAE version 5.0], 
timing, seriousness, and relationship 
to study treatments), laboratory test 
abnormalities (type, severity and 
timing)

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Objectives
Endpoints
•
To characterize the PK (for Phase 1b 
and Phase 2)
•
To characterize the immunogenicity
•
To assess anti-tumor activity 
•
To assess the correlation between 
clinical activity and PD-L1 
expression in baseline tumor tissue
•
PK parameters (e.g., Area Under the 
Curve (AUC) and Ctrough after first 
dose and Ctrough at steady state 
•
Immunogenicity (ADA/Nab 
incidence and titer)
•
OR and time to response (TTR) by 
investigator assessment using 
Response Evaluation Criteria in 
Solid Tumors (RECIST) v. 1.1 
•
PD-L1 expression in baseline
tumor tissue
 
 
 
 
 
 
 
 
 
Estimands
This section defines the estimands associated with the primary endpoints of the study.
The populations associated with estimands are as follows:
Phase 1b
•
Participants from Asian countries only with advanced solid tumors
Phase 2
•
Participants from global sites with 1L and 2L NSCLC
The endpoint definitions, the observations that will be considered in the derivation of the 
endpoint, and the associated analyses are described or referenced below.
Primary Estimand (DLT): DLT rate estimated based on data from DLT-evaluable 
participants during the DLT-evaluation period (Cycle 1, 28 days for 300 mg Q4W and 42 
Days for 600 mg Q6W) in Phase 1b.
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
Variable: Occurrence of DLTs.

Analysis population: DLT-evaluable participants defined as participants who receive 
at least one dose of study treatment in the Phase 1b and either experience DLT during 
the DLT-evaluation period or complete the DLT-evaluation period without DLT.
Participants without DLTs who withdraw from study treatment before receiving at 
least 75% of the planned dose of study drug in Cycle 1 for reasons other than 
treatment related toxicity are not evaluable for DLT. If there are participants non
evaluable for DLT, then additional participants can be enrolled to ensure that target 
number of DLT evaluable participants is reached.

Population-level summary measure: DLT rate defined as the number of 
DLT-evaluable participants with DLTs in the DLT-evaluation period divided by the 
number of DLT-evaluable participants in the DLT-evaluation period.
Primary Estimands (AUCτ and concentration at the end of the dosing interval (Ctrough) at 12 
weeks): Ratio of adjusted geometric means for AUCτ and Ctrough are estimated based on data 
from PK-evaluable participants in Phase 2. 

Variable: values of AUCτ and Ctrough at steady state, where τ = 4 weeks for Arm A2 
and 6 weeks for Arm B2.

Analysis population: PK-evaluable participants defined as all participants who 
received at least one dose of study drug in Phase 2 and have a Ctrough at 12 weeks.

Population-level summary measure: Ratio of adjusted geometric means for AUCτ and 
Ctrough. AUCτ and Ctrough will be summarized descriptively (n, mean, standard 
deviation, coefficient of variation (CV), median, minimum, maximum, geometric 
mean, its associated CV, and 95% confidence interval) by dose, cycle, and day.  Dose 
normalized parameters will be reported as appropriate.  The trough concentrations 
will be plotted for each dose using a box whisker plot by cycle and day in order to 
assess the attainment of steady state.
Overall Design:
This is a Phase 1b/2, open-label, multi-center study to evaluate PK, safety, efficacy and 
pharmacodynamics of PF-06801591 in Asian participants with advanced solid tumors 
(Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). The Phase 1b is 
composed of two parts, a dose escalation part and a dose expansion part. The Asian Phase 1b 
and global Phase 2 will be conducted in parallel and participants from Japan sites will be 
allowed to enter the global Phase 2 after Phase 1b meets safety criteria as defined by mTPI 
design. Chinese participants will be enrolled only in the Phase 1b part of this study.

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Phase 1b Design
Participants will be enrolled to 2 treatment arms

Arm A1: PF-06801591 300 mg SC Q4W (up to 6 DLT-evaluable participants in dose 
escalation and approximately 12 participants in dose expansion part) and 

Arm B1: PF-06801591 600 mg SC Q6W (up to 6 DLT-evaluable participants in dose 
escalation and approximately 12 participants in dose expansion part)
Dose escalation part: The first dose level of PF-06801591 will be 300 mg SC Q4W (Arm 
A1).  If this dose level is considered safe as per the Modified Toxicity Probability Interval 
(mTPI)12 design, the participant enrollment will start at the next dose level at 600 mg SC 
Q6W (Arm B1).  Each dose level will start with enrolling a group of 3-4 participants, 
allowing for additional participants (up to 6 in total) to be enrolled.  The DLT observation 
period will be 1 cycle (i.e. 4 weeks for Arm A1 and 6 weeks for Arm B1).
Safety of the doses will be determined using the adaptive mTPI design. The mTPI design 
uses a Bayesian statistics framework and a beta/binomial hierarchical model to compute the 
posterior probability of 3 toxicity intervals that reflect the relative difference between the 
toxicity rate of each dose level to the target probability (pT) rate (pT=0.30).  If the toxicity
rate of the currently used dose level is far smaller than pT, the mTPI will recommend 
escalating the dose level; if it is close to pT, the mTPI will recommend continuing at the 
current dose; if it is far greater than pT, the mTPI will recommend de-escalating the dose 
level.  The mTPI dose de-escalation/escalation recommendation will be based on the 
estimated toxicity rate and 3 intervals (underdosing, target toxicity, and excessive toxicity) as 
shown below:

If a dose is in underdosing [0, 0.25) toxicity interval: escalate to next higher dose;

If a dose is in target toxicity [0.25, 0.35) toxicity interval: stay at current dose;

If a dose is in excessive toxicity or overdosing [0.35, 1] toxicity interval: de-escalate 
to a lower dose.
Beginning with the first dose level, participants will be enrolled, treated, and monitored in 
cohorts of 3-4 participants during the 28-day or 42-day dose-limiting toxicity (DLT) 
evaluation period (Cycle 1) for Arms A1 and B1 respectively. 
Dose expansion part: Once the safety evaluation is completed in the dose escalation part, an 
expansion part will be opened and PF-06801591 will be further evaluated sequentially at 300 
mg SC Q4W (Arm A1) and at 600 mg SC Q6W (Arm B1) for further PK and safety 
evaluations. Each expansion dose level will enroll approximately 12 participants as long as 
DLT rate is below 0.35. After the enrollment in Arm A1 expansion part for DLT monitoring 
is completed and DLT rate is below 0.35, then Arm B1 expansion enrollment will be 
initiated. The DLT observation period will be 1 cycle (i.e. 4 weeks for Arm A1 and 6 weeks 

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for Arm B1). In the event of participant discontinuations prior to obtaining steady state PK at 
Cycle 4 for Q4W or Cycle 3 for Q6W, additional participants may be enrolled to achieve a 
minimum of 8 participants from mainland China at each dose level with evaluable PK at 
steady state.
Phase 2 Design
Participants will be randomized to 2 treatment arms in a 1:2 ratio: 

Arm A2: PF-06801591 300 mg SC Q4W (30 participants) and 

Arm B2: PF-06801591 600 mg SC Q6W (60 participants)
The randomization will be stratified by line of therapy (1st line vs 2nd line).
The primary objective is to compare PK exposure in terms of area under the curve over the 
dosing interval (AUCτ) and Ctrough at Week 12 (at steady state).  The objective of the 
exposure comparison is to demonstrate that the mean PK exposure obtained from 600 mg 
Q6W regimen is not lower than 20% of the PK exposure obtained from the reference 
regimen of 300 mg Q4W.   
For the primary PK objectives, a sample size of 90 participants (30 and 60 participants for 
Arms A2 (Reference) and B2 (Test), respectively) will provide at least 80% power that the 
lower bound for the 90% confidence interval (CI) for the ratio of Test to Reference treatment 
for the geometric mean of AUCτ and Ctrough at steady-state will be at least 80%.  This 
estimate is based on the assumption that the true ratio between (Test: PF-06801591 600 mg 
SC Q6W) and (Reference: PF-06801591 300 mg SC Q4W) treatments for both AUCτ and 
Ctrough is 1.0 and also assumes a CV of 26% for AUCτ and a CV of 40% for Ctrough.
The study will use interactive response technology (IRT) for participant 
randomization/treatment allocation in Phase 2.
DLT determination
For the Phase 1b, any of the following AEs occurring during the DLT observation period (the 
first cycle of treatment) which are attributable to the investigational product will be classified 
as DLTs. The DLT observation period will be 1 cycle.  Cycle 1 is defined as the time from 
the first dose to the next expected dose of PF-06801591. The planned treatment cycle 
duration is 4 weeks (28 days) for Arm A1 and 6 weeks (42 days) for Arm B1.

Grade 5 AE not clearly due to the underlying disease or extraneous causes

Hematologic toxicity:

Following Grade 3-4 hematologic AE:

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o
Grade 4 neutropenia lasting for > 7 days;  
o
Febrile neutropenia (defined as absolute neutrophil count (ANC) <1000/mm3
with a single temperature of >38.3°C (101 °F) or a sustained temperature of 
≥38°C (100.4°F) for more than 1 hour;
o
Grade ≥3 neutropenic infection (defined as ANC < 1000/mm3 or <1.0 × 109/L 
and Grade ≥3 infection); 
o
Grade 4 thrombocytopenia;
o
Grade 3 thrombocytopenia with clinically significant bleeding or requiring 
medical intervention (eg, transfusion);
o
Grade 4 anemia;
o
Grade 3 anemia requiring transfusion or steroids.

Non-Hematologic Toxicity:
o
Grade 4 non-hematologic AE;
o
Grade 3 AE lasting >3 days despite optimal supportive care;
o
Grade 3 central nervous system AE regardless of duration;
o
Meets criteria for drug-induced liver injury (see Appendix 6).

Delay of ≥3 weeks in receiving the next scheduled administration due to persisting 
treatment-related toxicities;
The following AEs will not be adjudicated as DLTs:

Any Grade 3 endocrinopathy that is adequately controlled by hormonal replacement.

Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites
of known or suspected tumor).

Isolated Grade 3-4 laboratory abnormalities that are not associated with clinical 
sequelae and are corrected with supplementation/appropriate management within 72 
hours of their onset.

Grade ≤ 3 injection reactions and allergic reactions will not be considered dose 
limiting as they are unlikely to be dose related, but all available information on these 
events will be collected. 

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In addition, clinically important persistent toxicities that are not included in the above criteria 
may be considered a DLT following review by the investigators and Pfizer.  All DLTs need 
to represent a clinically significant change from baseline. 
Disclosure Statement:
The Phase 1b is Dose Finding Treatment study with 2 arms. No masking will be used.
The Phase 2 is Parallel Treatment study with 2 arms. No masking will be used.
Number of Participants:
Approximately 126 participants will be assigned to study intervention.
Intervention Groups and Duration:
In the dose escalation part of Phase 1b, the first dose level of PF-06801591 will be 300 mg 
SC Q4W (Arm A1).  If this dose level is considered safe as per the mTPI design, the 
participant enrollment will start at the next dose level at 600 mg SC Q6W (Arm B1). Once 
the safety evaluation is completed in the dose escalation part, an expansion part will be 
opened and PF-06801591 will be evaluated sequentially at 300 mg SC Q4W (Arm A1) and at 
600 mg SC Q6W (Arm B1).
In the Phase 2, approximately 90 participants will be randomized in 1:2 ratio between 
2 treatment arms (in 1:2 ratio to 300 Q4W Arm A2 and 600 mg Q6W Arm B2).
The end of the study is defined up to 3 years after the last participant is randomized or if 
Sponsor determines the study should end earlier.
Data Monitoring Committee: No
1.2. Schema
The Study schema is presented in Figure 1.

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Figure 1.
Study Schema
Phase 1b population: Asian participants with advanced solid tumors; Phase 2 population: global participants 
with 1L and 2L NSCLC.
Phase 1b and Phase 2 will be conducted in parallel.
Arm A1, 300 
mg SC Q4W
(N=3-6)
Arm B1, 600 mg 
SC Q6W
(N=3-6)
Phase 1b
Phase 2
Arm B2, 600 mg 
SC Q6W
(N=60)
Randomize 1:2
Arm A2, 300 mg 
SC Q4W
(N=30)
Arm A1, 300 
mg SC Q4W
(N=12)
Arm B1, 600 
mg SC Q6W
(N=12)
expansion
expansion

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1.3. Schedule of Activities (SoA)
The SoA table provides an overview of the protocol visits and procedures. 
Refer to the STUDY ASSESSMENTS AND PROCEDURES section of the protocol for detailed information on each procedure and 
assessment required for compliance with the protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant. 
1.3.1. SoA for Phase 1b and Phase 2 (Q4W)
Table 1.
SoA for Phase 1b and Phase 2 for Q4W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 28 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last dose 
or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1 D8 D15 D22
D1
D1
Visit Window 
±0 ±1
±2
±2
±3
±3
+7
+7 +7 +7
Informed Consent
X
X (re-consent 
needed on Cycle 2 
Day 1 in Phase 1b 
in Japan)
Refer to Section 10.1.3
Inclusion and exclusion criteria
X
Tumor and Medical History
X
Tumor History: Includes history of disease under study 
including details of primary diagnosis, treatment history 
and staging.  Medical History: Includes history other than 
the cancer under study.  Includes prior and concurrent 
treatments.  Abnormalities observed during screening are 
to be considered as medical history. 
Physical Examination
X
X X* X*
X*
X
X
X
X
Refer to Section 8.2.1. 
Height
X

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Table 1.
SoA for Phase 1b and Phase 2 for Q4W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 28 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last dose 
or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1 D8 D15 D22
D1
D1
Visit Window 
±0 ±1
±2
±2
±3
±3
+7
+7 +7 +7
Weight
X
X
X
X
X
Vital Signs (BP/pulse 
rate/Temp)
X
X X* X*
X*
X
X
X
X
Refer to Section 8.2.2.  In Japanese participants SpO2 test 
should be done at the same time as vital signs collection.
ECOG Performance Status
X
X
X
X
X
Refer to Appendix 11.
Single/Triplicate 12-Lead ECG
X
X
X
X
X
X
X
Refer to Section 8.2.3. Triplicate ECG is required only at  
screening
Hematology
X
X X* X*
X*
X
X
X
X
Refer to Section 8.2.4 and Appendix 2.
Clinical Chemistry
X
X X* X*
X*
X
X
X
X
Refer to Section 8.2.4 and Appendix 2.
Coagulation
X
Refer to Section 8.2.4 and Appendix 2. Additional 
coagulation tests may be performed as clinically indicated.
ACTH/TSH
X
X
X (on cycle 4 
and then 
every 3 
cycles)
X
X
Refer to Section 8.2.4 and Appendix 2
KL-6/SpO2
If clinically indicated
Refer to Section 8.2.4 and Appendix 2. In Japanese 
participants SpO2 test should be done at the same time as 
vital signs collection.
Urinalysis
X
Refer to Section 8.2.4 and Appendix 2. Dipstick is 
acceptable.  Microscopic analyses if clinically indicated 
(eg, only after positive dipstick result).  If ≥ 2+ protein on 
urine dipstick, then collect spot urine sample to calculate 
UPCR or collect 24-hour urine. Additional urinalysis tests 
may be performed as clinically indicated.

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Table 1.
SoA for Phase 1b and Phase 2 for Q4W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 28 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last dose 
or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1 D8 D15 D22
D1
D1
Visit Window 
±0 ±1
±2
±2
±3
±3
+7
+7 +7 +7
Pregnancy Test (WOBCP only) 
X
X
X
X
X 
X
At 90 and 180 post-treatment period pregnancy status 
should be examined (allowed also by telephone call, unless 
the participant is visiting the site for other reasons) and 
pregnancy test can be conducted as necessary.  Refer to 
Section 8.2.5 and Appendix 2.
Randomization/Treatment 
allocation
X
The participant randomization number and treatment in 
Phase 2 will be assigned using an IRT system.
Study treatment should begin within 3 days from 
randomization/treatment allocation.
Study Treatment (PF-06801591)
X
X
X
Day 1 safety laboratory test results need to be reviewed by 
the investigator prior to dosing at the beginning of each 
cycle for dosing confirmation. 
Refer to Section 6.1.  
Local Site Injection Tolerability 
Assessment
X
X
Refer to Section 8.2.7. At Cycles > 3, the assessment will 
only be performed if clinically necessary.
Tumor Assessment
X
Every 12 weeks (±7 days) from C1D1 according to calendar, regardless of 
treatment delays and until progressive disease assessed by Investigator 
using RECIST v1.1 or start of new anti-cancer therapy.
Refer to Section 8.1.
AE
X
=============================
Assessment at 90 day post-treatment period may be done 
by telephone call, unless the participant is visiting the site 
for other reasons. 
Refer to Section 8.3.
SAE
X
=============================
Assessment at 90 day post-treatment period may be done 
by telephone call, unless the participant is visiting the site 
for other reasons. 
Refer to Section 8.3.

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Table 1.
SoA for Phase 1b and Phase 2 for Q4W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 28 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last dose 
or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1 D8 D15 D22
D1
D1
Visit Window 
±0 ±1
±2
±2
±3
±3
+7
+7 +7 +7
Prior and Concomitant 
Medication/Surgery /Radiation 
and non-drug supportive 
interventions
X
=============================
To be recorded in the CRF including supportive care drugs 
(eg, anti-emetic treatment and prophylaxis), drugs used to 
treat adverse events or chronic diseases, and non-drug 
supportive interventions (eg, transfusions).  Reporting 
period for concomitant medications for AEs and SAEs 
should follow respective guidance for AE and SAE 
reporting period. Refer to Section 6.5.
Contraception check
X
X
X
X
X
X X
X Assessments at 90 and 180 day post-treatment period may 
be done by telephone call, unless the participant is visiting 
the site for other reasons. 
Refer to Section 5.3 and Appendix 4.
* Assessments required only for participants enrolled in the Phase 1b.
# End of treatment: Obtain these assessments if not completed in the prior week, except for tumor assessment, which need not to be repeated if performed within 
the prior 12 weeks.

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1.3.2. SoA for Pharmacokinetics, Pharmacodynamics and Immunogenicity Assessments for Q4W dosing (Phase 1b and Phase 
2)
Table 2.
SoA for Pharmacokinetics, Pharmacodynamics and Immunogenicity Assessments for Q4W dosing
Visit Identifiers
Screening Cycle 1 (Days 1 to 
28)
Cycle 2Cycle 3 
Cycle 4 
Cycle 5 Cycles
>5 
EOT
Notes 
(up to 
28 days 
before 
D1)
D1
D8 D15 D22
D1
D1
D1
D8 D15 D22
D1
D1
Visit Window 
±0
±1 ±2
±2
±3
±3
±3
±3 ±3
±3
±3
±3
+7
PF-06801591 PK*
X 
(predose)
X
X
X
X 
(predose)
X 
(predose)
X 
(predose)
X
X
X
X 
(predose)
X 
(predose) 
only for 
cycles 6, 
8, 10)
X
Blood samples (3 mL) will be 
collected at each time point for 
PK analysis of PF-06801591. 
Refer to Section 8.5.
PF-06801591 
ADA/NAb
X 
(predose)
X 
(predose)
X 
(predose)
X 
(predose)
X 
(predose) 
only for 
cycles 6, 
8, 10)
X
Blood samples (6 mL) will be 
collected for ADA/NAb 
assessment. Refer to 
Section 8.8.3.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 2.
SoA for Pharmacokinetics, Pharmacodynamics and Immunogenicity Assessments for Q4W dosing
Visit Identifiers
Screening Cycle 1 (Days 1 to 
28)
Cycle 2Cycle 3 
Cycle 4 
Cycle 5 Cycles
>5 
EOT
Notes 
(up to 
28 days 
before 
D1)
D1
D8 D15 D22
D1
D1
D1
D8 D15 D22
D1
D1
Visit Window 
±0
±1 ±2
±2
±3
±3
±3
±3 ±3
±3
±3
±3
+7
 
 
 
 
 
 
 
 
 
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Table 2.
SoA for Pharmacokinetics, Pharmacodynamics and Immunogenicity Assessments for Q4W dosing
Visit Identifiers
Screening Cycle 1 (Days 1 to 
28)
Cycle 2Cycle 3 
Cycle 4 
Cycle 5 Cycles
>5 
EOT
Notes 
(up to 
28 days 
before 
D1)
D1
D8 D15 D22
D1
D1
D1
D8 D15 D22
D1
D1
Visit Window 
±0
±1 ±2
±2
±3
±3
±3
±3 ±3
±3
±3
±3
+7
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* For participants in Japan, overnight stay from Day 1 cycle 1 is allowed.
.
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1.3.3. SoA for Phase 1b and 2 (Q6W)
Table 3.
Schedule of Activities for Phase 1b and Phase 2 for Q6W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 42 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 
2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last 
dose or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1D8D15D22D29D36
D1
D1
Visit Window 
±0 ±1 ±2
±2
±2
±2
±3
±3
+7
+7 +7
+7
Informed Consent 
X
X (re-consent 
needed on 
Cycle 2 Day 1 
in Phase 1b in 
Japan)
Refer to Section 10.1.3. 
Inclusion and exclusion criteria
X
Tumor and Medical History
X
Tumor History: Includes history of disease under study 
including details of primary diagnosis, treatment history 
and staging.  Medical History: Includes history other 
than the cancer under study.  Includes prior and 
concurrent treatments.  Abnormalities observed during 
screening are to be considered as medical history.
Physical Examination
X
X X* X* X* X*
X*
X
X
X
X
Refer to Section 8.2.1. 
Height
X
Weight
X
X
X
X
X
Vital Signs 
(BP/pulse rate/Temp)
X
X X* X* X* X*
X*
X
X
X
X
Refer to Section 8.2.2. In Japanese participants SpO2 test 
should be done at the same time as vital signs collection.
ECOG Performance Status
X
X
X
X
X
Refer to Appendix 11.
Single/Triplicate 12-Lead ECG
X
X X
X
X
X
X
Refer to Section 8.2.3. Triplicate ECG is required only at 
screening
Hematology
X
X X* X* X* X*
X*
X
X
X
X
Refer to Section 8.2.4 and Appendix 2.

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Table 3.
Schedule of Activities for Phase 1b and Phase 2 for Q6W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 42 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 
2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last 
dose or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1D8D15D22D29D36
D1
D1
Visit Window 
±0 ±1 ±2
±2
±2
±2
±3
±3
+7
+7 +7
+7
Clinical Chemistry
X
X X* X* X* X*
X*
X
X
X
X
Refer to Section 8.2.4 and Appendix 2.
Coagulation
X
Refer to Section 8.2.4 and Appendix 2. Additional 
coagulation tests may be performed as clinically 
indicated.
ACTH/TSH
X
X
X (on 
Cycle 4 
and then 
every 2 
cycles)
X
X
Refer to Section 8.2.4 and Appendix 2.
KL-6/SpO2
If clinically indicated
Refer to Section 8.2.4 and Appendix 2. In Japanese 
participants SpO2 test should be done at the same time as 
vital signs collection.
Urinalysis
X
Refer to Section 8.2.4 and Appendix 2. Dipstick is 
acceptable.  Microscopic analyses if clinically indicated
(eg, only after the positive dipstick result).  If ≥ 2+ 
protein on urine dipstick, then collect spot urine sample 
to calculate UPCR or collect 24-hour urine. Additional 
urinalysis tests may be performed as clinically indicated.
Pregnancy Test (WOBCP only)
X
X
X
X
X
X
At 90 and 180 post-treatment period pregnancy status 
should be examined (allowed also by telephone call, 
unless the participant is visiting the site for other reasons) 
and pregnancy test can be conducted as necessary. 
Refer to Section 8.2.5 and Appendix 2.
Randomization/Treatment 
allocation
X
The participant randomization number and treatment in 
Phase 2 will be assigned using an IRT system. 
Study treatment should begin within 3 days from 
randomization/treatment allocation.

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Table 3.
Schedule of Activities for Phase 1b and Phase 2 for Q6W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 42 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 
2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last 
dose or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1D8D15D22D29D36
D1
D1
Visit Window 
±0 ±1 ±2
±2
±2
±2
±3
±3
+7
+7 +7
+7
Study Treatment (PF-06801591)
X
X
X
Day 1 safety laboratory test results need to be reviewed 
by the investigator prior to dosing at the beginning of 
each cycle for dosing confirmation.
Refer to Section 6.1. 
Local Site Injection Tolerability 
Assessment
X
X
Refer to Section 8.2.7. At Cycles > 3, the assessment will 
only be performed if clinically necessary.
Tumor Assessment
X
Every 12 weeks (±7 days) from C1D1 according to calendar, regardless of 
treatment delays and until progressive disease assessed by Investigator 
using RECIST v1.1 or start of new anti-cancer therapy.
Refer to Section 8.1.
AE
X
=============================
Assessment at 90 day post-treatment period may be done 
by telephone call, unless the participant is visiting the site 
for other reasons. 
Refer to Section 8.3.
SAE
X
=============================
Assessment at 90 day post-treatment period may be done 
by telephone call, unless the participant is visiting the site 
for other reasons. 
Refer to Section 8.3.
Prior and Concomitant 
Medication/Surgery /Radiation 
and non-drug supportive 
interventions
X
=============================
To be recorded in the CRF including supportive care 
drugs (eg, anti-emetic treatment and prophylaxis), drugs 
used to treat adverse events or chronic diseases, and 
non-drug supportive interventions (eg, transfusions).  
Reporting period for concomitant medications for AEs 
and SAEs should follow respective guidance for AE and 
SAE reporting period. Refer to Section 6.5.
Contraception check
X
X
X
X
X
X
X
X Assessments at 90 and 180 day post-treatment period 
may be done by telephone call, unless the participant is 
visiting the site for other reasons. 
Refer to Section 5.3 and Appendix 4.

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Table 3.
Schedule of Activities for Phase 1b and Phase 2 for Q6W dosing
Procedure
Screening 
(up to 
28 days 
before 
D1)
Treatment Period (One Cycle = 42 days)
Post-Treatment 
Period
Notes
Cycle 1
Cycle 
2-3
Cycles
≥4
EOT# D 
30
D
90
D 
180
Post-treatment period: visits at 30, 90, and 180 days 
after last dose.
Post-treatment period ends at 180 days after last 
dose or at the time a new anticancer treatment starts 
whichever comes first (Refer to Section 8.3.1.1 for 
SAEs).
D1D8D15D22D29D36
D1
D1
Visit Window 
±0 ±1 ±2
±2
±2
±2
±3
±3
+7
+7 +7
+7
* Assessments required only for participants enrolled in the Phase 1b
# End of treatment: Obtain these assessments if not completed in the prior week, except for tumor assessment, which need not to be repeated if performed within 
the prior 12 weeks.

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1.3.4. SoA for Pharmacokinetics, Pharmacodynamics and Immunogenicity Assessments for Q6W dosing  (Phase 1b and Phase 
2)
Visit identifiers
Screening
Cycle 1 (Days 1 to 42)
Cycle 2 
Cycle 3 (Days 1 to 42)
Cycle 
≥ 4
EOT
Notes
(up to 
28 days 
before 
D1)
D1
D8D15D22D29D36
D1
D1
D8D15D22D29D36
D1
Visit Window 
±0
±1 ±2 ±2 ±2 ±2
±3
±3
±3 ±3 ±3 ±3 ±3
±3
+7
PF-06801591 PK*
X 
(predose)
X
X
X
X 
(predose)
X 
(predose)
X
X
X
X 
(predose) 
only for 
cycles 4, 
5, 7
X
Blood samples (3 mL) will be collected for PK 
analysis of PF-06801591. Refer to Section 8.5
PF-06801591 ADA/ 
NAb
X 
(predose)
X 
(predose)
X 
(predose)
X 
(predose) 
only for 
cycles 4, 
5, 7
X
Blood samples (6 mL) will be collected for 
ADA/NAb assessment. Refer to Section 8.8.3.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Visit identifiers
Screening
Cycle 1 (Days 1 to 42)
Cycle 2 
Cycle 3 (Days 1 to 42)
Cycle 
≥ 4
EOT
Notes
(up to 
28 days 
before 
D1)
D1
D8D15D22D29D36
D1
D1
D8D15D22D29D36
D1
Visit Window 
±0
±1 ±2 ±2 ±2 ±2
±3
±3
±3 ±3 ±3 ±3 ±3
±3
+7
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* For participants in Japan, overnight stay from Day 1 cycle 1 is allowed
 
.
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2. INTRODUCTION
This is a Phase 1b/2 protocol to evaluate pharmacokinetics (PK), safety, efficacy, and 
pharmacodynamics of sasanlimab (PF-06801591), a programmed death-1(PD-1) antagonist 
monoclonal antibody (mAb) in participants with advanced malignancies. The primary 
purpose of this study is to assess the safety and tolerability of PF-06801591 in Asian 
participants (Phase 1b) and to compare PK exposure of 2 PF-06801591 subcutaneous (SC) 
regimens: 300 mg Q4W and 600 mg Q6W (Phase 2).  Data gathered from this study will 
support modeling and simulation approaches for optimizing the dosing interval for PF-
06801591.
2.1. Study Rationale
This is a Phase 1b/2 protocol to evaluate pharmacokinetics (PK), safety, efficacy, and 
pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal 
antibody (mAb) in participants with advanced malignancies.  This study consists of 2 parts: 
Phase 1b for participants with advanced malignancies in Asia only and a global Phase 2 in 
participants with non-small cell lung cancer (NSCLC).
The primary purpose is to assess the safety and tolerability of PF-06801591 in Asian 
participants (Phase 1b) and to support modeling and simulation approaches for optimizing 
the dosing interval for PF-06801591. 
The treatments with PD-1/PD-L1 inhibitors have demonstrated significant survival benefit 
for multiple tumor types.  To date, all approved PD-1/PD-L1 inhibitors are administered 
intravenously (IV) 1-5.  As participants receiving these agents achieve durable responses and 
long-term survival, the subcutaneous (SC) treatment administration offers an innovative 
approach decreasing medical costs and making more efficient use of resources while 
simultaneously improving participant experience and satisfaction 6-8. 
In Study B8011001, an open-label, multi-center Phase 1 study, the safety, tolerability, 
pharmacokinetics (PK), immunogenicity, pharmacodynamics and efficacy of PF-06801591 
were evaluated after IV or SC administration in participants with locally advanced or 
metastatic solid tumors.  PF-06801591, a PD-1 inhibitor, has shown safety and efficacy in 
tumor types tested, regardless of route of administration (Section 2.2.4).  Based on Study 
B8011001, the safety and tolerability of the PF-06801591, 300 mg Q4W, administered SC 
was selected for further evaluation in Phase 3 studies.
In the Phase 1b part of this study, 300 mg Q4W SC will be evaluated in Asian participants.  
Participants with advanced solid tumor will be enrolled for safety and PK evaluations.  Since 
no dose-limiting toxicities (DLTs) occurred in Study B8011001 and no ethnic differences 
have been identified for PF-06801591  or other PD-1 or PD-L1 inhibitors, no safety concerns 
are expected.
A second dose level with a longer dosing interval (600 mg Q6W) will be also investigated in 
Asian participants in Phase 1b to support potential future schedule optimization for Asian 
population.  The Asian Phase 1b and global Phase 2 will be conducted in parallel. 
Participants from Japan sites will be allowed to enter the global Phase 2 after Phase 1b meets 
safety criteria as defined by modified Toxicity Probability Interval (mTPI) design. Chinese 
participants will be enrolled only in the Phase 1b part of this study.

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Phase 1b is composed of two parts, a dose escalation part and a dose expansion part. Once 
the safety evaluation is completed in the dose escalation part, the expansion part will be 
opened for further safety and PK assessment in Asian participants.
In the global Phase 2 part of this study, the PK profile of PF-06801591 is planned to be 
characterized at 2 different dose levels and intervals (300 mg Q4W and 600 mg Q6W) to 
support further optimization of dosing schedule. Participants will be randomized in a 1:2 
ratio between 300 mg Q4W and 600 mg Q6W. The aim of the randomized Phase 2 is to 
explore and compare the PK exposure of PF-06801591 between those two regimens. The 
findings will support a modeling and simulation approach for extending the dosing interval 
from Q4W to Q6W and for enabling a flexible dosing interval for future combination 
programs. 
Recently, the PD-1 inhibitors, pembrolizumab and nivolumab, are also being evaluated at 
different dose intervals using a similar approach9,10. 
The study will enroll participants with NSCLC, a tumor with clinical evidence of response to 
PD-1/PD-L1 inhibitors 13,14, including PF-06801591.  The single tumor homogenous 
participant population is considered suitable for the collection of robust PK, safety and 
efficacy data.
In summary, the proposed dose of 600 mg Q6W will be investigated in addition to the 
previously studied dose 300 mg Q4W to support a modeling and simulation approach for 
extending the dosing interval from Q4W to Q6W. 
2.2. Background
PF-06801591 is a humanized, hinge region-stabilized IgG4 mAb, with antagonistic activities 
specific for human PD-1. It can selectively and reversibly bind to human PD-1 and block the 
interaction between PD-1 and PD-L1/PD-L2. PF-06801591 has shown to increase human 
T-cell proliferation and cytokine secretion (interferon gamma [IFN-] and interleukin [IL]-2) 
when PD-L1 is highly expressed in both in-vitro and in-vivo systems. PF-06801591 
blockade of the interaction between PD-1 on T cells and its ligands on tumor cells is 
expected to restore anti-tumor immunity and form the basis for an immunotherapeutic 
approach to treat cancer.
2.2.1. Nonclinical Pharmacology
Results from PF-06801591 nonclinical pharmacology studies are consistent with the 
expected effects of blocking the PD-1 pathway and demonstrate the potential to enhance 
tumor immuno-surveillance and anti-tumor immune responses.
PF-06801591 binds to human PD-1 with high affinity to both recombinant PD-1 protein and 
cell surface expressed PD-1. Binding affinity to cynomolgus monkey PD-1 was similar to 
human PD-1. The ability of PF-06801591 to block the PD-1 pathway, as measured on 
primary human and primary cynomolgus monkey T cells, was shown by increased T-cell 
proliferation and cytokine secretion in both of these systems.

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See Section 5.1 of the PF-06801591 Investigator’s Brochure (IB)11 for detailed information 
on in vitro and in vivo nonclinical studies.
2.2.2. Nonclinical Pharmacokinetics and Metabolism
Single- and repeat-dose PK were assessed after IV dosing of PF-06801591 in monkeys.  
Following single or repeat IV dosing, systemic exposure (as assessed by the maximum 
observed concentration [Cmax] and area under the concentration-time curve [AUC]) increased 
with increasing dose.  In the GLP toxicity studies, systemic exposure was higher after repeat 
dosing, and there were no sex-related differences observed in exposure.  Anti-drug antibody 
(ADA) was observed after repeat IV dosing in monkeys.
PF-06801591 has been shown to induce cytokine production (IFNγ, tumor necrosis factor 
(TNF)α, IL-2).  However, cytokine-mediated drug interactions observed in the clinic for 
other drugs have been modest, resulting in less than 2-fold changes in the exposure of a 
co-administered small molecule drug.
See Section 5.2 of the PF-06801591  IB 11 for detailed information on nonclinical studies.
2.2.3. Nonclinical Safety
The nonclinical safety profile of PF-06801591 has been well-characterized in repeat-dose 
toxicity studies in cynomolgus monkeys up to 1 month in duration.  The IV and SC routes of 
exposure were assessed as these are the intended routes of administration in initial clinical 
studies.
In repeat-dose toxicity studies up to 1-month duration in which PF-06801591 was 
administered via the intravenous or subcutaneous routes, no direct target organ toxicities 
were observed.  The key changes associated with PF-06801591 treatment of cynomolgus 
monkeys was minimal to mild mononuclear cellular infiltration of various tissues that 
persisted and were likely a result of prolonged exposure to PF-06801591 throughout the 
entire recovery phase.  These findings are both consistent with expected pharmacology, and 
previously described in monkey toxicity studies with similar compounds targeting the PD-1 
receptor.
See Section 5.3 of the PF-06801591 IB 11 for detailed information regarding nonclinical 
toxicology studies.
2.2.4. Clinical Overview
PF-06801591 is being evaluated as a single-agent in Study B8011001; in combination with 
PF-06753512, a vaccine-based immunotherapy regimen (VBIR) for prostate cancer, in 
Study B7791001; and in combination with PF-06936308, a VBIR-2 for advanced NSCLC 
and metastatic triple negative breast cancer (mTNBC), in Study C3621001.  
Study B8011001 is an ongoing Phase 1, open-label, dose escalation and expansion study of 
PF-06801591 in participants with locally advanced or metastatic melanoma, squamous cell 
carcinoma of the head and neck (SCCHN), ovarian cancer, sarcoma, non-small cell lung 

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carcinoma (NSCLC), urothelial carcinoma (UC) or other solid tumors.  The primary purpose 
of Study B8011001 is to evaluate safety and early signs of efficacy of PF-06801591.  This 
clinical study was divided into a dose escalation (Part 1) Phase, and a dose expansion (Part 2) 
Phase.  One hundred forty-six (146) participants have been dosed on the study.  Forty (40) 
participants were enrolled into Part 1 and 106 participants (68 with NSCLC and 38 with 
urothelial carcinoma [UC]) were enrolled into Part 2.  In Part 1, 4 pre-specified IV dose 
levels (0.5, 1, 3, and 10 mg/kg administered every 3 weeks [Q3W]), and 1 subcutaneous (SC) 
dose level (300 mg administered every 4 weeks [Q4W]) was evaluated for safety. No DLTs 
were observed and thus, there was no maximum tolerated dose (MTD) identified.
Efficacy
As of the latest data cut-off date of 27 December 2018, in Part 1, objective response (OR)
was achieved in 8 out of 40 (20%) participants; partial response (PR) was observed for 
ovarian cancer (3 of 15), SCCHN (2 of 7), sarcoma (1 of 6), small-cell lung cancer (1 of 3), 
and microsatellite instability-high endometrial adenocarcinoma (1 of 1); The median duration 
of treatment was 4.0 months; Disease control rate (DCR; best overall response of complete or 
partial response, or stable disease [SD] with minimum duration of 35 days) was achieved in 
52.5% (21 out of 40 participants).  Three (3) participants are still receiving treatment in Part 
1.  In Part 2, 11 out of 67 participants with NSCLC (one patient was not included because did 
not have any post-baseline tumor assessment) achieved PR (objective response rate [ORR]
16.4%) and 7 participants out of 37 with UC (one patient was not included because did not 
have any post-baseline tumor assessment) achieved PR (ORR 18.9%).  The median duration 
of treatment was 2.8 months.  The ORR was 25% (7 of 28) in participants with NSCLC with 
≥1% tumor cell PD-L1 expression by SP263 antibody testing.  Additionally, 26 participants 
with NSCLC achieved the best overall response of SD, for a DCR of 55.2%.  A total of 
12 participants with UC achieved the best overall response of SD, resulting in a DCR of 
51.4%.  The median duration of follow up was 5.1 months for participants with NSCLC and 
3.0 months for participants with UC.  Fifty-five (55) participants are still receiving treatment 
in Part 2.  
Safety
A total of 52 (35.6%) participants in Part 1 and Part 2 (regardless of IV or SC treatment) 
reported all-causality serious adverse events (SAEs), including 4 (2.7%) participants with 
treatment-related SAEs (3 pneumonitis and 1 arrhythmia). 
Of 106 participants exposed to 1 or more 300 mg SC injections of study drug, 98 participants 
(92.5%) experienced at least one treatment-emergent AE while on the study. The most 
common AEs experienced by ≥ 10% of participants were anemia (n = 23, 21.7%) followed 
by disease progression (n = 13, 12.3%), dyspnea (n = 13, 12.3%), amylase increase (n = 11, 
10.4%), decreased appetite (n = 11, 10.4%), and pruritis (n = 11, 10.4%). Thirteen (13) 
participants (12.3%) experienced maximum Grade 3 AEs, and 6 (5.7%) experienced 
maximum Grade 4 AEs. Grade 5 AEs (n = 23, 21.7%), reportable within 150 days from last 
study treatment, were disease progression (n = 13), death not otherwise specified (n = 2), 
cerebral infarction, urinary tract infection, arrhythmia, gastric ulcer hemorrhage, cognitive 

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disorder, urosepsis, general health deterioration and cardiac failure (n = 1 each). A total of 
58 participants (54.7%) had a least one treatment related adverse event (TRAE) while on 
study. The most common TRAEs (experienced by ≥5% of participants) were 
hyperthyroidism (n = 10, 9.4%), hypothyroidism (n = 7, 6.6%), lipase increase (n = 7, 6.6%), 
pruritis (n = 7, 6.6%), and amylase increase (n = 6, 5.7%). Nine (9) participants had 
maximum Grade 3 TRAEs and 1 had maximum Grade 4 TRAE. Grade 3 TRAEs were lipase 
increase, (n = 3) amylase increase (n = 2), pneumonitis, decreased appetite, lymphocyte 
count decrease, and creatinine increased (n = 1 each). There was one Grade 4 TRAE of 
white blood cell count/neutrophil decrease.  One Grade 5 treatment-related arrhythmia was 
reported.  The Grade 5 arrhythmia was assessed as unrelated by the sponsor.
No significant injection site reactions were reported.  Safety data including possible irAE are 
mostly consistent with the known safety profile of anti-PD-1 treatment.
Detailed information about these events can be found in the PF-06801591 IB 11.
Pharmacokinetics
Single- and multiple-dose pharmacokinetics (PK) of PF-06801591 is being evaluated in 
Study B8011001.  Preliminary PK data suggest PF-06801591 exhibits PK characteristics 
typical of IgG4 monoclonal antibodies.  The mean maximum serum concentration (Cmax) and 
area under the serum concentration-time curve over the dosing interval (AUCτ) of PF-
06801591 increased in an approximately dose-proportional manner over the dose range of 
0.5 -10 mg/kg following IV administration.  After SC administration at 300 mg, PF-
06801591 was slowly absorbed, with a median Tmax of approximately 8 days.  The estimated 
median terminal half-life of PF-06801591 is ~ 20 days for IV, ~ 30 days for SC (data on file).  
Initial PK modeling suggests that Ctrough levels can be maintained with longer dosing 
intervals. AUCss at 600 mg every 6 weeks (Q6W) has been estimated to be ~30% and 
Ctrough ~ 11% higher compared to the 300 mg Q4W dose level, with exposure expected to be 
well below the highest dose level tested in humans (10 mg/kg Q3W, highest dose level 
investigated in Study B8011001; no DLT were observed).
Immunogenicity
Based on a preliminary immunogenicity assessment in participants from Study B8011001, 
3 participants (8.6%) were positive for treatment-emergent ADAs following IV (n=21) or SC 
(n=14) administration of PF-06801591.  The presence of ADAs was not associated with 
hypersensitivity or infusion reactions nor significantly affected PF-06801591 clearance. No 
neutralizing antibodies (NAbs) against PF-06801591 were detected in any of the ADA 
positive participants.
No clinical data from Study B7791001 and Study C3621001 are available.   

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2.3. Benefit/Risk Assessment
Based on the nonclinical and Phase 1 clinical data available to date, the conduct of the trial
with the proposed single agent PF-06801591 doses and regimens is considered justifiable.
Single-agent PF-06801591 has been evaluated in Study B8011001 after IV (0.5, 1, 3, or 
10 mg/kg Q3W) and SC (300 mg Q4W) administration and the clinical safety data available 
to date, in participants with advanced or metastatic solid tumors, suggest an acceptable safety 
profile. PF-06801591 is well-tolerated and with a low frequency of treatment-related SAEs. 
Most of the observed events were either in line with those expected in participants with 
advanced solid tumors or with similar class effects of monoclonal antibodies blocking the 
PD-1/PD-L1 axis.  No relevant injection site AEs were observed.
However, measures including guidelines for treatment interruption and permanent 
discontinuation in case of toxicities, guidelines for steroid treatment, have been implemented.
The dose of 600 mg Q6W has been selected to support a modeling and simulation approach 
for extending the dosing interval of any approved indication to Q6W and to support future 
combination development across indications.  As per initial PK modeling evaluation the 
expected PF-06801591 exposure with this regimen is well below the highest dose level tested 
in humans (10 mg/kg Q3W, with no DLTs) and therefore safety concerns are not expected. 
Additionally, responses to PF-06801591 have been observed in Study B8011001 in a range 
of tumor types, including NSCLC, bladder cancer, ovarian cancer, SCCHN, sarcoma, SCLC 
and microsatellite instability-high endometrial adenocarcinoma (see PF-06801591 IB 11).  
The significant clinical benefit in terms of ORR and DCR (See Section 2.2.4) is consistent 
with the ORR and DCR in the same tumor types reported for other agents of the same class. 
These results, together with the acceptable safety profile, as currently demonstrated by the 
ongoing Phase 1 trial B8011001, support the hypothesis that PF-06801591 may represent an 
important therapeutic approach in participants with advanced solid tumors. Thus, the 
projected benefit/risk of B8011001 is favorable for investigation in this advanced cancer 
participant population.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of the study drug may be found in the PF-06801591 IB 11, which is the single 
reference safety document (SRSD) for this study. 

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3. OBJECTIVES, ESTIMANDS AND ENDPOINTS
Objectives
Endpoints
Primary
•
Phase 1b: To assess DLT rate of 
PF-06801591 
•
Phase 2: To compare PF-06801591 
exposure of 600 mg SC Q6W to 300 
mg SC Q4W in terms of AUCτ and 
Ctrough at steady state 
•
Phase 1b: DLTs observed in Cycle 1
(28 days for Q4W and 42 days for 
Q6W)
•
Phase 2: PK parameters (AUCτ and 
Ctrough at steady state, at Week 12)
Secondary
•
To assess the overall safety 
and tolerability
•
To characterize the PK (for Phase 1b 
and Phase 2)
•
To characterize the immunogenicity
•
To assess anti-tumor activity 
•
To assess the correlation between 
clinical activity and PD-L1 
expression in baseline tumor tissue
•
AEs (type, severity [as graded by 
NCI CTCAE version 5.0], timing, 
seriousness, and relationship to 
study treatments), laboratory test 
abnormalities (type, severity and 
timing)
•
PK parameters (e.g., AUC and 
Ctrough after first dose and Ctrough at 
steady state. 
•
Immunogenicity (ADA/NAb 
incidence and titer)
•
OR and Time-to-response (TTR) by 
investigator assessment using 
RECIST v. 1.1 
•
PD-L1 expression in baseline
tumor tissue.
 
 
 
 
 
 
 
 
 
CCI

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Estimands
This section defines the estimands associated with the primary endpoints of the study.
The populations associated with estimands are as follows:
Phase 1b

Participants from Asian countries only with advanced solid tumors
Phase 2

Participants from global sites with 1L and 2L NSCLC
The endpoint definitions, the observations that will be considered in the derivation of the 
endpoint, and the associated analyses are described or referenced below.
Primary Estimand (DLT): DLT rate estimated based on data from DLT-evaluable 
participants during the DLT-evaluation period (Cycle 1, 28 days for 300 mg Q4W and 42 
Days for 600 mg Q6W) in Phase 1b.

Variable: Occurrence of DLTs.  DLTs are defined in Section 4.1.

Analysis population: DLT-evaluable participants defined as participants who receive 
at least 1 dose of study treatment in the Phase 1b and either experience DLT during 
the DLT-evaluation period or complete the DLT-evaluation period without DLT.
Participants without DLTs who withdraw from study treatment before receiving at 
least 75% of the planned dose of study drug in Cycle 1 for reasons other than 
treatment-related toxicity are not evaluable for DLT. If there are participants non 
evaluable for DLT, then additional participants can be enrolled to ensure that target 
number of DLT evaluable participants is reached

Population-level summary measure: DLT rate defined as the number of 
DLT-evaluable participants with DLTs in the DLT-evaluation period divided by the 
number of DLT-evaluable participants in the DLT-evaluation period.
Primary Estimands (AUCτ and Ctrough at 12 weeks): Ratio of adjusted geometric means for 
AUCτ and Ctrough are estimated based on data from PK-evaluable participants in Phase 2. 

Variable: values of AUCτ and Ctrough at steady state, where τ = 4 weeks for Arm A2 
and 6 weeks for Arm B2.

Analysis population: PK-evaluable participants defined as all participants who 
received at least one dose of study drug in Phase 2 and have a Ctrough at 12 weeks.

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
Population-level summary measure: Ratio of adjusted geometric means for AUCτ and 
Ctrough.  AUCτ and Ctrough will be summarized descriptively (n, mean, standard 
deviation, coefficient of variation (CV), median, minimum, maximum, geometric 
mean, its associated CV, and 95% confidence interval) by dose, cycle, and day.  Dose 
normalized parameters will be reported as appropriate.  The trough concentrations 
will be plotted for each dose using a box whisker plot by cycle and day in order to 
assess the attainment of steady state.

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4. STUDY DESIGN
     
4.1. Overall Design
This is a Phase 1b/2, open-label, multi-center study to evaluate PK, safety, efficacy and 
pharmacodynamics of PF-06801591 in Asian participants with advanced solid tumors 
(Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). The Phase 1b is 
composed of two parts, a dose escalation part and a dose expansion part. The Asian Phase 1b 
and global Phase 2 will be conducted in parallel and participants from Japan sites will be 
allowed to enter the global Phase 2 after Phase 1b meets safety criteria as defined by mTPI 
design. Chinese participants will be enrolled only in the Phase 1b part of this study.
Phase 1b Design
Participants will be enrolled to 2 treatment arms

Arm A1:  PF-06801591 300 mg SC Q4W (up to 6 DLT-evaluable participants in dose 
escalation and approximately 12 participants in dose expansion part) and 

Arm B1: PF-06801591 600 mg SC Q6W (up to 6 DLT-evaluable participants in dose 
escalation and approximately 12 participants in dose expansion part)
Dose escalation part: The first dose level of PF-06801591 will be 300 mg SC Q4W (Arm 
A1).  If this dose level is considered safe as per the mTPI design, the participant enrollment 
will start at the next dose level at 600 mg SC Q6W (Arm B1).  Each dose level will start with 
enrolling a group of 3-4 participants, allowing for additional participants (up to 6 in total) to 
be enrolled.  The DLT observation period will be 1 cycle (i.e. 4 weeks for Arm A1 and 6 
weeks for Arm B1).
Safety of the doses will be determined using the adaptive mTPI design. The mTPI design 
uses a Bayesian statistics framework and a beta/binomial hierarchical model to compute the 
posterior probability of 3 toxicity intervals that reflect the relative difference between the 
toxicity rate of each dose level to the target probability (pT) rate (pT=0.30).  If the toxicity 
rate of the currently used dose level is far smaller than pT, the mTPI will recommend 
escalating the dose level; if it is close to pT, the mTPI will recommend continuing at the 
current dose; if it is far greater than pT, the mTPI will recommend de-escalating the dose 
level.  The mTPI dose de-escalation/escalation recommendation will be based on the 
estimated toxicity rate and 3 intervals (underdosing, target toxicity, and excessive toxicity) as 
shown below:

If a dose is in underdosing [0, 0.25) toxicity interval: escalate to next higher dose;

If a dose is in target toxicity [0.25, 0.35) toxicity interval: stay at current dose;

If a dose is in excessive toxicity or overdosing [0.35, 1] toxicity interval: de-escalate 
to a lower dose.

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Beginning with the first dose level, participants will be enrolled, treated, and monitored in 
cohorts of 3-4 participants during the 28-day or 42-day dose-limiting toxicity (DLT) 
evaluation period (Cycle 1) for Arms A1 and B1 respectively. 
Dose expansion part: Once the safety evaluation is completed in the dose escalation part, an 
expansion part will be opened and PF-06801591 will be further evaluated sequentially at 300 
mg SC Q4W (Arm A1) and at 600 mg SC Q6W (Arm B1) for further PK and safety 
evaluations. Each expansion dose level will enroll approximately 12 participants as long as 
DLT rate is below 0.35. After the enrollment in Arm A1 expansion part for DLT monitoring 
is completed and DLT rate is below 0.35, then Arm B1 expansion enrollment will be 
initiated. The DLT observation period will be 1 cycle (i.e. 4 weeks for Arm A1 and 6 weeks 
for Arm B1). In the event of participant discontinuations prior to obtaining steady state PK at 
Cycle 4 for Q4W or Cycle 3 for Q6W, additional participants may be enrolled to achieve a 
minimum of 8 participants from mainland China at each dose level with evaluable PK at 
steady state.
Phase 2 Design
Participants will be randomized to 2 treatment arms in a 1:2 ratio: 

Arm A2: PF-06801591 300 mg SC Q4W (30 participants) and 

Arm B2: PF-06801591 600 mg SC Q6W (60 participants)
The randomization will be stratified by line of therapy (1st line vs 2nd line).

1st line: no prior therapy for advanced or metastatic disease

2nd line: one prior therapy for advanced or metastatic disease 
The primary objective is to compare PK exposure in terms of area under the curve over the 
dosing interval (AUCτ) and Ctrough at Week 12 (at steady state).  The objective of the 
exposure comparison is to demonstrate that the mean PK exposure obtained from 600 mg 
Q6W regimen is not lower than 20% of the PK exposure obtained from the reference 
regimen of 300 mg Q4W.   
For the primary PK objectives, a sample size of 90 participants (30 and 60 participants for 
Arms A2 (Reference) and B2 (Test), respectively) will provide at least 80% power that the 
lower bound for the 90% confidence interval (CI) for the ratio of Test to Reference treatment 
for the geometric mean of AUCτ and Ctrough at steady-state will be at least 80%.  This 
estimate is based on the assumption that the true ratio between (Test: PF-06801591 600 mg 
SC Q6W) and (Reference: PF-06801591 300 mg SC Q4W) treatments for both AUCτ and 
Ctrough is 1.0 and also assumes a CV of 26% for AUCτ and a CV of 40% for Ctrough.
The study will use interactive response technology (IRT) for participant 
randomization/treatment allocation in Phase 2.

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DLT determination
For the Phase 1b, any of the following AEs occurring during the DLT observation period (the 
first cycle of treatment) which are attributable to the investigational product will be classified 
as DLTs. The DLT observation period will be 1 cycle.  Cycle 1 is defined as the time from 
the first dose to the next expected dose of PF-06801591. The planned treatment cycle 
duration is 4 weeks (28 days) for Arm A1 and 6 weeks (42 days) for Arm B1.

Grade 5 AE not clearly due to the underlying disease or extraneous causes

Hematologic toxicity:

Following Grade 3-4 hematologic AE:
o
Grade 4 neutropenia lasting for > 7 days;  
o
Febrile neutropenia (defined as absolute neutrophil count (ANC) <1000/mm3
with a single temperature of >38.3°C (101 °F) or a sustained temperature of 
≥38°C (100.4°F) for more than 1 hour;
o
Grade ≥3 neutropenic infection (defined as ANC < 1000/mm3 or <1.0 × 109/L 
and Grade ≥3 infection); 
o
Grade 4 thrombocytopenia;
o
Grade 3 thrombocytopenia with clinically significant bleeding or requiring 
medical intervention (eg, transfusion);
o
Grade 4 anemia;
o
Grade 3 anemia requiring transfusion or steroids.

Non-Hematologic Toxicity:
o
Grade 4 non-hematologic AE;
o
Grade 3 AE lasting >3 days despite optimal supportive care;
o
Grade 3 central nervous system AE regardless of duration;
o
Meets criteria for drug-induced liver injury (see Appendix 6).

Delay of ≥3 weeks in receiving the next scheduled administration due to persisting 
treatment-related toxicities;
The following AEs will not be adjudicated as DLTs:

Any Grade 3 endocrinopathy that is adequately controlled by hormonal replacement.

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
Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites
of known or suspected tumor).

Isolated Grade 3-4 laboratory abnormalities that are not associated with clinical 
sequelae and are corrected with supplementation/appropriate management within 72 
hours of their onset.

Grade ≤ 3 injection reactions and allergic reactions will not be considered dose 
limiting as they are unlikely to be dose related, but all available information on these 
events will be collected. 
In addition, clinically important persistent toxicities that are not included in the above criteria 
may be considered a DLT following review by the investigators and Pfizer.  All DLTs need 
to represent a clinically significant change from baseline. 
4.2. Scientific Rationale for Study Design
The primary purpose of the Phase 1b is to assess the safety and tolerability of PF-06801591 
in Asian participants. Chinese participants will be enrolled only in the Phase 1b part of this 
study. Japanese participants may also be enrolled in the Phase 2 part to support potential 
future schedule optimization. 
The Phase 1b escalation part of the study will use the mTPI design to govern dose 
escalation/de-escalation rules and to evaluate safety of the 300 mg Q4W and 600 mg Q6W 
PF-06801591 doses in Asian participants.  After an acceptable safety profile is established in 
the escalation part, the expansion part will be conducted to further assess safety and PK of 
the doses. The mTPI design is selected for Phase 1b escalation part for following reason.  
Being a model-based design, all the dose re-escalation/de-escalation decisions for a given 
study can be pre-calculated and presented in a 2-way table.  Thus, compared to other 
advanced model-based designs published in the literature, the mTPI design is logistically less 
complicated and easier to implement.  The rules in mTPI design are conceptually similar to 
those used by the 3+3 design, except the decisions of an mTPI design are based on posterior 
probabilities calculated under a coherent probability model.  As shown by Ji and Wang 12, 
mTPI design is more efficient and safer than the 3+3 design.
The Phase 2 part of the study will compare 600 mg Q6W regimen to 300 mg Q4W to support 
a modeling and simulation approach for potentially extending the PF-06801591 dosing 
interval to Q6W.  Phase 2 will use randomization in 1:2 ratio to 300 Q4W and 600 mg Q6W 
arms, respectively.  The 1:2 randomization is selected given that safety and efficacy data are 
available at 300 mg Q4W but these data are not available at 600 mg Q6W.  The 
randomization will be stratified 13, 14 by line of therapy (1st line vs 2nd line) given the different 
response rates of anti-PD-1 therapy in 1st line and 2nd line NSCLC participants.  The Phase 1b 
and Phase 2 parts of the study will run in parallel; however Japanese participants will be only 
enrolled in the Phase 2 part after the Phase 1b part has completed and only if both doses are 
determined to be tolerable.

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4.3. Justification for Dose
PF-06801591 300 mg will be given SC Q4W (Cycles are 28 days in length) in both the Phase 
1b and Phase 2 parts of the trial.  The 300 mg dose was selected for the Q4W regimen based 
on data from ongoing Phase 1 Study B8011001 where single- and multiple-dose PK, safety 
and efficacy of PF-06801591 are being evaluated.  The 300 mg Q4W regimen given SC has 
shown a favorable PK profile, in addition to clinical activity and acceptable safety in 
participants with advanced or metastatic solid tumors.
PF-06801591 600 mg will be also investigated SC Q6W (Cycles are 42 days in length) in 
both the Phase 1b and Phase 2 parts of the trial.  The 600 mg Q6W regimen was chosen to 1) 
maintain a comparable exposure to the 300 mg Q4W regimen and 2) to accommodate the SC 
presentation (as pre-filled syringe) is currently formulated for 300 mg injection increments.
Initial PK modeling suggests that C trough levels can be maintained with longer dosing 
intervals. AUC ss at 600 mg Q6W have been estimated to be ~30% and C trough ~ 11% higher 
compared to the 300 mg Q4W dose level, with exposure expected to be well below the 
highest dose level tested in humans (10 mg/kg Q3W, highest dose level investigated in Study 
B8011001; no DLTs were observed). 
Based on preliminary analyses, relatively flat exposure-response relationships for safety and 
efficacy were observed for PF-06801591 within the dose range studied.  Thus, there is no 
expectation that the 600 mg Q6W regimen will result in undue safety concerns or a 
compromise in efficacy. 
4.4. End of Study Definition
A participant is considered to have completed the study if he/she has completed all phases of 
the study including the last scheduled procedure and visit shown in the schedule of activities 
(SoA).  
The end of the study is defined as up to 3 years after the last participant is randomized or if 
the Sponsor determines the study should end earlier.
CCI

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5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled.  The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate.  All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a participant is suitable for this protocol. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted. 
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1. Participant must be ≥ 18 years of age inclusive, at the time of signing the informed 
consent (≥ 20 years of age in Japan; ≥ 19 years of age in South Korea)
Type of Participants and Disease Characteristics
2. Histological or cytological diagnosis of advanced solid tumor (Phase 1b, see details 
here below) and NSCLC (Phase 2, see details here below).
For Phase 1b:
a.
Histological or Cytological diagnosis of advanced solid tumor with clinical 
evidence of response to anti-PD-1 or PD-L1 agent. (No PD-L1 testing required)
b. Participant must have received at least 1 prior line of therapy for recurrent or 
metastatic disease, and must have progressed/relapsed, be refractory, or intolerant 
to standard therapy approved for the specific tumor type.  Exception: Participants 
who actively decline standard therapies. 
For Phase 2:
a.
All participants entering the study must have at least one measurable lesion as 
defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 
that has not been previously irradiated (lesions demonstrating definite progression 
after the radiation is allowed).
b. Participants must have a documented diagnosis of stage III where participants are 
not candidates for surgical resection or definitive chemoradiation, or stage IV 
NSCLC (per 8th International Association for the Study of Lung Cancer [IASLC] 
classification)15
c.
Activating epidermal growth factor receptor (EGFR) mutation (testing is required 
if status is unknown), known v-raf murine sarcoma viral oncogene homolog 
B1(BRAF) mutation, and anaplastic lymphoma kinase (ALK) or c-ros oncogene 1 

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(ROS1) translocation/rearrangement (testing not required if unknown) are not 
permitted. 
d. Participants whose tumor is known to be PD-L1 positive (Tumor Proportion 
Score [TPS] ≥1%) or unknown are eligible (testing not required if unknown).
e.
Up to 1 line of prior therapy in advanced or metastatic disease settings allowed. 
A neoadjuvant/adjuvant treatment will be counted as a line for advanced or 
metastatic disease if the development of recurrent or metastatic disease occurs 
during treatment or within 6 months after last dose. 
Based on country-specific regulations, when applicable participants should have 
actively declined chemotherapy or other standard therapies, including approved 
anti PD-1 or PD-L1 agents for the treatment of advanced disease (unresectable or 
metastatic).
f.
Participant should not have received prior treatment with anti PD-1/PD-L1 drugs.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
4. Estimated life expectancy of at least 3 months
5.
Adequate Bone Marrow Function, including:
a.
ANC ≥1,500/mm3 or ≥1.5 × 109/L;
b. Platelets ≥75,000/mm3 or ≥75 × 109/L;
c.
Hemoglobin ≥9 g/dL 
6. Adequate Renal Function, including:
a.
Estimated creatinine clearance ≥50 mL/min participants as calculated using the 
method standard for the institution.  In equivocal cases, a 24-hour urine collection 
test can be used to estimate the creatinine clearance more accurately. 
7. Adequate Liver Function, including:
a.
Total serum bilirubin ≤1.5 × upper limit of normal (ULN) unless the participant 
has documented Gilbert syndrome;
b. Aspartate and Alanine aminotransferase (aspartate aminotransferase [AST] and 
alanine aminotransferase [ALT]) ≤2.5 × ULN; ≤5.0 × ULN if there is liver 
involvement by the tumor; 
c.
Alkaline phosphatase ≤2.5 × ULN (≤5 × ULN in case of bone or liver metastasis). 
8. Assessments performed prior to dosing per SoA should also meet all inclusion 
requirements.

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9. Resolved acute effects of any prior therapy to baseline severity or Common 
Terminology Criteria for Adverse Events (CTCAE) Grade ≤1 except for AEs not 
constituting a safety risk by investigator judgment.
Sex
10. Male or Female
a.
Male participants:
Male participants are eligible to participate if they agree to the following during the 
intervention period and for at least 6 months after the last dose of study intervention.  

Refrain from donating sperm
PLUS either:
Be abstinent from heterosexual intercourse as their preferred and usual 
lifestyle (abstinent on a long term and persistent basis) and agree to remain 
abstinent 
OR

Must agree to use contraception/barrier as detailed below
o
Agree to use a male condom and should also be advised of the benefit 
for a female partner to use a highly effective method of contraception 
as a condom may break or leak when having sexual intercourse with a 
woman of childbearing potential who is not currently pregnant
b. Female participants:
A female participant is eligible to participate if she is not pregnant or 
breastfeeding, including participants who intend to interrupt breastfeeding, and at 
least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP) 
OR
Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of <1% per year), preferably with low user dependency, as 
described in Appendix 4 during the intervention period and for at least 6  
months after the last dose of study intervention, which corresponds to the time 
needed to eliminate any reproductive safety risk of the study intervention; and 
agrees not to donate eggs (ova, oocytes) for the purpose of reproduction 
during this period. As for participants using a highly effective method that is 
user dependent, this contraception method must be used together with a 
second effective method of contraception, as described in Appendix 4. The 
investigator should evaluate the effectiveness of the contraceptive method in 
relationship to the first dose of study intervention. 

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The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy.  
Informed Consent
11. Capable of giving signed informed consent as described in Appendix 1 which 
includes compliance with the requirements and restrictions listed in the informed 
consent form (ICF) and in this protocol
12. Participants who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, lifestyle considerations, and other study procedures. 
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Participants with known symptomatic brain metastases requiring steroids.  Participants 
with previously diagnosed brain metastases are eligible if they have completed their 
treatment and have recovered from the acute effects of radiation therapy or surgery prior 
to study entry, have discontinued corticosteroid treatment for these metastases for at 
least 4 weeks and are neurologically stable for 6 weeks (requires magnetic resonance 
imaging [MRI] confirmation). 
2. Participants with Interstitial Lung Disease (ILD) history or complication. 
3. Participants with any other active malignancy within 3 years prior to enrollment, except 
for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
4. Clinically significant multiple or severe drug allergies, intolerance to topical 
corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not 
limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, 
toxic epidermal necrolysis, and exfoliative dermatitis)
5. Participants with known active, uncontrolled bacterial, fungal, or viral infection, 
including hepatitis B virus (HBV), hepatitis C virus (HCV), sero-positivity to human 
immunodeficiency virus (HIV) infection. 
6. Q-T interval corrected for heart rate QTc > 450 msec for male participants or  QTc > 
470 msec for female participants or  QTc > 480 msec in participants with right bundle 
branch block.
7. Hypertension that cannot be controlled by medications (eg, systolic > 150 mmHg and 
diastolic > 90 mmHg) despite optimal medical therapy.
8. Known or suspected hypersensitivity to active ingredient or excipients of the study drug. 

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9. History of Grade ≥3 immune mediated AE (including AST/ ALT elevations that where 
considered drug related and cytokine release syndrome [CRS]) that was considered 
related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, 
co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b 
only).  
10. Serum or urine pregnancy test (for females of childbearing potential) positive at 
screening or C1D1. 
Prior/Concomitant Therapy
11. Major surgery within 3 weeks prior to study entry.
12. Radiation therapy within 3 weeks prior to study entry. 
13. Monoclonal antibody based anti-cancer therapy within 28 days prior to study entry or 
small-molecule based anti-cancer therapy (targeted therapy or chemotherapy) within 
14 days prior to study entry. 
14. Vaccination with live attenuated vaccines within 4 weeks prior to randomization is 
prohibited; however inactivated vaccines are permitted.
Prior/Concurrent Clinical Study Experience
15. Participation in active treatment with other studies involving investigational drugs
within 4 weeks prior to study entry.  
Other Exclusions
16. Other acute or chronic medical or psychiatric condition including recent (within the past 
year) or active suicidal ideation or behavior or laboratory abnormality that may increase 
the risk associated with study participation or investigational product administration or 
may interfere with the interpretation of study results and, in the judgment of the 
investigator, would make the participant inappropriate for entry into this study.
17. Investigator site staff members directly involved in the conduct of the study and their 
family members, site staff members otherwise supervised by the investigator, or Pfizer 
employees, including their family members, directly involved in the conduct of the 
study.
5.3. Lifestyle Considerations
Contraception: The investigator or his or her designee, in consultation with the 
participant, will confirm that the participant has selected an appropriate method of 
contraception for the individual participant and his or her partners from the permitted 
list of contraception methods (see Appendix 4, Section 10.4) and will confirm that the 
participant has been instructed in its consistent and correct use.  At time points 
indicated in the SoA, the investigator or designee will inform the participant of the 

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need to use highly effective contraception consistently and correctly and document 
the conversation and the participant’s affirmation in the participant’s chart 
(participants need to affirm their consistent and correct use of at least 1 of the selected 
methods of contraception; as for female participants using a highly effective method 
that is user dependent, this contraception method must be used  together with a 
second effective method of contraception, as described in Appendix 4).  In addition, 
the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued or if pregnancy is known or suspected 
in the participant or partner.

Please refer to the Inclusion Criteria (Section 5.1) under “Sex” for details on 
contraception timeframes.

Concomitant Therapy: Refer to Section 6.5

Special Precautions for Administration: Refer to Section 6.1 and Section 6.6.
5.3.1. Meals and Dietary Restrictions
No food restrictions.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently assigned to study intervention in the study. A minimal set of screen 
failure information is required to ensure transparent reporting of screen failure participants to 
meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements 
and to respond to queries from regulatory authorities.  Minimal information includes 
demography, screen failure details, eligibility criteria, and any SAE.
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened. 

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6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to a study participant according to 
the study protocol.
For the purposes of this protocol, the term investigational product may be used 
synonymously with study intervention.
6.1. Study Intervention(s) Administered
Intervention Name
PF-06801591 
Dose Formulation
Solution for injection
Unit Dose Strengths
150 mg/mL Syringe, 2 mL 
Dosage Levels
300 mg Q4W 
600 mg Q6W
Route of Administration
SC
Investigational Medicinal 
Product (IMP) and 
Non-investigational Medicinal 
Product (NIMP)
IMP
Sourcing
Provided centrally by the sponsor 
Packaging and Labeling
Study intervention will be provided as follows:

PF-06801591 150 mg/mL solution for injection (2 mL) pre-
filled syringes
Each pre-filled syringe (PFS) will be labeled as required per country 
requirement. Each PFS is for single use only. Additional dosing details 
will be provided in the IP Manual.
PF-06801591 150 mg/mL solution for injection (2 mL in 2.25 mL PFS) will be provided as a 
sterile solution for SC administration.  Each syringe of PF-06801591 at a nominal 
concentration of 150 mg/mL, contains a sufficient amount to deliver a dose of 300 mg (2 
mL).  The investigational product for this study is packaged into a sealed carton containing 1 
PFS and is labeled in a way that is consistent with the study design and with the regulatory 
requirements for each country in which the study is to be performed.
Participants will receive a dose of PF-06801591 on Day 1 of each cycle. Qualified and 
trained investigator site personnel will administer PF-06801591 at a fixed dose to participants 
by SC injections to the abdomen.  
Two (2) dosing regimens of PF-06801591 will be used in this study which are 300 mg SC 
Q4W and 600 mg SC Q6W.

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For both dose levels, 150 mg/ mL injection (1 injection for 300 mg SC Q4W and 2 injections 
for 600 mg SC Q6W) will be provided as a sterile solution for SC administration to the 
abdomen (with preference given to the lower quadrants when possible).  
For the 600 mg SC dose, PF-06801591 should be administered to 2 different quadrants of the 
abdomen.
If SC injections in the abdominal location are not possible, SC injections can be administered 
in a distributed manner in the thigh. SC injections in the upper extremities (e.g., deltoid, 
upper and lower arm) are not permitted. Study staff should refer to the Product Specific 
Investigational Product (IP) Manual for specific instructions on the handling and 
administration of study drug.
6.1.1. Medical Devices

The medical device used to deliver PF-06801591 is a Pre-Filled Syringe (PFS).

Instructions for medical device use are provided in the IP manual.

All medical device deficiencies (including malfunctions, use error, and inadequate 
labeling), shall be documented and reported by the investigator throughout the 
clinical investigation (see Section 8.3.9) and appropriately managed by the sponsor.
6.2. Preparation/Handling/Storage/Accountability

The investigator or designee must confirm appropriate temperature conditions have 
been maintained during transit for all study intervention received and any 
discrepancies are reported and resolved before use of the study intervention.

Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study 
intervention must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with 
access limited to the investigator and authorized site staff.  

The investigator, institution, or the head of the medical institution (where applicable) 
is responsible for study intervention accountability, reconciliation, and record 
maintenance (i.e., receipt, reconciliation, and final disposition records).  

Further guidance and information for the final disposition of unused study 
intervention are provided in the Investigational Product Manual. 

Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the product label.

Study intervention should be stored in their original containers and in accordance 
with the labels.

Deviations from the storage requirements, including any actions taken, must be 
documented and reported to Pfizer upon discovery.  The site should actively pursue 
options for returning the study intervention to the storage conditions described in the 
labeling, as soon as possible.  Once an excursion is identified, the study intervention 

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must be quarantined and not used until Pfizer provides permission to use the study 
intervention.  It will not be considered a protocol deviation if Pfizer approves the use 
of the study intervention after the temperature deviation.  Specific details regarding 
the definition of an excursion and information the site should report for each 
excursion will be provided to the site in the IP manual.

The sponsor or designee will provide guidance on the destruction of unused study 
intervention (e.g., at the site).  If destruction is authorized to take place at the 
investigator site, the investigator must ensure that the materials are destroyed in 
compliance with applicable environmental regulations, institutional policy, and any 
special instructions provided by Pfizer, and all destruction must be adequately 
documented.
6.2.1. Preparation and Dispensing
PF-06801591
See the IP manual for instructions on how to prepare the investigational product for 
administration.  Investigational product should be prepared and dispensed by an 
appropriately qualified and experienced member of the study staff (e.g., physician, nurse, 
physician’s assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as 
allowed by local, state, and institutional guidance.
6.3. Measures to Minimize Bias: Randomization and Blinding
This an open label study. In Phase 2, random allocation of participants between two 
treatment arms (300 mg Q4W and 600 mg Q6W) will be stratified according to lines of 
therapies (1L vs. 2L).  This stratified randomization will be centrally allocated across all 
centers via the IRT system.  The central randomization will help minimize the risk of 
participant selection bias between two treatment arms. 
Once a participant has signed consent, the site staff will complete registration in interactive 
response technology (IRT). The IRT will assign a participant identification number and 
supply this number to the site. The participant identification number will be used on all 
study-related documentation at the site.
Allocation of participants to treatment groups will proceed using an IRT system (interactive 
Web-based response [IWR]). 
No participant shall receive investigational product until the investigator or designee has 
received the following information in writing from the sponsor:

Confirmation of the participant’s enrollment;

Specification of the dose level for that participant and; 

Permission to proceed with dosing the participant.

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The site personnel (study coordinator or specified designee) will be required to have an 
active or valid account and password with the IRT system, enter or select information 
including but not limited to the protocol number, specific protocol entrance criteria indicated 
in the system and the screening number. The site personnel will then be provided with, at a 
minimum, a treatment assignment, and dispensable unit (DU) or container number when 
investigational product is being supplied via the IRT system. The IRT system will provide a 
confirmation report containing the participant number, allocation number and DU or 
container number assigned. The confirmation report must be stored in the site’s file. 
Investigational product will be administered at the study visits as summarized in the 
Schedule of Activities (SoA).
The participant must receive the first dose of study treatment within 3 days after 
randomization. 
The study-specific IRT reference manual will provide the contact information and further 
details on the use of the IRT system.
6.4. Study Intervention Compliance
The site will complete required dosage Preparation Record located in the IP manual.  The use 
of the Preparation Record is preferred but it does not preclude the use of an existing 
appropriate clinical site documentation system.  The existing clinical site’s documentation 
system should capture all pertinent /required information on the preparation and 
administration of the dose.  This may be used in place of the Preparation Record after 
approval from the sponsor and/or designee.
6.5. Concomitant Therapy
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, 
and/or herbal supplements) that the participant is receiving at the time of enrollment or 
receives during the study must be recorded.
The Medical Monitor should be contacted if there are any questions regarding concomitant or 
prior therapy.
All prior and concomitant treatments, received by participants from screening until the end of 
study visit including supportive care drugs (eg, anti-emetic treatment and prophylaxis), drugs 
used to treat AEs or chronic diseases, and non-drug supportive interventions (eg, 
transfusions) will be recorded on the case report form (CRF).  Concomitant medications for 
AEs and SAEs should follow respective guidance for AE and SAE reporting period.
6.5.1. Other Anti-tumor/Anti-cancer or Experimental Drugs
No additional anti-tumor treatment including cancer vaccination therapy is permitted while 
participants are receiving study treatment.  
Palliative radiotherapy on study is permitted for the treatment of painful bony lesions 
provided that the lesions were known at the time of study entry and the investigator clearly 
indicates that the need for palliative radiotherapy is not indicative of disease progression.  In 
view of the current lack of data about the interaction of investigational product with 

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radiotherapy, treatment should be interrupted during palliative radiotherapy.  Investigational 
treatment should not be administered within 7 days before starting radiotherapy and resume 
investigational treatment only after recovery of any radiotherapy associated signs and 
symptoms to baseline.
6.5.2. Supportive Care
Palliative and supportive care for disease related symptoms may be administered at the 
investigator’s discretion and according to the specific supportive care product Prescribing 
Information or the current American Society of Clinical Oncology (ASCO) guidelines. 
6.5.3. Hematopoietic Growth Factors
Primary prophylactic use of granulocyte-colony stimulating factors is not permitted, but they 
may be used to treat treatment emergent neutropenia as indicated by the current ASCO
guidelines16. If the secondary prophylactic use of granulocyte-colony stimulating factors is 
needed it should be discussed with the study clinician before implementation. During 
screening, Granulocyte Colony-Stimulating Factor (G-CSF) is not permitted to qualify a 
participant with low ANC counts. 
Erythropoietin may be used at the investigator’s discretion for the supportive treatment of 
anemia.  
For the countries, including Japan, where the indication and dosage of G-CSF compounds 
may differ from ASCO guidelines, refer to local package insert or follow clinical practice in 
their countries. Erythropoietin is not approved in Japan and other countries for anemia caused 
by cancer treatment.
6.5.4. Anti-Diarrheal, Anti-Emetic Therapy
Primary prophylaxis is not required.  If required for an individual participant, the decision to 
incorporate pre-medication will be made following discussions between the sponsor and the 
investigator.
6.5.5. Anti-Inflammatory Therapy
Anti-inflammatory or narcotic analgesic is allowed as needed. 
6.5.6. Corticosteroids
The use of steroids during this trial is restricted as follows:
a) Therapeutic use: for the treatment of injection-related reactions and short-term 
treatment of irAEs, steroids are permitted according to the modalities indicated in 
Appendix 12.
b) Physiologic use: replacement for adrenal insufficiency at doses equivalent to İ10 mg 
prednisone daily is acceptable. 

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c) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular 
injection) are permitted.
d) Corticosteroids are not prohibited during the Post-Treatment Follow-up Phase.
Any other use of corticosteroids should be discussed with the sponsor before implementation.
6.5.7. Vaccines 
Live attenuated vaccines within 4 weeks prior to the first dose of PF 06801591 and through 
30 days following the last dose of PF 06801591 are not allowed.  Examples of live attenuated 
vaccines include, but are not limited to, the following: measles, mumps, rubella, chickenpox, 
yellow fever, rabies, and oral typhoid vaccine.  Seasonal influenza vaccines for injection are 
inactivated virus vaccines and are allowed; however intranasal influenza vaccines (e.g., 
FluMist®) are live attenuated vaccines, and are not allowed.
6.5.8. Surgery 
Caution is advised on theoretical grounds for any surgical procedures during the study.  The 
appropriate interval of time between surgery and investigational product required to 
minimize the risk of impaired wound healing and bleeding has not been determined.  
Stopping investigational product is recommended at least 7 days prior to surgery.  
Postoperatively, the decision to reinitiate investigational product treatment should be based 
on a clinical assessment of satisfactory wound healing and recovery from surgery.
6.5.9. Rescue Medicine
There is no rescue therapy to reverse the AEs observed with the investigational product; 
standard medical supportive care must be provided to manage the AEs (Refer to Section 6.6
and 6.8 for dose modification and management of treatment-related adverse events).
6.5.10. Proton-Pump Inhibitors
No restrictions.
6.5.11. Antacids or H2-Receptor Antagonists
No restrictions.
6.6. Dose Modification
Every effort should be made to administer investigational product on the planned dose and 
schedule.  In the event of significant toxicity, dosing may be 
interrupted/delayed/discontinued as described below.  In the event of multiple toxicities, dose 
modification should be based on the worst toxicity observed.  Participants are to be instructed 
to notify investigators at the first occurrence of any adverse symptom.  Following dose 
modifications will be allowed as described in Table 4.

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Dosing interruption: When participant develops treatment related adverse event meeting 
“Withhold the treatment” criteria, the treatment administration should be immediately 
stopped and should not be resumed until the criteria to restart treatment are met.
Dosing Delays: If any treatment related adverse event is not resolved by next scheduled 
dosing, the dosing should be delayed until the criteria to restart treatment are met.
Permanent Treatment Discontinuation: If participant develops TRAE meeting 
discontinuation criteria as defined in Section 7.1, the treatment should be permanently 
discontinued. 
General Dose Modification Guidelines: 
Appropriate follow-up assessments should be done until adequate recovery occurs as 
assessed by the investigator.  If a treatment delay results from worsening of hematologic or 
biochemical parameters, the frequency of relevant blood tests should be increased as 
clinically indicated.
In the event of a treatment interruption for reasons other than treatment-related toxicity (eg, 
elective surgery) lasting > 4 weeks, treatment resumption will be decided in consultation 
with the sponsor.
All dosing modifications should be based on recommendations described in Table 4 unless 
expressly agreed otherwise following discussion between the investigator and the sponsor. 
All dosing modifications must be clearly documented in the participant's source notes and 
CRF. 
Depending on when the adverse event resolved, the treatment may lead to delay the initiation 
of the subsequent cycle.  Retreatment is permitted as soon as the criteria to restart treatment 
are met. The day when treatment is restarted will be counted as Day 1 of the next cycle.

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Table 4.
Treatment Modification for Related Events**
Severity
PF-06801591
Grade 1

Continue per schedule.
Grade 2

First occurrence: continue per schedule.

Follow modifications for G3 event if G2 AE is considered intolerable and recurrent 
based on medical judgment
Grade 3*

Withhold until re-treatment criteria are met. (See below)

If re-treatment criteria are not met within 8 weeks of last administration or if based on 
medical judgment the event is considered critical, permanently discontinue the 
treatment.

Upon the second occurrence of the same G3 toxicity that does not meet re-treatment 
criteria within 2 weeks of last administration, treatment must be permanently 
discontinued.

Exceptions: Laboratory test values out of normal range that do not have any clinical 
correlation
Grade 4*

Permanent discontinuation.

Exceptions: Laboratory test values out of normal range that do not have any clinical 
correlate.
* Nausea, vomiting, or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy to require dose 
modification.
**When applicable AE specific guideline described in Appendix 12 must be followed.
Re-treatment criteria: Retreatment following treatment interruption for treatment-related 
toxicity may not occur until all of the following parameters have been met:

ANC ≥1,000/mm3

Platelets count ≥50,000/mm3

Non-hematologic toxicities have returned to baseline or Grade ≤1 severity (or, at 
the investigator’s discretion, Grade ≤2 if not considered a safety risk for the 
participant).
No dose reduction is allowed for PF-06801591.

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6.7. Intervention after the End of the Study
No intervention will be provided to study participants at the end of the study.
6.8. Management of Treatment Related Adverse Events
Treatment recommendations for the management of irAE are outlined in Appendix 12.
All other AEs should be treated as per standard of care.

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7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
     
7.1. Discontinuation of Study Intervention
     
Participants who only discontinue study intervention (ie, study treatment) should continue in 
the study and complete all protocol specified activities after discontinuing study treatment.
See the SoA for data to be collected at the time of intervention discontinuation and follow-up 
and for any further evaluations that need to be completed.
Reasons for discontinuing study treatment may include:

Objective disease progression;

Global deterioration of health status requiring discontinuation;

Unacceptable toxicity;

Pregnancy;

Significant protocol violation;

Lost to follow-up;

Participant refused further treatment;

Study terminated by sponsor;

Death;  
Discontinuation of study treatment does not represent withdrawal from the study.  Participants 
who only discontinue study treatment for reasons other than lost to follow-up and death should 
continue in the study and complete all protocol specified activities even after discontinuing 
study treatment, in order to provide the data required for the study estimands. 
7.1.1. Treatment after Initial Evidence of Radiological Disease Progression
Immunotherapeutic agents, may produce anti-tumor effects by potentiating endogenous 
cancer specific immune responses.  The response patterns seen with such an approach may 
extend beyond the typical time course of responses seen with cytotoxic agents and can 
manifest as a clinical response after an initial increase in tumor burden or even the 
appearance of new lesions. 
If radiologic imaging shows disease progression, participants may continue to receive the 
investigational product, at the Investigator’s discretion after the participant is re-consented 
via informed consent addendum and informed that, by continuing to receive the 
investigational product, the participant may be foregoing approved or investigational 

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therapies with possible clinical benefit(s). The sponsor needs to agree to continuation of the 
treatment.
The following criteria must be met for continuation of treatment beyond progression: 

Absence of clinical signs and symptoms (including worsening of laboratory test 
values) of disease progression;

No decline in ECOG performance status;

Absence of rapid progression of disease by radiographic imaging;

Absence of progressive tumor at critical anatomical sites (eg, cord compression) 
requiring urgent alternative medical intervention.
If the repeat imaging confirms disease progression, participant should be considered for 
discontinuation from study treatment. However, according to the Investigator’s clinical 
judgment and after discussion between the Investigator and the Sponsor, if a participant with 
evidence of disease progression is still experiencing clinical benefit, the participant may be 
eligible for continued treatment with PF-06801591. The Investigator’s judgment should be 
based on the overall benefit-risk assessment and the participant’s clinical condition, including 
performance status, clinical symptoms, adverse events, and laboratory data.
7.2. Participant Discontinuation/Withdrawal from the Study
A participant may withdraw from the study at any time at his/her own request. Reasons for 
discontinuation from the study include the following:

Completed study post-treatment period.”

Refused further follow-up;

Lost to follow-up;

Death;

Study terminated by sponsor;
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations should be performed and no 
additional data should be collected.  The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.

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Lack of completion of all or any of the withdrawal procedures will not be viewed as protocol 
deviations so long as the participant’s safety was preserved.
7.2.1. Withdrawal of Consent
Participants who request to discontinue receipt of study treatment will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures.  The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information.  Participants should notify the investigator in writing of the decision to 
withdraw consent from future follow-up, whenever possible.  The withdrawal of consent 
should be explained in detail in the medical records by the investigator, as to whether the 
withdrawal is only from further receipt of investigational product or also from study 
procedures and/or posttreatment study follow-up and entered on the appropriate CRF page.  
In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law.
7.3. Lost to Follow up
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:

The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study.

Before a participant is deemed lost to follow up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record.

Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
Discontinuation of specific sites or of the study as a whole are described in Appendix 1.
8. STUDY ASSESSMENTS AND PROCEDURES

Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.

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
The investigator (or an appropriate delegate at the investigator site) must obtain a 
signed and dated informed consent document (ICD) before performing any study-
specific procedures.

Immediate safety concerns should be discussed with the sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or 
discontinue study intervention.

Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct.

All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening 
log to record details of all participants screened and to confirm eligibility or record 
reasons for screening failure, as applicable.

Procedures conducted as part of the participant’s routine clinical management (eg, 
blood count) and obtained before signing of the ICF may be utilized for screening or 
baseline purposes provided the procedures met the protocol-specified criteria and 
were performed within the time frame defined in the SoA.
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described.  However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test.  In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant.  When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible.  The study team must be informed of these incidents in a timely manner.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study. 
8.1. Efficacy Assessments
8.1.1. Tumor Response Assessment
The decision for body areas to be scanned will depend on disease under study and extent of 
disease.  Tumor assessments must include all known or suspected disease sites. The 
minimum body areas to be scanned at screening include chest, abdomen and brain. Imaging 
methods may include contrast enhanced computed tomography (CT) or MRI scans for chest, 
abdomen and brain. For imaging chest, CT scan is preferred. If stable brain metastases are 
present at baseline, brain imaging should be repeated at each tumor assessment. Bone 
imaging using bone scan (bone scintigraphy) or 18-fluorodeoxyglucose positron emission 
tomography (18F-FDG-PET) required at baseline only if bone metastases are known or 
suspected outside the body areas scanned using other techniques, then every 12 weeks only if 
bone metastases are present at baseline. Otherwise, bone imaging is required only if new 

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bone metastases are suspected. Bone imaging is also required at the time of confirmation of 
complete response (CR) for participants who have bone metastases. 
For participants with known CT contrast allergy, a non-contrast CT of the chest with contrast 
enhanced abdominal and brain MRI can be used.  The same imaging technique used to 
characterize each identified and reported lesion at baseline will be employed in the following 
tumor assessments.  If the imaging technique is changed due to unavoidable circumstances, 
as assessed by radiologist/investigator, if a comparable measurement of lesion is feasible 
then the tumor measurement should be reported, otherwise the lesion should be reported as 
non-evaluable.
When appropriate, clinical evaluation (presence/absence of a superficial lesion or 
measurement by caliper), X-ray or positron emission tomography (PET) scans can be used. 
If PET scan is to occur on the same day as the CT scan, it is to be performed prior to the CT 
due to the sustained levels of the contrast agent.
Anti-tumor activity will be assessed through radiological tumor assessments conducted at 
following occasions:

Screening (must be performed within 28 days prior to first dose of study treatment 
[Phase 1b] or randomization [Phase 2]),

During treatment as specified in the SoA, 

Whenever disease progression is suspected (eg, symptomatic deterioration), 

After first occurrence of PR or CR is observed according to RECIST version 1.1, 
repeat imaging at least 4 weeks after initial documentation to confirm the PR or CR.
Assessment of tumor response will be made using RECIST version 1.1 (see Appendix 10).
Measurable or evaluable lesions that have been previously irradiated will not be considered 
target lesions unless increase in size has been observed following completion of radiation 
therapy. 
All participants’ files and radiologic images must be available for source verification and for 
potential peer review.
8.1.2. Tumor Markers
No tumor markers will be collected for efficacy assessment.
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the SoA. Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety concerns.

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8.2.1. Physical Examinations
The body systems included in the scope of examination will be decided by the treating 
physician based on the standard of care at the center.  The details of the physical examination 
will not be recorded on a CRF, instead any abnormalities detected during the physical 
examination will be reported on the medical history or adverse event CRF. 
Investigators should pay special attention to clinical signs related to previous serious 
illnesses.
8.2.2. Vital Signs

Temperature, pulse rate and blood pressure will be assessed as per the SoA. 
Temperature and pulse rate need not be recorded in the CRF but if the results 
represent an AE please record on the AE CRF.

Blood pressure and pulse rate measurements will be assessed in a sitting or supine 
position with a completely automated device. Manual techniques will be used only 
if an automated device is not available.

Blood pressure and pulse rate measurements should be preceded by at least 5 
minutes of rest for the participant in a quiet setting without distractions (eg, 
television, cell phones) and prior to administration of study drug.
8.2.3. Electrocardiograms
A standard 12-lead (with a 10-second rhythm strip) tracing will be used for all ECGs as 
outlined in the SoA.  Triplicate ECG is required at screening. Three consecutive ECGs will 
be performed at approximately [2-4] minutes apart to determine the mean QTc interval.  At 
C1D1, C2D1 and C3D1, single ECG will be collected at 2 timepoints, first prior to 
administration of study drug, and then within 1 hour after the administration of study drug.  
For remaining timepoints, single ECGs will be collected only prior to administration of study 
drug.  When the timing of these measurements coincides with a blood collection, the ECG 
should be obtained prior to the nominal time of the blood collection, blood pressure (BP), 
and pulse rate.  Additional ECGs may be performed as clinically indicated.  Clinically 
significant findings seen on follow-up ECGs should be recorded as adverse events.
If participant experiences a cardiac or neurologic AE (specifically syncope, dizziness, 
seizures, or stroke) single ECGs should be obtained at time of the event. 
To ensure safety, if there is finding of corrected QT (QTc) prolongation (≥60 msec from the 
pre-dose baseline, or >500 msec), ECG must be reviewed by qualified personnel at the site as 
soon as the finding is made, including verifying that the machine reading is accurate and that 
the Fridericia correction formula is applied. If manual reading verifies the observation, 
repeat ECGs should be immediately performed at least two times approximately 2 minutes 
apart.  In such cases, while reporting ECG data in CRF, manual reading should be reported.
ECG values of potential clinical concern are listed in Appendix 8.

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8.2.4. Clinical Safety Laboratory Assessments

See Appendix 2 for the list of clinical laboratory tests to be performed and to the 
SoA for the timing and frequency.
Assessments and physician’s evaluation of the following labs must be performed, at 
a minimum, prior to dosing:.
o
Negative pregnancy test (as applicable)
o
Hematology 
o
Liver function: AST, ALT, and bilirubin 
o
Renal function: Creatinine 
o
Any other per protocol lab test(s) to correlate clinical signs or 
symptoms
No need to repeat on C1D1 if screening assessment is performed within 72 
hours prior to that date.  Assessments performed on C2D1 and each 
subsequent cycle should be performed within 72 hours prior to dosing. 

The investigator must review the laboratory report, document this review, and 
record any clinically relevant changes occurring during the study in the AE section 
of the CRF.  The laboratory reports must be filed with the source documents. 
Clinically significant abnormal laboratory findings are those which are not 
associated with the underlying disease, unless judged by the investigator to be more 
severe than expected for the participant's condition.

All laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 30 days after the last dose of study intervention 
should be repeated until the values return to normal or baseline or are no longer 
considered clinically significant by the investigator or medical monitor.
o
If such values do not return to normal/baseline within a period of time judged 
reasonable by the investigator, the etiology should be identified and the sponsor 
notified.
o
All protocol-required laboratory assessments, as defined in Appendix 2, must be 
conducted in accordance with the laboratory manual and the SoA.
o
If laboratory values from non-protocol specified laboratory assessments 
performed at the institution’s local laboratory require a change in participant 
management or are considered clinically significant by the investigator (eg, SAE 
or AE or dose modification), then the results must be recorded in the CRF.
8.2.5. Pregnancy Testing 
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 25 
mIU/mL as required by local regulatory requirements.  Pregnancy tests will be performed in 
women of childbearing potential (WOCBP) at the times listed in the SoA. 

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Following a negative pregnancy test result at screening, appropriate contraception must be 
commenced and the second negative pregnancy test result will then be required at the 
baseline visit on C1D1 before the participant may receive the study treatment.  Pregnancy 
tests will also be done as per SoA and whenever 1 menstrual cycle is missed during the 
active treatment period (or when potential pregnancy is otherwise suspected), at the end of 
treatment and until Day 30 during the post-treatment period. At Day 90 and Day 180 during 
the post-treatment period, pregnancy status should be examined (allowed also by telephone 
call, unless the participant is visiting the site for other reasons) and pregnancy test can be 
conducted as necessary.  Pregnancy tests may also be repeated if requested by institutional 
review boards (IRBs)/ethics committees (ECs) or if required by local regulations. If a urine 
test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is 
required.  In such cases, the participant must be excluded if the serum pregnancy result is 
positive.
8.2.6. ECOG Performance Status
ECOG Performance Status will be evaluated as outlined in the SoA.  Refer to Appendix 11
for ECOG Performance Status Criteria.
8.2.7. Local Site Injection Tolerability Assessment
Assessments to monitor local tolerability to PF-06801591 SC injections will be performed 
for at least 1 hour following study drug administration, as per the SoA.  The injection sites 
will be assessed for erythema, induration, ecchymosis, injection site pain, injection site 
pruritus, or other observed characteristics after study drug dosing. At Cycles > 3, the 
assessment will only be performed if clinically necessary given participant’s previous 
injection tolerability or if injection site pain or injection site reaction (ISR) characteristics 
continue to persist.  Any observed abnormality at the injection site will be judged by the 
investigator to determine whether a corresponding AE should be reported.  When 
appropriate, at the discretion of the investigator, a participant with an ISR may be referred for 
a dermatological consultation and skin biopsy may be obtained for future examination of the 
ISR.  If injection site reaction is noted, site tolerability assessments should continue until the 
symptoms resolve.
8.3. Adverse Events and Serious Adverse Events
The definitions of an AE or SAE can be found in Appendix 3.  .
The definitions of device-related safety events (ADEs and SADEs) can be found in 
Appendix 7.  Device deficiencies are covered in Section 8.3.9.
AE will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant's legally authorized representative).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether it 
meets the criteria for classification as an SAE, or that caused the participant to discontinue 
the study intervention (see Section 7).

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Each participant (or their legally authorized representative) will be questioned about the 
occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion. 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving investigational product), through and including 
a minimum of 90 calendar days after the last administration of the study intervention.
After completion of the active collection period described above only SAEs will be actively 
elicited and collected. The SAEs identified after completion of the active collection will be 
reported to Pfizer Safety on the CT SAE Report Form only if considered reasonably related 
to the study intervention.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
Follow up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator, and Pfizer concurs with that assessment.
If a participant definitively discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the CT SAE Report Form.
Investigators are not obligated to actively seek AE or SAE after the participant has concluded 
study participation. However, if the investigator learns of any SAE, including a death, at any 
time after a participant has completed the study, and he/she considers the event to be 
reasonably related to the study intervention, the investigator must promptly report the SAE to 
Pfizer using the CT SAE Report Form.
8.3.1.1. Reporting SAEs to Pfizer Safety 
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the clinical trial SAE Report Form immediately 
upon awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3. The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available.
If a participant begins a new anticancer therapy, SAEs occurring during the above-indicated 
active collection period must still be reported to Pfizer Safety irrespective of any intervening 

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treatment. Note that a switch to a commercially available version of the study intervention is 
considered as a new anticancer therapy for the purposes of SAE reporting.
8.3.1.2. Recording Non-serious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF. The investigator is to record on the CRF all directly observed 
and all spontaneously reported AEs and SAEs reported by the participant.
If a participant begins a new anticancer therapy, the recording period for non-serious AEs 
ends at the time the new treatment is started; however, SAEs must continue to be recorded on 
the CRF during the above-indicated active collection period. Note that a switch to a 
commercially available version of the study intervention is considered as a new anticancer 
therapy for the purposes of SAE reporting.
8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AE and SAE and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.3.3. Follow-up of AEs and SAEs
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality.  Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided.  In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 3.
8.3.4. Regulatory Reporting Requirements for SAEs

Prompt notification by the investigator to the sponsor of a SAE is essential so that 
legal obligations and ethical responsibilities towards the safety of participants and 
the safety of a study intervention under clinical investigation are met.

The sponsor has a legal responsibility to notify both the local regulatory authority 
and other regulatory agencies about the safety of a study intervention under clinical 
investigation. The sponsor will comply with country-specific regulatory 

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requirements relating to safety reporting to the regulatory authority, IRB/ IEC, and 
investigators.

Investigator safety reports must be prepared for suspected unexpected serious 
adverse reactions (SUSAR) according to local regulatory requirements and sponsor 
policy and forwarded to investigators as necessary.

An investigator who receives SUSARs or other specific safety information (eg, 
summary or listing of SAEs) from the sponsor will review and then file it along with 
SRSD for the study and will notify the IRB/IEC, if appropriate according to local 
requirements.
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study intervention under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness.
8.3.5.1. Exposure During Pregnancy
An EDP occurs if: 

A female participant is found to be pregnant while receiving or after discontinuing 
study intervention. 

A male participant who is receiving or has discontinued study intervention exposes a 
female partner prior to or around the time of conception.

A female is found to be pregnant while being exposed or having been exposed to 
study intervention due to environmental exposure.  Below are examples of 
environmental exposure during pregnancy:  

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by different routes of exposure (e.g 
injection, ingestion, inhalation, or skin contact) 

A male family member or healthcare provider who has been exposed to the study 
intervention by different routes of exposure (e.g injection, ingestion, inhalation, or 
skin contact) then exposes his female partner prior to or around the time of 
conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred.  The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
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
If EDP occurs in a participant or a participant’s partner, the investigator must report 
this information to Pfizer Safety on the CT SAE Report Form and an EDP 
Supplemental Form, regardless of whether an SAE has occurred.  Details of the 
pregnancy will be collected after the start of study intervention and until at least 180 
days after the last dose.

If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the CT SAE Report Form and EDP Supplemental 
Form.  Since the exposure information does not pertain to the participant enrolled in 
the study, the information is not recorded on a CRF; however, a copy of the 
completed CT SAE Report Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs.  If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly [in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death]), the investigator should follow the procedures 
for reporting SAEs.  Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows: 

Spontaneous abortion including miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention. 
Additional information regarding the EDP may be requested by the sponsor.  Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner.  The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.

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8.3.5.2. Exposure During Breastfeeding
An exposure during breastfeeding occurs if: 

A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention.

A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure).  An example of environmental 
exposure during breastfeeding is a female family member or healthcare provider who 
reports that she is breastfeeding after having been exposed to the study intervention 
by inhalation or skin contact.  
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred.  The 
information must be reported using the CT SAE Report Form.  When exposure during 
breastfeeding occurs in the setting of environmental exposure, the exposure information does 
not pertain to the participant enrolled in the study, so the information is not recorded on a 
CRF.  However, a copy of the completed CT SAE Report Form is maintained in the 
investigator site file.
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use.  However, if the infant experiences an SAE associated with such a drug, the 
SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure 
An occupational exposure occurs when a person receives unplanned direct contact with the 
study intervention, which may or may not lead to the occurrence of an AE.  Such persons 
may include healthcare providers, family members, and other roles that are involved in the 
trial participant’s care.
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the 
investigator’s awareness, regardless of whether there is an associated SAE.  The information 
must be reported using the CT SAE Report Form.  Since the information does not pertain to a 
participant enrolled in the study, the information is not recorded on a CRF; however, a copy 
of the completed CT SAE Report Form is maintained in the investigator site file
8.3.6. Cardiovascular and Death Events
Not applicable
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable

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8.3.8. Adverse Events of Special Interest
Any AE that is suspected to be a potential irAE is considered an AE of special interest 
(AESI). Specific guidance for the management of irAEs is provided in Appendix 12.
All AESIs must be reported as an AE or SAE following the procedures described in 
Sections 8.3.1 through 8.3.4.  An AESI is to be recorded as an AE or SAE on the CRF.  In 
addition, an AESI that is also an SAE must be reported using the CT SAE Report Form.
8.3.8.1. Lack of Efficacy
Lack of efficacy (see Section 10.3.1) is reportable to Pfizer Safety only if associated with an 
SAE.
8.3.9. Medical Device Deficiencies
Medical device is being provided for use in this study for SC injection. In order to fulfill 
regulatory reporting obligations worldwide, the investigator is responsible for the detection 
and documentation of events meeting the definitions of device deficiency that occur during 
the study with such device.
The definition of a Medical Device deficiency can be found in Appendix 7.
NOTE: Deficiencies fulfilling the definition of an AE/SAE will also follow the processes 
outlined in Section 8.3.1 through 8.3.4 and Appendix 3 of the protocol. 
8.3.9.1. Time Period for Detecting Medical Device Deficiencies

Medical device deficiencies or malfunctions of the device will be detected, 
documented, and reported during all periods of the study in which the medical 
device is used.

If the investigator learns of any device deficiency at any time after a participant has 
been discharged from the study, and such incident is considered reasonably related 
to a medical device provided for the study, the investigator will promptly notify the 
sponsor.
The method of documenting Medical Device Incidents is provided in Appendix 7.
8.3.9.2. Follow-up of Medical Device Deficiencies
Follow-up applies to all participants, including those who discontinue study intervention.
The investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency.
New or updated information will be recorded on a follow-up form with all changes signed 
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8.3.9.3. Prompt Reporting of  Device Deficiencies to Sponsor
Device deficiencies will be reported to the sponsor within 1 day after the investigator 
determines that the event meets the protocol definition of a medical device deficiency.
Information will be provided to the sponsor as described in the IP Manual.  
Any device deficiency that is associated with an SAE must be reported to Pfizer Safety 
within 24 hours upon the investigator’s awareness as outlined in Sections 8.3.1.1 and 8.3.1.2.
The sponsor will be the contact for the receipt of device deficiency information.
8.3.9.4. Regulatory Reporting Requirements for Device Deficiencies

The investigator will promptly report all device deficiencies occurring with any 
medical device provided for use in the study in order for the sponsor to fulfill the 
legal responsibility to notify appropriate regulatory authorities and other entities 
about certain safety information relating to medical devices being used in clinical 
studies.

The investigator, or responsible person according to local requirements (eg, the head
of the medical institution), will comply with the applicable local regulatory 
requirements relating to the reporting of device deficiencies to the IRB/IEC.
8.3.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength 
or from inadvertent exposure.
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors.
Safety Event
Recorded on the CRF
Reported on the CT SAE Report 
Form to Pfizer Safety Within 24 
Hours of Awareness
Medication errors All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;

Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.

Incorrect study treatment taken by participant;

Overdose
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.

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In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and non-serious, are recorded on an AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
8.4. Treatment of Overdose
For this study, if a participant receives a dose higher than the assigned dose level of PF-
06801591, it will be considered an overdose.
Sponsor does not recommend specific treatment for an overdose.
In the event of an overdose, the treating physician should:
1. Contact the Medical Monitor within 24 hours.
2. Closely monitor the participant for any AE/SAE and laboratory abnormalities for at 
least 6 months after the overdose of PF-06801591.
3. Obtain a plasma sample for PK analysis within 90 days from the date of the last dose 
of study intervention if requested by the Medical Monitor (determined on a case-by-
case basis).
4. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
5. Overdose is reportable to Safety only when associated with a SAE.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the Medical Monitor based on the clinical evaluation of the participant.
8.5. Pharmacokinetics
All efforts will be made to obtain the PK samples as required at scheduled visits (see SoA). 
The exact time of the sample collection will always be noted. If a scheduled blood sample 
collection cannot be completed for any reason, the missed sample time may be re-scheduled 
with agreement of clinical investigators, participant and sponsor. PK sampling schedule may 
be modified based on emerging PK data. 
PK samples will be analyzed using a validated analytical method in compliance with Pfizer 
standard operating procedures (SOPs).
Details regarding the collection, processing, storage and shipping of the PK blood samples 
will be provided to the investigator site prior to initiation of the trial. The PK samples must 
be processed and shipped as indicated in the instructions provided to the investigator to 
maintain sample integrity. Any deviations from the PK sample handling procedure (eg, 
sample collection and processing steps, interim storage or shipping conditions), including 
any actions taken, must be documented and reported to the sponsor. On a case-by-case basis, 
the sponsor may make a determination as to whether sample integrity has been compromised.  

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Any deviation from the specified sample handling procedure resulted in compromised 
sample integrity, will be considered a protocol deviation.
As part of understanding the PK of the investigational product, samples may be used for
metabolite identification and/or further bioanalytical evaluation, 
unless prohibited by local regulations or ethics committee decision. 
These data will not be included in the Clinical Study Report (CSR).  
Samples collected for this purpose will be retained in accordance with local regulations and,
if not used within this timeframe, will be destroyed.
8.5.1. Blood for PK Analysis of PF-06801591
Blood samples (3 mL whole blood at each time point) will be collected for PK analysis of 
PF-06801591, as outlined in the SoA.  Samples collected on day of dosing with the 
investigational product should be obtained within 2 hours prior to dosing. Refer to the 
Laboratory Manual for instructions for specific details on collection tubes, processing and 
shipping.
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8.9. Medical Resource Utilization and Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
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9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a statistical analysis plan (SAP), which will be 
maintained by the sponsor.  
The data will be summarized with respect to demographic and baseline characteristics, 
efficacy observations and measurements, safety observations and measurements, 
pharmacokinetic
measurements.
9.1. Estimands and Statistical Hypotheses
9.1.1. Estimands
The endpoint definitions, the observations that will be considered in the derivation of the
endpoint, and the associated analyses are described or referenced below.
Primary Estimand (DLT): DLT rate estimated based on data from DLT-evaluable 
participants during the DLT-evaluation period (Cycle 1, 28 days for 300 mg Q4W and 42 
Days for 600 mg Q6W) in Phase 1b.
•
Variable: Occurrence of DLTs.  DLTs are defined in Section 4.1.
•
Analysis population: DLT-evaluable participants defined as participants who receive 
at least 1 dose of study treatment in the Phase 1b and either experience DLT during 
the DLT-evaluation period or complete the DLT-evaluation period without DLT.
Participants without DLTs who withdraw from study treatment before receiving at 
least 75% of the planned dose of study drug in Cycle 1 for reasons other than 
treatment-related toxicity are not evaluable for DLT. If there are participants non
evaluable for DLT, then additional participants can be enrolled to ensure that target 
number of DLT evaluable participants is reached.
•
Population-level summary measure: DLT rate defined as the number of 
DLT-evaluable participants with DLTs in the DLT-evaluation period divided by the 
number of DLT-evaluable participants in the DLT-evaluation period.
Primary Estimands (AUCτ and Ctrough at 12 weeks): Ratio of adjusted geometric means for 
AUCτ and Ctrough are estimated based on data from PK-evaluable participants in Phase 2. 
•
Variable: values of AUCτ and Ctrough at steady state, where τ = 4 weeks for Arm A2 
and 6 weeks for Arm B2.
•
Analysis population: PK-evaluable participants defined as all participants who 
received at least 1 dose of study drug in Phase 2 and have a Ctrough at 12 weeks.
•
Population-level summary measure: Ratio of adjusted geometric means for AUCτ and 
Ctrough.  AUCτ and Ctrough will be summarized descriptively (n, mean, standard 
deviation, coefficient of variation (CV), median, minimum, maximum, geometric 
mean, its associated CV, and 95% confidence interval) by dose, cycle, and day.  Dose 
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normalized parameters will be reported as appropriate.  The trough concentrations 
will be plotted for each dose using a box whisker plot by cycle and day in order to 
assess the attainment of steady state.
9.2. Sample Size Determination
Approximately 126 participants will be assigned to study intervention based on eligibility, 
for an estimated total of 3-6 DLT-evaluable participants at each dose level (6-12 in total) in 
the dose escalation part and approximately 12 additional participants at each dose level (24 in 
total) in the expansion part of Phase 1b and approximately 90 randomized participants in 1:2 
ratio between two treatment arms in Phase 2.  
9.2.1. Phase 1b
Approximately 36 participants in total will be enrolled in Phase 1b with 3-6 participants at 
each dose level (6-12 in total) in the dose escalation part and approximately 12 additional 
participants at each dose level (24 in total) in the expansion part. However, the final number 
of participants in Phase 1b will depend on the number of participants evaluable for DLT at 
each dose level. Each dose level in the dose escalation part will start with enrolling a group 
of 3-4 participants, allowing for additional participants (up to 6 in total) to be enrolled. Once 
the safety evaluation is completed in the dose escalation part, the expansion part will be 
opened and PF-06801591will be evaluated sequentially at 300 mg SC Q4W (Arm A1) and at 
600 mg SC Q6W (Arm B1). Each expansion dose level will enroll approximately 12 
participants as long as DLT rate is below 0.35 . After the enrollment in Arm A1 expansion 
part for DLT monitoring is completed and DLT rate is below 0.35, then Arm B1 expansion 
enrollment will be initiated. The DLT observation period will be 1 cycle (i.e. 4 weeks for
Arm A1 and 6 weeks for Arm B1).  In the event of participant discontinuations prior to 
obtaining steady state PK at Cycle 4 for Q4W or Cycle 3 for Q6W, additional participants 
may be enrolled to achieve a minimum of 8 participants from mainland China at each dose 
level with evaluable PK at steady state.   
9.2.2. Phase 2
The primary objective is to compare PK exposure in terms of AUCτ and Ctrough at Week 12 
(at approximately steady state).  The objective of the exposure comparison is to demonstrate 
that the mean PK exposure obtained from 600 mg SC Q6W regimen is not lower than 20% of 
the PK exposure obtained from the reference regimen of 300 mg SC Q4W.
For the primary PK objectives, a sample size of 90 participants (30 and 60 participants for 
Arms A2 (Reference) and B2 (Test), respectively) will provide at least 80% power that the 
lower bound for the 90% confidence interval (CI) for the ratio of Test to Reference treatment 
for the geometric mean of AUCτ and Ctrough at steady-state will be at least 80%.  This 
estimate is based on the assumption that the true ratio between (Test: PF-06801591 600 mg 
SC Q6W) and (Reference: PF-06801591 300 mg SC Q4W) treatments for both AUCτ and 
Ctrough is 1.0 and also assumes a CV of 26% for AUCτ and a CV of 40% for Ctrough.  
The randomization will be stratified by line of therapy (1st line vs 2nd line).

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9.3. Populations for Analyses
For purposes of analysis, the following populations are defined:
Population
Description
Full analysis set (FAS)
Phase 1b: All enrolled participants who take at least 1 dose of study 
drug.  Participants will be classified according to the study treatment 
actually received.  
Phase 2: All participants who are randomized. Participants will be
classified according to the treatment assigned at randomization. 
Safety analysis set
All enrolled participants who take at least 1 dose of study drug.  
Participants will be classified according to the study treatment 
actually received.  
DLT-Evaluable analysis set
The DLT-evaluable analysis set includes all participants who 
receive at least 1 dose of study treatment in the Phase 1b and either 
experience DLT during the DLT-evaluation period or complete the 
DLT-evaluation period without DLT. Participants without DLTs
who withdraw from study treatment before receiving at least 75% of 
the planned dose of each study drug in Cycle 1 for reasons other 
than treatment-related toxicity are not evaluable for DLT.
If there are participants non evaluable for DLT, then additional 
participants can be enrolled to ensure that target number of DLT 
evaluable participants is reached.
Immunogenicity analysis 
set
The immunogenicity analysis set is a subset of the safety analysis 
set and will include participants who have at least 1 ADA/NAb 
sample collected.
PK analysis sets 
Phase 1b and Phase 2: The PK concentration analysis set is a subset 
of the safety analysis set and will include participants who have at 
least 1 post-dose concentration measurement above the lower limit 
of quantitation (LLQ). 
The PK parameter analysis set is a subset of the safety analysis set 
and will include participants who have at least 1 Ctrough at 12 weeks.
9.4. Statistical Analyses
The statistical analysis plan will be developed and finalized before database lock and will 
describe the participant populations to be included in the analyses, and procedures for 
accounting for missing, unused, and spurious data. The primary analysis will include all data 
up to a clinical cut-off date corresponding to 12 months after the last participant randomized in 
Phase 2. The final analysis of the data will be performed after last participant last visit (LPLV). 
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This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints. 
9.4.1. DLT rate assessment 
Safety assessment will be performed using the DLT-Evaluable analysis set and the mTPI 
dosing finding method.
The dosing decision and safety assessment will be guided by the estimation of the probability 
of DLT in Cycle 1.  However, other evidence such as safety data beyond DLT, including 
safety data from treated participants who are not DLT evaluable, clinical activity, PK, and 
PD data will play an important role in the final decision. 
A safe dose will be determined using the adaptive mTPI design.  The mTPI design uses a 
Bayesian statistics framework and a beta/binomial hierarchical model to compute the 
posterior probability of 3 toxicity intervals that reflect the relative difference between the 
toxicity rate of each dose level to the target probability (pT) rate (pT=0.30).  If the toxicity 
rate of the currently used dose level is far smaller than pT, the mTPI will recommend 
escalating the dose level; if it is close to pT, the mTPI will recommend continuing at the 
current dose; if it is far greater than pT, the mTPI will recommend de-escalating the dose 
level.  The mTPI dose de-escalation/escalation recommendation will be based on the 
estimated toxicity rate and 3 intervals (underdosing, target toxicity, and excessive toxicity) as 
shown below:

If a dose is in the underdosing [0, 0.25) toxicity interval: escalate to next higher dose;

If a dose is in the target toxicity [0.25, 0.35) toxicity interval: stay at current dose;

If a dose is in the excessive toxicity or overdosing [0.35, 1] toxicity interval: 
de-escalate to a lower dose.
Each dose level will start with enrolling a group of 3-4 participants, allowing for additional 
participants (up to 6 in total) to be enrolled in dose escalation part. Once the safety evaluation 
is completed in the dose escalation part, the expansion part will be opened and PF-06801591
will be evaluated sequentially at 300 mg SC Q4W (Arm A1) and at 600 mg SC Q6W (Arm 
B1) as long as the DLT rate is below 0.35.   
Refer to Appendix 9 for additional details of the mTPI design.
9.4.2. Efficacy Analyses
All efficacy analyses will be performed by dose levels for Phase 1b and Phase 2 using the 
full analysis set. 
The efficacy endpoints of OR and TTR will be summarized based on investigator assessment 
using RECIST v1.1.  
Objective response (OR) defined as CR, or PR according to RECIST v1.1 based on 
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randomization (Phase 2) until the date of the first documentation of progression of disease 
(PD).  Both CR and PR must be confirmed by repeat assessments performed no less than 4 
weeks after the criteria for response are first met. Only tumor assessments performed on or 
before the start date of any further anti-cancer therapies will be considered in the assessment.  
ORR, defined as the proportion of participants in the analysis population with OR, will be 
calculated along with the 2-sided 95% confidence interval (CI) using the Clopper-Pearson 
method.  Participants who do not have a post-baseline tumor assessment due to early 
progression of disease, who receive anti-cancer therapies other than the study treatments 
prior to reaching a CR or PR, or who die, have PD, or stop tumor assessments for any reason 
prior to reaching a CR or PR will be counted as non-responders in the assessment of OR.  
Each participant will have an objective response status (0: no OR; 1: OR).
TTR is defined for participants with confirmed objective response (CR or PR) as the time 
from the date of first dose (Phase 1b) or randomization (Phase 2) to the date of first 
documentation of objective tumor response which is subsequently confirmed.  TTR will be 
summarized using simple descriptive statistics (eg, median and range).  Point estimates will 
be presented with 95% CIs.
9.4.3. Safety Analyses
9.4.3.1. Primary Safety Analyses
DLT during the DLT evaluation period (Cycle 1) is the primary endpoint of the Phase 1b. 
Analyses of DLT are based on the DLT-evaluable analysis set.
The occurrence of DLTs and AEs constituting DLTs will be summarized for participants in 
the Phase 1b as described in Section 9.1.
9.4.3.2. Secondary Safety Analyses
Simple summary statistics (descriptive) will be presented for participants with SAEs, AEs of 
special interest, laboratory abnormalities, and other secondary safety endpoints during the 
on-treatment period.  The on-treatment period is defined as the period starting with first dose 
of study treatment through the earliest of (30 days after date of last dose of study treatment) 
or (start date of new anti-cancer drug – 1). 
AEs, ECGs, BP, and safety laboratory data will be reviewed on an ongoing basis during the 
study to evaluate the safety of participants.  Any clinical laboratory test, ECG, or BP
abnormalities of potential clinical concern will be described.  Safety data will be summarized 
descriptively, where appropriate.
Medical history information, as applicable, collected during the course of the study will be 
considered source data and will not be required to be reported, unless otherwise noted.  
However, any untoward findings identified on physical examination during the active 
collection period will be captured as AEs, if those findings meet the definition of an AE.  
Data at screening that are used for inclusion/exclusion criteria, such as laboratory test data, 
ECGs, and vital signs, will be considered source data, and will not be required to be reported, 
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9.4.3.3. ECG Analyses
Any data obtained from ECGs repeated for safety reasons after the nominal time points will 
not be averaged along with the preceding values. Interval measurements from repeated 
ECGs will be included in the outlier analysis (categorical analysis) as individual values 
obtained at unscheduled time points.
QT intervals will be corrected for heart rate (QTc) using standard correction factors (ie, 
Fridericia’s [QTcF; default correction], Bazett’s [QT interval corrected by Bazett’s formula
{QTcB}], and possibly a study specific factor, as appropriate).  Data will be summarized and 
listed for QT interval, HR, RR interval, PR interval, QRS complex, QTcF and QTcB.
Descriptive statistics (n, mean, median, standard deviation, minimum, and maximum) will be 
used to summarize the absolute QTcF and QTcB, and changes from baseline in QTcF and 
QTcB during the on-treatment period. Categorical analysis will be conducted for the 
maximum change from baseline in QTcF and QTcB and the maximum post baseline QTcF 
and QTcB during the on-treatment period. 
The effect of drug concentrations on QTcF change from baseline will be explored 
graphically.  Additional concentration QTcF analyses may be performed.  Data may be 
pooled with other study results and/or explored further with PK/PD models.
9.4.3.4. Adverse Events
AEs will be graded by the investigator according to the CTCAE version 5.0 and coded using 
the Medical Dictionary for Regulatory Activities (MedDRA).  AE data will be reported in 
tables and listings.  Summaries of AE by toxicity grade, and seriousness and relationship to 
study treatment will be presented, as well as summaries of adverse events leading to death 
and premature withdrawal from study treatment.  The number and percentage of participants 
who experienced any AE, SAE, treatment related AE, and treatment related SAE will be 
summarized.  Listings of DLTs and deaths will be provided.
9.4.3.5. Laboratory Test Abnormalities
The number and percentage of participants who experienced laboratory test abnormalities 
will be summarized according to worst toxicity grade observed for each laboratory assay at 
baseline and during the on-treatment period.  For laboratory tests without CTCAE grade 
definitions, results will be categorized as normal, abnormal, or not done. 
9.4.4. Other Analyses 
9.4.4.1. PK Analyses
The concentration-time data of PF-06801591 will be summarized by descriptive statistics (n, 
mean, and standard deviation, coefficient of variation, median, minimum, maximum, and 
geometric mean) according to dosing cohort and time for each part of the study.  
For participants enrolled in the Phase 2 of the study, the individual concentration-time data of 
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will be analyzed separately by non-compartmental methods to estimate the PK parameters.  
The PK parameters will include Ctrough at 12 weeks and AUCτ (where τ = 4 weeks for Arm 
A2 and 6 weeks for Arm B2).  Cmax, Tmax, and AUClast will also be calculated.  If data permit 
or if considered appropriate, PK parameters such as t½, CL, volume of distribution (Vd)/ 
volume of distribution at steady state (Vss), and accumulation ratio (Rac, when feasible) will 
also be estimated for Cycle 1 (both arms), Cycle 4 (for Arm A2) and Cycle 3 (for Arm B2). 
The PK parameters will be summarized descriptively by dose level and cycle.  The trough 
concentrations will be plotted for each dose using a box whisker plot by cycle and day in 
order to assess the attainment of steady state. These plots will be used to help understand the 
relationship between PK parameters and dose.
The observed accumulation ratio and the linearity will be summarized descriptively.
Individual and median profiles will be presented on both linear-linear and log-linear scales.
Natural log transformed PK parameters (AUCτ or Ctrough at steady-state) will be analyzed 
using an Analysis of variance (ANOVA) model with treatment as fixed effects and 
participant as random effect.
For the primary PK objectives of AUCτ or Ctrough at steady-state, estimates of the adjusted 
mean differences (Test – Reference) and the corresponding 90% CIs will be obtained from 
the model.  The adjusted mean differences and the 90% CIs for the differences will be 
exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) 
and the 90% CIs for the ratios.  Test treatment relative to Reference treatment will be 
concluded if the lower bound of the 90% CIs for the ratio of adjusted geometric means of 
Test treatment relative to Reference treatment for AUCτ or Ctrough at steady-state fall is 
greater than equal to 80%.  PF-06801591 300 mg SC Q4W will be the Reference treatment, 
while PF-06801591 600 mg SC Q6W will be the Test treatment.
9.4.4.2. Population Pharmacokinetic Analysis or Pharmacokinetic/Pharmacodynamic 
(PK/Pharmacodynamic) Modeling
Pharmacokinetic and pharmacodynamic data from this study will be analyzed using 
modeling approaches and may also be pooled with data from other studies to explore any 
association between study drug exposure and biomarkers or significant safety endpoints.  
Details of these analyses will be outlined in a separate pharmacometric analysis plan 
(PMAP).  The results of these analyses will be reported separately.
PK, pharmacodynamic,
 analyses will be described and finalized 
in the statistical analysis plan before database lock.  The population PK analysis and 
pharmacodynamic analyses, 
 will be presented 
separately from the main clinical study report (CSR).
9.4.4.3. Analysis of Immunogenicity Data
ADA/NAb data will be listed and summarized.  The percentage of participants with positive 
ADA and NAbs will be summarized by treatment arm and, if deemed appropriate, combined 
across treatments.  For participants with positive ADA, the magnitude (titer), time of onset, 
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and duration of ADA response will also be described, if data permit.  The effect of ADA on 
PF-06801591 pharmacokinetics may be evaluated, if data permit.
9.5. Interim Analyses
No formal interim analysis will be conducted in this study.  However, as this is an open-label 
Phase 1b/2 study, the sponsor may conduct unblinded reviews of the data during the course 
of the study for the purpose of safety assessment, facilitating dose-finding decisions, 
facilitating PK/Pharmacodynamic modeling, or to support clinical development.
9.5.1. Data Monitoring Committee (DMC)
This study will not use a data monitoring committee (DMC).
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations

This study will be conducted in accordance with the protocol and with the 
following:
o
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines
o
Applicable International Council for Harmonisation (ICH) Good Clinical Practice 
(GCP) Guidelines
o
Applicable laws and regulations, including applicable privacy laws.

The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant 
documents (eg, advertisements) must be reviewed and approved by the sponsor and 
submitted to an IRB/(institutional) ethics committee (IEC) by the investigator and 
reviewed and approved by the IRB/IEC before the study is initiated.

Any amendments to the protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes necessary 
to eliminate an immediate hazard to study participants.

The investigator will be responsible for the following:
o
Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC
o
Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures
o
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
regulations

In the event of any prohibition or restriction imposed (ie, clinical hold) by an 
applicable regulatory authority in any area of the world, or if the investigator is 
aware of any new information that might influence the evaluation of the benefits 
and risks of the investigational product, Pfizer should be informed immediately.

In addition, the investigator will inform Pfizer immediately of any urgent safety 
measures taken by the investigator to protect the study participants against any 
immediate hazard, and of any serious breaches of this protocol or of ICH GCP that 
the investigator becomes aware of.

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10.1.2. Financial Disclosure
Investigators and sub-investigators will provide the sponsor with sufficient, accurate 
financial information as requested to allow the sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate regulatory authorities.  
Investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study.
10.1.3. Informed Consent Process

The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study.

Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of 
informed consent that meets the requirements of 21 CFR 50, local regulations, ICH 
guidelines, Health Insurance Portability and Accountability Act (HIPAA) 
requirements, where applicable, and the IRB/IEC or study center.

The investigator must ensure that each study participant [or his or her legally 
authorized representative] is fully informed about the nature and objectives of the 
study, the sharing of data related to the study and possible risks associated with 
participation, including the risks associated with the processing of the participant’s 
personal data.  The participant must be informed that his/her personal study-related 
data will be used by the sponsor in accordance with local data protection law.  The 
level of disclosure must also be explained to the participant.

The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities.

The investigator further must ensure that each study participant or his or her legally 
authorized representative is fully informed about his or her right to access and 
correct his or her personal data and to withdraw consent for the processing of his or 
her personal data.

The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained. The authorized person obtaining the informed consent must 
also sign the ICF.

In Japan, participants enrolled in the Phase 1b of the trial will be asked to sign an 
additional consent document after completion of Cycle 1 for confirmation of the 
participant’s willingness to continue participation in this study before starting Cycle 
2.

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•
Participants must be re-consented to the most current version of the ICF(s) during 
their participation in the study.
•
A copy of the ICF(s) must be provided to the participant or the participant’s legally 
authorized representative.
Participants who are rescreened are not required to sign another ICD if the rescreening occurs 
within 28 days from the previous ICD signature date. If the rescreening occurs more than 28 
days from the previous ICD signature date, a new ICD should be signed.
10.1.4. Data Protection
•
All parties will comply with all applicable laws, including laws regarding the 
implementation of organizational and technical measures to ensure protection of 
participant data.
•
Participants’ personal data will be stored at the study site in encrypted electronic 
and /or paper form and will be password protected and secured in a locked room to 
ensure that only authorized study staff have access.  The study site will implement 
appropriate technical and organizational measures to ensure that the personal data 
can be recovered in the event of disaster.  In the event of a potential personal data 
breach, the study site shall be responsible for determining whether a personal data 
breach has in fact occurred and, if so, providing breach notifications as required by 
law.
•
To protect the rights and freedoms of natural persons with regard to the processing 
of personal data, participants will be assigned a single, participant-specific 
numerical code.  Any participant records or datasets that are transferred to the 
sponsor will contain the numerical code; participant names will not be transferred.  
All other identifiable data transferred to the sponsor will be identified by this single, 
participant-specific code.  The study site will maintain a confidential list of 
participants who participated in the study, linking each participant’s numerical code 
to his or her actual identity.  In case of data transfer, the sponsor will protect the 
confidentiality of participants’ personal data consistent with the Clinical Study 
Agreement and applicable privacy laws.
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10.1.5. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials 
Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance with 
applicable local laws/regulations.  In addition, Pfizer reports study results outside of the 
requirements of local laws/regulations pursuant to its standard operating procedures (SOPs).
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in participants) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted.  These results are 
submitted for posting in accordance with the format and timelines set forth by the US law.
EudraCT
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies that 
are in scope of EU requirements.
www.pfizer.com
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov.
Documents within marketing authorization packages/submissions
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the European Medicines Agency (EMA) website. Clinical data, under Phase 1 of this 
policy, includes clinical overviews, clinical summaries, CSRs, and appendices containing the 
protocol and protocol amendments, sample CRFs, and statistical methods.  Clinical data, 
under Phase 2 of this policy, includes the publishing of individual participant data.  
Policy 0070 applies to new marketing authorization applications submitted via the 
centralized procedure since 01 January 2015 and applications for line extensions and for new 
indications submitted via the centralized procedure since 01 July 2015.
Data Sharing
Pfizer provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contribute to the scientific understanding of 
the disease, target, or compound class.  Pfizer will make available data from these trials 

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24 months after study completion.  Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations.  CSRs will have personally identifiable 
information redacted.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses.  Research teams must include a biostatistician.  Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.6. Data Quality Assurance

All participant data relating to the study will be recorded on printed or electronic 
CRF unless transmitted to the sponsor or designee electronically (eg, laboratory 
data).  The investigator is responsible for verifying that data entries are accurate and 
correct by physically or electronically signing the CRF.

The investigator must maintain accurate documentation (source data) that supports 
the information entered in the CRF.

The investigator must ensure that the CRFs are securely stored at the study site in 
encrypted electronic and/or paper form and are password protected or secured in a 
locked room to prevent access by unauthorized third parties.

The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.  
This verification may also occur after study completion. It is important that the 
investigator(s) and their relevant personnel are available during the monitoring visits 
and possible audits or inspections and that sufficient time is devoted to the process.

Monitoring details describing strategy (eg, risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical Risk-
Based Monitoring), methods, responsibilities and requirements, including handling 
of noncompliance issues and monitoring techniques (central, remote, or on-site 
monitoring) are provided in the monitoring plan.

The sponsor or designee is responsible for the data management of this study 
including quality checking of the data.

Study monitors will perform ongoing source data verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements.

Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the investigator for 15 years after study completion unless 
local regulations or institutional policies require a longer retention period.  No 

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records may be destroyed during the retention period without the written approval of 
the sponsor. No records may be transferred to another location or party without 
written notification to the sponsor.  The investigator must ensure that the records 
continue to be stored securely for so long as they are maintained.

When participant data are to be deleted, the investigator will ensure that all copies 
of such data are promptly and irrevocably deleted from all systems.

The investigator(s) will notify sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study.  Furthermore, the investigator will 
cooperate with sponsor or its agents to prepare the investigator site for the 
inspection and will allow sponsor or its agent, whenever feasible, to be present 
during the inspection.  The investigator site and investigator will promptly resolve 
any discrepancies that are identified between the study data and the participant's 
medical records.  The investigator will promptly provide copies of the inspection 
findings to sponsor or its agent.  Before response submission to the regulatory 
authorities, the investigator will provide sponsor or its agents with an opportunity to 
review and comment on responses to any such findings.
10.1.7. Source Documents

Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the 
investigator’s site.

Data reported on the CRF or entered in the electronic case report form (eCRF) that 
are transcribed from source documents must be consistent with the source 
documents or the discrepancies must be explained.  The investigator may need to 
request previous medical records or transfer records, depending on the study. Also, 
current medical records must be available.

Definition of what constitutes source data can be found in the clinical monitoring 
plan.
10.1.8. Study and Site Closure
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor.  Study sites will be closed upon 
study completion.  A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time upon notification to CRO if 
requested to do so by the responsible IRB/IEC or if such termination is required to protect the 
health of Study Participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:

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
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines

Inadequate recruitment of participants by the investigator

Discontinuation of further study intervention development
Study termination is also provided for in the clinical study agreement.  If there is any conflict 
between the contract and this protocol the contract will control as to termination rights.
10.1.9. Publication Policy

The results of this study may be published or presented at scientific meetings by the 
Investigator after publication of the overall study results or one year after end of the 
study (or study termination), whichever comes first. 

The investigator agrees to refer to the primary publication in any subsequent 
publications such as secondary manuscripts, and submit all manuscripts or abstracts 
to the sponsor 30 days before submission.  This allows the sponsor to protect 
proprietary information and to provide comments and the Investigator will, on 
request, remove any previously undisclosed confidential information before 
disclosure, except for any study- or Pfizer intervention-related information 
necessary to the appropriate scientific presentation or understanding of the study 
results.

For all publications relating to the study, the Investigator will comply with 
recognized ethical standards concerning publications and authorship, including 
those established by the International Committee of Medical Journal Editors.

The sponsor will comply with the requirements for publication of the overall study 
results covering all Investigator sites. In accordance with standard editorial and 
ethical practice, the sponsor will support publication of multicenter studies only in 
their entirety and not as individual site data.  In this case, a coordinating investigator 
will be designated by mutual agreement.

Authorship of publications for the overall study results will be determined by 
mutual agreement and in line with International Committee of Medical Journal 
Editors authorship requirements.

If publication is addressed in the clinical study agreement, the publication policy set 
out in this section will not apply.
10.1.10. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the study portal and study team on 
demand (SToD) system. 
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, participants are provided with a contact card.  The contact card 

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contains, at a minimum, protocol and investigational product identifiers, participant study 
numbers, contact information for the investigator site, and contact details for a contact center 
in the event that the investigator site staff cannot be reached to provide advice on a medical 
question or problem originating from another healthcare professional not involved in the 
participant’s participation in the study.  The contact number can also be used by investigator 
staff if they are seeking advice on medical questions or problems; however, it should be used 
only in the event that the established communication pathways between the investigator site 
and the study team are not available.  It is therefore intended to augment, but not replace, the 
established communication pathways between the investigator site and the study team for 
advice on medical questions or problems that may arise during the study.  For sites other than 
a Pfizer CRU, the contact number is not intended for use by the participant directly, and if a 
participant calls that number, he or she will be directed back to the investigator site.

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10.2. Appendix 2: Clinical Laboratory Tests

The tests detailed in Table 5 will be performed by the local laboratory.

Protocol-specific requirements for inclusion or exclusion of participants are detailed 
in Section 5 of the protocol.

Additional tests may be performed at any time during the study as determined 
necessary by the investigator or required by local regulations.

Pregnancy Testing 
o
Refer to Section 5.1 Inclusion Criteria for screening pregnancy criteria.
o
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25mIU/mL as required by local regulatory requirements.  Pregnancy tests will be 
performed in women of childbearing potential (WOCBP) at the times listed in the 
SoA.  Following a negative pregnancy test result at screening, appropriate 
contraception must be commenced and the second negative pregnancy test result 
will then be required at the baseline visit on C1D1 before the participant may 
receive the study treatment.  Pregnancy tests will also be done as per SoA and 
whenever 1 menstrual cycle is missed during the active treatment period (or when 
potential pregnancy is otherwise suspected), at the end of treatment and until Day 
30 during the post-treatment period.  At Day 90 and Day 180 during the post-
treatment period, pregnancy status should be examined (allowed also by 
telephone call, unless the participant is visiting the site for other reasons) and 
pregnancy test can be conducted as necessary.  Pregnancy tests may also be 
repeated if requested by institutional review boards (IRBs)/ethics committees 
(ECs) or if required by local regulations. If a urine test cannot be confirmed as 
negative (eg, an ambiguous result), a serum pregnancy test is required.  In such 
cases, the participant must be excluded if the serum pregnancy result is positive.

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Table 5.
Protocol-Required Safety Laboratory Assessments
Laboratory 
Assessments
Parameters
Hematology
Platelet Count
White blood cell (WBC) count with Differential:
Absolute Neutrophils
Absolute Lymphocytes
Absolute Monocytes
Absolute Eosinophils
Absolute Basophils
Hemoglobin
Clinical 
Chemistry1
ALT
AST                           
Albumin  
Alk Phos
Amylase
Lipase
                                 
BUN or Urea
Chloride 
Creatinine
Glucose (random)    
Magnesium
Phosphorus/Phosphate   
Potassium
Sodium
Total Bilirubin
Total Calcium 
Total Protein
Uric Acid                   
Pulmonary 
function 

Sialylated carbohydrate antigen (KL-6)

Arterial oxygen saturation (SpO2) 
Routine 
Urinalysis2

Protein (qual) and blood (qual)

Microscopy (only if urine dipstick is positive for blood, protein)
Coagulation

international normalized ratio (INR)

aPTT
Endocrinology

adrenocorticotropic hormone (ACTH)

thyroid-stimulating hormone (TSH)
Serology

HBV (only if clinically indicated)

HCV (only if clinically indicated)
Pregnancy Test

For female participants of childbearing potential
NOTES:
1. Details of liver chemistry required actions and follow-up assessments after liver event are given in 
Appendix 6. All events of ALT ≥3 × upper limit of normal (ULN) and bilirubin ≥2 × ULN (>35% direct 
bilirubin) or ALT ≥3 × ULN and international normalized ratio (INR) >1.5, if INR measured which may 
indicate severe liver injury (possible Hy’s Law), must be reported as an SAE (excluding studies of hepatic 
impairment or cirrhosis). 
2. Local urine testing will be standard for the protocol unless serum testing is required by local regulation or 
IRB/IEC.
Investigators must document their review of each laboratory safety report.  The results of 
each test must be entered in the CRF.

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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
10.3.1. Definition of AE
AE Definition

An AE is any untoward medical occurrence in a participant or clinical study 
participant, temporally associated with the use of study intervention, whether or not 
considered related to the study intervention.

NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator. Any 
abnormal laboratory test results that meet any of the conditions below must be 
recorded as an AE:

Is associated with accompanying symptoms.

Requires additional diagnostic testing or medical/surgical intervention.

Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy.

Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition.

New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae.

“

The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will 
be reported as an AE or SAE if they fulfill the definition of an AE or SAE and meet 

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the requirements as per Section 8.3.8.1.  Also, “lack of efficacy” or “failure of 
expected pharmacological action” does not constitute an AE or SAE.
Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.

The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.

Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.

Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).

Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen.

Worsening of signs and symptoms of the malignancy under study should be 
recorded as AEs in the appropriate section of the CRF.  Disease progression 
assessed by measurement of malignant lesions on radiographs or other methods 
should not be reported as AEs.
10.3.2. Definition of SAE
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death 
due to progression of disease).
A SAE is defined as any untoward medical occurrence that, at any dose:
a.
Results in death
b.
Is life-threatening
The term 'life-threatening' in the definition of 'serious' refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, which 
hypothetically might have caused death, if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE 
should be considered serious.

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Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
baseline is not considered an AE.
d.
Results in persistent disability/incapacity

The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.

This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Other situations:

Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the participant or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events 
should usually be considered serious.
Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.

Progression of the malignancy under study (including signs and symptoms of 
progression) should not be reported as an SAE unless the outcome is fatal within 
the active collection period.  Hospitalization due to signs and symptoms of disease 
progression should not be reported as an SAE.  If the malignancy has a fatal 
outcome during the study or within the active collection period, then the event 
leading to death must be recorded as an AE on the CRF, and as an SAE with 
Common Terminology Criteria for Adverse Events (CTCAE) Grade 5 (see the 
Severity Assessment section).

Suspected transmission via a Pfizer product of an infectious agent, pathogenic or 
non-pathogenic, is considered serious.  The event may be suspected from clinical 
symptoms or laboratory findings indicating an infection in a patient exposed to a 
Pfizer product.  The terms “suspected transmission” and “transmission” are 
considered synonymous.  These cases are considered unexpected and handled as 
serious expedited cases by pharmacovigilance personnel.  Such cases are also 
considered for reporting as product defects, if appropriate.

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10.3.3. Recording/Reporting and Follow-Up of AE and/or SAE
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording adverse events on the CRF 
and for reporting serious adverse events on the Clinical Trial (CT) Serious Adverse Event 
(SAE) Report Form to Pfizer Safety.  These requirements are delineated for 3 types of 
events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the study 
intervention under study during pregnancy or breastfeeding, and occupational exposure.  
It should be noted that the CT SAE Report Form for reporting of SAE information is not 
the same as the AE page of the CRF.  When the same data are collected, the forms must be 
completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
SAE
All
All
Non-serious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding, and 
occupational exposure
All AEs/SAEs associated 
with exposure during 
pregnancy or breastfeeding
Occupational exposure is 
not recorded.
All (And exposure during 
pregnancy [EDP] 
supplemental form for 
EDP).
Note:  Include all SAEs 
associated with exposure 
during pregnancy or 
breastfeeding. Include all 
AEs/SAEs associated with 
occupational exposure.  

When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics 
reports) related to the event.

The investigator will then record all relevant AE/SAE information in the CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the CT SAE Report Form 
/AE/SAE CRF page.

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 

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exception of the participant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety.

The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE/SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories:
GRADE
Clinical Description of Severity
1
MILD adverse event
2
MODERATE adverse event
3
SEVERE adverse event
4
LIFE-THREATENING consequences; urgent intervention indicated
5
DEATH RELATED TO adverse event
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes 
as described in the definition of an SAE, NOT when it is rated as severe.
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.

The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment.

For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is 
very important that the investigator always make an assessment of causality 
for every event before the initial transmission of the SAE data to the sponsor.

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
The investigator may change his/her opinion of causality in light of follow-up 
information and send a SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.

If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as “related to investigational product” for 
reporting purposes, as defined by the sponsor". "In addition, if the investigator 
determines that an SAE is associated with study procedures, the investigator must 
record this causal relationship in the source documents and CRF, and report such 
an assessment in the dedicated section of the CT SAE Report Form and in 
accordance with the SAE reporting requirements.
Follow-up of AEs and SAEs

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE or SAE as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other health careproviders.

If a participant dies during participation in the study or during a recognized follow-
up period, the investigator will provide Pfizer Safety with a copy of any 
post-mortem findings including histopathology.

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.
10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool

The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic data collection tool.

If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours.

The site will enter the SAE data into the electronic system as soon as the data 
become available.

After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data.

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
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (see 
next section) or to the Pfizer Safety by telephone.

SAE Reporting to Pfizer Safety via Paper CRF

Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Report Form sent by overnight mail or courier 
service.


Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated reporting 
time frames.

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10.4. Appendix 4: Contraceptive Guidance 
Definitions: Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming post-menopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP
1. Premenarchal
2. Premenopausal female with 1 of the following:

Documented hysterectomy

Documented bilateral salpingectomy

Documented bilateral oophorectomy
For individuals with permanent infertility due to an alternate medical cause other than 
the above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion 
should be applied to determining study entry.
Note: Documentation for any of the above conditions can come from the site 
personnel’s review of the participant’s medical records, medical examination, or 
medical history interview. The method of documentation should be recorded in the 
participant’s medical record for the study.
3. Postmenopausal female

A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. In addition, a

high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using 
hormonal contraception or HRT. (The states of high FSH level should be 
confirmed if there is no other medical cause).

Females on HRT and whose menopausal status is in doubt will be required to 
use one of the nonestrogen hormonal highly effective contraception methods 
if they wish to continue their HRT during the study. Otherwise, they must 
discontinue HRT to allow confirmation of postmenopausal status before 
study enrollment.

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Contraception Guidance:
10.4.1. Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following during the 
intervention period and for at least 6 months after the last dose of study intervention.  

Refrain from donating sperm
PLUS either:
Be abstinent from heterosexual intercourse as their preferred and usual 
lifestyle (abstinent on a long term and persistent basis) and agree to remain 
abstinent 
OR

Must agree to use contraception/barrier as detailed below
o
Agree to use a male condom and should also be advised of the benefit 
for a female partner to use a highly effective method of contraception 
as a condom may break or leak when having sexual intercourse with a 
woman of childbearing potential who is not currently pregnant
10.4.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, 
including participants who intend to interrupt breastfeeding, and at least one of the 
following conditions applies:
Is not a woman of childbearing potential (WOCBP) 
OR
Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of <1% per year), preferably with low user dependency, as 
described in the table below during the intervention period and for at least 6  
months after the last dose of study intervention, which corresponds to the time 
needed to eliminate any reproductive safety risk of the study intervention; and 
agrees not to donate eggs (ova, oocytes) for the purpose of reproduction 
during this period. As for participants using a highly effective method that is 
user dependent, this contraception method must be used together with a 
second effective method of contraception, as described below. The 
investigator should evaluate the effectiveness of the contraceptive method in 
relationship to the first dose of study intervention.

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The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy.
10.4.3. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.

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CONTRACEPTIVES ALLOWED DURING THE STUDY INCLUDE:
Highly Effective Methods That Have Low User Dependency 

Implantable progestogen-only hormone contraception associated with inhibition of ovulation*

Intrauterine device (IUD)

Intrauterine hormone-releasing system (IUS)

Bilateral tubal occlusion

Vasectomized partner
o
(Vasectomized partner is a highly effective contraceptive method provided that the partner is 
the sole sexual partner of the woman of childbearing potential and the absence of sperm has 
been confirmed. If not, an additional highly effective method of contraception should be used. 
Spermatogenesis cycle is approximately 90 days.)
Highly Effective Methods That Are User Dependent 

Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of 
ovulation
o
oral
o
intravaginal*
o
transdermal*
o
injectable*

Progestogen-only hormone contraception associated with inhibition of ovulation
o
oral
o
injectable*

Sexual abstinence
o
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 intervention. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant.

One of the following effective barrier methods must be used in addition to the highly effective methods 
listed above that are user dependent:
o
Male or female condom with or without spermicide
o
Cervical cap, diaphragm, or sponge with spermicide
o
A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide
(double-barrier methods)
*Not commercially available in Japan

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10.5. Appendix 5: Genetics
Use/Analysis of DNA
•
Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease. Therefore, where local 
regulations and IRB/IEC allow, a blood sample will be collected for DNA analysis.
•
Genetic research may consist of the analysis of one or more candidate genes or the 
analysis of genetic markers throughout the genome or analysis of the entire genome 
(as appropriate).
•
The samples may be analyzed as part of a multi-study assessment of genetic factors 
involved in the response to study intervention or study interventions of this class, 
treatments for the disease(s) under study or the disease(s) themselves.
•
The results of genetic analyses may be reported in the clinical study report (CSR) or 
in a separate study summary, or may be used for internal decision-making without 
being included in a study report.
•
The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality.
•
The samples will be retained as indicated:
•
Samples for specified genetic analysis (see Section 8.7) will be stored for 
up to 15 years or other period as per local requirements. 
•
Samples for banking (see Section 8.7.2) will be stored indefinitely or other 
period as per local requirements.  
CCI

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10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury, but adapt 
are termed “adaptors.”  In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome.  These participants fail to adapt and therefore are 
"susceptible" to progressive and serious liver injury, commonly referred to as drug-induced 
liver injury (DILI).  Participants who experience a transaminase elevation above 3 times the 
upper limit of normal (× ULN) should be monitored more frequently to determine if they are 
an “adaptor” or are “susceptible.”
In the majority of DILI cases, elevations in AST and/or ALT precede total bilirubin (TBili) 
elevations (>2 × ULN) by several days or weeks.  The increase in TBili typically occurs 
while AST/ALT is/are still elevated above 3 × ULN (ie, AST/ALT and TBili values will be 
elevated within the same lab sample).  In rare instances, by the time TBili elevations are 
detected, AST/ALT values might have decreased.  This occurrence is still regarded as a 
potential DILI.  Therefore, abnormal elevations in either AST OR ALT in addition to TBili 
that meet the criteria outlined below are considered potential DILI (assessed per Hy’s law 
criteria) cases and should always be considered important medical events, even before all 
other possible causes of liver injury have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions.  Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values: 

Participants with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available;

For participants with baseline AST OR ALT OR TBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed,
depending on which values are above the ULN at baseline:
o
Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values >2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is 
smaller).
o
Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches >3 × ULN 
(whichever is smaller).
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor.

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The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results.  This evaluation should 
include laboratory tests, detailed history, and physical assessment.  The possibility of hepatic 
neoplasia (primary or secondary) should be considered.  
In addition to repeating measurements of AST and ALT and TBili for suspected cases of 
Hy’s Law, additional laboratory tests should include albumin, creatine kinase (CK), direct 
and indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time 
(PT)/international normalized ratio (INR), total bile acids, and alkaline phosphatase. 
Consideration should also be given to drawing a separate tube of clotted blood and an 
anticoagulated tube of blood for further testing, as needed, for further contemporaneous 
analyses at the time of the recognized initial abnormalities to determine etiology.  A detailed 
history, including relevant information, such as review of ethanol, acetaminophen (either by 
itself or as a coformulated product in prescription or over-the-counter medications), 
recreational drug, supplement (herbal) use and consumption, family history, sexual history, 
travel history, history of contact with a jaundiced person, surgery, blood transfusion, history 
of liver or allergic disease, and potential occupational exposure to chemicals, should be 
collected.  Further testing for acute hepatitis A, B, C, D, and E infection and liver imaging 
(eg, biliary tract) and collection of serum sample for acetaminophen drug and/or protein 
adduct levels may be warranted.
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found.  Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.  
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.

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10.7. Appendix 7: Medical Device Adverse Events, Adverse Device Effects, Serious 
Adverse Events, and Device Deficiencies: Definition and Procedures for Recording,
Evaluating, Follow-up, and Reporting
Definitions of a Medical Device Deficiency
The definitions and procedures detailed in this appendix are in accordance with ISO 14155. 
Both the investigator and the sponsor will comply with all local medical device reporting 
requirements.
The detection and documentation procedures described in this protocol apply to all sponsor 
medical devices provided for use in the study (see Section 6.1.1 for the list of sponsor 
medical devices).
10.7.1. Definition of AE and ADE
AE and ADE Definition

An AE is defined as any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory finding) in study 
participants, users, or other persons, whether or not related to the investigational 
medical device.  This definition includes events related to the investigational 
medical device or comparator for study participants, users, and other persons.  This 
definition also includes events considered related to procedures for study 
participants only.

An ADE is defined as an adverse event related to the use of an investigational 
medical device.  This definition includes any adverse events resulting from 
insufficient or inadequate instructions for use, deployment, implantation, 
installation, or operation, or any malfunction of the investigational medical device 
as well as any event resulting from use error or from intentional misuse of the 
investigational medical device.
10.7.2. Definition of SAE, SADE, and Unanticipated Serious Adverse Device Effect
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death 
due to progression of disease).

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An SAE is an AE that:
a. Led to death. 
b. Led to serious deterioration in the health of the participant, that either resulted in:

A life-threatening illness or injury.  The term “life-threatening” in the definition of 
serious refers to an event in which the participant was at risk of death at the time of 
the event.  It does not refer to an event, that hypothetically might have caused 
death, if it were more severe.

A permanent impairment of a body structure or a body function.

Inpatient or prolonged hospitalization.  Planned hospitalization for a preexisting 
condition, or a procedure required by the protocol, without serious deterioration in 
health, is not considered an SAE.

Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
c.
Led to fetal distress, fetal death, or a congenital abnormality or birth defect.
SADE Definition

An SADE is defined as an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event.
USADE Definition

A USADE is a serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the current version of the risk 
analysis management file.
10.7.3. Definition of Device Deficiency
Device Deficiency Definition

A device deficiency is an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety, or performance.  Device deficiencies 
include malfunctions, use errors, and inadequate labeling.

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10.7.4. Recording/Reporting and Follow-up of AEs and/or SAEs and Device 
Deficiencies
AE, SAE, and Device Deficiency Recording

When an AE/SAE/device deficiency occurs, it is the responsibility of the 
investigator to review all documentation (eg, hospital progress notes, laboratory 
reports, and diagnostic reports) related to the event.

The investigator will then record all relevant AE/SAE/device deficiency 
information in the participant’s medical records, in accordance with the 
investigator’s normal clinical practice and on the appropriate form of the CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of following the reporting process described 
in the IP Manual 

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety.  In this case, all participant identifiers, with the 
exception of the participant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety.

The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information.  Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE/SAE.

For device deficiencies, it is very important that the investigator describes any 
corrective or remedial actions taken to prevent recurrence of the incident.

A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessary to prevent recurrence of a device 
deficiency.  This includes any amendment to the device design to prevent 
recurrence.
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE/device deficiency.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.

The investigator will use clinical judgment to determine the relationship.

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
Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.

The investigator will also consult the IB in his/her assessment.

For each AE/SAE/device deficiency, the investigator must document in the 
medical notes that he/she has reviewed the AE/SAE/device deficiency and has 
provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is 
very important that the investigator always make an assessment of causality for 
every event before the initial transmission of the SAE data to the sponsor.

The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
Follow-up of AE/SAE/Device Deficiency

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE/SAE/device deficiency as 
fully as possible.  This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized follow-
up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings including histopathology.  

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.

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10.7.5. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool

The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic data collection tool.

If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours.

The site will enter the SAE data into the electronic system as soon as the data 
become available.

After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (see 
next section) or to Pfizer Safety by telephone.
SAE Reporting to Pfizer Safety via CT SAE Report Form

Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Report Form sent by overnight mail or 
courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated reporting 
time frames.
10.7.6. Reporting of SADEs
SADE Reporting to Pfizer Safety 
NOTE: There are additional reporting obligations for medical device deficiencies that are 
potentially related to SAEs that must fulfill the legal responsibility to notify appropriate 
regulatory authorities and other entities about certain safety information relating to medical 
devices being used in clinical studies. 

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
Any device deficiency that is associated with an SAE must be reported to the 
sponsor within 24 hours after the investigator determines that the event meets the 
definition of a device deficiency.

The sponsor shall review all device deficiencies and determine and document in 
writing whether they could have led to an SAE.  These shall be reported to the 
regulatory authorities and IRBs/ECs as required by national regulations.
10.8. Appendix 8: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as Adverse Events (AEs)

Marked sinus bradycardia (rate <40 bpm) lasting minutes.

New PR interval prolongation >280 msec.

New prolongation of QTcF to >480 msec (absolute) or by ≥60 msec from 
baseline.

New-onset atrial flutter or fibrillation, with controlled ventricular response rate:
ie, rate <120 bpm.

New-onset type I second-degree (Wenckebach) Atrioventricular (AV) block of 
>30 seconds’ duration.

Frequent premature ventricular complexes (PVCs), triplets, or short intervals 
(<30 seconds) of consecutive ventricular complexes.
ECG Findings That May Qualify as Serious Adverse Events (SAEs)
QTcF prolongation >500 msec.
New ST-T changes suggestive of myocardial ischemia.
New-onset left bundle branch block (QRS complex >120 msec).
New-onset right bundle branch block (QRS complex >120 msec).
Symptomatic bradycardia.
Asystole:
In awake, symptom-free participants in sinus rhythm, with documented periods of 
asystole ≥3.0 seconds or any escape rate <40 bpm, or with an escape rhythm 
that is below the AV node. 
In awake, symptom-free participants with atrial fibrillation and bradycardia with 1 
or more pauses of at least 5 seconds or longer. 

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Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 beats per minute (bpm).
Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short duration 
with relevant symptoms or lasting >1 minute).
Ventricular rhythms >30 seconds’ duration, including idioventricular rhythm (rate 
<40 bpm), accelerated idioventricular rhythm (40< x <100), and 
monomorphic/polymorphic ventricular tachycardia >100 bpm (such as torsades de 
pointes).
Type II second-degree (Mobitz II) AV block.
Complete (third-degree) heart block.
ECG Findings That Qualify as Serious Adverse Events
Change in pattern suggestive of new myocardial infarction.
Sustained ventricular tachyarrhythmias (>30 seconds’ duration).
Second- or third-degree AV block requiring pacemaker placement.
Asystolic pauses requiring pacemaker placement.
Atrial flutter or fibrillation with rapid ventricular response requiring cardioversion.
Ventricular fibrillation/flutter.
At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The enumerated list of major events of potential clinical concern are recommended as “alerts” or 
notifications from the core ECG laboratory to the investigator and Pfizer study team, and not to be 
considered as all inclusive of what to be reported as AEs/SAEs.

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10.9. Appendix 9: Detailed Dose Escalation/De-Escalation Scheme for mTPI design
A safe dose will be determined using the adaptive mTPI design.  The mTPI design is flexible 
and allows dose reduction to doses in between the planned doses.
The mTPI design uses a Bayesian statistics framework and a beta/binomial hierarchical
model to compute the posterior probability of 3 dosing intervals that reflect the relative
difference between the toxicity rate of each dose level to the target probability (pT) rate (pT 
=0.30).  If the toxicity rate of the currently used dose level is far smaller than pT, the mTPI 
will recommend escalating the dose level; if it is close to pT, the mTPI will recommend 
continuing at the current dose; if it is far greater than pT, the mTPI will recommend de-
escalating the dose level.  These rules are conceptually similar to those used by the 3+3 
design, except the decisions of an mTPI design are based on posterior probabilities calculated 
under a coherent probability model.  As shown by Ji and Wang 12, mTPI design is more 
efficient and safer than the 3+3 design.  They considered 42 scenarios to cover a wide range 
of practical dose-response shapes, and concluded that the 3 + 3 design was more likely to 
treat participants at toxic doses above the MTD and less likely to identify the true MTD than 
the mTPI design.  For example, the 3 + 3 design exhibited a lower overall toxicity percentage 
than the mTPI design in only 1 of 42 scenarios.
Being a model-based design, mTPI automatically and appropriately tailors dose re-escalation 
and de-escalation decisions for different studies with different toxicity parameters.  More 
importantly, all the dose re-escalation/de-escalation decisions for a given study can be 
pre-calculated under the mTPI design and presented in a 2-way table.  Thus, compared to 
other advanced model-based designs published in the literature, the mTPI design is 
logistically less complicated and easier to implement.
Decision rules are based on calculating unit probability mass (UPM) of 3 dosing intervals 
corresponding to under, proper, and overdosing in terms of toxicity.  Specifically, the 
underdosing interval is defined as [0, pT-e1), the overdosing interval (pT+e2, 1], and the 
proper-dosing interval [pT- e1, pT+ e2), where e1 and e2 are small fractions.  Based on the 
safety profile of PF-06801591, e1 is selected as 0.05, and e2 is selected as 0.05.  Therefore, 
the target interval for the DLT rate is [0.25, 0.35).  The 3 dosing intervals are associated with 
3 different dose-escalation decisions.  The underdosing interval corresponds to a dose 
escalation (E), overdosing corresponds to dose de-escalation (D), and proper dosing 
corresponds to staying at the current dose (S).  Given a dosing interval and a probability 
distribution, the UPM of that dosing interval is defined as the probability of a participant 
belonging to that dosing interval divided by the length of the dosing interval. The mTPI 
design calculates the UPMs for the 3 dosing intervals, and the one with the largest UPM 
informs the corresponding dose-finding decision, which is the dose level to be used for future 
participants. For example, if the underdosing interval has the largest UPM, the decision will 
be to escalate, and the next 3-4 participants will be treated at the next higher dose level. 
Simulations have demonstrated that the decision based on UPM is optimal in that it 
minimizes a posterior expected loss (ie, minimizes the chance of making a wrong dosing 
decision). 

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The following table defines the dose finding scenarios:
Table 6.
Dose finding Rules
Number of participants treated at current dose
3
4
5
6
7
8
9
10
11
12
Number of dose limiting toxicities (DLTs)
0
E
E
E
E
E
E
E
E
E
E
1
S
S
S
E
E
E
E
E
E
E
2
D
S
S
S
S
S
S
S
E
E
3
DU
DU
D
S
S
S
S
S
S
S
4
DU
DU
DU
D
D
S
S
S
S
5
DU
DU
DU
DU
DU
D
S
S
6
DU
DU
DU
DU
DU
DU
D
7
DU
DU
DU
DU
DU
DU
8
DU
DU
DU
DU
DU
9
DU
DU
DU
DU
10
DU
DU
DU
11
DU
DU
12
DU
E = Escalate to the next higher dose
S = Stay at the current dose.
D = De-escalate to the next lower dose level.
U = The current dose is unacceptably toxic.
Targeted DLT rate =30%.
Escalation/De-escalation algorithms for total number of participants treated at the 
current dose level (current and previous cohorts)
With 3 participants treated at current dose level:
0 DLT -> escalate;
1 DLT -> remain at the same dose;
2 DLTs -> de-escalate; 
3 DLTs -> de-escalate and consider current dose as intolerable.
With 4 participants treated at current dose level:
0 DLT -> escalate;
1-2 DLTs -> remain at the same dose;
3-4 DLTs -> de-escalate and consider current dose as intolerable.

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With 5 participants treated at current dose level:
0 DLT -> escalate;
1-2 DLTs -> remain at the same dose;
3 DLTs -> de-escalate; 4-5 DLTs -> de-escalate and consider current dose as intolerable;
With 6 participants treated at current dose level:
0-1 DLT -> escalate;
2-3 DLTs -> remain at the same dose;
4-6 DLTs -> de-escalate and consider current dose as intolerable.

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10.10. Appendix 10: RECIST (Response Evaluation Criteria In Solid Tumors) 
version 1.1 Guidelines
Adapted from E.A. Eisenhauer, et al (2009)17. 
CATEGORIZING LESIONS AT BASELINE
Measurable Lesions 
Lesions that can be accurately measured in at least one dimension.
Lesions with longest diameter twice the slice thickness and at least 10 mm or greater when 
assessed by CT or MRI (slice thickness 5-8 mm).
Lesions with longest diameter at least 20 mm when assessed by chest X-ray. 
Superficial lesions with longest diameter 10 mm or greater when assessed by caliper. 
Malignant lymph nodes with the short axis 15 mm or greater when assessed by CT.
NOTE:  The shortest axis is used as the diameter for malignant lymph nodes, longest axis for 
all other measurable lesions. 
Non-measurable disease 
Non-measurable disease includes lesions too small to be considered measurable (including 
nodes with short axis between 10 and <15 mm) and truly non-measurable disease such as 
pleural or pericardial effusions, ascites, inflammatory breast disease, leptomeningeal disease, 
lymphangitic involvement of skin or lung, clinical lesions that cannot be accurately measured 
with calipers, abdominal masses identified by physical exam that are not measurable by 
reproducible imaging techniques.
Bone disease: Bone disease is non-measurable with the exception of soft tissue components 
that can be evaluated by CT or MRI and meet the definition of measurability at baseline. 
Previous local treatment: A previously irradiated lesion (or lesion subjected to other local 
treatment) is non-measurable unless it has progressed since completion of treatment.
Normal sites
Cystic lesions: Simple cysts should not be considered as malignant lesions and should not be 
recorded either as target or non-target disease.  Cystic lesions thought to represent cystic 
metastases can be measurable lesions, if they meet the specific definition above.  If 
non-cystic lesions are also present, these are preferred as target lesions.
Normal nodes: Nodes with short axis <10 mm are considered normal and should not be 
recorded or followed either as measurable or non-measurable disease.

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RECORDING TUMOR ASSESSMENTS 
All sites of disease must be assessed at baseline.  Baseline assessments should be done as 
close as possible prior to initiation of study treatment.  For an adequate baseline assessment, 
all required scans must be done within 28 days prior to initiation of study treatment (Phase 
1b) or randomization (Phase 2) and all disease must be documented appropriately.  If 
baseline assessment is inadequate, subsequent statuses generally should be inevaluable. 
Target Lesions
All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total, 
representative of all involved organs, should be identified as target lesions at baseline.  
Target lesions should be selected on the basis of size (longest lesions) and suitability for 
accurate repeated measurements.  Record the longest diameter for each lesion, except in the 
case of pathological lymph nodes for which the short axis should be recorded.  The sum of 
the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target lesions 
at baseline will be the basis for comparison to assessments performed post-baseline. 
If two target lesions coalesce the measurement of the coalesced mass is used.  If a large target 
lesion splits, the sum of the parts is used.
Measurements for target lesions that become small should continue to be recorded.  If the 
lesion is considered to have disappeared, 0 mm should be recorded; otherwise if a lesion is 
determined to be present but too small to measure, the lesion status will indicate “too small to 
measure and judged to be less than 10 mm” and 5 mm will be used in the calculation of the 
sum of the diameters.
NOTE: When nodal lesions decrease to <10 mm (normal), the actual measurement should 
still be recorded.
Non-target Disease 
All non-measurable disease is non-target.  All measurable lesions not identified as target 
lesions are also included as non-target disease.  Measurements are not required but rather 
assessments will be expressed as ABSENT,  INEVALUABLE, PRESENT WITHOUT 
UNEQUIVOCAL PROGRESSION, UNEQUIVOCAL PROGRESSION.  Multiple 
non-target lesions in one organ may be recorded as a single item on the case report form 
(eg, ‘multiple enlarged pelvic lymph nodes’ or ‘multiple liver metastases’).
OBJECTIVE RESPONSE STATUS AT EACH EVALUATION
Disease sites must be assessed using the same technique as baseline, including consistent 
administration of contrast and timing of scanning.  If a change needs to be made the case 
should be discussed with the radiologist and the sponsor to determine if substitution is 
possible.  If not, subsequent objective statuses are not evaluable. 

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Target Disease
Complete Response (CR): Complete disappearance of all target lesions with the exception of 
nodal disease.  All target nodes must decrease to normal size (short axis <10 mm).  All target 
lesions must be assessed.
Partial Response (PR): Greater than or equal to 30% decrease under baseline of the sum of 
diameters of all target measurable lesions.  All target lesions must be assessed. 
Stable Disease (SD): Does not qualify for CR, PR or Progression.  All target lesions must be 
assessed.  Stable can follow PR only in the rare case that the sum increases by less than 20% 
from the nadir (smallest sum of diameters consider baseline and all assessments prior to the 
time point under evaluation), but enough that a previously documented 30% decrease no 
longer holds. 
Objective Progression (PD): 20% increase in the sum of diameters of target measurable 
lesions above the smallest sum observed (over baseline if no decrease in the sum is observed 
during therapy), with a minimum absolute increase of 5 mm. 
Not evaluable (NE): Progression has not been documented, and 

1 or more target lesions have not been assessed; or

Assessment methods used were inconsistent with those used at baseline; or

1 or more target lesions cannot be measured accurately (eg, poorly visible unless due 
to being too small to measure); or

1 or more target lesions were excised or irradiated and have not reappeared or 
increased. 
Non-target Disease
CR: Disappearance of all non-target lesions and normalization of tumor marker levels (if 
being followed).  All lymph nodes must be ‘normal’ in size (<10 mm short axis).
Non-CR/Non-PD: Persistence of any non-target lesions and/or tumor marker level (if being 
followed) above the normal limits. 
PD: Unequivocal progression of pre-existing lesions.  Generally, the overall tumor burden 
must increase sufficiently to merit discontinuation of therapy.  In the presence of SD or PR in 
target disease, progression due to unequivocal increase in non-target disease should be rare. 
Not evaluable (NE): Progression has not been determined and 

1 or more non-target lesion sites have not been assessed; or 

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
assessment methods used were inconsistent with those used at baseline; or 

1 or more non-target lesions cannot be assessed (eg, poorly visible or unclear 
images); or

1 or more non-target lesions were excised or irradiated and have not reappeared or 
increased. 
New Lesions
The appearance of any new unequivocal malignant lesion indicates PD.  If a new lesion is 
equivocal, for example due to its small size, continued assessment will clarify the etiology.  
If repeat assessments confirm the lesion, then progression should be recorded on the date of 
the initial assessment.  A lesion identified in an area not previously scanned will be 
considered a new lesion.
Supplemental Investigations
If CR determination depends on a residual lesion that decreased in size but did not disappear 
completely, it is recommended the residual lesion be investigated with biopsy or fine needle 
aspirate.  If no disease is identified, objective status is CR.
If progression determination depends on a lesion with an increase possibly due to necrosis, 
the lesion may be investigated with biopsy or fine needle aspirate to clarify status. 
Subjective Progression
Participants requiring discontinuation of treatment without objective evidence of disease 
progression should not be reported as PD on tumor assessment CRFs.  This should be 
indicated on the end of treatment CRF as off treatment due to Global Deterioration of Health 
Status.  Every effort should be made to document PD even after discontinuation of study 
treatment. 
Determination of Tumor Response by RECIST
When both target and non-target lesions are present, individual assessments will be recorded 
separately.  New lesions will also be recorded separately.  Determination of tumor response 
at each assessment based on target, non-target and new lesions is summarized in the 
following table.

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Objective Response Status at Each Assessment for Participants with Measurable 
Disease at Baseline
Target Lesions
Non-target Lesions
New Lesions
Objective status
CR
CR
No
CR
CR
Non-CR/Non-PD or not 
all evaluated
No
PR
PR
Non-PD* or not all 
evaluated
No
PR
SD
Non-PD* or not all 
evaluated
No
SD
Not all evaluated
Non-PD
No
NE
PD
Any
Yes or No
PD
Any
PD
Yes or No
PD
Any
Any
Yes**
PD
*Non-PD includes CR and Non-CR/Non-PD
** New lesions must be unequivocal
Determination of tumor response at each assessment based on non-target and new lesions is 
summarized in the following table.
Objective Response Status at Each Assessment for Participants with Non-Measurable 
Disease at Baseline
Non-target Lesions
New Lesions
Objective status
CR
No
CR
Non-CR/Non-PD 
No
Non-CR/non-PD
Not all evaluated
No
NE
Unequivocal PD
Yes or No
PD
Any
Yes 
PD
Determination of Best Overall Response
The best overall response is the best response recorded from the start of the treatment (Phase 
1b) or randomization (Phase 2) until disease progression/recurrence (taking as reference for 
progressive disease (PD) the smallest sum on study).  For CR and PR, the participant’s best 
response assignment will depend on the achievement of both measurement and confirmation 
criteria.  CR and PR must be confirmed by 2 measurements at least 4 weeks apart.  In the 
case of SD, follow up measurements must have met the SD criteria at least once after start of 
the treatment (Phase 1b) or randomization (Phase 2) at a minimum interval of 6 weeks.

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10.11. Appendix 11: ECOG Performance Status
Grade
ECOG Performance Status
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 more than 50% of waking hours.
3
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
4
Completely disabled.  Cannot carry on any self-care.  Totally confined to bed or chair.
5
Dead
Source: From Oken, NM et al 18

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10.12. Appendix 12 Management of Immune-related Adverse Event (irAEs)
Gastrointestinal irAEs
Severity of Diarrhea/Colitis
(NCI-CTCAE v5.0)
Initial Management
Follow-up Management
Grade 1
Diarrhea: < 4 stools/day over
Baseline
Colitis: asymptomatic
-Continue study treatment
-Symptomatic treatment
(e.g. loperamide)
-Close monitoring for worsening 
symptoms
-Educate participant to
report worsening
immediately
-If worsens:
Treat as Grade 2, 3 or 4.
Grade 2
Diarrhea: 4 to 6 stools per day over
Baseline; IV fluids indicated < 24 
hours; limiting instrumental ADL
Colitis: abdominal pain; blood in
stool
-Withhold study treatment
-Symptomatic treatment
-If improves to Grade ≤1:
Resume study treatment
-If persists > 5-7 days or 
recurs: Treat as Grade 3 or 4.
Grade 3 to 4
Diarrhea (Grade 3): ≥7 stools per day
over Baseline; incontinence; IV fluids ≥
24 h; interfering with ADL
Colitis (Grade 3):
severe abdominal
pain, medical intervention
indicated,
peritoneal signs
Grade 4: life-threatening, perforation
-Withhold for Grade
3.
-Permanently discontinue 
study treatment for Grade 4 or 
recurrent Grade 3.
-1.0 to 2.0 mg/kg/day 
prednisone 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; resume study treatment
following steroids taper (for 
initial Grade 3).
-If worsens, persists > 3 to 5 
days, or recurs after
improvement:
-Add infliximab 5mg/kg (if no 
contraindication).
-Note: infliximab should not be
used in cases of perforation or 
sepsis.

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Dermatological irAEs
Grade of
Rash (NCI-
CTCAE v5.0)
Initial Management
Follow-up Management
Grade 1 to 2
Covering ≤ 30% body surface area
-Continue study treatment  
-Symptomatic therapy (for 
example, antihistamines, 
topical steroids)
-If Grade 2 persists > 1 to 2 weeks or 
recurs: 
-Withhold study treatment 
-Consider skin biopsy
-Consider 0.5-1.0 mg/kg/day 
prednisone or equivalent. Once 
improving, taper steroids over at 
least 1 month, consider prophylactic 
antibiotics for opportunistic 
infections, and resume study 
treatment following steroids taper.
-If worsens: Treat as Grade 3 to 4.
Grade 3 to 4
Grade 3: Covering > 30% 
body surface area;
Grade 4: Life
threatening 
consequences
-Withhold study 
treatment for Grade 3.
-Permanently discontinue for
Grade 4 or recurrent Grade 3.
-Consider skin biopsy
-Dermatology consult
-1.0 to 2.0 mg/kg/day 
prednisone or equivalent
-Add prophylactic antibiotics 
for opportunistic infections
-If improves to Grade ≤1:
-Taper steroids over at least 1 month; 
resume study treatment following
steroids taper (for initial Grade 3).

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Pulmonary irAEs
Grade of Pneumonitis
(NCI-CTCAE v5.0)
Initial Management
Follow-up Management
Grade 1
Radiographic changes only
-Consider withholding study 
treatment
-Monitor for symptoms
every 2 to 3 days
-Consider Pulmonary and
Infectious Disease consults
-Re-assess at least
every 3 weeks
-If worsens: Treat as Grade 2
or Grade 3 to 4.
Grade 2
Mild to moderate new symptoms
-Withhold study treatment
-Pulmonary and Infectious 
Disease consults
-Monitor symptoms 
daily; consider 
hospitalization
-1.0 to 2.0 mg/kg/day 
prednisone or equivalent
-Add prophylactic 
antibiotics for opportunistic 
infections
-Consider bronchoscopy, 
lung biopsy
-Re-assess every 
1 to 3 days If
improves:
-When symptoms return to Grade
≤1, taper steroids over at least 1 
month, and then resume study 
treatment following steroids 
taper
-If not improving after 2 weeks 
or worsening: Treat as Grade 3
to 4.
Grade 3 to 4
Grade 3: Severe new symptoms;
New/worsening hypoxia;
Grade 4: Life-threatening
-Permanently
discontinue study 
treatment.
-Hospitalize.
-Pulmonary and 
Infectious Disease 
consults.
-1.0 to 2.0 mg/kg/day 
prednisone or equivalent
-Add prophylactic antibiotics 
for opportunistic infections
-Consider bronchoscopy, lung
biopsy
-If improves to Grade ≤ 1:
-Taper steroids over at least 1 
month
-If not improving after 48 hours
or worsening: Add additional
immunosuppression (for
example, infliximab, 
cyclophosphamide, IV
immunoglobulin, or 
mycophenolate mofetil)

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Hepatic irAEs
Grade of Liver
Test Elevation
(NCI-CTCAE 
v5.0)
Initial Management
Follow-up Management
Grade 1
Grade 1 AST or ALT > 
ULN to 3.0 x ULN if 
baseline was normal, > 
1.5-3.0 x baseline if 
baseline was abnormal; 
and/or Total bilirubin > 
ULN to
1.5 x ULN if baseline was 
normal, > 1.0-1.5 x 
baseline if baseline was 
abnormal
-Continue study treatment
-Continue liver function monitoring
-If worsens: Treat as Grade 2 or 3 - 4.
Grade 2
AST or ALT > 3.0 to 
≤ 5 x ULN if 
baseline was normal, 
> 3.0-5.0 x baseline 
if baseline was 
abnormal; and/or 
total bilirubin > 1.5 
to ≤ 3 x ULN if 
baseline was normal, 
> 1.5-3.0 x baseline 
if baseline was 
abnormal
-Withhold study treatment
-Increase frequency of monitoring
to every 3 days.
-If returns to Grade ≤ 1:
-Resume routine monitoring; 
resume study treatment.
-If elevation persists > 5 to 7 days or 
worsens: 
-Treat as Grade 3 to 4.

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Hepatic irAEs
Grade of Liver
Test Elevation
(NCI-CTCAE 
v5.0)
Initial Management
Follow-up Management
Grade 3 to 4
AST or ALT > 5 x 
ULN if baseline was 
normal, > 5.0 x 
baseline if baseline 
was abnormal; and/or 
total bilirubin > 3 x 
ULN if baseline was 
normal, > 3 x baseline 
if baseline was 
abnormal
-Permanently discontinue study 
treatment
-Increase frequency of
monitoring to every 1 to 2 days
-1.0 to 2.0 mg/kg/day prednisone or
equivalent
-Add prophylactic antibiotics for
opportunistic infections
-Consult gastroenterologist/ 
hepatologist
-Consider obtaining MRI/CT scan of 
liver and liver biopsy if clinically 
warranted
-If returns to Grade ≤ 1:
-Taper steroids over at least 1 month
-If does not improve in > 3 to 5 days,
worsens or rebounds:
-Add mycophenolate mofetil 1 gram 
(g) twice daily
-If no response within an additional 3
to 5 days, consider other 
immunosuppressants per local
guidelines.
Renal irAEs
Grade of Creatinine 
Increased (NCI-CTCAE 
v5.0)
Initial Management
Follow-up
Management
Grade 1
Creatinine increased > ULN to 1.5
x ULN
-Continue study treatment
-Continue renal function
monitoring
-If worsens: Treat as
Grade 2 to 3 or 4.
Grade 2 to 3
Creatinine increased > 1.5 and ≤6
x ULN
-Withhold study treatment  
-Increase frequency of monitoring to
every 3 days
-1.0 to 2.0 mg/kg/day prednisone or 
equivalent.
-Add prophylactic antibiotics for
opportunistic infections
-Consider renal biopsy
-If returns to Grade ≤1:
-Taper steroids over at
least 1 month, and
resume study treatment
following steroids taper.
-If worsens:
-Treat as Grade 4.

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Renal irAEs
Grade of Creatinine 
Increased (NCI-CTCAE 
v5.0)
Initial Management
Follow-up
Management
Grade 4
Creatinine increased > 6 x ULN
-Permanently discontinue study 
treatment 
-Monitor creatinine daily
-1.0 to 2.0 mg/kg/day prednisone or 
equivalent.
-Add prophylactic antibiotics for
opportunistic infections Consider 
renal biopsy
-Nephrology consult
-If returns to Grade ≤1:
Taper steroids over at least 1 
month.

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Cardiac irAEs
Myocarditis
Initial Management
Follow-up
Management
New onset of cardiac signs or 
symptoms and / or new laboratory
cardiac biomarker elevations (e.g.
troponin I, CK-MB, BNP) or 
cardiac imaging abnormalities
suggestive of myocarditis.
-Withhold study treatment.
-Hospitalize.
-In the presence of life threatening cardiac 
decompensation, consider transfer to a 
facility experienced in advanced heart 
failure and arrhythmia management.
-Consult cardiologist to establish etiology
and rule-out immune-mediated
myocarditis.
-Guideline based supportive treatment as
per cardiology consult.*
-Consider myocardial biopsy if
recommended per cardiology consult.
-If
symptoms
improve
and
immune-mediated
etiology is ruled out, re-
start study treatment.
-If symptoms do not 
improve/worsen, viral 
myocarditis is excluded, 
and immune-mediated
etiology is suspected or 
confirmed following
cardiology consult, 
manage as immune-
mediated myocarditis.
Immune-mediated myocarditis
-Permanently discontinue study treatment.
-Guideline based supportive treatment as
appropriate as per cardiology consult.*
1.0 to 2.0 mg/kg/day prednisone or
equivalent
-Add prophylactic antibiotics for
opportunistic infections.
-Once improving, taper
steroids over at least 1 
month.
If no improvement or 
worsening, consider 
additional 
immunosuppressants
(e.g. azathioprine,
cyclosporine A, 
abatacept).
*Local guidelines, or eg. ESC or AHA guidelines

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Endocrine irAEs
Endocrine Disorder
Initial Management
Follow-up
Management
Grade 1 or Grade 2 
endocrinopathies
(hypothyroidism,
hyperthyroidism, adrenal
insufficiency, type I
diabetes mellitus)
-Continue study treatment 
-Endocrinology consult if needed
-Start thyroid hormone replacement 
therapy (for hypothyroidism),
anti-thyroid treatment (for 
hyperthyroidism), corticosteroids (for
adrenal insufficiency) or insulin (for 
Type I diabetes mellitus) as appropriate 
-Rule-out secondary endocrinopathies (ie,
hypopituitarism / hypophysitis)
-Continue hormone 
replacement/suppression
and monitoring of 
endocrine function as 
appropriate.
Grade 3 or Grade 4 
endocrinopathies
(hypothyroidism,
hyperthyroidism, adrenal
insufficiency, type I
diabetes mellitus)
-Withhold study treatment
-Consider hospitalization -----
Endocrinology consult
-Start thyroid hormone replacement 
therapy (for hypothyroidism),
anti-thyroid treatment (for 
hyperthyroidism), corticosteroids (for
adrenal insufficiency) or insulin (for type
I diabetes mellitus) as appropriate.
-Rule-out secondary endocrinopathies (ie,
hypopituitarism / hypophysitis)
-Resume study treatment 
once symptoms and/or
laboratory tests improve to
Grade ≤ 1 (with or without
hormone
replacement/suppression).
-Continue hormone 
replacement/suppression
and monitoring of 
endocrine function as 
appropriate.
Hypopituitarism/ 
Hypophysitis (secondary
endocrinopathies)
-If secondary thyroid and/or adrenal 
insufficiency is confirmed (ie, subnormal
serum FT4 with inappropriately low TSH
and/or low serum cortisol with
inappropriately low ACTH):

-Refer to endocrinologist for dynamic 
testing as indicated and measurement
of other hormones (FSH, LH,
GH/IGF-1, PRL,
testosterone in men, estrogens in 
women)

-Hormone replacement/suppressive 
therapy as appropriate


-Perform pituitary MRI and visual 
field examination as indicated
-If hypophysitis is confirmed:

-Continue study treatment if 
mild symptoms with normal 
MRI. Repeat the MRI in 1 
month

-Resume study treatment 
once symptoms and
hormone tests improve to
Grade ≤ 1 (with or without
hormone replacement).
-In addition, for
hypophysitis with
abnormal MRI, resume
study treatment only once
shrinkage of the pituitary
gland on MRI/CT scan is 
documented.
-Continue hormone 
replacement/suppression 
therapy as appropriate.

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Endocrine irAEs
Endocrine Disorder
Initial Management
Follow-up
Management

-Withhold study treatment if moderate,
severe or life-threatening symptoms of 
hypophysitis and/or abnormal MRI.
Consider hospitalization. Initiate 
corticosteroids (1 to 2 mg/kg/day 
prednisone or equivalent) followed by
corticosteroids taper during at least 1 
month.

-Add prophylactic antibiotics for
opportunistic infections.

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10.13. Appendix 13 Japan-specific Requirements 
•
Conditions for judging whether the participant can be discharged during the DLT 
evaluation period (Section 1.1 Synopsis and Section 4.1 Overall design; DLT 
determination)
When a participant is discharged from the hospital during the DLT evaluation period, the 
following conditions/status of the participant should be evaluated on the day of the scheduled 
discharge by the investigators, and the propriety of discharge should be determined. The 
tests/medical examinations needed to confirm the participant’s status will be conducted per 
clinical practice at the study site by investigator’s judgement as appropriate.
•
There are currently no clinically significant adverse events or other medical 
conditions that require monitoring in a hospital setting.
•
If a clinically significant adverse event has occurred or continues to be present, the 
investigator has determined that the event is manageable by appropriate treatment or 
prophylaxis in an out of the hospital setting. The investigator will ensure the adverse 
event is followed up according to the protocol requirement.
•
Overall physical condition is stable and acceptable.
•
In case of emergency, the participant may return to the clinical study site or other 
medical institution. If participants go to a medical institution other than the clinical 
study site, the clinical study site asks that the participants contact the study site and 
study investigator and the doctor at the medical institution will communicate to 
discuss appropriate treatments. A study site keeps ready for emergency situations and 
is available even during nights and holidays, and the sponsor will ensure and the 
selected study site will thoroughly follow all participants according to study 
procedures.
10.13.1. Definitions of serious adverse event, serious adverse event caused by medical 
device, and unanticipated serious adverse event caused by medical device
Definition of serious adverse event caused by medical device.
A serious adverse event caused by medical device is defined as an adverse event caused by a 
medical device which led to an outcome characteristic to serious adverse events, or a device-
related incident whose recurrence might lead to death or serious deterioration in health.
CCI

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10.14. Appendix 14. Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic globally and will become effective for other public emergencies 
only upon written notification from Pfizer. 
Use of these alternative study measures are expected to cease upon the return of business as 
usual circumstances (including the lifting of any quarantines and travel bans/advisories). 
To fulfill the primary and secondary PK endpoints, it is highly recommended that in-clinic 
study visits are conducted for the following visits (and not substituted with visits/safety 
assessments listed in Sections 10.14.2 and 10.14.3 below, if feasible):

For participants receiving Q4W regimen: C1D1, C1D8, C1D15, C1D22, C2D1; and 
C4D1, C4D8, C4D15, C4D22, C5D1

For participants receiving Q6W regimen: C1D1, C1D8, C1D15, C1D29, C2D1; and 
C3D1, C3D8, C3D15, C3D29, C4D1  
Sponsor should be contacted prior to implementation of the procedures reported below and 
discussed with the Medical Monitor case-by-case  
10.14.1. Eligibility
While SARS-CoV2 testing is not mandated for this study, local clinical practice standards for 
testing should be followed. A patient should be excluded if he/she has a positive test result 
for SARS-CoV2 infection, is known to have asymptomatic infection, or is suspected of 
having SARS-CoV2. Patients with active infections are excluded from study participation as 
per

Exclusion criteria Number 5: Participants with known active, uncontrolled bacterial, 
fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), 
sero-positivity to human immunodeficiency virus (HIV) infection 

Exclusion criteria Number 16: Other acute or chronic medical or psychiatric 
condition including recent (within the past year) or active suicidal ideation or 
behavior or laboratory abnormality that may increase the risk associated with study 
participation or investigational product administration or may interfere with the 
interpretation of study results and, in the judgment of the investigator, would make 
the participant inappropriate for entry into this study.
10.14.2. Telehealth Visits
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow up on the safety of study participants at scheduled visits per the Schedule of 
Activities or unscheduled visits. Telehealth visits may be used to continue to assess 
participant safety and collect data points. Telehealth includes the exchange of healthcare 
information and services via telecommunication technologies (e.g., audio, video, video-
conferencing software) remotely, allowing the participant and the investigator to 

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communicate on aspects of clinical care, including medical advice, reminders, education, and 
safety monitoring. The following assessments must be performed during a telehealth visit:
 

Review and record any AEs and SAEs since the last contact. Refer to Section 8.3.

Review and record any new concomitant treatments or changes in concomitant 
treatments since the last contact.

Review and record contraceptive method and results of pregnancy testing, if 
applicable for the participant. Confirm that the participant is adhering to the 
contraception method(s) required in the protocol. Refer to Appendix 4 and Section 
10.10.3.1 of this appendix regarding pregnancy tests.

Assess ECOG performance status.
Study participants must be reminded to promptly notify site staff about any change in their 
health status.
10.14.3. Alternative Facilities for Safety Assessments
Alternative facilities to the study site may be used as described in this section.
10.14.3.1. Laboratory Testing
If a study participant is unable to visit the site for protocol-specified safety laboratory 
evaluations, testing may be conducted at a local laboratory if permitted by local regulations. 
. Note that per protocol, participants may have safety labs completed at a local laboratory 
even in the absence of a public emergency; however, this section is included to highlight the 
option to use local labs if needed to facilitate collection of safety laboratory assessments 
during a public emergency. The local laboratory may be a standalone institution or within a 
hospital. The following safety laboratory evaluations may be performed at a local laboratory: 
Please refer to the Table 5 for protocol required safety laboratory assessments.
If a local laboratory is used, qualified study site personnel must order, receive, and review 
results. Site staff must collect the local laboratory reference ranges and certifications/
accreditations for filing at the site. Laboratory test results are to be provided to the site staff 
as soon as possible.  The local laboratory reports should be filed in the participant’s source 
documents/medical records. Relevant data from the local laboratory report should 
be recorded on the CRF. 
If a participant requiring pregnancy testing cannot visit a local laboratory for pregnancy 
testing, a home urine pregnancy testing kit with a sensitivity of at least 25 IU/mL may be 
used by the participant to perform the test at home, if compliant with local regulatory 
requirements. The pregnancy test outcome should be documented in the participant’s source 
documents/medical records and relevant data recorded on the CRF. Confirm that the 
participant is adhering to the contraception method(s) required in the protocol. 

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10.14.3.2. Electrocardiograms
If the participant is unable to visit the study site for ECGs, the participant may visit an 
alternative facility to have the ECGs performed. Qualified study site personnel must order, 
receive, and review results. Note that per protocol, participants may have ECGs completed at 
an alternative facility to the site even in the absence of a public emergency; however, this 
section is included to highlight the option to use an alternative facility if needed to allow 
completion of ECGs during a public emergency.
10.14.4. Study Intervention
If the safety of a trial participant is at risk because they cannot complete required evaluations 
or adhere to critical mitigation steps, then discontinuing that participant from study 
intervention must be considered.
This guidance below is intended to support decision making, but it is not meant to supersede 
clinical assessment of any individual study participant case.
Regarding the continued administration of PF-06801591 for ongoing participants who 
have active [confirmed (positive by regulatory authority-approved test) or presumed (test 
pending/clinical suspicion)] SARS-CoV2 infection, the following is recommend:

For symptomatic participants with active SARS-CoV2 infection, study intervention 
should be delayed for at least 14 days from the start of symptoms. This delay is 
intended to allow the resolution of symptoms of SARS-CoV2 infection.

Prior to restarting treatment, the participant should be afebrile for 72 hours, and SARS-
CoV2-related symptoms should have recovered to ≤Grade 1 for a minimum of 72 
hours.  It is requested that the site inform the study team when treatment is restarted.

Continue to consider potential drug-drug interactions for any concomitant medication 
administered for treatment of SARS-CoV2 infection.
10.14.5. Adverse Events and Serious Adverse Events
If a participant has COVID-19 during the study, this should be reported as an adverse event 
(AE) or serious adverse events (SAE) and appropriate medical intervention provided.
It is recommended that the investigator discuss temporary or permanent discontinuation of 
study intervention with the Sponsor. 

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10.15. Appendix 15: Abbreviations
Abbreviation
Term
ACTH
adrenocorticotropic hormone
ADA
anti-drug antibody
ADE
adverse device effect
AE
adverse event
ALK
anaplastic lymphoma kinase 
AESI
Adverse event of special interest
ALT
alanine aminotransferase
ANC
absolute neutrophil count
ANOVA
analysis of variance
ASCO
American Society of Clinical Oncology
AST
aspartate aminotransferase
AUC
area under the curve
AUCτ
area under the concentration-time curve during the dosing
interval (τ)
AV
atrioventricular
BP
blood pressure
BRAF
v-raf murine sarcoma viral oncogene homolog B1
cfDNA
cell-free DNA
C1D1
Cycle 1 Day 1
CI
confidence interval
CK
creatine kinase 
CIOMS
Council for International Organizations of Medical Sciences
Cmax
maximum observed concentration
CONSORT
Consolidated Standards of Reporting Trials
CR
complete response
CRF
case report form
CRS
cytokine release syndrome
CSR
clinical study report
CT
computed tomography
CTC
circulating tumor cells 
CTCAE
Common Terminology Criteria for Adverse Events
ctDNA
circulating tumor DNA
Ctrough
concentration at the end of the dosing interval
CV
coefficient of variation 
D
de-escalation
DCR
disease control rate
DILI
drug-induced liver injury
DLT
dose-limiting toxicity
DMC
data monitoring committee
DNA
deoxyribonucleic acid
CCI

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Abbreviation
Term
DU
dispensable unit
E
escalation
EC
ethics committee
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDP
exposure during pregnancy
EDTA
ethylenediaminetetraacetic acid
EGFR
epidermal growth factor receptor
EMA
European Medicines Agency
EOT
end of treatment
EU
European Union
EudraCT
European Clinical Trials Database
18F-FDG-PET
18-fluorodeoxyglucose positron emission tomography 
FAS
full analysis set
FFPE
formalin-fixed paraffin-embedded
FSH
follicle stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
G-CSF
Granulocyte Colony-Stimulating Factor
KL-6
sialylated carbohydrate antigen
HBV
hepatitis B virus
HCV
hepatitis C virus
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficiency virus
HRT
hormonal replacement therapy
IASLC
International Association for the Study of Lung Cancer
IB
investigator’s brochure
ICD
informed consent document
ICF
informed consent form
ICH
International Council for Harmonisation
(I)EC
(institutional) ethics committee
IFN-
interferon gamma 
IL
interleukin
ILD
Interstitial Lung Disease
INR
international normalized ratio
IP manual
investigational product manual
irAE
immune-related adverse event
IRB
institutional review board
IRT
interactive response technology
ISR
injection site reaction
IV
intravenous(ly)

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Abbreviation
Term
IWR
interactive Web-based response
LBBB
left bundle branch block
LPLV
last patient last visit
mAb
monoclonal antibody
MedDRA
Medical Dictionary for Regulatory Activities
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
mTNBC
metastatic triple negative breast cancer
mTPI
modified toxicity probability interval
N/A
not applicable
NAb
neutralizing antibodies
NCI
National Cancer Institute
NE
not evaluable
(N)IMP
(non-)investigational medicinal product
NSCLC
non-small-cell lung carcinoma
OR
objective response
ORR
objective response rate
PCD
primary completion date
PD
progressive disease
PD-1/L1/L2
programmed death - 1/L1/L2, respectively
PET
positron emission tomography
PFS
pre-filled syringe
PK
pharmacokinetic(s)
PMAP
pharmacometric analysis plan   
PMDA
Pharmaceuticals and Medical Devices Agency
PR
partial response
pT
target probability
PT
prothrombin time
PVC
premature ventricular complex
Q3W/Q4W/Q6W
every 3 / 4 / 6 weeks, respectively
QRS
depolarization of the ventricles, between the beginning of the Q 
wave and the end of S wave
QTc
corrected QT
QTcB
QT interval corrected by Bazett’s formula
QTcF
QT interval corrected by Fridericia's formula
RECIST
Response Evaluation Criteria in Solid Tumors
RNA
ribonucleic acid
ROS1
c-ros oncogene 1
SADE
serious adverse device effect
SAE
serious adverse event
SAP
statistical analysis plan
S
staying at the current dose

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Abbreviation
Term
SC
subcutaneous(ly)
SCCHN
squamous cell carcinoma of the head and neck
SD
stable disease
SoA
schedule of activities
SOP
standard operating procedure
SRSD
single reference safety document
SpO2
arterial oxygen saturation
StoD
study team on demand
SUSAR
suspected unexpected serious adverse reaction
TBili
total bilirubin
TCR
T-cell receptor
TMB
tumor mutational burden
TME
tumor microenvironment
TNF
tumor necrosis factor
TPS
Tumor Proportion Score
TRAE
treatment related adverse event
TSH
thyroid-stimulating hormone
TTR
time to response
UC
urothelial carcinoma
ULN
upper limit of normal
UPCR
urinary protein creatinine ratio
UPM
unit probability mass
VBIR
vaccine-based immunotherapy regimen
USADE
unanticipated serious adverse device effect
WOCBP
woman of childbearing potential

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