Clinical trial NCT04949191
Conditions: Advanced Malignancies
Keywords: pemigatinib
Sponsor: Incyte Corporation
Start date: 2021-07-08; Completion date: 2024-04-11
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.

Detailed description:
A Phase 2 Open-Label, Multicenter, Rollover Study to evaluate the long term safety and tolerability of Pemigatinib and to provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib

Arms: arm 1: Pemigatinib will be taken orally once daily arm 2: Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks arm 3: Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.
Interventions: intervention 1: Pemigatinib intervention 2: Retifanlimab intervention 3: Pembrolizumab
Intervention descriptions: intervention 1: Pemigatinib tablets taken by mouth once daily as per protocol intervention 2: Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle) intervention 3: Commercially labeled products

Protocol documents:
Prot_000.pdf: 
Official Title:    An Open-Label, Multicenter, Rollover Study to Provide Continued 
Treatment for Participants With Advanced Malignancies 
Previously Enrolled in Studies of Pemigatinib 
NCT Number: 
 NCT04949191 
Document Date: 
Original Clinical Study Protocol: 17-May-2021


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Protocol INCB 54828-801 
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Clinical Study Protocol 
TITLE PAGE 
INCB 54828-801 
An Open-Label, Multicenter, Rollover Study to Provide Continued 
Treatment for Participants With Advanced Malignancies Previously 
Enrolled in Studies of Pemigatinib 
Product: 
Pemigatinib (INCB054828) 
IND Number: 
124,358 
EudraCT Number: 
2021‐002207‐36 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, Delaware, USA 19803 
Original Protocol: 
17 MAY 2021 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws 
and country-specific regulations in which the study is being conducted. 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 


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INVESTIGATOR'S AGREEMENT 
 
I have read the INCB 54828-801 Protocol (dated 17 MAY 2021) and agree to conduct the study 
as outlined.  I agree to maintain the confidentiality of all information received or developed in 
connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 


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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ..........................................................................................................7 
1. 
PROTOCOL SUMMARY ............................................................................................8 
2. 
INTRODUCTION ......................................................................................................11 
2.1. 
Background .................................................................................................................11 
2.2. 
Study Rationale ...........................................................................................................11 
2.2.1. 
Scientific Rationale for Study Design ........................................................................11 
2.2.2. 
Justification for Dose of Pemigatinib .........................................................................11 
2.2.3. 
Justification for Dose of Pembrolizumab and INCMGA00012 .................................11 
2.3. 
Benefit/Risk Assessment ............................................................................................12 
2.3.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic ......................................12 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................13 
4. 
STUDY DESIGN .......................................................................................................13 
4.1. 
Overall Design ............................................................................................................13 
4.2. 
Overall Study Duration ...............................................................................................13 
4.3. 
Study Termination ......................................................................................................13 
5. 
STUDY POPULATION .............................................................................................14 
5.1. 
Inclusion Criteria ........................................................................................................14 
5.2. 
Exclusion Criteria .......................................................................................................15 
5.3. 
Lifestyle Considerations .............................................................................................15 
5.4. 
Screen Failures ............................................................................................................15 
5.5. 
Replacement of Participants .......................................................................................15 
6. 
STUDY TREATMENT ..............................................................................................15 
6.1. 
Study Treatments Administered .................................................................................15 
6.2. 
Preparation, Handling, and Accountability ................................................................17 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................17 
6.4. 
Study Treatment Compliance .....................................................................................18 
6.5. 
Dose Modifications and Interruptions ........................................................................18 
6.6. 
Concomitant Medications and Procedures .................................................................18 


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7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
WITHDRAWAL ........................................................................................................18 
7.1. 
Discontinuation of Study Treatment ...........................................................................18 
7.1.1. 
Reasons for Discontinuation .......................................................................................18 
7.1.2. 
Discontinuation Procedures ........................................................................................19 
7.2. 
Participant Withdrawal From the Study .....................................................................19 
7.3. 
Lost to Follow-Up.......................................................................................................19 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................20 
8.1. 
Administrative and General Procedures .....................................................................20 
8.1.1. 
Informed Consent Process ..........................................................................................20 
8.1.2. 
Interactive Response Technology Procedure ..............................................................21 
8.1.3. 
Demography and Medical History ..............................................................................21 
8.1.3.1. 
Disease Characteristics and Treatment History ..........................................................21 
8.2. 
Efficacy Assessments .................................................................................................21 
8.3. 
Safety Assessments .....................................................................................................21 
8.3.1. 
Adverse Events ...........................................................................................................21 
8.3.2. 
Laboratory Assessments .............................................................................................22 
8.3.2.1. 
Pregnancy Testing ......................................................................................................24 
8.4. 
Unscheduled Visits .....................................................................................................24 
8.5. 
End of Treatment ........................................................................................................24 
8.6. 
Follow-Up ...................................................................................................................24 
8.6.1. 
Safety Follow-Up ........................................................................................................24 
8.6.2. 
Post-Treatment Disease Follow-Up ............................................................................24 
8.6.3. 
Survival Follow-Up ....................................................................................................24 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................25 
9.1. 
Definition of Adverse Event .......................................................................................25 
9.2. 
Definition of Serious Adverse Event ..........................................................................25 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........26 
9.4. 
Reporting of Serious Adverse Events .........................................................................28 
9.5. 
Emergency Unblinding of Treatment Assignment .....................................................29 
9.6. 
Pregnancy ...................................................................................................................30 
9.7. 
Warnings and Precautions ..........................................................................................30 


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9.8. 
Product Complaints ....................................................................................................30 
9.9. 
Treatment of Overdose of Pemigatinib .......................................................................31 
10. 
STATISTICS ..............................................................................................................31 
10.1. 
Sample Size Determination ........................................................................................31 
10.2. 
Populations for Analyses ............................................................................................31 
10.3. 
Statistical Analyses .....................................................................................................31 
10.3.1. 
Disposition and Demographics ...................................................................................31 
10.3.2. 
Exposure .....................................................................................................................31 
10.3.3. 
Safety Analyses ..........................................................................................................31 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................32 
11.1. 
Investigator Responsibilities .......................................................................................32 
11.2. 
Data Management .......................................................................................................33 
11.3. 
Data Privacy and Confidentiality of Study Records ...................................................35 
11.4. 
Financial Disclosure ...................................................................................................35 
11.5. 
Publication Policy .......................................................................................................36 
11.6. 
Study and Site Closure................................................................................................36 
12. 
REFERENCES ...........................................................................................................37 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND DEFINITIONS ............................................38 
APPENDIX B. LIST OF PARENT PROTOCOLS ....................................................................40 
APPENDIX C. COVID-19 PANDEMIC MITIGATION STRATEGIES AND 
INSTRUCTIONS .......................................................................................................41 
APPENDIX D. PROTOCOL AMENDMENT SUMMARY OF CHANGES ...........................44 
 
LIST OF TABLES 
Table 1: 
Objectives and Endpoints .............................................................................................8 
Table 2: 
Key Study Design Elements .........................................................................................8 
Table 3: 
Schedule of Activities .................................................................................................10 
Table 4: 
Objectives and Endpoints ...........................................................................................13 
Table 5: 
Study Treatment Information .....................................................................................16 
Table 6: 
Required Laboratory Analytes ....................................................................................23 
 


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LIST OF FIGURES 
Figure 1: 
Study Design Schema ...................................................................................................9 
 


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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
AE 
adverse event 
CFR 
Code of Federal Regulations 
COVID-19 
coronavirus disease 2019 
CTCAE 
Common Terminology Criteria for Adverse Events 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EOT 
end of treatment   
FDA 
Food and Drug Administration 
FGFR 
fibroblast growth factor receptor 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
IB 
Investigator's Brochure 
ICF 
informed consent form  
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
ID 
identification 
IEC 
independent ethics committee 
IRB 
institutional review board 
IRT 
interactive response technology 
IV 
intravenous 
MedDRA 
Medical Dictionary for Regulatory Activities 
PD-1 
programmed death 1 
RSI 
reference safety information 
SAE 
serious adverse event 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SOP 
standard operating procedure 
study treatment 
refers to pemigatinib monotherapy or combination therapy with pemigatinib 
TEAE 
treatment-emergent adverse event 


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1. 
PROTOCOL SUMMARY 
Protocol Title: 
An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants 
With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib 
Protocol Number:  INCB 54828-801 
Objectives and Endpoints: 
Table 1 presents the primary and major/key secondary objectives and endpoints. 
Table 1: 
Objectives and Endpoints 
Objectives 
Endpoints 
To evaluate the long-term safety and tolerability 
of pemigatinib. 
Frequency and nature of AEs and SAEs as 
assessed by CTCAE v5.0. 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 
Table 2: 
Key Study Design Elements 
Study Phase 
Phase 2 
Clinical Indication 
Treatment of patients with advanced malignancies 
Population 
Male and female participants at least 18 years of age who are actively 
receiving treatment with pemigatinib under a parent protocol and 
receiving clinical benefit and who do not have access to pemigatinib 
outside of a clinical trial.   
Number of Participants 
Approximately 20 participants will be enrolled from prior pemigatinib 
studies. 
Study Design 
Single-arm, open-label, rollover 
Estimated Duration of 
Study Participation 
Participants will be allowed to continue to receive pemigatinib until they 
meet the criteria noted in Section 7.1. 
Data Safety Monitoring 
Board/Data Monitoring 
Committee 
No 
Coordinating Principal 
Investigator 
Not applicable 
Figure 1 presents the study design schema, and Table 3 presents the schedule of activities. 


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Figure 1: 
Study Design Schema 
Participants receiving and benefiting from ongoing treatment from pemigatinib studies
Continue to qualify and sign 
ICF
Enroll in roll-over 
study and continue 
treatment
Safety assessments performed at regular intervals; 
disease assessments performed per institutional standard 
of care
Progression of disease or 
toxicity reported
Discontinue treatment with study drug and complete 30 day follow up visit


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Table 3: 
Schedule of Activities 
 
Day 1 of Each 
Cycle 
EOT 
Safety 
Follow-Up 
Comments 
Informed consent 
X* 
 
 
*Only on Day 1 of rollover protocol. 
Demography 
X* 
 
 
*Only on Day 1 of rollover protocol. 
Contact IRT 
X 
X 
 
 
Dispense pemigatinib 
X 
 
 
 
Collect remaining pemigatinib 
X* 
X 
 
*Starting Cycle 2 Day 1. 
Administer pembrolizumab (only for participants 
receiving under parent protocol) 
X* 
 
 
*Administer 200 mg IV once every 3 weeks on Day 1 of a 21-day 
cycle (3 weeks). 
Administer INCMGA00012 (only for participants 
receiving under parent protocol) 
X* 
 
 
*Administer 500 mg IV once every 4 weeks on Day 1 of a 28-day 
cycle (4 weeks). 
AE assessments 
X 
X 
X 
 
12-lead ECG 
X* 
X 
 
*Every 6 cycles starting from last ECG on parent study. 
Ophthalmologic examinations 
X* 
 
 
*Every 3 cycles starting from last eye examination on parent study. 
Serum chemistry 
 X 
X 
 
 
Hematology 
X* 
X 
 
*Every 3 cycles starting from last blood draw on parent study. 
Disease assessment 
X* 
 
 
*Assess per standard of care guidelines; only report date of 
progression. 
Urine pregnancy test 
X* 
X 
X 
*If urine test is positive, perform serum test to confirm. 
 
 
 
 


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2. 
INTRODUCTION 
2.1. 
Background 
The rollover protocol is intended for participants currently enrolled in Incyte-sponsored studies 
who are continuing to receive clinical benefit from treatment with pemigatinib (monotherapy or 
in combination).  Continued, uninterrupted treatment will be provided under this single protocol.  
The population for the rollover study should be consistent with the populations defined in the 
parent studies.  The primary eligibility criterion for a participant to enter the rollover protocol is 
participation in an Incyte-sponsored study with pemigatinib as monotherapy or combination 
therapy and receiving ongoing treatment with pemigatinib.  Disease assessments should be 
performed per standard of care, with date of progression reported and safety data collected. 
Participants who have enrolled in a prior study with pemigatinib as monotherapy or combination 
therapy and are assessed by the investigator to continue to benefit from ongoing treatment and 
who are unable to access pemigatinib outside of a clinical study will be eligible. 
2.2. 
Study Rationale 
2.2.1. 
Scientific Rationale for Study Design 
Pemigatinib is an inhibitor of the FGFR family of receptor tyrosine kinases; aberrant signaling 
through FGFR resulting from gene amplification or mutation, chromosomal translocation, and 
ligand-dependent activation of the receptors has been demonstrated in multiple types of human 
cancers.  Fibroblast growth factor receptor signaling contributes to the development of 
malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis.  Refer 
to the pemigatinib IB for additional background information on pemigatinib. 
2.2.2. 
Justification for Dose of Pemigatinib 
Participants will continue to receive uninterrupted treatment with pemigatinib as monotherapy or 
combination therapy during the transition to this protocol.  The participants will continue to be 
treated with pemigatinib monotherapy or combination therapy at the dose and schedule 
(intermittent or continuous) that the participant is receiving under the parent protocol.  For 
example, if the participant's dose had been reduced to 9 mg once daily continuous dosing on the 
parent protocol, the participant will rollover into this protocol at that dose and regimen.   
2.2.3. 
Justification for Dose of Pembrolizumab and INCMGA00012 
Participants will continue to receive uninterrupted treatment with pemigatinib in combination 
with either pembrolizumab or INCMGA00012 as per the parent protocol during the transition to 
this protocol.  The participants will continue to be treated with pembrolizumab or 
INCMGA00012 at the dose and schedule that the participant is receiving under the parent 
protocol.  No changes to the dose or regimen of the combination (either compound) is allowed 
during the transition to the rollover study.   


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2.3. 
Benefit/Risk Assessment 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of pemigatinib, INCMGA00012, and pembrolizumab may be found in the 
pemigatinib IB, INCMGA00012 IB, and KEYTRUDA® (pembrolizumab) prescribing 
information, respectively. 
2.3.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic 
Participants to be enrolled into this study have recurrent advanced or metastatic endometrial 
cancer and may be at higher risk for complications if they contract COVID-19.  In this Phase 2 
study population, standard of care therapy options for advanced or metastatic endometrial cancer 
that progressed on or following platinum-based chemotherapy are limited.  A European Society 
for Medical Oncology multidisciplinary panel highlighted the importance of clinical cancer 
research to find better therapeutic options for participants even during the pandemic, including 
potential investigational therapies similar to immunotherapy with a known survival benefit 
(Curigliano et al 2020).  Preliminary data released based on real-world data indicate that the use 
of immunotherapy either alone or in combination with chemotherapy does not appear to increase 
the risk of hospitalization in patients with COVID-19 infection (Horn et al 2020) or cause an 
increased risk of mortality (Lee et al 2020).  The effects of immune checkpoint inhibitors on 
SARS-CoV-2 infection are currently unknown.  However, at early stages of SARS-CoV-2 
infection, CD8+ T-cell exhaustion and PD-1 upregulation have been observed (Riva et al 2020, 
Zheng et al 2020).  Those findings suggest that immune checkpoint inhibitors may ameliorate the 
early phase of COVID-19 through the reactivation of T cells expressing PD-1 (Maio et al 2020).  
Conversely, potential risks of cytokine release syndrome, pneumonitis, or myocarditis related to 
immune checkpoint inhibitor therapy may represent a clinical issue and impact a course of 
COVID-19 (Maio et al 2020, Sullivan et al 2020).  Considering the critical medical need for 
alternative therapies in the setting of recurrent advanced/metastatic endometrial cancer and the 
importance of continuing clinical cancer research even during the pandemic and taking into 
account the lack of conclusive clinical data on the impact of immune checkpoint inhibitor 
therapy on the course of COVID-19, the sponsor is implementing additional guidance for 
participation in this study in the context of the COVID-19 pandemic and study treatment 
management in the event of SARS-CoV-2 infection (see Appendix C). 
During the COVID-19 pandemic, additional risks to participants exist either related to going to a 
health care facility or as a result of study-related activities.  The investigators need to carefully 
assess both the benefit/risk and the medical data (eg, performance status, past medical history, 
comorbidities) available at screening to determine if it is in the best interest of the potential 
participant to enroll and participate in the study.  In addition, country-specific requirements will 
be followed with regard to COVID-19 testing, as specified in Appendix C.  Investigators will 
follow up with repeated tests during the study as per medical judgment and/or local practices as 
well as follow up with enrolled participants who may be newly suspected of being exposed to 
SARS-CoV-2, have symptoms of COVID-19, or demonstrate recovery from COVID-19.   
Participants will be monitored with safety procedures as described in Section 8 and with 
additional safety assessments as per standard of care.  Additional information regarding the 
flexibility of assessments/visits scheduling, where possible and warranted, and a strategy for 
participant management during the dynamic pandemic, as applicable, are described in 
Appendix C. 


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3. 
OBJECTIVES AND ENDPOINTS 
Table 4 presents the objectives and endpoints. 
Table 4: 
Objectives and Endpoints 
Objectives 
Endpoints 
To evaluate the long-term safety and tolerability 
of pemigatinib. 
Frequency and nature of AEs and SAEs as 
assessed by CTCAE v5.0. 
4. 
STUDY DESIGN 
4.1. 
Overall Design 
This rollover protocol allows study participants from multiple protocols who are receiving 
clinical benefit to continue to be treated during the completion of the parent study (also referred 
to as parent protocol).  The population for the rollover study should be consistent with the 
population defined in each parent protocol.  The primary eligibility criterion for a participant to 
enter the rollover protocol is participation in an Incyte-sponsored study (parent protocol) with 
pemigatinib as monotherapy or combination therapy and receiving ongoing treatment with 
pemigatinib.  
Participants who have enrolled in a prior study (parent protocol) with pemigatinib as 
monotherapy or combination therapy and are assessed by the investigator to continue to benefit 
from ongoing treatment and who cannot access pemigatinib outside of a clinical trial will be 
eligible. 
Disease assessments will be performed per standard of care, with date of progression reported 
and safety data collected. 
Once a participant has rolled over into this protocol from a parent protocol, the database for the 
parent protocol will be closed and locked, and the parent protocol study will be considered 
completed and closed.  However, the participant in the rollover protocol will still be treated as 
per the plan outlined in the parent protocol.  The list of parent protocols is provided in 
Appendix B. 
4.2. 
Overall Study Duration 
The study begins when the first participant signs the study ICF.  The end of the study is defined 
as the date of the last visit of the last participant in the study.  It is estimated that an individual 
will participate for approximately 12 months. 
The study is considered completed when the last participant's last visit has occurred. 
4.3. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator is to notify the IRB/IEC of the study's 
completion or early termination in writing, send a copy of the notification to the sponsor or 
sponsor's designee, and retain 1 copy for the site study regulatory file. 


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5. 
STUDY POPULATION 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the parent protocol as well as this protocol is essential.  
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, are not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Currently enrolled and receiving treatment in an Incyte-sponsored clinical study (parent 
protocol) of pemigatinib as monotherapy or combination therapy. 
2. Currently benefiting from and tolerating treatment with pemigatinib, as determined by the 
investigator. 
3. Demonstrated compliance, as assessed by the investigator, with the parent protocol 
requirements. 
4. Willingness and ability to comply with scheduled visits, treatment plans, and any other 
study procedures. 
5. Currently have no evidence of progressive disease, as determined by the investigator, 
following treatment with pemigatinib as monotherapy or combination therapy. 
6. Willingness to avoid pregnancy or fathering children based on the criteria below. 
a. Male participants must agree to take appropriate precautions to avoid fathering 
children (with at least 99% certainty) from signing of the ICF through 90 days after 
the last dose of pemigatinib and 6 months after the last dose of gemcitabine and/or 
cisplatin and must refrain from donating sperm during this period.  Permitted methods 
that are at least 99% effective in preventing pregnancy (see Appendix A) should be 
communicated to the participants and their understanding confirmed.  NOTE:  Men 
being treated with gemcitabine must be advised to seek further advice regarding 
cryoconservation of sperm before treatment because of the possibility of infertility 
due to therapy with gemcitabine. 
b. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or 
bilateral oophorectomy OR ≥ 12 months of amenorrhea) are eligible. 
c. Women of childbearing potential must have a negative serum pregnancy test at 
signing of the ICF and before the first dose on Day 1 and must agree to take 
appropriate precautions to avoid pregnancy (with at least 99% certainty) from signing 
of the ICF through safety follow-up (30-35 days after the last dose of pemigatinib) 
and through 6 months after the last dose of gemcitabine and/or cisplatin.  Permitted 
methods that are at least 99% effective in preventing pregnancy (see Appendix A) 
should be communicated to the participants and their understanding confirmed. 
7. Written informed consent obtained prior to enrolling in the rollover study.  If consent 
cannot be expressed in writing, it must be formally documented and witnessed, ideally 
via an independent trusted witness. 


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5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Able to access pemigatinib commercially or outside of a clinical trial. 
2. Permanently discontinued from the parent protocol for any reason. 
3. No longer meet the inclusion/exclusion criteria from the parent protocol if still receiving 
treatment. 
4. Women who are pregnant or breastfeeding or participants expecting to conceive or father 
children within the projected duration of the study, starting with Day 1 of the rollover 
study visit through completion of safety follow-up or through 90 days from the date of 
last dose of study treatment. 
5.3. 
Lifestyle Considerations 
No restrictions are required. 
5.4. 
Screen Failures 
There are no screen failures for this rollover study.  Only participants actively receiving 
treatment in another pemigatinib study (parent protocol) are eligible to enroll. 
5.5. 
Replacement of Participants 
Not applicable. 
6. 
STUDY TREATMENT 
6.1. 
Study Treatments Administered 
Table 5 presents the study treatment information.  This information is also found in the parent 
protocol. 


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Table 5: 
Study Treatment Information 
 
Study Treatment 1 
Study Treatment 2 
Study Treatment 3 
Study treatment name: 
Pemigatinib (INCB054828) 
INCMGA00012 
(INCB 54828-101 only) 
Pembrolizumab 
(INCB 54828-101 only) 
Dosage formulation: 
Oral 
IV 
IV 
Unit dose strength(s) 
/dosage level(s): 
2 mg, 4.5 mg, 9 mg, 13.5 mg 
500 mg/500 mg 
200 mg 
Administration instructions: 
Taken by mouth once daily 
Administered over 60 minutes 
once every 4 weeks (Day 1 of a 
28-day cycle) 
 
Packaging and labeling: 
 
Pemigatinib 4.5 mg, 9 mg, and 
13.5 mg tablets will be provided 
in 14-count bottles; 2 mg tablets 
will be provided in 60-count 
bottles. 
Each bottle will be labeled as 
required per country requirement. 
500 mg vials 
Each vial will be labeled as per 
country requirement. 
Commercially labeled product 
Storage: 
 
Room temperature 
Stored upright under refrigeration 
at 2°C to 8°C (36°F-46°F) and 
protected from light 
Stored under refrigeration at 2°C 
to 8°C (36°F-46°F) 
Status of treatment in 
participating countries: 
Approved 
Not approved 
Approved 
 


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6.2. 
Preparation, Handling, and Accountability 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatments received and any discrepancies are reported and 
resolved before use of the study treatment. 
Only participants enrolled in the study may receive study treatment, and only authorized site 
staff may supply or administer study treatment.  All study treatment 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 (or designee) is responsible for study treatment accountability, reconciliation, 
and record maintenance (ie, receipt, reconciliation, and final disposition records).  Inventory and 
accountability records must be maintained and readily available for inspection by the study 
monitor and are open to inspection at any time by any applicable regulatory authorities.  The 
investigator or designee must maintain records that document the following: 
• Delivery of study drugs (except pembrolizumab for INCB 54828-101 only) to the 
study site. 
• Inventory of study drugs at the site. 
• Participant use of the study drugs, including tablets and/or vials from each supply 
dispensed. 
• Return of study drugs (except pembrolizumab for INCB 54828-101 only) to the 
investigator or designee by participants. 
The investigational product must be used only in accordance with the parent protocol and this 
protocol.  The investigator will also maintain records adequately documenting that the 
participants were provided the specified study drug.  These records should include dates, 
quantities, and any available batch or serial numbers or unique code numbers assigned to the 
investigational product and study participants. 
Completed accountability records will be archived by the site.  The investigator or designee will 
be expected to collect and retain all used, unused, and partially used containers of study drug 
until verified by the study monitor (unless otherwise agreed to by the sponsor).  At the 
conclusion of the study, the investigator or designee will oversee shipment of any remaining 
study drug back to the sponsor or its designee for destruction according to institutional SOPs.  If 
local procedures mandate on-site destruction of the investigational supply, the site should (where 
local procedures allow) maintain the investigational supply until the study monitor inspects the 
accountability records in order to evaluate compliance and accuracy of accountability by the 
investigative site.  At sites where the study drug is destroyed before monitor inspection, the 
monitors rely on documentation of destruction per the site SOP. 
Further guidance and information for the final disposition of unused study treatments are 
provided in the Pharmacy Manual from the parent protocol.   
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
Not applicable. 


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6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments should be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study.  
Compliance with study drug administration will be calculated by the sponsor based on study 
drug accountability and infusion records documented by the site staff and monitored by the 
sponsor/designee. 
6.5. 
Dose Modifications and Interruptions  
Instructions for dose modifications and interruptions for pemigatinib and/or combinations are 
outlined in the parent protocols. 
6.6. 
Concomitant Medications and Procedures 
Currently used medications and treatments (including over-the-counter or prescription 
medicines, vitamins, vaccines, and/or herbal supplements) must be recorded in the eCRF.  Any 
medications actively being taken while the participant is on treatment under the parent protocol 
that will continue must be recorded in the eCRF for this study.  Any addition, deletion, or change 
in the dose of these medications will also be recorded.  Concomitant medications administered 
for treatment of SAEs (as defined in Section 9.2) should be recorded even if the SAE is reported 
beyond 30 days after the last dose of study treatment.  Concomitant treatments/procedures that 
are required to manage a participant's medical condition during the study will also be recorded in 
the eCRF.   
7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
7.1.1. 
Reasons for Discontinuation 
Participants must be discontinued from study treatment for the following reasons: 
• Documented disease progression. 
• Pregnancy. 
• Lack of treatment compliance.  
• Consent is withdrawn.   
• Further participation would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
• Unacceptable toxicity as noted in the parent protocol. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority, IRB, or IEC. 


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7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, the EOT 
visit should be conducted.  Reasonable efforts should be made to have the participant return for a 
follow-up visit.  These visits are described in Table 3.  The last date of the last dose of study 
treatment and the reason for discontinuation of study treatment will be recorded in the eCRF. 
If a participant is discontinued from study treatment: 
• The study monitor or sponsor must be notified. 
• The reason(s) for discontinuation must be documented in the participant's medical 
record and the primary reason for discontinuation must be included in the eCRF. 
• The EOT visit should be performed and date recorded. 
• The status of the participant should be updated to EOT in the IRT.  
• Participants must be followed for safety until the time of the follow-up visit or until 
study treatment–related toxicities resolve, return to baseline, or are deemed 
irreversible, whichever is longest. 
If the participant discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up), then no additional data collection should occur; however, 
participants will have the option of withdrawing consent for study treatment but continuing in the 
follow-up period of the study for safety assessment.   
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons.  
If a participant withdraws from the study, he/she may request destruction of any samples taken 
for this study and/or the parent study and not tested, and the investigator must document this in 
the site study records.  If the participant withdraws consent for disclosure of future information, 
the sponsor may retain and continue to use any data collected before such a withdrawal of 
consent. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he/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. 


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• 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. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
A new consent will need to be obtained prior to the participant rolling over from the parent 
protocol to this study. 
• 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. 
− Informed consent must be obtained before any procedures specific to this protocol 
and the first dose of study treatment is administered under this protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• 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 applicable requirements and regulations for the countries in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  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. 


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• 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. 
• Participants must provide consent to the most current version of the ICF 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. 
8.1.2. 
Interactive Response Technology Procedure 
Each participant will obtain a new ID number when enrolling in this study.  It will be different 
from the ID number on the parent protocol; however, the participant ID number from the parent 
protocol will be entered on the appropriate form of the eCRF so there is a link between the parent 
study and this study.   
Site staff should contact the IRT to obtain the participant ID number prior to rolling the 
participant over into this study.  Additionally, the IRT will be contacted at each regular study 
visit to update the study drug supply.  Additional details are provided in the IRT Manual. 
8.1.3. 
Demography and Medical History 
Demographic data will be collected in the eCRF for this study and will include year of birth/age 
at entry to roll over study, race, and ethnicity.  Medical history data will be linked from the 
parent protocol.  NOTE:  Any ongoing AEs at the time of rollover will be entered on the Adverse 
Event Form in the eCRF for this study. 
8.1.3.1. 
Disease Characteristics and Treatment History 
All disease history and treatment history will be linked from the parent protocol.  No additional 
data will need to be entered for this study. 
8.2. 
Efficacy Assessments 
Participants should undergo disease assessments according to the institution's standard of care.  
Disease assessment details will not be captured with the exception of documenting the date of 
disease progression.  The date of disease progression will be noted in this study's eCRF. 
8.3. 
Safety Assessments 
8.3.1. 
Adverse Events 
NOTE:  Adverse events that are ongoing at the time of rollover from the parent protocol 
will be entered on the Adverse Event Form in the eCRF for this study.   
Adverse events will be monitored from the time the participant signs the ICF until at least 
30 days after the last dose of study treatment.  Adverse events for enrolled participants that begin 
or worsen after informed consent should be recorded on the Adverse Event Form in the eCRF 
regardless of the assumption of a causal relationship with the study treatment.  Adverse events 


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(including laboratory abnormalities that constitute AEs) should be described using a diagnosis 
whenever possible rather than by individual underlying signs and symptoms. 
Adverse events 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 for following up on AEs that are serious, 
considered related to the study treatment or procedures, or caused the participant to withdraw 
from the study.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?", is the preferred method to inquire about AE occurrences.  Adverse events may also be 
detected when they are volunteered by the participant between visits or through physical 
examinations, laboratory tests, or other assessments.  The definition, reporting, and recording 
requirements for AEs are described in Section 9. 
All SAEs will be reported to the sponsor or designee within 24 hours.  The investigator will 
submit any updated SAE data to the sponsor within 24 hours of it being available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
8.3.2. 
Laboratory Assessments 
See Table 6 for the list of clinical laboratory tests to be performed and Table 3 for the timing and 
frequency.  A certified laboratory local to the investigative site will perform all clinical 
laboratory assessments for safety.  The investigative site will enter the laboratory results and 
laboratory normal ranges into the eCRF.  Additional tests may also be performed if clinically 
indicated. 
Clinically significant abnormal laboratory findings are those that 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 treatment 
should be repeated until the values return to normal or baseline or are no longer considered 
clinically significant by the investigator or medical monitor. 
NOTE:  If Day 1 on the rollover study is within 1 week of the last laboratory sample on the 
parent protocol, no additional sample is required for Day 1 of the rollover study. 


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Table 6: 
Required Laboratory Analytes 
Blood Chemistries  
Hematology  
Albumin  
Alkaline phosphatase 
ALT 
AST 
Amylase 
Bicarbonate or CO2 
Blood urea nitrogen 
Calcium (uncorrected) 
Chloride 
Creatinine 
Glucose 
Lactate dehydrogenase 
Lipase 
Magnesium 
Phosphate 
Potassium 
Sodium 
Total bilirubin 
Direct bilirubin (if total bilirubin is elevated above ULN) 
Total protein 
Uric acid 
Urea 
Vitamin D 1,25 
Vitamin D 25-OH 
Complete blood count, including: 
• Hemoglobin 
• Hematocrit 
• Platelet count 
• Red blood cell count 
• WBC count 
 
Differential count, including: 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
 
Absolute values must be provided for: 
• WBC differential laboratory results 
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal; WBC = white blood cell. 
Note:  Additional tests may be required, as agreed upon by the investigator and sponsor, based on emerging safety data or to rule out a diagnosis.  


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8.3.2.1. 
Pregnancy Testing 
A urine pregnancy test will be required for all women of childbearing potential on Day 1 of this 
study and at the EOT and safety follow-up visits.  Urine pregnancy tests will be performed 
locally as outlined in Table 3, as medically indicated (eg, in case of loss of menstrual cycle, 
when pregnancy is suspected), or per country-specific requirement (note that country-required 
urine pregnancy testing will be outlined and communicated to investigational sites under separate 
cover).  If a urine pregnancy test is positive, the result should be confirmed with a serum 
pregnancy test. 
If the serum pregnancy test is negative after a urine test was positive, the investigator will assess 
the potential benefit/risk to the participant and determine whether it is in the participant's best 
interest to resume study treatment and continue participation in the study. 
If a pregnancy is confirmed by a serum pregnancy test, see Section 9.6 for reporting 
requirements. 
8.4. 
Unscheduled Visits 
Not applicable. 
8.5. 
End of Treatment  
When the participant permanently discontinues study treatment, the EOT visit should be 
conducted.  If the EOT visit coincides with a regular study visit, the EOT evaluations will 
supersede those of that scheduled visit, and the data should be entered in the EOT visit in the 
eCRF.  The participant should be encouraged to return for the follow-up visit. 
8.6. 
Follow-Up 
8.6.1. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT visit and the scheduled follow-up 
visit, which should occur 30 to 35 days after the EOT visit.  Adverse events and SAEs must be 
reported up until at least 30 days after the last dose of study treatment or until toxicities resolve, 
return to baseline, or are deemed irreversible, whichever is longer.  Reasonable efforts should be 
made to have the participant return for the follow-up visit and report any AEs that may occur 
during this period.   
8.6.2. 
Post-Treatment Disease Follow-Up 
Participants who discontinue study treatment for a reason other than disease progression will not 
be required to continue disease assessments per this protocol.  No additional information will be 
collected once treatment discontinues.    
8.6.3. 
Survival Follow-Up 
Not applicable.  


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9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING 
9.1. 
Definition of Adverse Event 
Adverse Event Definition 
• An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or 
not it is considered drug-related. 
• An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
treatment. 
Additional Guidance for Events Meeting the Adverse Event Definition 
• Any safety assessments (eg, ECG, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator 
(ie, not related to progression of underlying disease) are to be reported as an AE. 
• Abnormal laboratory test results are to be reported as an AE if they are considered clinically 
meaningful, induce clinical signs or symptoms, require concomitant therapy, or require changes in 
study treatment.  Whenever possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded 
in the eCRF rather than the abnormal laboratory test result (eg, low hemoglobin, platelet count 
decreased). 
• Exacerbation of a chronic or intermittent pre-existing condition/disease, including either an increase 
in the frequency and/or intensity of the condition, is to be reported as an AE. 
• New conditions detected or diagnosed after the start of study treatment administration are to be 
reported as an AE. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction are to be reported as an 
AE. 
• Signs and/or symptoms from dosing errors of a study treatment (eg, overdose) or a concomitant 
medication are to be reported as an AE. 
• "Lack of efficacy," "disease progression," or "failure of expected pharmacological action" will not be 
reported as an AE or SAE.   
• A condition that leads to a medical or surgical procedure (eg, endoscopy, appendectomy) will be 
reported as an AE if it occurs after obtaining informed consent. 
9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per the 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 serious adverse event 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 adverse drug experience that 
places the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurs.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 


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c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (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. 
Hospitalization for elective treatment or planned surgery (eg, stent replacement, hip surgery) is not 
considered an SAE. 
Hospitalization for medical interventions in which no unfavorable medical occurrence occurred 
(ie, elective procedures or routine medical visits) is not considered an SAE. 
d. Results in persistent or significant 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), that may interfere with or prevent everyday life functions but do not 
constitute a substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. Is an important medical event 
An important medical event is an event that may not result in death, be immediately life-threatening, or 
require hospitalization but may be considered serious when, based on appropriate medical judgment, 
the event may jeopardize the participant and may require medical or surgical intervention to prevent 
one of the outcomes listed in the above definition.  Examples of such events include new invasive or 
malignant cancers; intensive treatment in an emergency department or at home for allergic 
bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization; or development of 
drug dependency or drug abuse.  Secondary malignancies should always be considered SAEs. 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• Adverse events that are ongoing at the time of rollover to this study must be recorded on the Adverse 
Event Form in the eCRF for this study. 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  AEs/SAEs should be reported for enrolled participants, but only 
SAEs need to be reported for screen failure participants.  For detailed information, refer to the eCRF 
guidelines. 
• When an AE/SAE 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 (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records 
in lieu of completing the Adverse Event Form in the eCRF. 


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• There may be rare instances when copies of medical records for certain cases are requested.  In this 
case, all participant identifiers, with the exception of the participant number, will be redacted by the 
site staff on the copies of the medical records before submission.  These records can be submitted to 
Incyte Pharmacovigilance by email/fax per the contact information listed as per SAE completing 
guidelines.   
• 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.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine the following: 
• The severity grade (CTCAE v5.0 Grade 1 to 5).  See below for further instructions on the assessment 
of intensity. 
• Whether there is at least a reasonable possibility that the AE is related to the study treatment:  
suspected (yes) or not suspected (no).  See below for further instructions on the assessment of 
causality. 
• The start and end dates, unless unresolved at the final safety follow-up visit. 
• The action taken with regard to study treatment as a result of the AE/SAE(s). 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, etc.). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event.  Note:  If an AE is treated with a concomitant medication 
or nondrug therapy, this action should be recorded on the Adverse Event Form and the treatment 
should be specified on the appropriate eCRF (eg, Prior/Concomitant Medications). 
Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5.0 Grades 1 through 5.  If an event is not 
classified by CTCAE, the severity of the AE will be graded according to the scale below to estimate the 
grade of severity. 
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 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate 
activities of daily living. 
• Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each occurrence 
of each AE/SAE.  If reference therapy is used in combination with an Incyte study drug or if multiple 
Incyte study drugs are used, then the relationship to each study drug/reference therapy must be 
assessed.   
• A "reasonable possibility" of a relationship conveys that there are medical facts, evidence, and/or 
arguments to suggest a causal relationship, rather than that a relationship cannot be ruled out. 


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• The investigator will use clinical judgment to determine the possibility of a relationship. 
• The investigator will also consult the RSI in the IB or Product Information for study drug/treatment, 
or marketed products, respectively, in making his/her assessment. 
• Alternative causes, such as underlying or concurrent disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study treatment administration, will be 
considered and investigated. 
• 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. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report.  However, the causality assessment is one of the 
criteria used when determining regulatory reporting requirements.  Therefore, it is very 
important that the investigator always make an assessment of causality based on the 
available information for every event before the initial transmission of the SAE. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
submit the updated causality assessment. 
Follow-Up of Adverse Events and Serious Adverse Events 
• 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 care 
professionals. 
• Once an AE is detected, it should be followed in the Adverse Event Form in the eCRF until it has 
resolved or until it is judged to be permanent; assessment should be made at each visit (or more 
frequently if necessary) of any changes in severity, the suspected relationship to the study treatment, 
the interventions required to treat the event, and the outcome. 
• When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE. 
• Updated SAE information will be recorded in the originally completed eCRF and reported to Incyte 
Pharmacovigilance (either via email/fax) until resolution, stabilization, the event is otherwise 
explained, or the participant is lost to follow-up. 
• Any updated SAE data (including SAEs being downgraded to nonserious) will be submitted to the 
sponsor (or designee) within 24 hours of receipt of the information. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study treatment), all SAEs occurring after 
the participant has signed the ICF through at least 30 days after the last dose of study treatment 
must be reported to the sponsor (or designee) immediately, without undue delay but not later 
than within 24 hours of obtaining knowledge of its occurrence unless otherwise specified by the 
protocol.  The investigator will submit any updated SAE data to the sponsor (or designee) 
immediately, without undue delay but not later than within 24 hours of it being available.  
Investigators are not obligated to actively seek SAE information after the safety follow-up visit.  
If the investigator learns of any SAE, including death, at any time during this period, and he/she 
considers the event to be reasonably related to the study treatment or study participation, then the 


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investigator must notify the sponsor (or designee) within 24 hours of becoming aware of the 
event.  
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor regarding an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the RSI of the pemigatinib IB or INCMGA00012IB for the 
study treatment (new occurrence) and is thought to be related to the study treatment, the sponsor 
or its designee may urgently require further information from the investigator for expedited 
reporting to health authorities.  The sponsor or its designee may need to issue an Investigator 
Notification to inform all investigators involved in any study with the same drug that this SAE 
has been reported.  Suspected unexpected serious adverse reactions will be collected and 
reported to the competent authorities and relevant ethics committees in accordance with 
Directive 2001/20/EC or as per national regulatory requirements in participating countries. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation.  The 
sponsor will comply with country-specific regulatory 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 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing an SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate, according to local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must report within 24 hours of learning of its occurrence any SAE by completing 
the Serious Adverse Event Report Form in English.  
• Follow-up information is also recorded and transmitted to Incyte Pharmacovigilance on an amended 
or new Serious Adverse Event Report Form, with an indication that it is follow-up to the previously 
reported SAE and the date of the original report.  The follow-up report should include information 
that was not provided on the previous Serious Adverse Event Report Form, such as the outcome of 
the event (eg, resolved or ongoing), treatment provided, action taken with study treatment because of 
the SAE (eg, dose reduced, interrupted, or discontinued), or participant disposition (eg, continued or 
withdrew from study participation).  Each recurrence, complication, or progression of the original 
event should be reported as a follow-up to that event, regardless of when it occurs. 
• Contacts for SAE reporting can be found in the Study Procedures Manual. 
9.5. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 


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9.6. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that the study 
treatment may have interfered with the effectiveness of a contraceptive medication or method.  
When a pregnancy has been confirmed in a participant during maternal or paternal exposure to 
study treatment, the following procedures should be followed in order to ensure safety: 
• The study treatment must be interrupted immediately (female participants only). 
• If the female participant is no longer pregnant and meets the treatment continuation 
criteria within 14 days of the scheduled start of a cycle, study treatment may be 
resumed after approval has been received from the sponsor medical monitor.  
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy Form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation.  
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee.  Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the first well-baby 
visit or the duration specified in local regulations, whichever is later.  Refer to the Incyte 
Reference Guide for Completing the Clinical Trial Pregnancy Form or Study Reference Manual. 
Any SAE occurring during pregnancy of a study participant must be recorded on the 
Serious Adverse Event Report Form and submitted to the sponsor or its designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.7. 
Warnings and Precautions 
Special warnings or precautions for the study treatment, derived from safety information 
collected by the sponsor or its designee, are presented in the pemigatinib IB and INCMGA00012 
IB.  Additional safety information collected between IB updates will be communicated in the 
form of Investigator Notifications.  Any important new safety information should be discussed 
with the participant during the study as necessary.  If new significant risks are identified, they 
will be added to the ICF. 
9.8. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
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All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 
The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be recorded as described in Section 9.3. 
If the investigator is asked to return the product for investigation, he/she will return a copy of the 
product complaint communication with the product. 
9.9. 
Treatment of Overdose of Pemigatinib 
There has been no clinical experience with overdose of pemigatinib.  Treatment of overdose 
should consist of general supportive measures. 
10. 
STATISTICS 
This is a rollover study for participants currently receiving pemigatinib on a parent protocol.  All 
the efficacy parameters will be analyzed in the parent protocol; no additional efficacy analysis 
will be performed in this protocol.   
10.1. 
Sample Size Determination 
Not applicable. 
10.2. 
Populations for Analyses 
The full analysis set/safety population includes all participants who received at least 1 dose of 
study treatment in this study. 
10.3. 
Statistical Analyses 
10.3.1. 
Disposition and Demographics 
Disposition of participants and demographics will be summarized descriptively for the full 
analysis set. 
10.3.2. 
Exposure 
Measure of exposure for study treatment will be summarized descriptively using the safety 
population. 
10.3.3. 
Safety Analyses 
Adverse events/serious adverse events that are ongoing at the time of rollover will be regraded 
per CTCAE v5.0 if graded per CTCAE v4.03.  Safety analyses will be conducted.  Adverse 
events will be coded by the MedDRA dictionary, severity of AEs will be assessed using CTCAE 
v5.0 Grades 1 through 5, and TEAEs (ie, AEs reported for the first time in this protocol and 
within 30 days of last dose of study treatment, or any AE ongoing and defined as 


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treatment-emergent from the parent protocol) will be tabulated by preferred term and system 
organ class for all events, related events, and events of Grade 3 or higher.  All AEs will be listed.  
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
• The Protocol, Protocol amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC before the study is initiated. 
• The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
• Any amendments to the Protocol will require approval from both Health Authorities 
and IRB/IEC 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: 
− 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. 
− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
− Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC.  Each investigator is responsible for enrolling participants who have met 
the specified eligibility criteria. 
• Retaining records in accordance with all local, national, and regulatory laws but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 


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− The investigator must not destroy any records associated with the study without 
receiving approval from the sponsor.  The investigator must notify the sponsor or 
its designee in the event of accidental loss or destruction of any study records.  If 
the investigator leaves the institution where the study was conducted, the sponsor 
or its designee must be contacted to arrange alternative record storage options. 
− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided with eCRF completion guidelines for instructions on data entry in the 
eCRF.  The study monitor will reference the Monitoring Plan in order to ensure that each issue 
identified is appropriately documented, reported, and resolved in a timely manner in accordance 
with the plan's requirements.  Other data outside the EDC system required in the study conduct 
of the Protocol such as documents or results transmitted to the sponsor via a central laboratory or 
specialized technical vendors and, as designated by the sponsor, will have their own data flow 
management plans, study charters, or biomarker plans, as applicable. 
The sponsor (or designee) will be responsible for: 
• Managing the integrity of the data and the quality of the conduct of the study, such as 
ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF 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. 
• Managing and reconciling the data generated, and/or collected including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 
The investigator (principal investigator or subinvestigator) will be responsible for: 
• Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
• Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data, biomarker data, photographs, diary data), 
or as otherwise specified in the Protocol. 


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• Maintaining adequate and accurate source documents and trial records that include all 
pertinent observations on each of the site's trial participants.  Source data should be 
attributable, legible, contemporaneous, original, accurate, and complete.  Changes to 
source data should be traceable, should not obscure the original entry, and should be 
explained if necessary (e.g., via an audit trail).  Source data are in general all 
information in original records and certified copies of original records of clinical 
findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial.  Source data are contained in source 
documents (original records or certified copies).  
• Verifying that data entries are accurate and correct by physically or electronically 
signing the eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF, or sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed and 
available at the investigator's site.  Examples of source documents are original 
documents, data, and records (e.g., hospital records, electronic hospital records, 
clinical and office charts, laboratory notes, memoranda, participants' diaries or 
evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being 
accurate copies, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, participants' files, and e-records/records kept at the pharmacy, at 
the laboratories and at medico-technical departments involved in the clinical 
trial).   
− Data entered in the 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.  Current applicable medical records must be available. 
• Sending participants' data, either as unique samples, or copies, or photographs, to be 
evaluated centrally or analyzed centrally, or both, by a qualified vendor designated by 
the sponsor.  
• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 


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− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data protection laws 
and regulations.  The investigator and the sponsor or its designee are responsible for ensuring 
that sensitive personal information is handled in accordance with local data protection laws 
(including but not limited to HIPAA and GDPR) as applicable.  Appropriate consent for 
collection, use and disclosure and/or transfer (if applicable) of personal information must be 
obtained in accordance with local data protection laws. 
Participant names will not be supplied to the sponsor or its designee.  Only the participant 
number will be recorded in the eCRF; if the participant's name appears on any other document 
(eg, laboratory report), it must be obliterated on the copy of the document to be supplied to the 
sponsor or its designee.  Study findings stored on a computer will be stored in accordance with 
appropriate technical and organizational measures as required by local data protection laws. 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator for 10 years after study completion unless local regulations require 
otherwise.  No 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. 
11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered 
studies") are required to submit a completed Clinical Investigator Financial Disclosure form that 
sufficiently details any financial interests and arrangements that apply.  For the purpose of this 
regulation, "clinical investigator" is defined as any investigator or subinvestigator who is directly 
involved in the treatment or evaluation of research participants, including the spouse and each 
dependent child of the clinical investigator or subinvestigator.  These requirements apply to both 
US and foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Investigator Financial Disclosure Form.  During a covered clinical study, 
any changes to the financial information previously reported by a clinical investigator must be 


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reported to the sponsor or its designee.  At the conclusion of the covered clinical study, the 
clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 
11.5. 
Publication Policy 
By signing the study Protocol, the investigator and his/her institution agree that the results of the 
study may be used by the sponsor, Incyte Corporation, for the purposes of national and 
international registration, publication, and information for medical and pharmaceutical 
professionals.  Study results will be published in accordance with applicable local and national 
regulations.  If necessary, the authorities will be notified of the investigator's name, address, 
qualifications, and extent of involvement.  The terms regarding the publication of study results 
are contained in the agreement signed with the sponsor or its designee.  A signed agreement will 
be retained by the sponsor or its designee. 
The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally 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 will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.6. 
Study and Site Closure 
The sponsor or 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, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• 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 treatment development. 


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12. 
REFERENCES 
Clinical Trials Facilitation and Coordination Group. Recommendations related to contraception 
and pregnancy testing in clinical trials. 2020.  
Curigliano G, Banerjee S, Cervantes A, et al. Managing cancer patients during the COVID-19 
pandemic: an ESMO multidisciplinary expert consensus. Ann Oncol 2020;31:1320-1335. 
Horn L, Whisenant J, Torri V, et al. Thoracic Cancers International COVID-19 Collaboration 
(TERAVOLT): Impact of type of cancer therapy and COVID therapy on survival. J Clin Oncol 
2020;39(suppl 18):Abstract LBA111. 
INCMGA00012 Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Keytruda (pembrolizumab) [prescribing information]. Merck & Co, Inc; January 2020.  
Lee LYW, Cazier JB, Angelis V, et al. COVID-19 mortality in patients with cancer on 
chemotherapy or other anticancer treatments: a prospective cohort study. 
Lancet 2020;395:1919-1926. 
Maio M, Hamid O, Larkin J, et al. Immune checkpoint inhibitors for cancer therapy in the 
COVID-19 era. Clin Cancer Res 2020;26:4201-4205.  
Pemigatinib Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Riva G, Nasillo V, Tagliafico E, Trenti T, Luppi M. COVID-19: room for treating T cell 
exhaustion? Crit Care 2020;24:229. 
Sullivan RJ, Johnson DB, Rini BI, et al. COVID-19 and immune checkpoint inhibitors: initial 
considerations. J Immunother Cancer 2020;8:e000933. 
Zheng M, Gao Y, Wang G, et al. Functional exhaustion of antiviral lymphocytes in COVID-19 
patients. Cell Mol Immunol 2020;17:533-535.  


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND DEFINITIONS 
Definitions 
WOCBP:  A woman who is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below). 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal with 1 of the following:a 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
• Postmenopausal 
− A postmenopausal state is defined as no menses for 12 months without an alternative medical 
cause. 
o A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state 
in women not using hormonal contraception or HRT.  However, in the absence of 12 months 
of amenorrhea, confirmation with 2 FSH measurements in the postmenopausal range is 
required.   
− Females on HRT and whose menopausal status is in doubt will be required to use 1 of the 
nonhormonal, 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. 
For male participants of reproductive potentialb 
The following methods during the Protocol-defined timeframe in Section 5.1 are highly effective: 
• Use of a male condom plus partner use of an additional contraceptive method when having 
penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. 
• Vasectomy with medical assessment of the surgical success (verified by site personnel's review of 
the participant's medical records) 
• Sexual abstinencec 
− Abstinence from penile-vaginal intercourse  
The following are not acceptable methods of contraception: 
• Periodic abstinence (calendar, symptothermal, post ovulation methods), withdrawal (coitus 
interruptus), spermicides only, and lactational amenorrhea method. 
• Male condom with cap, diaphragm, or sponge with spermicide. 
• Male and female condom used together. 
Note:  Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal 
intercourse or use a male condom during each episode of penile penetration.   


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For female participants who are WOCBP 
The following methods during the Protocol-defined timeframe in Section 5.1 that can achieve a failure 
rate of less than 1% per year when used consistently and correctly are considered as highly effective 
birth control methods: 
• Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulationd 
− oral 
− intravaginal  
− transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulationd  
− oral 
− injectable 
− implantablee 
• Intrauterine devicee 
• Intrauterine hormone-releasing systeme 
• Bilateral tubal occlusione 
• Vasectomized partnere,f 
• Sexual abstinencec  
FSH = follicle-stimulating hormone; HRT = hormone replacement therapy. 
a Documentation can come from the site personnel's review of the participant's medical records, medical 
examination, or medical history interview. 
b If the male participant has a partner with childbearing potential, the partner should also use contraceptives. 
c In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the 
preferred and usual lifestyle of the participant.   
d Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may 
reduce the efficacy of the contraception method.  In this case, 2 methods of contraception should be used. 
e Contraception methods that in the context of this guidance are considered to have low user dependency. 
f Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the WOCBP study participant and that the vasectomized partner has received medical assessment of the 
surgical success. 
Source:  Clinical Trials Facilitation and Coordination Group 2020. 


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APPENDIX B. LIST OF PARENT PROTOCOLS 
INCB 54828-101 (FIGHT-101) 
INCB 54828-201 (FIGHT-201) 
INCB 54828-202 (FIGHT-202) 


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APPENDIX C. COVID-19 PANDEMIC MITIGATION STRATEGIES AND 
INSTRUCTIONS 
The COVID-19 global pandemic presents challenges to the ongoing conduct of clinical trials.  In 
line with regulatory guidance regarding clinical trial execution during the pandemic, the sponsor 
has issued the following Protocol considerations to ensure participant safety is maintained and 
adequate benefit/risk analyses are applied relative to participation in the study and the 
completion of study procedures and objectives while maintaining the investigational product 
supply chain. 
Recognizing the dynamic nature and flexibility required to manage the impact of the pandemic 
on this clinical trial, additional details will be incorporated into respective study manuals and 
site-specific monitoring plans as applicable, with institutional requirements as warranted, and 
communicated and discussed with investigative sites as needed.  Relevant test results will be 
documented in the eCRF, and applicable changes to the ICF will be made and monitored.  
Given the critical medical need for alternative treatments for patients in the setting of recurrent 
advanced/metastatic endometrial cancer and the importance of continuing cancer research, a 
positive COVID-19 screening test should not result in definitive exclusion.  Participants with a 
positive COVID-19 test during screening may be reassessed for eligibility in the study only after 
normalization of their COVID-19 screening test and clinical recovery as per the investigator's 
evaluation.   
SARS-CoV-2 Infection and Participation in the Study 
Benefit/risk assessment in the context of the COVID-19 pandemic is provided in Section 2.3.1.  
During the COVID-19 pandemic, additional risks to participants exist either related to going to a 
health care facility or as a result of study-related activities.  It is at the principal investigator's 
discretion to balance the risk/benefit while considering the participant's safety, existing 
comorbidities, and current malignancy.  In addition, country-specific requirements are to be 
followed with regard to COVID-19 testing.  
Study Site Visits 
If local travel restrictions, isolation requirements, or the investigator's benefit/risk assessment 
determines it to be unsafe for participants to attend study visits at the investigational site, the site 
staff may elect to pursue the following: 
• In order to minimize participant risk, study visits may be conducted via telemedicine 
modalities (phone or video) or as per site institutional guidelines.  At a minimum, a 
review of AEs and concomitant medications must be completed.  On-site visits 
should be conducted whenever feasible and are required for administration of study 
treatment.  The participant may also be asked to undergo additional safety laboratory 
assessments. 


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• In order to support investigator oversight of participant safety and disease 
management, the participant may be asked to undergo some laboratory tests or study 
procedures (eg, imaging) at a local laboratory or facility closer to the participant's 
residence rather than at the investigational site.  In this case, the study physician will 
provide the participant with the list of parameters to be checked.  These tests should 
be performed in certified laboratories and ensure data may be transferred to the 
investigational site. 
• Some tests, such as ECG or computed tomographic scan assessments, may require 
longer windows due to the COVID-19 pandemic and may be performed outside the 
regularly scheduled visit window or may be conducted at the next scheduled visit.  It 
is the investigator's responsibility to check with the facility (if performed at a 
different facility) that the data will be obtained and available for evaluation.  General 
procedures performed outside of protocol time windows will be captured as protocol 
deviations due to COVID-19 in the eCRF.    
Study Treatment Management in the Event of SARS-CoV-2 Infection  
If a participant develops a SARS-CoV-2 infection, the event should be reported as an SAE (if it 
meets the SAE definition requirements) and appropriate medical intervention provided.  
Postbaseline COVID-19 testing should follow country-specific requirements depending on the 
extent of the COVID-19 pandemic, local institutional guidance, or the investigator's clinical 
judgment.  For participants who are diagnosed with COVID-19 during the study (positive 
COVID-19 test) or presumed (test pending/clinical suspicion) to be affected by SARS-CoV-2 
infection, study treatment should be delayed until COVID-19 test normalization and clinical 
recovery.  Prior to restarting treatment, the study medical monitor should be notified regarding 
the participant's condition; that is, the participant should be afebrile for 72 hours and 
SARS-CoV-2–related symptoms (if any) should have recovered for a minimum of 72 hours.  
Safety monitoring following COVID-19 infection should be implemented as per institutional 
guidance or clinical judgment (eg, coagulation factors).  Concomitant medication administered 
for treatment of SARS-CoV-2 infection should be carefully considered for potential drug-drug 
interactions and recorded in the clinical database (EDC). 
COVID-19 Vaccination 
Participants may receive the COVID-19 vaccine as long as it is not a live vaccine.  A live 
COVID-19 vaccine requires prior consultation with the medical monitor.  COVID-19 
vaccination will be captured in the eCRF as a concomitant medication.  Administration of study 
treatment may be delayed to ensure vaccination is completed and acute AEs (if any) are 
managed.  The medical monitor may be consulted if needed.     
Clinical Trial Monitoring 
Study monitoring visits could be postponed; however, the site monitor and sponsor will continue 
to employ off-site monitoring practices such as routine communication methods (eg, phone calls, 
emails, video visits) with the sites to get information on trial progress, participant status, and 
information on issue resolution.  The study monitor may remotely review data entered into the 


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EDC for accuracy and completeness if allowed by the national regulatory body, investigational 
site, and/or in compliance with local authorities.   
Reimbursement of Additional Expenses 
The sponsor will reimburse for any extraordinary expenses, keeping appropriate documentation 
as evidence (eg, travel expenses for the local laboratory visit[s], the costs of local [proximate] 
laboratory tests). 
 


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APPENDIX D. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Not applicable. 
 


Signature Page for VV-CLIN-014919 v1.0
Signature Page for VV-CLIN-014919 v1.0
Approval
Approver
17-May-2021 13:10:41 GMT+0000
Approval
Document Preparer
17-May-2021 13:27:53 GMT+0000
Approval
Approver
17-May-2021 14:13:08 GMT+0000
Approval
Approver
17-May-2021 17:25:51 GMT+0000

SAP_001.pdf: 
Official Title:    An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment 
for Participants With Advanced Malignancies Previously Enrolled in Studies 
of Pemigatinib 
NCT Number: 
 NCT04949191 
Document Date: 
Statistical Analysis Plan: 15-March-2024


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Statistical Analysis Plan 
TITLE PAGE 
INCB 54828-801 
An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment 
for Participants With Advanced Malignancies Previously Enrolled in Studies 
of Pemigatinib 
IND Number: 
124,358 
EudraCT Number: 
2021-002207-36 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
United States  
Protocol Version: 
Protocol dated 17 MAY 2021 
CRF Approval Date: 
08 MAR 2023 
SAP Version: 
Original 
SAP Author: 
 
, Biostatistics 
Date of Plan: 
15 MAR 2024 
This study is being conducted in compliance with Good Clinical Practice, 
including the archiving of essential documents. 


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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
TABLE OF CONTENTS .................................................................................................................2 
LIST OF ABBREVIATIONS ..........................................................................................................4 
1. 
INTRODUCTION ........................................................................................................5 
2. 
STUDY INFORMATION, OBJECTIVE, AND ENDPOINT .....................................6 
2.1. 
Protocol and Case Report Form Version ......................................................................6 
2.2. 
Study Objective and Endpoint ......................................................................................6 
3. 
STUDY DESIGN .........................................................................................................7 
3.1. 
Randomization ..............................................................................................................9 
3.2. 
Control of Type I Error .................................................................................................9 
3.3. 
Sample Size Considerations .........................................................................................9 
3.4. 
Schedule of Assessments ..............................................................................................9 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................10 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................10 
4.1.1. 
Day 1 ...........................................................................................................................10 
4.1.2. 
Study Day ...................................................................................................................10 
4.1.3. 
Baseline Value ............................................................................................................10 
4.1.4. 
Handling of Missing and Incomplete Dates ...............................................................10 
4.1.5. 
Cycle Length and Duration .........................................................................................10 
4.2. 
Variable Definitions ....................................................................................................11 
4.2.1. 
Prior and Concomitant Medication .............................................................................11 
5. 
STATISTICAL METHODOLOGY ...........................................................................12 
5.1. 
General Methodology .................................................................................................12 
5.2. 
Treatment Groups .......................................................................................................12 
5.3. 
Analysis Populations ..................................................................................................12 
5.3.1. 
Full Analysis Set .........................................................................................................12 
5.3.2. 
Safety Population ........................................................................................................12 
6. 
BASELINE, EXPOSURE, AND DISPOSITION ......................................................13 
6.1. 
Demographics and Baseline Characteristics ...............................................................13 
6.2. 
Disposition of Participants ..........................................................................................13 
6.3. 
Protocol Deviations ....................................................................................................13 


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6.4. 
Exposure .....................................................................................................................13 
6.5. 
Study Treatment Compliance .....................................................................................13 
6.6. 
Prior and Concomitant Medication .............................................................................13 
7. 
SAFETY AND TOLERABILITY ..............................................................................14 
7.1. 
General Considerations ...............................................................................................14 
7.2. 
Adverse Events ...........................................................................................................14 
7.2.1. 
Adverse Event Definitions ..........................................................................................14 
7.2.2. 
Adverse Event Summaries ..........................................................................................15 
8. 
INTERIM ANALYSES ..............................................................................................15 
9. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................16 
9.1. 
Changes to Protocol-Defined Analyses ......................................................................16 
9.2. 
Changes to the Statistical Analysis Plan .....................................................................16 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS ........................................17 
 
LIST OF TABLES 
Table 1: 
Objective and Endpoint ................................................................................................6 
Table 2: 
Statistical Analysis Plan Versions ..............................................................................16 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema ...................................................................................................8 
 


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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
AE 
adverse event 
CRF 
case report form 
CTCAE 
Common Terminology Criteria for Adverse Events 
eCRF 
electronic case report form 
FAS 
full analysis set 
MedDRA 
Medical Dictionary for Regulatory Activities 
PT 
preferred term 
QD 
once daily 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SOC 
system organ class 
Study treatment 
refers to pemigatinib monotherapy or combination therapy with 
pemigatinib 
TEAE 
treatment-emergent adverse event 
WHO  
World Health Organization 
 


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1. 
INTRODUCTION 
This is a Phase 2, open-label, multicenter, rollover study for participants with advanced 
malignancies currently enrolled in Incyte-sponsored studies of pemigatinib who are continuing to 
receive clinical benefit from treatment with pemigatinib (monotherapy or in combination). 
Section 2 of the Protocol provide a detailed description of the investigational product, 
background, study rationale for doses to be examined, and potential risks and benefits of 
treatment with study treatment. 
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the Study INCB 54828-801 Protocol. 


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2. 
STUDY INFORMATION, OBJECTIVE, AND ENDPOINT 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on INCB 54828-801 Protocol dated 17 MAY 2021 and CRFs approved 
08 MAR 2023. Unless superseded by an amendment, this SAP will be effective for all 
subsequent Protocol amendments and eCRF versions. 
2.2. 
Study Objective and Endpoint 
Table 1 presents the study objective and its endpoint. 
Table 1: 
Objective and Endpoint 
Objective 
Endpoint 
To evaluate the long-term safety and tolerability 
of pemigatinib. 
Frequency and nature of AEs and SAEs as assessed 
by CTCAE v5.0. 
 


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3. 
STUDY DESIGN 
This rollover study allows participants from multiple Protocols, who are receiving clinical 
benefit from pemigatinib as either monotherapy or combination therapy, to continue to be treated 
following the completion of the parent study (also referred to as parent Protocol). The population 
for the rollover study should be consistent with the population defined in each parent Protocol. 
The primary eligibility criterion for a participant to enter the rollover study is participation in an 
Incyte-sponsored study (parent Protocol) and receiving ongoing study treatment. 
Participants who have enrolled in a prior study (parent Protocol) with pemigatinib as 
monotherapy or combination therapy and are assessed by the investigator to continue to benefit 
from ongoing treatment and who cannot access pemigatinib outside of a clinical trial will be 
eligible. 
Disease assessments will be performed per standard of care, with date of progression reported 
and safety data collected. 
Once a participant has rolled over into this study from a parent study, the database for the parent 
study will be closed and locked, and the parent Protocol study will be considered completed and 
closed; however, the participant in the rollover study will still be treated as per the plan outlined 
in the parent Protocol. The parent Protocols include INCB 54828-101 (FIGHT-101); 
INCB 54828-201 (FIGHT-201); INCB 54828-202 (FIGHT-202); and INCB 54828-207 
(FIGHT-207). The study treatments include pemigatinib, INCMGA00012 (INCB 54828-101 
only), and pembrolizumab (INCB 54828-101 only). 
The study begins when the first participant signs the study informed consent form. The end of 
the study is defined as the date of the last visit of the last participant in the study. It is estimated 
that an individual will participate for approximately 12 months. The study is considered 
completed when the last participant's last visit has occurred. Figure 1 elaborates on the study 
design. 


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Figure 1: 
Study Design Schema 
 
Participants receiving and benefiting from ongoing treatment from pemigatinib studies
Continue to qualify and sign 
ICF
Enroll in roll-over 
study and continue 
treatment
Safety assessments performed at regular intervals; 
disease assessments performed per institutional standard 
of care
Progression of disease or 
toxicity reported
Discontinue treatment with study drug and complete 30 day follow up visit


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3.1. 
Randomization 
Not applicable. 
3.2. 
Control of Type I Error 
This study will only conduct analyses on safety data with regard to AEs. All statistical analyses 
are exploratory in nature. Control of Type I error is not applicable. 
3.3. 
Sample Size Considerations 
Approximately 20 participants will be enrolled from prior (parent) pemigatinib studies. 
No formal sample size calculations will be performed for this study. 
3.4. 
Schedule of Assessments 
Refer to Protocol dated 17 MAY 2021 for a full description of all study procedures and 
assessment schedules for this study. 


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4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Day 1 
Day 1 is the date that the first dose of study treatment (pemigatinib as monotherapy or 
combination therapy) in the rollover study is administered to the participants. 
4.1.2. 
Study Day 
If a visit/reporting date is on or after Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (visit/reporting date – Day 1 date + 1). 
If the visit/reporting date is before Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (visit/reporting date – Day 1 date). 
A study day of −1 indicates 1 day before Day 1. 
4.1.3. 
Baseline Value 
Participants are continually taking study treatments before Day 1 of this study. Baseline is not 
applicable in this study. 
4.1.4. 
Handling of Missing and Incomplete Dates 
In general, values for missing dates will not be handled unless methods for handling missing 
dates are specified in this section or relevant sections. The original reported dates collected on 
the eCRF should be used in all relevant listings. The following rules will be used for handling 
partial dates for analyses requiring dates. 
When date of last dose is used in deriving variables such as duration of treatment or TEAE flag, 
a missing or partial date of last dose will be handled as follows: 
• If only the day is missing, then use the earlier date of the last day of the month or the 
date that the participant discontinued treatment will be used. 
• If both the month and day are missing, then the earlier date of 31 DEC of the year or 
the date that the participant discontinued treatment will be used. 
• Otherwise, the date that the participant discontinued treatment will be used as the date 
of the last dose. 
4.1.5. 
Cycle Length and Duration 
Cycle 1 Day 1 is the day that the first dose of study treatment in the rollover study is 
administered. The scheduled cycle length is 21 days with the first day of each cycle 
corresponding with the first day of pemigatinib as monotherapy or combination therapy 
(pembrolizumab or INCMGA00012) administrated in that cycle. 


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4.2. 
Variable Definitions 
4.2.1. 
Prior and Concomitant Medication 
Prior medication is defined as any nonstudy medication started before the first dose of 
pemigatinib as monotherapy or combination therapy. 
Concomitant medication is defined as any nonstudy medication that is started accordingly: 
• Before the date of first administration of pemigatinib as monotherapy or combination 
therapy and is ongoing throughout the rollover study or ends on/after the date of first 
administration of study treatment. 
• On/after the date of first administration of pemigatinib as monotherapy or 
combination therapy and is ongoing or ends during the course of study treatment 
administration. 
A prior medication could also be classified as "both prior and concomitant medication," if the 
end date is on or after the first dose of pemigatinib as monotherapy or combination therapy. In 
the listing, it will be indicated whether a medication is only prior, only concomitant, or both prior 
and concomitant. 
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant. 


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5. 
STATISTICAL METHODOLOGY 
5.1. 
General Methodology 
Unless otherwise noted, SAS® software (SAS Institute Inc, Cary, NC; v9.4 or later) will be used 
for the generation of all tables, listings, and statistical analyses. Descriptive summaries for 
continuous variables will include, but not be limited to, the number of participants, mean, 
standard deviation, median, minimum, and maximum. Descriptive summaries for categorical 
variables will include the number and percentage of participants in each category. 
Participants will undergo disease assessments according to the institution's standard of care. 
Disease assessment details will not be captured, with the exception of documenting the date of 
disease progression. Analyses of efficacy data will not be performed under this SAP. 
5.2. 
Treatment Groups 
This is an open-label, multicenter, rollover study for participants with advanced malignancies 
currently enrolled in Incyte-sponsored studies of pemigatinib who are continuing to receive 
clinical benefit from treatment with pemigatinib (as either monotherapy or in combination 
therapy). 
Participants will be summarized by initially assigned dose level and overall monotherapy total 
(pemigatinib monotherapy 6 mg QD, pemigatinib monotherapy 9 mg QD, pemigatinib 
monotherapy 13.5 mg QD, pemigatinib monotherapy total, pemigatinib 9 mg QD + 
pembrolizumab 200 mg) in this study. 
5.3. 
Analysis Populations 
5.3.1. 
Full Analysis Set 
The FAS will include all participants who received at least 1 dose of study treatment (ie, 
pemigatinib as monotherapy or combination therapy) in the rollover study. 
The FAS will be used for the summary of participant disposition, as well as the listing and 
summary of demographics. 
5.3.2. 
Safety Population 
The safety population will include all participants who received at least 1 dose of study treatment 
(ie, pemigatinib as monotherapy or combination therapy). 
All safety analyses will be conducted using the safety population. 


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6. 
BASELINE, EXPOSURE, AND DISPOSITION 
Appendix A provides a list of data displays. 
6.1. 
Demographics and Baseline Characteristics 
The following demographics characteristics will be summarized and listed for the FAS: age (at 
entry into the rollover study), sex, race, and ethnicity. 
6.2. 
Disposition of Participants 
The number and percentage of participants who were treated, who were ongoing with study 
treatment, who discontinued from study treatment with a primary reason for discontinuation, 
who were still in the study, and who withdrew from the study with a primary reason for 
withdrawal will be summarized for the FAS. 
6.3. 
Protocol Deviations 
Protocol deviations recorded in this study will be listed, if applicable. 
6.4. 
Exposure 
For participants in the safety population, exposure to pemigatinib will be summarized 
descriptively as the following: 
• Duration of treatment with pemigatinib (days): 
Date of last dose of pemigatinib – date of first dose of pemigatinib + 1 
• Pemigatinib dose modifications: 
Number of participants who had pemigatinib dose reduction and interruption 
6.5. 
Study Treatment Compliance 
Not applicable. 
6.6. 
Prior and Concomitant Medication 
Prior medications concomitant medications will be coded using the WHO Drug Dictionary. The 
prior and concomitant medication will be listed for participants in the safety population by WHO 
drug class and WHO drug preferred term. 


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7. 
SAFETY AND TOLERABILITY 
Appendix A provides a list of data displays. 
7.1. 
General Considerations 
The analyses for this section will be provided for the safety population. Summary tables may be 
replaced with listings when appropriate. For instance, an AE frequency table may be replaced 
with a listing if it only contains a few unique PTs reported on relatively few participants. 
Unless otherwise stated, table summaries will be limited to TEAEs. 
7.2. 
Adverse Events 
7.2.1. 
Adverse Event Definitions 
Adverse events that are ongoing at the time of rollover from the parent Protocol will be entered 
on the Adverse Event Form in the eCRF for this study. 
A TEAE is any AE either reported for the first time in this Protocol and within 30 days of last 
dose of study treatment, or any AE ongoing and defined as treatment-emergent from the parent 
Protocol. Analysis of AEs (as discussed below) will be limited to TEAEs, but data listings will 
include all AEs regardless of their timing and in relation to study treatment administration. For 
purposes of analysis, all AEs will be considered TEAEs unless the AE can unequivocally be 
defined as not treatment-emergent. 
Adverse events will be tabulated by MedDRA PT and SOC. Severity of AEs will be graded 
using the National Cancer Institute CTCAE v5.0. The CTCAE reporting guidelines and grading 
details are available on the Cancer Therapy Evaluation Program website. 
A grading (severity) scale is provided for each AE term. If the toxicity is not included in the 
CTCAE v5.0 criteria, it will be rated on a scale of 1 to 5 as follows: 1 = mild, 2 = moderate, 
3 = severe, 4 = life-threatening, and 5 = fatal. All toxicities will be graded based on the worst 
level reached, not the level they may have reached if they had not been treated. When the 
intensity of an AE changes over time for a reporting period (eg, between visits), each change in 
intensity will be reported as an AE until the event resolves. 
The subset of AEs considered by the investigator to be related to study treatment will be 
considered to be treatment-related AEs. If the investigator does not specify the relationship of the 
AE to study drug, the AE will be considered to be treatment-related. The incidence of AEs and 
treatment-related AEs will be tabulated. Serious TEAEs will also be tabulated. In addition, 
serious TEAEs and serious AEs will be listed. 
Any missing data pertaining to date of onset, causality, or severity must be queried for 
resolution. Unresolved missing causality and severity will be handled according to the following 
rules: 
• An unresolved missing causality will be considered treatment-related. 
• An unresolved missing severity will be identified as an unknown severity. 


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7.2.2. 
Adverse Event Summaries 
An overall summary of AEs by dose level will include the following: 
• Number (%) of participants reporting any TEAEs 
• Number (%) of participants reporting any serious TEAEs 
• Number (%) of participants reporting any Grade 3 or higher TEAEs 
• Number (%) of participants who had any TEAEs related to pemigatinib 
• Number (%) of participants who temporarily interrupted pemigatinib because of 
TEAEs 
• Number (%) of participants who permanently discontinued from pemigatinib because 
of TEAEs 
• Number (%) of participants who had pemigatinib dose reductions because of TEAEs 
• Number (%) of participants who had any TEAEs with a fatal outcome 
The following summaries will be produced by MedDRA term (if 10 or fewer participants appear 
in a table, a listing may be appropriate): 
• Summary of TEAEs by MedDRA SOC and PT 
• Summary of TEAEs by MedDRA PT in decreasing order of frequency 
• Summary of Grade 3 or higher TEAEs by MedDRA SOC and PT 
• Summary of serious TEAEs by MedDRA SOC and PT 
• Summary of TEAEs with a fatal outcome by MedDRA SOC and PT 
• Summary of pemigatinib treatment-related serious TEAEs by MedDRA SOC and PT 
• Summary of TEAEs leading to pemigatinib dose reduction by MedDRA SOC and PT 
• Summary of TEAEs leading to pemigatinib dose interruption by MedDRA SOC and 
PT 
• Summary of TEAEs leading to discontinuation of pemigatinib by MedDRA SOC and 
PT 
Listings will be provided for all AEs, SAEs, AEs of Grade 3 and higher, treatment-related AEs, 
fatal AEs, and AEs leading to interruption, reduction, or discontinuation of study drug. All 
listings will be presented for the safety population. 
8. 
INTERIM ANALYSES 
There are no planned, formal interim analyses for this study. 


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9. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 2. 
Table 2: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
15 MAR 2024 
9.1. 
Changes to Protocol-Defined Analyses 
Not applicable. 
9.2. 
Changes to the Statistical Analysis Plan 
Not applicable. 


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APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS 
This appendix provides a list of the planned tables, figures, and listings for the clinical study 
report. Standard tables will follow the conventions in the Standard Safety Tables v1.13. In-text 
tables are identical in structure and content as appendix tables but follow a Rich Text Format. 
The lists of tables, figures, and listings are to be used as guidelines. Modifications of the lists that 
do not otherwise affect the nature of the analysis will not warrant an amendment to the SAP. 
Tables 
Table No. 
Title 
Population 
Standard 
Baseline and Demographic Characteristics 
1.1 Disposition 
1.1.2 
Summary of Participant Disposition 
FAS 
X 
1.2 Demography and Baseline Characteristics 
1.2.1 
Summary of Demographic Characteristics 
FAS 
X 
Safety 
3.1 Dose Exposure 
3.1.1 
Summary of Exposure and Duration of Exposure to Pemigatinib 
Safety 
X 
3.2 Adverse Events 
3.2.1 
Overall Summary of Treatment-Emergent Adverse Events 
Safety 
X 
3.2.2 
Summary of Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term 
Safety 
X 
3.2.3 
Summary of Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Safety 
X 
3.2.6 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Safety 
X 
3.2.8 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Safety 
X 
3.2.15 
Summary of Pemigatinib-Related Serious Treatment-Emergent Adverse 
Events by MedDRA System Organ Class and Preferred Term 
Safety 
X 
3.2.16 
Summary of Treatment-Emergent Adverse Events with a Fatal Outcome 
by MedDRA System Organ Class and Preferred Term 
Safety 
X 
3.2.18 
Summary of Treatment-Emergent Adverse Events Leading to 
Pemigatinib Dose Reduction by MedDRA System Organ Class and 
Preferred Term 
Safety 
X 
3.2.19 
Summary of Treatment-Emergent Adverse Events Leading to 
Pemigatinib Dose Interruption by MedDRA System Organ Class and 
Preferred Term 
Safety 
X 
3.2.20 
Summary of Treatment-Emergent Adverse Events Leading to 
Pemigatinib Discontinuation of Study Drug by MedDRA System Organ 
Class and Preferred Term 
Safety 
X 


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Listings 
Listing No. 
Title 
2.1 Participant Disposition 
2.1.1 
Participant Enrollment and Disposition Status 
2.2 Protocol Deviations 
2.2.1 
Protocol Deviations  
2.3 Safety Analyses 
2.3.1 
Analysis Populations 
2.4 Demographics (Including Concomitant Medications) 
2.4.1 
Demographic Characteristics 
2.4.2 
Prior and Concomitant Medication 
2.5 Drug Compliance 
2.5.1 
Study Treatment Administration - Pemigatinib 
2.7 Adverse Events 
2.7.1 
Adverse Events  
2.7.2 
Serious Adverse Events 
2.7.3 
Grade 3 and Higher Adverse Events 
2.7.4 
Fatal Adverse Events 
2.7.5 
Treatment-Related Adverse Events 
2.7.6 
Adverse Events Leading to Interruption, Reduction, or Discontinuation of Study Treatment 
2.11 Eye Examinations 
2.11.1 
Eye Examination 
2.11.2 
Optical Coherence Tomography