A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
Phase: PHASE2
Conditions: Urinary Bladder Neoplasms
Sponsor: Janssen Research & Development, LLC

NCT04919512

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
2
Status: Approved,  Date: 20 April 2023
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE
DOCUMENT HISTORY
Document
Date
Amendment 2
20 April 2023
Amendment 1
19 September 2022
Original Protocol
06 April 2021
Amendment 2 (20 April 2023)
Overall Rationale for the Amendment: The primary focus of the protocol amendment is to provide 
greater clarity for Investigators, to harmonize shared protocol elements within the protocol and across 
SunRISe protocols for the TAR-200/cetrelimab program, and to align with the latest Sponsor protocol 
template.
The changes made to this clinical protocol 17000139BLC2002 as part of Protocol Amendment 2 are listed 
below, including the rationale of each change and a list of all applicable sections, Changes made in previous 
protocol amendments are listed in Section 10.19 Appendix 19: Protocol Amendment History.
In the following table, new text added to the protocol is shown in bold. Deleted text is shown in strike
through.
Section Number
and Name
Description of Change
Brief Rationale
1.1 Synopsis
Updates made to harmonize with changes in the 
protocol body
For consistency with the 
protocol
1.3 Schedule of Activities 
Table 1 (Cohort 1) and 
Table 2 (Cohort 2)
4.1 Overall Design
5. Study Population
5.1 Inclusion Criteria 
(Criterion 2)
90-day window extended to 120-day from diagnostic 
TURBT to randomization
To increase feasibility of 
enrollment due to concern 
from investigators that 
90 days is not practical in 
all cases
1.3 Schedule of Activities
Table 1 (Cohort 1) and 
Table 2 (Cohort 2)
Clarifications to footnote for Revised Cardiac Risk 
Index (RCRI): 1-2 weeks prior to radical cystectomy
(RC) updated to “1-3 weeks prior to RC”
Added cross-reference for further information on 
vital sign monitoring
To improve clarity
1.3 Schedule of Activities 
Table 1 (Cohort 1) and 
Table 2 (Cohort 2)
10.2 Appendix 2 (Clinical 
Laboratory Tests)
Hematology, Blood, Chemistry. Footnote text 
amended as HbA1c testing must be performed at 
Screening through Week 
post RC, and fasting 
glucose will be captured at baseline but does not 
need to be done during treatment. Text added: HbA1c
results can replace the requirement for fasting blood 
glucose prior to each dose; however, if fasting glucose 
results are available, the HBA1c result does not need to 
be reviewed prior to dosing, but should still be collected
To align with other 
SunRISe protocols
1.3 Schedule of Activities 
Table 1 (Cohort 1) and 
Table 2 (Cohort 2)
Urine and blood biomarkers analyses. Text added to 
footnote that urine and blood is collected at Week
 
if radical cystectomy is not performed at this visit 
Footnote text amended to state that urine sample 
collection is not required immediately prior to radical 
cystectomy at Screening
To clarify biomarker 
collection requirements
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JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
3
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
1.3 Schedule of Activities
Table 1 (Cohort 1)
6.1.1 TAR-200 Insertion 
(Cohort 1); 6.5.1.1
Management of Adverse 
Events Related to 
TAR-200 and Procedures
6.8 Concomitant Therapy
Cystoscopy, Cetrelimab, and TAR-200 Removal 
with Cystoscopy updated: To mitigate the risk of 
UTI’s, participants must receive at least one dose of 
periprocedural prophylactic antibiotics for any 
intravesical study procedures.at time of TAR200 
insertion and/or removal. 
Note added to Week cystoscopy - **An 
assessment cystoscopy for participants in 
Cohort 1 and Cohort 2 may be performed at 
Week  if clinically indicated.
Sections updated to clarify that periprocedural 
prophylactic antibodies are for TAR-200 insertion 
and/or removal and not for any intravesical 
procedure
To clarify use of 
periprocedural 
prophylactic antibiotics
1.3 Schedule of Activities 
Table 2 (Cohort 2)
Cystoscopy: Text updated: To mitigate the risk of 
UTI’s, participants must receive at least one dose of 
periprcdural prophylactic antibiotics for any 
intravescial study procedures
Week  cystoscopy updated - **An assessment 
cystoscopy for participants in Cohort 1 and 
Cohort 2 may be performed at Week  if clinically 
indicated.
Prophylactic antibodies are 
for TAR-200 insertion and 
removal (Cohort 1 only)
To align with Table 1
2 Introduction 
6.1 Study Treatment (s) 
Administered
Language to describe TAR-200 and Urinary 
Placement Catheter (UPC) updated
To improve clarity and to 
harmonize shared protocol 
elements across protocols 
for the 
TAR-200/cetrelimab 
program
2. Introduction
Language for the term “study drug” and “study 
treatment(s)” updated 
To clarify the definitions 
of study drugs and study 
drug combinations used in 
this study
2.2.2 Cetrelimab Clinical 
Studies
2.2.2.1 IV Cetrelimab
Section 2.2.2 updated to include total number of 
participants who have received cetrelimab 
monotherapy or in combination. 
New Section 2.2.2.1 describing clinical study results 
for IV cetrelimab
To provide updated clinical 
study results for IV 
cetrelimab
2.2.3.1 TAR-200 + IV 
Cetrelimab Combination 
New Section 2.2.3.1 includes details of the ongoing 
studies with TAR-200 + IV cetrelimab: the Phase 3 
Study 17000139BLC3001, the Phase 3 Study 
17000139BLC3002, and the Phase 2 Study 
17000139BLC2001; and is updated with outcomes 
from Independent Data Monitoring Committee 
(IDMC). Reference to Investigator’s Brochure (IB) 
for safety results included
To provide an overview of 
clinical studies for 
TAR-200 in combination 
with cetrelimab.
3. Objectives and 
Endpoints
Name of Cohort (1 or 2) added to each objective 
(where applicable).
To improve clarity.
3. Objectives and 
Endpoints
Exploratory objective and endpoint, respectively 
updated: To determine whether the baseline immune 
status, molecular subtype or mutational status
Reference to mutational 
profiling added to support 
exploratory objectives
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JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
4
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
influences treatment response; and mutational 
status by DNA sequencing
4.1 Overall Design
TAR-200 removal visit schedule updated for 
Cohort 1: A cystoscopy is not required at these 
visits if TAR-200 removal is not needed
To improve clarity for 
cystoscopy requirements in 
Cohort 1
4.3 Justification for Dose
Justification for dose selection for IV cetrelimab 
updated
To expand the justification 
of dose selection provided 
in the protocol
4.4. End of Study 
Definition
Participant End of Study Definition and Completion 
of Study Definition has been updated
For consistency across 
protocols for the 
TAR-200/cetrelimab 
program
5.1 Inclusion Criteria
Inclusion criterion 2 modified per Amendment 2:
Histologically proven, cT2-T4a N0, M0 infiltrating 
urothelial carcinoma (AJCC 2017) of the bladder. 
Initial diagnosis must have been within 90 120 days 
of randomization date. Participants with variant 
histologic subtypes (eg squamous differentiation) are 
allowed if urothelial (transitional cell) differentiation 
is predominant (eg, <20% variant histologic subtype) 
if tumor(s) demonstrate urothelial predominance.
However, the presence of any small cell or
neuroendocrine, micropapillary, signet ring cell,
plasmacytoid, or sarcomatoid features variants will 
make a participant ineligible.
To ensure patients who 
may derive benefit from 
this therapeutic regimen 
are included in this study
5.1 Inclusion Criteria
8.7.1.1 TURBT Biopsies, 
Cystoscopy, and Radical 
Cystectomy Pathology
(Disease Assessments)
8.7.2.1 TURBT Biopsies, 
Cystoscopy, and Radical 
Cystectomy Pathology 
(Response Assessments)
Inclusion criterion 3 modified per amendment 2 to 
include: Participants with no residual tumor, or an 
individual intravesical tumor size of ≤3 cm following 
TURBT are eligible; debulking TURBT for any 
residual disease is encouraged but not mandated.
Participants with persistent multifocal tumors >3 cm
at screening must undergo a second debulking, re-
staging TURBT. to reduce the tumor burden.
Participants will be ineligible if any individual tumor 
is >3 cm after debulking TURBT.
Text amended: If screening cystoscopy 
demonstrates any residual mucosal disease, 
debulking TURBT is encouraged to attain 
complete resection, but not mandated if all 
individual residual tumors are <3 cm. All 
individual residual tumors should be ≤ 3 cm.
Text added: A debulking re-TURBT is encouraged 
if there is residual mucosal disease ≤3 cm.
To encourage debulking 
for tumors ≤3 cm
5.1 Inclusion Criteria
Inclusion criterion 6 modified per amendment 2 to 
include “Note: If thyroid stimulating hormone 
(TSH) is not within normal limits, the participant 
may still be eligible if T3 (either total or free) and 
free T4 are within normal limits.
To clarify eligibility 
criteria for participants 
with TSH not within 
normal limits 
5.1 Inclusion Criteria
Inclusion criterion 7 modified per amendment 2 to 
include link to Section 10.17, Appendix 17, 
Inclusion criteria for study 
participants is ≥30 mL/min 

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
5
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
10.17: Appendix 17: 
Cockcroft-Gault Formula
Cockroft-Gault formula – Calculated and Measured 
Creatinine Clearance
New Appendix
based on Cockcroft -Gault 
formula
5.1 Inclusion Criteria
10.18: Appendix 18: 
CKD-EPI Creatinine 
Equation (2021)
Inclusion criterion 8 modified per amendment 2 to 
include link to Section 10.18, Appendix 18, 
CKD-EPI Creatinine Equation (2021)
New Appendix
To determine ineligibility 
to platinum therapy the 
CKD-EPI equation is used
5.1 Inclusion Criteria 
Inclusion criterion 11 modified per amendment 2 to 
include Investigators will advise participants on 
the options for banking of sperm and ova for 
reproductive conservation. 
and:
•
not be breastfeeding (including temporarily 
withholding breastfeeding in order to participate 
in the study) and not planning to become pregnant 
during the study and for at least 6 months after the 
last dose of study treatment. Female participants 
should consider preservation of eggs prior to study 
treatment as anti-cancer treatments may impair 
fertility. Investigators will advise female 
participants on the options for banking of ova for 
reproductive conservation.
•
not plan to father a child while enrolled in this 
study or within 6 months after the last dose of study 
drug treatment. Male participants should consider 
preservation of sperm prior to study treatment as 
anti-cancer treatments may impair fertility. 
Investigators will advise male participants on the 
options for banking of sperm for reproductive 
conservation.
For consistency across 
protocols for the TAR-200 
/cetrelimab program
5.2 Exclusion Criteria
Exclusion criterion 13 modified per Amendment 2
Participants with an active, known or suspected 
autoimmune disease that has required systemic 
treatment in the past 2 years are excluded. 
Participants with autoimmune disorders not requiring 
systemic treatment (eg, skin conditions such as 
vitiligo or alopecia) or conditions requiring hormonal 
replacement therapies such as type 1 diabetes 
mellitus or hypothyroidism are permitted to enroll.
To provide further 
clarification by combining 
with Exclusion criterion 27
5.2 Exclusion Criteria
Exclusion criterion 16 modified per Amendment 2 to 
include: Evidence of active or chronic hepatitis B or 
C infection
To clarify exclusion 
criteria for participants 
with hepatitis B or C 
infection
5.2 Exclusion Criteria
Exclusion criterion 17 updated per Amendment 2: 
Urinary tract infection (UTI), defined as a 
symptomatic infection with a positive urine culture 
with a bacterial count of ≥105 colony forming units 
(CFU)/mL in urine voided from women, or >104
CFU/mL in urine voided from men, or in straight 
catheter urine from women, that cannot be cleared 
To clarify exclusion 
criteria for participants 
with UTI

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
6
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
with adequate antibiotic therapy. Symptoms may 
include dysuria, urgency, frequency, and/or systemic 
symptoms such as fever, chills, elevated white blood 
cell, and/or abdominal/flank pain. Participants free 
from symptoms for 7 days with no culture evidence 
of ≥105 CFUs may be eligible.
5.2 Exclusion Criteria
Exclusion criterion 18 deleted per Amendment 2
Active, uncontrolled urogenital bacterial, viral or 
fungal infections, including UTI. Skin/nail fungal 
infections are not exclusionary. Participants with 
active shingles (varicella zoster infection) will be 
excluded from the study.
Details of exclusion 
criteria for participants 
with UTI is covered 
separately in exclusion 
criterion 17; and for 
consistency across 
protocols for the TAR-200 
/cetrelimab program
5.2 Exclusion Criteria
Exclusion criterion 21 updated per Amendment 2
Participants who have had a history of with current
acute diverticulitis, intra-abdominal abscess, 
gastrointestinal obstruction and abdominal 
carcinomatosis which are known risk factors for 
bowel perforation, and participants who have a 
history immune-mediated colitis
To update exclusion 
criteria and to exclude 
participants with a history 
immune-mediated colitis
5.2 Exclusion Criteria
Exclusion criterion 22 deleted per Amendment 2
Impaired wound healing capacity defined as 
skin/decubitus ulcers, chronic leg ulcers, known 
gastric ulcers, or unhealed incisions
Delay or arrest of wound 
healing not associated with 
TAR-200 or cetrelimab 
administration
5.2 Exclusion Criteria
Exclusion criterion 26 to include that, in addition to 
non-live vaccines, non-replicating vaccines 
approved or authorized for emergency use (eg, 
COVID-19) by local health authorities are allowed. 
Added link to Section 6.8 (Concomitant Therapy)
For consistency throughout 
the protocol and to 
improve clarity on types of 
vaccines allowed
5.2 Exclusion Criteria
Exclusion criterion 27 deleted per Amendment 2
Active autoimmune disease that has required 
systemic treatment in the past 2 years
The exclusion of 
participants with active 
autoimmune disease is 
covered separately in 
Exclusion Criterion 13
5.2 Exclusion Criteria
Exclusion criterion 39 updated per Amendment 2
Note: Participants with planned surgical procedures 
to be conducted under local anesthesia may 
participate.
To update exclusion 
criteria for participants 
with planned surgical 
procedures
5.1 Inclusion Criteria
5.2 Exclusion Criteria
Minor edits/clarifications incorporated
To improve clarity
6.1 Study Treatment(s) 
Administered
Table 8 updated to include route of administration, 
Use, IMP, and NIMP information. Added details on 
the liquid formulation product for IV cetrelimab
Dosing instructions were updated in Table 8 to 
include that flexible cystoscope is preferred for the 
removal process; the same clarifications were added 
to Section 6.1.2 TAR-200 Removal.
Section 6.1.2 includes additional clarifications to 
guidance for removal: ‘The TAR-200 should be 
grasped fully (wireform and tubing) ...’ and
To improve clarity and 
align with the Sponsor 
oncology protocol template 
and for consistency across
protocols for the 
TAR-200/cetrelimab 
program

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
7
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
’trained credentialed medical professional’ updated 
to ‘healthcare professional’
Section 6.1.1 TAR-200 Insertion, note added to 
indicate the bladder should not be completely 
empty when TAR-200 is inserted.
Bladder analgesics corrected: phenopyrazidine
replaced by phenazopyridine
New Section 6.1.3 Cetrelimab Administration
To clarify dosing 
instructions
Section 6.2 Subheading “Accountability of Study 
Treatment”, ‘Treatment accountability form’ 
replaced by ‘treatment administration form’.
The following statement was deleted: ‘The return to 
the Sponsor of unused study treatment will be 
documented on the applicable return form’
To ensure correct reporting 
requirements are provided 
and to improve clarity
6.5 Management of 
Adverse Events and Dose 
Modification
Heading 6.5 updated to include Management of 
Adverse Events. Structure of Section 6.5 and 
subheadings updated to include the 2 study 
treatments (6.5.1 TAR-200, 6.5.2 Cetrelimab), and to 
describe management of adverse events (AEs) prior 
to dose modification.
Cross-reference to Section 7.1 Discontinuation of 
Study Treatment included
To improve clarity and to 
harmonize shared protocol 
elements across protocols 
for the 
TAR-200/cetrelimab 
program
Section 6.5.2 list of cetrelimab-related 
immune-related AEs (irAEs) requiring delay or 
discontinuation updated
To align with irAEs 
reported in the Cetrelimab 
IB Annual Update
6.8 Concomitant Therapy
Text updated: ‘non-live or non-replicating vaccines 
such as annual inactivated influenza, COVID-19,
and monkeypox vaccine are allowed’
For consistency with 
exclusion criterion 7, to 
include non-replicative 
vaccines like monkeypox
7.1 Discontinuation of 
Study Treatment
Text included: ‘The Investigator believes that for 
safety reasons or tolerability reasons (eg, due to 
an AE, laboratory abnormality or intercurrent 
illness) it is in the best interest of the participant 
to discontinue study treatment. ‘
To harmonize shared 
protocol elements across 
protocols for the 
TAR-200/cetrelimab 
program
7.3.1 Withdrawal From the 
Future Use of Research 
Samples and Appendix 
Section 7.3.1, duplicated information about long-
term retention of samples deleted
This information is 
presented in Section 10.3.5
(Long-Term Retention of 
Samples for Additional 
Future Research)
8. Study Assessments and 
Procedures
‘Home Health Care and Telehealth Visits’ subsection 
incorporated.
Study-Specific Materials list updated to include 
TAR-200 IFU, cetrelimab IPPI, PRO 
questionnaire(s) and ePRO completion guidelines, 
and eCOA manual
To clarify operational 
aspects within the protocol
8.2 Treatment
(Cohort 1and Cohort 2): Instructions for vital signs 
monitoring during IV cetrelimab infusion updated to: 
For the first infusion, vital signs should be monitored 
before the start of the infusion, during infusion, 
every 15 to 20 minutes during the infusion, at the end 
of infusion (+10 minutes), and 2 hours (±15 min) 
after the completion of infusion. After the 
To harmonize shared 
protocol elements across 
protocols for the 
TAR-200/cetrelimab 
program

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
8
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
completion of the first infusion, the participant may 
be discharged if considered clinically stable and all 
other study procedures have been completed. During 
subsequent infusions of cetrelimab, vital signs should 
be monitored before the start of the infusion. pre
dose, once during infusion, and at the end of 
infusion.
TAR-200 text (Cohort 1) updated to: ‘All 
Investigators or healthcare professional designees
must have training completed per and documented 
in accordance with TAR-200 training guidance’
Text added for Cohort 1 and Cohort 2 Early Disease 
Progression: In cases of discordance or equivocal 
findings, additional imaging may be obtained at 
Investigator’s discretion to adjudicate; these cases 
must be discussed with Sponsor
Minor edits incorporated
To align with TAR-200 
training guidance and 
instructions for use
To provide further 
operational aspects for 
CT/MRI-assessed response 
to treatment 
To improve clarity
8.7.1.2 Computed 
Tomography/Magnetic 
Resonance Imaging 
(CT/MRI)
Updated instructions for CT/MRI assessments: 
Eligibility is determined by central read of 
CT/MRI at screening. All on-study treatment 
decisions should be based on the Investigator’s 
assessment of the CT/MRI images and not on the 
central review. In cases of discordance between 
local and central review of CT/MRI images, the 
Investigator should consult with Sponsor for 
support.
To provide further 
operational aspects for 
CT/MRI-assessed response 
to treatment
8.8.1. Specification of 
Safety Parameters
Updates made to clarify reporting of AEs and serious 
AEs (SAEs) relative to the 100-day safety follow-up 
visit
Statement added: ‘In the event that a participant 
complains of unexpected fever, shortness of 
breath/dyspnea, or dry cough, a thorough 
evaluation for interstitial pneumonitis is 
recommended per institution standard of care.’
To ensure alignment of 
safety reporting across 
protocols in the 
TAR-200/cetrelimab 
program
For consistency across 
protocols for the 
TAR-200/cetrelimab 
program
8.9.5. Pregnancy
Text added: ‘Any participant who becomes 
pregnant during the study must discontinue 
further study treatment.’
‘Because the effect of the study drugs on sperm is 
unknown, pregnancies in partners of male 
participants included in the study will be reported 
as noted above.’
To align with the Sponsor 
oncology protocol template
8.9 Adverse Events, 
Serious Adverse Events, 
and Other Safety 
Reporting; 9.4.5 Safety 
Analysis; 10.4.6 Product 
Quality Complaint (PQC) 
Handling; 10.10 Adverse 
Events, Adverse Device 
Text regarding PQC and Device Deficiency 
reporting updated and cross-references to 
Appendices included when applicable.
Headings of sections modified with updated 
terminology
Section 8.9.8, text added: ‘If a PQC or Device 
Deficiency is reported, the TAR-200, cetrelimab, 
or UPC, respectively, must be retained by the site 
Per the latest Sponsor 
template/Standard 
Operating Procedures 
(SOPs) and regulatory 
reporting requirements

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
9
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
Effects, Serious Adverse 
Events, Serious Adverse 
Device Effects, 
Unanticipated Serious 
Adverse Device Effects, 
and Device Deficiencies: 
Definition and Procedures 
for Recording, Evaluating, 
Follow-up, and Reporting 
in Medical Device, and 1.3 
Schedule of Activities
under the correct storage conditions until a 
shipment request is received from the Sponsor.’
Same note added to SoA tables, PQC Assessments
Section 10.10, Appendix 10 updated: 
title of appendix updated, subsections created, 
headings modified
8.10. Pharmacokinetics 
8.10.1 Evaluations
Subheading: Sparse Urine PK Samples for 
Gemcitabine and dFdU Analysis (Cohort 1 only)
Text deleted: Labeled urine collection containers will 
be stored in the refrigerator during each 24 hour 
collection interval and then transferred to the study 
clinic where the samples will be stored at 20°C or 
colder.
Text added: The 20 participants in Cohort 1 in the 
serial urine sampling are not required to complete 
Week 0 and Week
 sparse timepoints as the 
serial sampling will meet these requirements
Subheading: Serial Urine PK Samples for 
Gemcitabine and dFdU Analysis (Cohort 1 Only)
Text deleted: For these 20 participants, the sparse 
pre dose time points at Week 0 and Week 
do 
not need to be collected as this serial urine sampling 
will meet these requirements
Text deleted: Labeled urine collection containers will 
be stored at room temperature during each 24 hour 
collection interval.
Detailed instructions for 
urine PK sample collection 
and storage are provided in 
the Laboratory Manual
For consistency across
protocols for the 
TAR-200/cetrelimab 
program
Detailed instructions for 
urine PK sample collection 
and storage are provided in 
the Laboratory Manual
8.12 Biomarkers
Section updated to include DNA mutation profiling 
to explore molecular markers of response and 
resistance
Circulating tumor DNA: paragraph describing the 
role of ctDNA fragments removed
To support exploratory 
objective
Superfluous text
9.4.2 Primary Endpoint
Text added: Additionally, 95% exact confidence 
interval will also be calculated for each cohort 
based on binomial distribution
To provide further details 
of statistical analyses
9.4.4 Exploratory 
Endpoint(s)
80% exact confidence interval amended to 95%
To update statistical 
analysis for pOR rate
9.4.6 Other Analyses
Text added to TAR-200 PK Analyses: For serial 
urine PK, PK parameters will be listed and 
summarized using descriptive statistics. Details of 
the analyses will be described in the Clinical 
Pharmacology Analysis Plan.
New Subsection added: 
Pharmacokinetic/pharmacodynamic Analyses
To improve clarity
To align across the 
TAR-200/cetrelimab 
CCI
CCI

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
10
Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
Pharmacokinetic/pharmacodynamic models may 
be explored to understand and characterize the 
exposure-response relationship for key efficacy, 
safety, and pharmacodynamic/biomarker data 
parameters, to detect the influence of covariates,
and to identify inter-individual variability in 
response. The details will be provided in a 
separate analysis plan and the results of the 
analyses will be summarized in a separate report
program for the FDA 
Diversity Plan
9.5 Interim Analysis 
(Cohort 1 and Cohort 2)
Section updated: 1 interim analysis was originally 
planned for this study but as per Amendment 2, there 
are now 2 interim analyses planned
To update the statistical 
considerations sections 
with the 2 planned interim 
analyses
10.2 Appendix 2: Clinical 
Laboratory Tests
Text deleted in Protocol-Required Safety Laboratory 
Assessments Table:
Red blood cell count (RBC), Hematocrit, Monocytes, 
Eosinophils, Basophils
Note: A WBC evaluation may include any abnormal 
cells, which will then be reported by the laboratory. 
An RBC evaluation may include abnormalities in the 
RBC count, RBC parameters, or RBC morphology, 
which will then be reported by the laboratory. In 
addition, any other abnormal cells in a blood smear 
will also be reported.
Text added to HIV antibody testing: ‘if positive, 
further testing of CD4 count and HIV viral load 
should be carried out.’
To harmonize shared 
protocol elements across 
protocols for the 
TAR-200/cetrelimab 
program
10.3 Appendix 3: 
Regulatory, Ethical, and 
Study Oversight 
Considerations
In Section 10.3.3, statement about impartial witness 
updated from ‘should’ to ‘must’ personally date and 
sign the ICF
To improve clarity
10.5 Appendix 5: 
Contraceptive and Barrier 
Guidance
Removed footnote b regarding susceptibility of 
hormonal contraception to interaction with study 
treatment as it is not applicable to the study 
treatments administered
To remove misinformation 
on study treatment 
interactions
10.9 Appendix 9: 
Guidelines for 
Management of Immune-
Related Adverse Events 
and Adverse Events of 
Clinical Interest
Section 10.9.1. Table 11: Management of Immune-
Related Gastrointestinal Adverse Events: Text added 
to Grade 3-4 events: Persistence >3 days, high-risk 
endoscopic features (large deep ulceration, 
multiple ulcers, extensive colitis beyond left 
colon), or recurrence: add infliximab 5 mg/kg (if no 
contraindication such as perforation or sepsis)
To harmonize shared 
protocol elements across 
protocols for the 
TAR-200/cetrelimab 
program
10.13 Appendix 10.13: 
Cytokine Release 
Syndrome – Severity 
Grading and Management
Appendix updated using NCI-CTCAE (Version 5.0) 
grading systems
To align with NCI-CTCAE 
Version 5.0
10.19 Appendix 19: 
Protocol Amendment 
History
Text revised to note that the Protocol Amendment 
Summary of Changes Table for this amendment is 
located directly before the Table of Contents
Changes for Protocol 
Amendment 2
Throughout the protocol
Protocol template-driven updates were made where 
applicable
To align with updates to 
the Sponsor oncology 
protocol template

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Section Number
and Name
Description of Change
Brief Rationale
Language containing potential Company 
Confidential Information and considered not 
essential for the protocol has been deleted
In accordance with the 
European Union (EU) 
Clinical Trial Regulations 
(CTR) effective as of 31 
January 2022
Minor clarifications including grammatical, 
formatting, or spelling changes were made, and links 
and cross-references corrected/updated. 
Abbreviations added to tables where applicable 
within the document, and the list of abbreviations 
and definitions updated (Section 10.1, Appendix 1).
Minor errors were 
corrected

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TABLE OF CONTENTS
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................................... 2
TABLE OF CONTENTS ............................................................................................................................. 12
LIST OF IN-TEXT TABLES AND FIGURES.............................................................................................. 16
1.
PROTOCOL SUMMARY ................................................................................................................... 17
1.1.
Synopsis......................................................................................................................................... 17
1.2.
Schema .......................................................................................................................................... 22
1.3.
Schedule of Activities (SoA)........................................................................................................... 23
2.
INTRODUCTION................................................................................................................................ 38
2.1.
Study Rationale.............................................................................................................................. 39
2.2.
Background .................................................................................................................................... 41
2.2.1.
TAR-200 Clinical Studies............................................................................................................ 41
2.2.2.
Cetrelimab Clinical Studies......................................................................................................... 42
2.2.2.1.
IV Cetrelimab........................................................................................................................... 43
2.2.3.
Combination Therapy ................................................................................................................. 44
2.2.3.1.
TAR-200 + IV Cetrelimab Combination...................................................................................45
2.3.
Benefit-Risk Assessment ............................................................................................................... 45
3.
OBJECTIVES AND ENDPOINTS ..................................................................................................... 47
4.
STUDY DESIGN ................................................................................................................................ 48
4.1.
Overall Design................................................................................................................................ 48
4.2.
Scientific Rationale for Study Design............................................................................................. 50
4.2.1.
Study-Specific Ethical Design Considerations ........................................................................... 52
4.3.
Justification for Dose...................................................................................................................... 52
4.3.1.
TAR-200 Dose Selection ............................................................................................................ 52
4.3.2.
IV Cetrelimab Dose Selection..................................................................................................... 53
4.4.
End of Study Definition................................................................................................................... 53
5.
STUDY POPULATION ...................................................................................................................... 54
5.1.
Inclusion Criteria ............................................................................................................................ 54
5.2.
Exclusion Criteria ........................................................................................................................... 58
5.3.
Lifestyle Considerations................................................................................................................. 63
5.3.1.
Meals and Dietary Restrictions................................................................................................... 63
5.3.2.
Caffeine, Alcohol, and Tobacco.................................................................................................. 63
5.3.3.
Activity......................................................................................................................................... 63
5.4.
Screen Failures .............................................................................................................................. 63
5.5.
Criteria for Temporarily Delaying Administration of Study Treatment ........................................... 64
6.
STUDY TREATMENT AND CONCOMITANT THERAPY ................................................................64
6.1.
Study Treatment(s) Administered .................................................................................................. 64
6.1.1.
TAR-200 Insertion (Cohort 1) ..................................................................................................... 65
6.1.2.
TAR-200 Removal (Cohort 1)..................................................................................................... 67
6.1.3.
Cetrelimab Administration........................................................................................................... 68
6.2.
Preparation/Handling/Storage/Accountability ................................................................................ 68
6.3.
Measures to Minimize Bias: Randomization and Blinding.............................................................69
6.4.
Study Treatment Compliance ........................................................................................................ 70
6.5.
Management of Adverse Events and Dose Modification...............................................................70
6.5.1.
TAR-200...................................................................................................................................... 70
6.5.1.1.
Management of Adverse Events Related to TAR-200 and Procedures.................................. 70
6.5.2.
Cetrelimab .................................................................................................................................. 72
6.5.2.1.
Management of Adverse Events Related to Cetrelimab .........................................................72
6.5.2.2.
Cetrelimab Dose Modification.................................................................................................. 73
6.6.
Continued Access to Study Treatment After the End of the Study................................................ 75

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6.7.
Treatment of Overdose .................................................................................................................. 75
6.8.
Concomitant Therapy..................................................................................................................... 76
6.8.1.
Rescue Medication ..................................................................................................................... 78
7.
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ...............................................................................................79
7.1.
Discontinuation of Study Treatment............................................................................................... 79
7.2.
Discontinuation from Efficacy (Imaging) Follow-up........................................................................80
7.3.
Participant Discontinuation/Withdrawal From the Study................................................................80
7.3.1.
Withdrawal From the Use of Research Samples .......................................................................81
7.4.
Lost to Follow-up............................................................................................................................ 81
7.5.
Death.............................................................................................................................................. 82
8.
STUDY ASSESSMENTS AND PROCEDURES ...............................................................................82
8.1.
Screening ....................................................................................................................................... 84
8.2.
Treatment....................................................................................................................................... 85
8.3.
Follow-up Phase ............................................................................................................................ 87
8.4.
Overall Survival.............................................................................................................................. 87
8.5.
End of Study Visit........................................................................................................................... 88
8.6.
Unscheduled Visits......................................................................................................................... 88
8.7.
Efficacy Assessments .................................................................................................................... 88
8.7.1.
Disease Assessments ................................................................................................................ 88
8.7.1.1.
TURBT Biopsies, Cystoscopy, and Radical Cystectomy Pathology ....................................... 88
8.7.1.2.
Computed Tomography/Magnetic Resonance Imaging (CT/MRI).......................................... 89
8.7.2.
Response Assessments ............................................................................................................. 90
8.7.2.1.
TURBT Biopsies, Cystoscopy, and Radical Cystectomy Pathology ....................................... 90
8.7.2.2.
Imaging.................................................................................................................................... 91
8.7.3.
Overall Response Assessment .................................................................................................. 91
8.7.4.
Patient-Reported Outcomes ....................................................................................................... 92
8.8.
Safety Assessments....................................................................................................................... 92
8.8.1.
Specification of Safety Parameters ............................................................................................ 92
8.8.2.
Immune-Mediated Adverse Events ............................................................................................ 93
8.8.3.
Physical Examinations................................................................................................................ 93
8.8.4.
Vital Signs................................................................................................................................... 94
8.8.5.
Electrocardiograms..................................................................................................................... 94
8.8.6.
Clinical Safety Laboratory Assessments .................................................................................... 94
8.8.7.
Pregnancy Testing...................................................................................................................... 94
8.8.8.
ECOG Performance Status ........................................................................................................ 95
8.9.
Adverse Events, Serious Adverse Events, and Other Safety Reporting ....................................... 95
8.9.1.
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event 
Information.................................................................................................................................. 95
8.9.2.
Method of Detecting Adverse Events and Serious Adverse Events .......................................... 96
8.9.3.
Follow-up of Adverse Events and Serious Adverse Events, PQCs, and Device 
Deficiencies ................................................................................................................................ 96
8.9.4.
Regulatory Reporting Requirements for Serious Adverse Events and Anticipated 
Events......................................................................................................................................... 97
8.9.5.
Pregnancy................................................................................................................................... 97
8.9.6.
Adverse Events of Special Interest............................................................................................. 97
8.9.7.
Disease-related Events and Disease-related Outcomes Not Qualifying as Adverse 
Events or Serious Adverse Events .............................................................................................97
8.9.8.
Product Quality Complaints and Medical Device Deficiencies................................................... 98
8.10.
Pharmacokinetics........................................................................................................................... 98
8.10.1.
Evaluations ................................................................................................................................. 98
8.10.2.
Analytical Procedures............................................................................................................... 100
8.11.
Genetics and Pharmacogenomics............................................................................................... 100
8.12.
Biomarkers ................................................................................................................................... 100
8.13.
Immunogenicity Assessments ..................................................................................................... 102
8.14.
Medical Utilization and Health Economics................................................................................... 102

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9.
STATISTICAL CONSIDERATIONS................................................................................................102
9.1.
Statistical Hypotheses.................................................................................................................. 102
9.2.
Sample Size Determination ......................................................................................................... 103
9.3.
Participant for Analysis Sets ........................................................................................................ 103
9.4.
Statistical Analyses ...................................................................................................................... 103
9.4.1.
General Considerations............................................................................................................ 103
9.4.2.
Primary Endpoint ...................................................................................................................... 103
9.4.3.
Secondary Endpoint(s) ............................................................................................................. 104
9.4.4.
Exploratory Endpoint(s) ............................................................................................................ 104
9.4.5.
Safety Analyses ........................................................................................................................ 105
9.4.6.
Other Analyses ......................................................................................................................... 106
9.5.
Interim Analysis (Cohort 1 and Cohort 2)..................................................................................... 108
10.
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .......................... 109
10.1.
Appendix 1: Abbreviations and Definitions .................................................................................. 109
10.2.
Appendix 2: Clinical Laboratory Tests ......................................................................................... 111
10.3.
Appendix 3: Regulatory, Ethical, and Study Oversight Considerations....................................... 113
10.3.1.
Regulatory and Ethical Considerations .................................................................................... 113
10.3.2.
Financial Disclosure.................................................................................................................. 116
10.3.3.
Informed Consent Process ....................................................................................................... 116
10.3.4.
Data Protection ......................................................................................................................... 117
10.3.5.
Long-Term Retention of Samples for Additional Future Research .......................................... 118
10.3.6.
Committees Structure............................................................................................................... 118
10.3.7.
Publication Policy/Dissemination of Clinical Study Data .......................................................... 119
10.3.8.
Data Quality Assurance............................................................................................................ 120
10.3.9.
Case Report Form Completion................................................................................................. 120
10.3.10.
Source Documents ................................................................................................................... 121
10.3.11.
Monitoring ................................................................................................................................. 122
10.3.12.
On-Site Audits........................................................................................................................... 123
10.3.13.
Record Retention...................................................................................................................... 123
10.3.14.
Study and Site Start and Closure ............................................................................................. 124
10.4.
Appendix 4: Adverse Events, Serious Adverse Events, Product Quality Complaints, and 
Other Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up, 
and Reporting............................................................................................................................... 125
10.4.1.
Adverse Event Definitions and Classifications ......................................................................... 125
10.4.2.
Attribution Definitions................................................................................................................ 126
10.4.3.
Severity Criteria ........................................................................................................................ 126
10.4.4.
Special Reporting Situations .................................................................................................... 127
10.4.5.
Procedures ............................................................................................................................... 128
10.4.6.
Product Quality Complaint Handling......................................................................................... 129
10.4.7.
Contacting Sponsor Regarding Safety, Including Product Quality........................................... 130
10.5.
Appendix 5: Contraceptive and Barrier Guidance .......................................................................131
10.6.
Appendix 6: PRO Questionnaires (FACT-Bl)............................................................................... 134
10.7.
Appendix 7: PRO Questionnaires (PGIS)....................................................................................137
10.8.
Appendix 8: PRO Questionnaires (PGIC)....................................................................................138
10.9.
Appendix 9: Guidelines for Management of Immune-Related Adverse Events and 
Adverse Events of Clinical Interest .............................................................................................. 139
10.9.1.
Gastrointestinal Adverse Events .............................................................................................. 139
10.9.2.
Hepatic Adverse Events ........................................................................................................... 141
10.9.3.
Endocrinopathies ...................................................................................................................... 141
10.9.4.
Rash.......................................................................................................................................... 142
10.9.5.
Renal Adverse Events .............................................................................................................. 143
10.9.6.
Neurological Adverse Events ................................................................................................... 143
10.9.7.
Pulmonary Adverse Events ...................................................................................................... 144
10.9.8.
Uveitis and Visual Complaints .................................................................................................. 145
10.9.9.
Lipase/Amylase Elevations....................................................................................................... 145
10.9.10.
Infection .................................................................................................................................... 145
10.9.11.
Treatment of Anti-PD-1 Infusion-related Reactions.................................................................. 145

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10.9.12.
Monitoring During and After Study Drug Administration........................................................... 146
10.10.
Appendix 10: Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious 
Adverse Device Effects, Unanticipated Serious Adverse Device Effects, and Device 
Deficiencies: Definition and Procedures for Recording, Evaluating, Follow-up, and 
Reporting in Medical Device ........................................................................................................ 147
10.10.1.
Definitions (UPC Only).............................................................................................................. 147
10.10.2.
Recording and Follow-up of Adverse Events and/or Serious Adverse Events, and 
Device Deficiencies (UPC Only)...............................................................................................148
10.10.3.
Reporting Requirements (Investigator to Sponsor) (UPC only) ...............................................152
10.10.3.1.
Reporting of Serious Adverse Events and Serious Adverse Device Effects......................... 152
10.10.3.2.
Reporting of Device Deficiencies (UPC only)........................................................................153
10.10.4.
Sponsor Reporting Requirements (UPC only) .........................................................................154
10.11.
Appendix 11: Study Conduct During a Natural Disaster..............................................................155
10.12.
Appendix 12: ECOG Performance Status Scale ......................................................................... 157
10.13.
Appendix 13: Cytokine Release Syndrome – Severity Grading and Management ..................... 158
10.14.
Appendix 14: Hepatitis B Virus Screening ................................................................................... 159
10.15.
Appendix 15: Cardiovascular Risk Assessment Prior to Study Enrollment and Prior to 
Radical Cystectomy ..................................................................................................................... 160
10.16.
Appendix 16: Anticipated Events (US Only) ................................................................................162
10.17.
Appendix 17: Cockcroft-Gault Formula – Calculated and Measured Creatinine Clearance ....... 165
10.18.
Appendix 18: CKD-EPI Creatinine Equation (2021) .................................................................... 166
10.19.
Appendix 19: Protocol Amendment History .................................................................................167
11.
REFERENCES................................................................................................................................. 174
INVESTIGATOR AGREEMENT ............................................................................................................... 177

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LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1:
Cohort 1 (TAR-200 + IV Cetrelimab) ........................................................................................ 23
Table 2:
Cohort 2 (IV Cetrelimab Alone)................................................................................................. 30
Table 3:
Sparse Urine Pharmacokinetic Sampling for Gemcitabine and dFdU Analysis (Cohort 
1 Only) ...................................................................................................................................... 35
Table 4:
Serial Urine Pharmacokinetic – (up to 20 Participants in Cohort 1) ......................................... 35
Table 5:
Plasma Pharmacokinetic for Gemcitabine and dFdU Analysis (Cohort 1 Only) ...................... 35
Table 6:
Serum Pharmacokinetics for Cetrelimab (Cohort 1 and Cohort 2)........................................... 36
Table 7:
Serum Immunogenicity Samples for Cetrelimab (Cohort 1 and Cohort 2) ............................... 37
Table 8:
Description of Treatments......................................................................................................... 65
Table 9:
Retreatment Criteria for Cetrelimab.......................................................................................... 73
Table 10:
Overall Response Assessments after Radical Cystectomy......................................................92
Table 11:
Management of Immune-Related Gastrointestinal Adverse Events....................................... 140
Table 12:
Management of Immune-related Hepatic Adverse Events..................................................... 141
Table 13:
Management of Immune-Related Endocrinopathies .............................................................. 142
Table 14:
Management of Rash.............................................................................................................. 143
Table 15:
Management of Renal Adverse Events ..................................................................................143
Table 16:
Management of Neurological Adverse Events ....................................................................... 144
Table 17:
Management of Pulmonary Adverse Events ..........................................................................144
Table 18:
Management of Uveitis and Visual Complaints ......................................................................145
Table 19:
Management of Infusion-Related Reactions ..........................................................................146
FIGURES
Figure 1:
Schematic Overview of the Study............................................................................................. 22
Figure 2:
TAR-200.................................................................................................................................... 38
Figure 3:
Loading and Deployment (Insertion) of TAR-200 using the UPC............................................. 66
Figure 4:
TAR-200 Removal .................................................................................................................... 67

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For safety details of intravesical gemcitabine and the TAR-200 drug-device combination product, refer to 
the most recent version of the IB. 
Overall, the safety profile of IV cetrelimab monotherapy is well-tolerated and generally consistent across 
completed and ongoing clinical trials. Most adverse events (AEs) were low-grade (Grade 1 to 2) with 
relatively few related high-grade (Grade 3 to 4) AEs. There was no pattern in the incidence, severity, or 
causality of AEs with respect to cetrelimab dose level. 
For the recognized pattern of immune-related AEs (irAEs) that are defined, management algorithms and 
treatment plans have been developed. Most high-grade events were manageable with the use of 
corticosteroids or hormone replacement therapy (endocrinopathies) as instructed in these algorithms. 
Additional details on the safety profile of cetrelimab, including results from other clinical studies, are also 
available in the cetrelimab IB.
Overall, for participants who are ineligible for cisplatin-based treatment, the treatment of TAR-200 in 
combination with IV cetrelimab (hereafter referred to as "TAR-200 + IV cetrelimab”), or IV cetrelimab 
alone, has the potential to increase disease-free and survival periods relative to patients who are unable to 
receive neoadjuvant chemotherapy. 
Accounting for the measures taken to minimize AEs in participants of this study, the identified potential 
risks of TAR-200 in combination with IV cetrelimab are justified by the anticipated benefits that may be 
afforded to participants with MIBC who are scheduled for RC and ineligible for platinum chemotherapy. 
From a risk-based alternative treatment perspective, chemoradiotherapy has been proposed as an alternative 
to RC. Several organizations, including the AUA and the EAU, have updated their guidelines to support 
chemoradiotherapy as an alternative to RC in patients with muscle invasive disease. However, 
chemoradiotherapy has been associated with both acute and latent toxicity, including local and systemic 
symptoms. Such acute toxicities include anemia, fatigue, colitis, and cystitis, while latent longer-term 
toxicities and side effects may include bladder contracture, hemorrhagic cystitis, secondary malignancy, 
and urethral or rectal stricture. Therefore, while participants in this clinical study should be counseled on 
all treatment options, RC remains a standard of care.
More detailed information about the known and expected benefits and risks of TAR-200 and cetrelimab 
may be found in the respective IBs for these study drugs.
OBJECTIVES
The primary objective is to determine the anti-tumor effects, as assessed by pathologic complete response 
(pCR) at RC) of TAR-200 + IV cetrelimab (Cohort 1) and IV cetrelimab alone (Cohort 2). Secondary 
objectives are to evaluate the safety and recurrence-free survival (RFS) in participants receiving 
TAR-200 + IV cetrelimab (Cohort 1), and IV cetrelimab alone (Cohort 2).
Hypothesis
The primary hypothesis is that the treatment with TAR-200 + IV cetrelimab (Cohort 1) and IV cetrelimab 
alone (Cohort 2) will produce a pCR rate 
. The statistical evaluation of the hypothesis will use a 
Bayesian approach to assess the likelihood of whether a true pCR rate 
 can be ruled out.
OVERALL DESIGN
This is a randomized, open-label, multicenter, Phase 2 clinical study of intravesical gemcitabine delivered 
via the TAR-200 drug-device combination product in combination with neoadjuvant IV cetrelimab and
neoadjuvant IV cetrelimab alone in participants with muscle-invasive urothelial carcinoma of the bladder 
(clinically referred to as MIBC [muscle invasive bladder cancer]) who are scheduled for RC and are 
ineligible for or refusing platinum-based neoadjuvant chemotherapy. The transurethral resection of bladder 
tumor (TURBT) demonstrating an initial pathologic diagnosis of cT2-T4a MIBC must have been completed
CCI
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within 120 days of randomization. All enrolled participants who have confirmed MIBC with absence of 
nodal or metastatic disease at screening and have met all eligibility criteria will be randomly assigned (5:3) 
to receive intravesical TAR-200 + IV cetrelimab (Cohort 1) or IV cetrelimab alone (Cohort 2). Two
stratification factors for analysis will be completeness of TURBT (visibly complete vs incomplete and 
≤3 cm) and tumor stage (cT2 vs. cT3-4a) at initial diagnosis. Participants must have tumor volume ≤3 cm 
prior to randomization. Participants in screening must undergo a cardiovascular risk assessment based on 
available guidelines for cardiac and surgical risk assessment and must not be enrolled if not considered 
eligible for RC.
An Independent Data Monitoring Committee (IDMC) will be commissioned for this study.
NUMBER OF PARTICIPANTS
A target of approximately 160 participants will be enrolled and be randomly assigned in a 5:3 ratio in this 
study with 100 participants planned to be randomized into Cohort 1 and 60 participants into Cohort 2.
TREATMENT GROUPS AND DURATION
The Treatment Phase will begin following random assignment into the study and continue with dosing 
every 21 days for 4 consecutive cycles. The RC should occur within  weeks following the Week  visit. 
Treatment should continue unless the participant has metastatic progression, intolerable toxicity, withdraws 
consent, there is a decision by the Investigator to discontinue study treatment, or the study is terminated, 
whichever occurs first.
All scheduled non-dosing assessments should be completed prior to dosing of any treatment. 
At the initial treatment visit, study treatments will be administered as follows: 
!
TAR-200 + IV cetrelimab (Cohort 1): TAR-200 will be placed intravesically via the UPC and 
cetrelimab will be dosed IV at 360 mg approximately every 21 days for 4 consecutive cycles, with 
cycles starting at Week 0, Day 1.
!
IV cetrelimab (Cohort 2): Cetrelimab alone will be dosed intravenously at 360 mg approximately 
every 21 days for 4 consecutive cycles, with cycles starting at Week 0, Day 1.
For both cohorts, Week 0, Day 1 will be defined as the day of the first dose of the first study drug 
administered. During Week 
 the participants will undergo an imaging assessment via computed 
tomography/magnetic resonance imaging (CT/MRI). If metastatic progression is noted on local report and 
confirmed by central radiology review, the participant will be discontinued from the Treatment Phase of 
the study. If local progression is suspected from cystoscopy or clinical symptoms warrant, the participant 
will proceed with immediate RC and urinary diversion, at local Investigator’s discretion. Alternatively, if 
the RC is delayed due to clinical symptoms, TAR-200 will be removed at the regularly scheduled Week 
 
visit. The date of the RC surgery will become the protocol specified ‘RC visit.’ All participants should 
undergo pre-operative cardiac and risk stratification prior to RC per institutional guidelines. 
Following the RC and urinary diversion, all participants will have regular follow-up study visits from 
Week 4 to Week 108 (End of Study) post RC.
EFFICACY EVALUATIONS
The rate of pCR (ypT0N0) within the bladder at the RC as well as analysis of residual tumor stage, 
ypTa-ypT4 will be performed as an outcome assessment for Cohort 1 and Cohort 2. Participants who 
develop metastatic disease at any timepoint within the study will be discontinued from the efficacy 
(imaging) follow-up and continued to be followed for survival status, subsequent anti-cancer therapies, and 
other malignancies. If a participant develops imaging consistent with pelvic nodal disease, radical 
cystectomy and/or percutaneous biopsy should proceed at Investigator’s discretion. Participants with 
C
C
C
C
C
C
C
CI

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1.2.
Schema
Figure 1:
Schematic Overview of the Study
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ECOG=Eastern Cooperative Oncology Group; FACT-Bl= Functional Assessment of Cancer Therapy – Bladder; MRI=magnetic resonance imaging; PE=physical exam; PGIC= Patient 
Global Impression of Change, PGIS= Patient Global Impression of Severity; POCBP=participants of childbearing potential; PQC=product quality complaint; PVR=post void residual; 
RC=radical cystectomy; SAE=serious adverse event; TURBT=transurethral resection of bladder tumor; UPC=Urinary Placement Catheter; Wk=week

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(hPD-1KI) mice bearing MC38 murine colon carcinoma tumors. Two recommended Phase 2 doses 
(RP2Ds) were recently established in Study 63723283LUC1001, an ongoing, multicenter, 
Phase 1/2 First in Human study of cetrelimab in participants with advanced solid tumor 
malignancies. In this study, cetrelimab was administered intravenously (IV) at doses ranging from 
80 mg once every 2 weeks (Q2W) up to 800 mg once every 4 weeks (Q4W). Doses of 240 mg 
Q2W and 480 mg Q4W were comparable in maintaining trough serum cetrelimab concentrations 
and saturation of PD-1 receptor occupancy throughout continued treatment with cetrelimab. The 
planned dose in this Phase 2b study is 360 mg once every 3 weeks (Q3W).
Note the definition of the following key terms used throughout this protocol:
!
The term "Sponsor" used throughout this document refers to the entities listed in the Contact
Information page(s), which will be provided as a separate document.
!
The term "participant" throughout the protocol refers to the common term "subject".
!
The term “study drug” throughout the protocol refers to TAR-200, or cetrelimab.
!
The term “study treatment(s)” throughout the protocol refers to TAR-200 in combination with 
systemic IV cetrelimab (hereafter referred to as TAR200 + IV cetrelimab, Cohort 1), and IV 
cetrelimab alone (Cohort 2).
General abbreviations can be found in Section 10.1, Appendix 1, Abbreviations and Definitions.
2.1.
Study Rationale
Bladder cancer is the tenth most common type of cancer worldwide (WCRF 2020) and sixth most 
common type of cancer in the US (National Cancer Institute 2019). Approximately 550,000 new 
bladder cancer cases occurred worldwide in 2018 (WCRF 2020). In the US, the prevalence of 
people living with bladder cancer was 708,444 in 2015 (National Cancer Institute 2019), and the 
National Cancer Institute estimated that 81,190 new cases and 17,240 deaths occurred in 2018.
Approximately 25% of all new bladder cancer patients present with muscle invasive bladder cancer 
(MIBC) at the time of diagnosis (Scarpato 2015), and roughly 50% will ultimately develop distant 
metastases (Milowsky 2016).
The standard treatment generally involves neoadjuvant 
platinum-based chemotherapy, followed by radical cystectomy (RC) with bilateral lymph-node 
dissection (Scarpato 2015). Despite the aggressive nature of this standard treatment, the 5-year 
survival rates for patients with localized, regional, or distant disease are 69%, 35%, and 5%, 
respectively (American Cancer Society 2020). When measured as a cumulative per patient cost 
from diagnosis until death, the cost to treat bladder cancer exceeds all other forms of cancer (Kemp 
2005). In 2017, the estimated national expenditure in the United States (US) on bladder cancer was 
$4.6B (Cancer Trends Progress Report 2019).
These findings illustrate the relatively poor efficacy of current therapies and the significant need 
for new treatment approaches for MIBC. Further, approximately 40% of patients with MIBC do 
not receive potentially curative therapy, consisting of neoadjuvant chemotherapy and RC or 
chemoradiotherapy, due to the high level of patient burden associated with these standards of care 

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(Gray 2013, Westergren 2019); these patients have a very poor overall prognosis, with median 
survival of less than one year (Duchesne 2000; Guerrero 2017).
The National Comprehensive Cancer Network (NCCN), American Urological Association 
(AUA), and European Association of Urology (EAU) guidelines for the management of MIBC are 
founded upon treatment paradigms that provide both local definitive therapy in combination with 
systemic control. There is substantial clinical evidence that effective targeting and eradication of 
primary bladder tumors significantly improves outcomes in MIBC patients with organ-confined 
disease. This is believed to be due to tumor debulking and the inhibition of disease dissemination 
deeper into the bladder wall, the lymph nodes of the pelvis, and beyond. Thus, combination 
treatment regimens affording local and systemic disease control, without concomitant overlapping 
toxicity, may result in improved overall survival (OS), as well as prolonged recurrence- and 
metastasis-free survival. 
Radical cystectomy remains the standard of care in the management of MIBC, and systemic 
neoadjuvant chemotherapy is associated with increased OS. Specifically, pathologic partial and 
complete responses (pPR and pCR), as well as negative lymph node status at RC, correlate with 
meaningful disease-free and OS benefits (Sonpavde 2009). Systemic chemotherapy, however, is 
associated with significant toxicity, risks overtreatment in a significant proportion of patients, and 
up to 80% of patients may refuse or be ineligible for neoadjuvant and/or adjuvant regimens 
(Haseebuddin 2015). In this Phase 2 study, the approximate 
 window to RC is 
congruent with neoadjuvant treatment strategies that have been employed in other MIBC studies. 
There is a significant unmet need for efficacious and more tolerable neoadjuvant treatments, 
specifically for patients who are ineligible for cisplatin-based chemotherapy.
In recent years, new immunotherapeutic options have been developed for locally advanced and 
metastatic MIBC patients, specifically checkpoint inhibitors (PD-1/PDL-1 inhibitors). Integrating 
courses of pre-RC immunotherapy in nonmetastatic MIBC has the potential to become a new 
strategy for neoadjuvant therapy (Necchi 2018, Powles 2019) particularly in those patients unable 
to receive or refusing chemotherapy. The PURE-01 (pembrolizumab) and ABACUS 
(atezolizumab) neoadjuvant studies were designed to assess the efficacy of neoadjuvant anti-PD-1 
antibody administration in patients with MIBC who were scheduled for RC and unable to receive 
platinum-based chemotherapy. Following dosing of systemic checkpoint blockade in the 
neoadjuvant period (PURE-01, 3 doses; ABACUS, 2 doses), both studies demonstrated significant 
improvements in pathologic downstaging rates at RC as compared to historical controls of 
transurethral resection of bladder tumor (TURBT) alone (Grossman 2003, Brant 2017). However, 
these response rates were not appreciably different from those previously demonstrated with 
classic platinum-based neoadjuvant chemotherapy regimens (Grossman 2003). The overall 
response rates to these immunotherapies remains approximately 30% (Powles 2019). There is a 
clear clinical need to identify treatment strategies that provide benefit for more patients with 
MIBC, potentially through a combination of systemic and local therapies, without significant 
additive toxicity (Stenehjem 2018; Bellmunt 2017).
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Status: Approved,  Date: 20 April 2023
Gemcitabine, an anti-metabolite routinely used in the systemic treatment of various forms of 
cancer, has demonstrated activity across all stages of urothelial cancer, from organ-confined 
recurrent low-grade tumors to metastatic disease (Calabro 2002; Grossman 2003; Messing 2018;
Skinner 2013). TAR-200 is a passive, non-resorbable investigational drug-device combination 
product whose primary mode of action is the controlled release of gemcitabine into bladder urine. 
The novel design of TAR-200 provides continuous delivery of gemcitabine at an average of 
24 mg/day over the first 7 days for a maximum of 225 mg delivered over 21 days. 
By continuously administering gemcitabine at significantly lower doses than those employed in 
standard bladder instillations (~2 g/100 mL normal saline over 1 hour), Gemcitabine HCl Tablets 
225 mg Intravesical Delivery System (TAR-200), or TAR-200, increases the effective tumor 
exposure 150‑fold (multi-day versus 1-hour instillation) and optimizes tumor uptake by 
maintaining intravesical concentrations approximating the human nucleoside transporter (HNT) 
1,9’s maximum saturable concentrations of 1- to 25-μg/mL. Prolonged gemcitabine delivery 
ensures uniform tumor contact, regardless of location within the bladder, as drug concentrations 
are maintained over many voiding cycles. Finally, because TAR-200 delivers extremely low, yet 
continuous and potent doses of gemcitabine to the bladder tissue (approximately 1% of the 
standard intravenous or intravesical instillation doses), such directed anti-tumor treatment 
significantly limits both systemic drug exposure and local bladder toxicity relative to standard 
dosing schemas employed today.
In this clinical study (17000139BLC2002), we hypothesize that metronomic gemcitabine dosing 
via TAR-200, in combination with cetrelimab, a PD-1 inhibitor, will not only have marked local 
cytotoxic effects on bladder tumors, but will have a systemic priming effect, increasing tumor 
antigen presentation as well as tumor antigen specific T-cell activation and maintenance. When 
these T cells are activated by co-treatment with cetrelimab, this systemic anti-tumor activity could 
potentially result in material benefits in patients with MIBC, including those groups that are not 
suitable for platinum-based chemotherapy.
2.2.
Background
2.2.1.
TAR-200 Clinical Studies
Rationale for TAR-200 Regimen
TAR-200 is available in one dose only (containing 225 mg free base equivalents of gemcitabine). 
Each TAR-200 releases gemcitabine into the bladder during the indwelling period, with the 
majority of drug being delivered within the first 7 days. TAR-200 maintains therapeutic 
gemcitabine urine concentrations, exceeding the EC90 of many bladder tumor cell lines in the 
bladder urine over the first 5 to 10 days (Jeon 2011). Studies have also demonstrated that prolonged 
gemcitabine exposure increases intracellular concentrations of the active di- and tri-
phosphorylated metabolites, enhancing overall drug potency compared to short duration dosing 
(Cattel 2006).

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Status: Approved,  Date: 20 April 2023
Four prospective, open-label Phase 1b clinical studies evaluating TAR-200 have been completed 
in bladder cancer participants. Three of these studies were performed in MIBC patients; 
NCT02722538 evaluated TAR-200 neoadjuvant to RC in patients ineligible to receive or who 
refused cisplatin-based systemic chemotherapy, NCT03404791 evaluated those participants who 
were unfit for RC and ineligible to receive or refused cisplatin-based systemic chemotherapy; 
NCT03518320 evaluated TAR-200 in combination with nivolumab in patients with MIBC who 
were scheduled for RC and ineligible for or refused platinum-based neoadjuvant chemotherapy. 
One prior study, NCT02720367, has been performed in participants with non-muscle invasive 
bladder cancer (NMIBC). As of 26 February 2021, 
participants have attempted to undergo 
insertion with TAR-200, and 
participants have undergone at least one dosing cycle across all 
four studies. Each of these studies were designed to evaluate safety, tolerability, PK, and 
preliminary 
efficacy 
following 
dosing 
with 
TAR-200. 
Additionally, 
gemcitabine 
pharmacokinetics following insertion of TAR-200 in MIBC patients scheduled for RC was 
evaluated in participants before or after TURBT (NCT02722538). Gemcitabine was not detected 
in plasma samples before or after TURBT, suggesting maximal tumor resection did not increase 
gemcitabine 
systemic 
exposure. 
Gemcitabine 
metabolites 
such 
as 
plasma 
2′,2′-difluorodeoxyuridine (dFdU) concentrations were observed infrequently, with low but 
measurable concentrations found in 
of the 
 plasma samples analyzed, ranging from 
(median 
 The frequency of positive dFdU samples was higher 
in participants administered TAR-200 before TURBT compared to after TURBT (
 
suggesting the tumor is the main source of plasma dFdU. 
The Phase 1b clinical study NCT02722538 demonstrated that TAR-200 had encouraging 
anti-tumor activity in MIBC. This study of platinum-ineligible patients with bulky (>3 cm) 
muscle invasive urothelial carcinoma of the bladder (cT2 and T3), dosed with two 7-day cycles 
over 28 days prior to RC, complete ablation or substantial downstaging of the gross tumor was 
observed visually at the time of bladder removal in 8 of 10 patients (80%) (Daneshmand 2017). 
Furthermore, TAR-200 was well tolerated, with no exacerbation of urinary symptoms or 
hematuria, demonstrated no measurable systemic levels of gemcitabine, and did not result in bone 
marrow suppression or delay of RC. Moreover, 
 showed no nodal 
involvement on final histopathologic analysis and no patients were upstaged on final pathology. 
In a separate study evaluating the safety and preliminary efficacy of TAR-200 in MIBC patients 
ineligible for curative intent therapy (NCT03404791), the complete response (CR) rate at 3 months 
following 4-cycles of TAR-200 was found to be 37.9%. These initial responses have been durable, 
with disease control rates of 67%. TAR-200 has been well-tolerated in this frail population with 
MIBC.
Please refer to the IB for further details on the ongoing TAR-200 clinical studies and published 
clinical studies investigating intravesical gemcitabine.
2.2.2.
Cetrelimab Clinical Studies
Clinical experience with cetrelimab in humans to date is based on data from 7 clinical studies:
3 monotherapy 
studies 
(63723283LUC1001,
63723283LUC1002 
[Part 
1]), 
and 
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63723283HPB1001,
and 
5
combination 
studies, 
excluding
those 
with 
TAR-200
(63723283LUC1002 [Part 2], 54767414MMY2036, 64091742PCR2002, 42756493BLC2002, 
and 56021927PCR2032). As of the clinical efficacy data cutoff date of 01 September 2022, a total 
of 
participants have received at least 1 dose of cetrelimab as monotherapy (
 participants) 
or in combination (
participants). Of the participants treated with cetrelimab monotherapy, 
participants were evaluable for response.
Study 63723283LUC1001 is an ongoing First in Human, open-label, multicenter, Phase 1/2 study 
in participants with selected solid tumor types who previously received or were ineligible for 
standard treatment options. Safety and efficacy data available to date for participants receiving IV 
cetrelimab (Parts 1 and 2) are summarized below:
2.2.2.1.
IV Cetrelimab
Part 1 of Study 63723283LUC1001, initiated on 21 November 2016, evaluated dose escalation 
cohorts and PK/pharmacodynamics cohorts. Part 1 established the RP2D, which may be 
administered at either 240 mg Q2W or 480 mg Q4W. In Part 2, initiated on 03 May 2017, this 
RP2D has been evaluated in selected solid tumor types, including non-small cell lung cancer 
(NSCLC), melanoma, renal cancer, bladder cancer, SCLC, gastric/esophageal cancer, and high-
level microsatellite instability or mismatch-repair deficiency colorectal cancer. The purposes of 
dose expansion in Part 2 were to further characterize the safety and to assess the antitumor activity 
of the RP2D.
Part 1 (dose escalation) included 
participants, and Part 2 included 
participants, for a total 
enrollment of
 participants. The overall response rate (ORR) by RECIST 1.1 for all 204 treated 
participants was
, with 
participants having a confirmed response of complete response 
(CR) or partial response. The complete benefit rate by RECIST 1.1 for all treated participants was 
 with 
participants having a confirmed response of CR, partial response, or stable disease 
for at least 24 weeks from the start of treatment. 
 
experienced at least 1 treatment-emergent AE, and
participants
 experienced at least 
1 treatment-related AE. In summary, the overall efficacy and safety profile for cetrelimab was 
consistent with that of other marketed anti-PD-1 antibodies such as pembrolizumab and 
nivolumab. However, the sample size for various tumor histologies included in the current study 
is small: (NSCLC=
 participants; melanoma=
participants; bladder=
participants; renal 
cell
 participants; SCLC:
participants; MSI H/dMMR colorectal cancer (CRC)=
 
participants; other=
 participants) (CSR 63723283LUC1001 2020).
As of the pharmacokinetic data cut-off date of 03 December 2019 the pharmacokinetic analysis 
included a total of 
PK-evaluable participants. Cetrelimab clinical PK with IV administration 
was linear and dose proportional with moderate variability. The model-derived half-life of the 
terminal phase was approximately 
 days, indicating that steady state of serum cetrelimab 
concentration would be reached around approximately 
 weeks in advanced cancer patients, 
similar to endogenous immunoglobulins. Full PD-1 receptor occupancy with JNJ-63723283 was 
sustained for both 240 mg IV Q2W and 480 mg IV Q4W. The IV RP2Ds for JNJ-63723283 (both 
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8.
Altered immune tumor microenvironment may increase the Teffector population and/or decrease 
the Tregulatory population. For example, in an orthotopic model of pancreatic ductal 
adenocarcinoma, local, low-dose gemcitabine therapy resulted in a decrease of the 
immunosuppressive CD4+/FoxP3+ Tregulatory
cells and improved survival in mice 
(Shevchenko 2013). Additionally, in a small cohort of participants with pancreatic cancer 
receiving gemcitabine, the ratio of Teffector:Tregulatory was increased, myeloid-derived 
suppressor cells were decreased, TGFβ-1 levels were reduced, and the proliferative ability of 
T cells was unaffected (Eriksson 2016)
2.2.3.1.
TAR-200 + IV Cetrelimab Combination
In addition to this study, TAR-200 + IV cetrelimab is currently being evaluated in 3 ongoing 
studies: 17000139BLC2001 (NCT04640623) in patients with Bacillus Calmette-Guérin (BCG)
unresponsive high risk-NMIBC who are ineligible for or refusing RC, 17000139BLC3002 
(NCT05714202) in participants with BCG-naïve, high-risk NMIBC, and 17000139BLC3001 
(NCT04658862) in patients with MIBC who are not receiving RC. The Independent Data 
Monitoring Committees (IDMCs) conducted per charter to date for ongoing studies have 
recommended to continue studies unmodified. No safety concerns were identified (refer to the 
TAR-200 IB for safety data at the last data cut).
2.3.
Benefit-Risk Assessment
The standard of care in MIBC includes RC with urinary diversion and is considered the preferred 
treatment option for patients who are considered surgical candidates. Systemic neoadjuvant 
chemotherapy for these patients is associated with increased OS. Specifically, pathologic partial 
and complete responses, as well as negative lymph node status, correlate with meaningful disease-
free and OS benefits (Sonpavde 2009). However, systemic chemotherapy is associated with 
significant toxicity, and up to 80% of patients may refuse or be ineligible for neoadjuvant and/or 
adjuvant regimens (Haseebuddin 2015). There is a significant unmet need for efficacious and more 
tolerable neoadjuvant treatments, specifically for patients who are ineligible for cisplatin-based 
chemotherapy. A clinical benefit has been demonstrated in this platinum-ineligible patient 
population utilizing checkpoint inhibitor monotherapy (anti-PD-1/PDL-1) and provides rationale 
for potential efficacy of single-agent cetrelimab. (Necchi 2019; Powles 2019). In addition, it is
postulated that the sustained antineoplastic local therapy of TAR-200, in combination with an 
efficacious anti-PD1 immunotherapy, could potentially provide comparable CR rates to
neoadjuvant chemotherapy, without an overlapping toxicity profile. 
Intravesical gemcitabine has consistently exhibited activity and a good toxicity profile in bladder 
cancer, albeit in the setting of non-muscle invasive disease (Shelley 2012). Ongoing clinical 
studies in MIBC and NMIBC have demonstrated good tolerability of intravesical dosing. Prior 
clinical trials evaluating the safety of TAR-200 itself have noted an excellent tolerability ad safety 
profile.
For safety details of intravesical gemcitabine and the TAR-200 drug-device combination product, 
refer to the most recent version of the IB. 

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Overall, the safety profile of cetrelimab monotherapy is well-tolerated and generally consistent 
across completed and ongoing clinical trials. Most AEs were low-grade (Grade 1 to 2) with 
relatively few related high-grade (Grade 3 to 4) AEs. There was no pattern in the incidence, 
severity, or causality of AEs with respect to cetrelimab dose level. 
For the recognized pattern of immune-related adverse events that are defined, management 
algorithms have been developed. Treatment plans for diarrhea/colitis, renal insufficiency, 
pneumonitis, transaminitis, asymptomatic thyroid stimulating hormone elevation, symptomatic 
endocrinopathy, retinopathy, suspicion of adrenal crisis, rash, and neurological toxicity are 
provided in Section 10.9, Appendix 9, Guidelines for Management of Immune-Related Adverse 
Events and Adverse Events of Clinical Interest. Most high-grade events were manageable with the 
use of corticosteroids or hormone replacement therapy (endocrinopathies) as instructed in these 
algorithms. 
Additional details on the safety profile of cetrelimab, including results from other clinical studies, 
are also available in the cetrelimab IB.
Overall, for participants who are ineligible for cisplatin-based treatment, the treatment of TAR-200 
in combination with IV cetrelimab or IV cetrelimab alone, has the potential to increase disease-
free and survival periods relative to patients who are unable to receive neoadjuvant chemotherapy. 
 
Accounting for the measures taken to minimize adverse events in participants of this study, the
identified potential risks of TAR-200 in combination with IV cetrelimab are justified by the 
anticipated benefits that may be afforded to participants with MIBC who are scheduled for radical 
cystectomy and ineligible for platinum chemotherapy. 
From a risk-based alternative treatment perspective, chemoradiotherapy has been proposed as an 
alternative to RC. Several organizations, including the AUA and the EAU, have updated their 
guidelines to support chemoradiotherapy as an alternative to RC in patients with muscle-invasive 
disease. However, chemoradiotherapy has been associated with both acute and latent toxicity, 
including local and systemic symptoms. Such acute toxicities include anemia, fatigue, colitis, and 
cystitis, while latent longer-term toxicities and side effects may include bladder contracture, 
hemorrhagic cystitis, secondary malignancy, and urethral or rectal stricture. Therefore, while 
participants in this clinical study should be counseled on all treatment options, radical cystectomy 
remains a standard of care.
More detailed information about the known and expected benefits and risks of TAR-200 and 
cetrelimab may be found in the respective IBs for these study drugs.
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Status: Approved,  Date: 20 April 2023
disease at screening and have met all eligibility criteria will be randomly assigned (5:3) to receive 
intravesical TAR-200 in combination with IV cetrelimab (Cohort 1, Table 1) or IV cetrelimab 
alone (Cohort 2, Table 2). Two stratification factors for analysis will be completeness of TURBT 
(visibly complete vs incomplete and ≤3 cm) and tumor stage (cT2 vs. cT3-4a) at initial diagnosis. 
Participants must have tumor volume ≤3 cm prior to randomization.
A target of 160 participants will be enrolled and be randomly assigned in a 5:3 ratio in this study 
with 100 participants planned to be randomized into Cohort 1 and 60 participants into Cohort 2.
Potential participants with newly diagnosed, histologically confirmed, muscle-invasive urothelial 
carcinoma of the bladder will be screened following documented informed consent. Participants 
who underwent the diagnostic TURBT at an outside, referring institution from the study site, will 
undergo a screening assessment cystoscopy within the 
-day screening window. Residual tumors 
>3 cm at this screening cystoscopy will undergo repeat completion re-TURBT prior to 
randomization. Formal evaluation of the diagnostic TURBT pathologic specimens will initially be 
performed by the study site and confirmed by central pathologic review. Staging imaging will be 
performed during the screening period to ensure the absence of N+ or M+ disease (as assessed by 
RECIST 1.1). This imaging will undergo central radiology review. Participants who meet 
eligibility criteria will be randomly assigned (5:3) to receive intravesical TAR-200 in combination 
with IV cetrelimab (Cohort 1) or IV cetrelimab alone (Cohort 2) neoadjuvant to scheduled radical 
cystectomy and urinary diversion. For Cohort 1, at the initial treatment visit, TAR-200 will be 
placed intravesically via the UPC and cetrelimab will be dosed intravenously (360 mg via a 60 [+/-
10] minute initial IV infusion). For Cohort 1 and Cohort 2, IV cetrelimab will be dosed 
approximately every 21 days for 4 consecutive cycles, with cycles starting at Week 0, Day 1. 
Subsequent doses will be administered at 
 
Cetrelimab is not required to be administered on the same day as placement of TAR-200, but 
treatments should occur within 
 and no more than 
of each other. On days in 
which both TAR-200 and IV cetrelimab are administered on the same day, TAR-200 placement 
should be separated by a minimum of 
 from the start of IV cetrelimab infusion to allow 
for discrete evaluation of potential adverse events of each treatment.
For Cohort 1, the initial TAR-200 will be removed via flexible and rigid cystoscopy at 
 
 and then the second TAR-200 will be placed via a UPC. This removal/replacement 
procedure will be repeated for 
 
 The fourth TAR-200 will be removed at 
). A cystoscopy 
is not required at these visits if TAR-200 removal is not needed.
For all cohorts, cetrelimab will be dosed approximately every 21 days for 4 consecutive cycles, 
with cycles starting at Week 0, Day 1. Subsequent doses will be administered at Weeks 
 
For all cohorts, Week 0, Day 1 will be defined as the day of the first dose of the first treatment 
administered. The RC should occur no later than  weeks following the Week  visit. During Week 
 participants in all cohorts will undergo an imaging assessment via computed 
tomography/magnetic resonance imaging (CT/MRI). If metastatic progression is noted on the local 
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Status: Approved,  Date: 20 April 2023
report and confirmed by central radiology review, the participant will be discontinued from the 
efficacy (imaging) follow-up and continued to be followed for survival status, subsequent anti-
cancer therapies, and other malignancies. If local progression is suspected or clinical symptoms 
warrant, the participant will proceed with immediate RC and urinary diversion, at local 
Investigator’s discretion. If the RC is delayed, from the Week 
 visit, the date of the RC surgery 
will become the protocol-specified ‘RC visit’ (per Schedule of Activities, Section 1.3).
Following the RC and urinary diversion, all participants will have a safety follow-up visit 4 weeks 
following the RC surgery. Additionally, participants will have follow-up study visits at Weeks 8, 
12, 24, 36, 48, 60, 72, 84, 96, and 108 (End of Study) post RC. The post RC follow-up visits (eg, 
Weeks 4, 8, 12, 24, etc) are derived from the date of the RC surgery. No restrictions are placed on 
adjuvant therapy after RC.
An IDMC will be commissioned for this study. Refer to Committees Structure in Section 10.3, 
Appendix 3, Regulatory, Ethical, and Study Oversight Considerations for details.
Diversity and Inclusion
Cancer affects all population groups in the United States, but due to social, environmental, and 
economic disadvantages, certain groups bear a disproportionate burden of cancer compared with 
other groups. Although cancer incidence and mortality overall are declining in all population 
groups in the United States, certain groups continue to be at increased risk of developing or dying 
from particular cancers. 
The 17000139BLC2002 study will aim to enroll a participant population that is geographically 
reflective of the overall incidence/prevalence of MIBC. Enrollment of study participants in a given 
country may continue beyond the global enrollment period defined to reach the overall planned 
sample size, in order to ensure adequate representation of this country in the study. 
For further discussion of diversity metrics and goals, refer to the latest version of the Diversity 
Plan. 
A diagram of the study design is provided in Section 1.2, Schema.
4.2.
Scientific Rationale for Study Design
Radical cystectomy remains the standard of care in the management of MIBC, and systemic 
neoadjuvant chemotherapy is associated with increased overall survival. Specifically, pathologic 
partial and complete responses, as well as negative lymph node status at RC, correlate with 
meaningful disease-free and overall survival benefits (Sonpavde 2009). This Phase 2 study design 
is congruent with previous studies such as PURE-01 (pembrolizumab) and ABACUS 
(atezolizumab) neoadjuvant studies, which were designed to assess the efficacy of neoadjuvant 
anti-PD-1 antibody administration in patients with MIBC who are scheduled for Radical 
Cystectomy. In addition, the primary and secondary outcome measurements are also in alignment 
with previously conducted trials. 
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While this clinical study is similar in study design and outcome measurements as previously 
conducted neoadjuvant MIBC studies, it also has differentiating factors which include additional 
dosing of an anti-PD-1 antibody (cetrelimab), and inclusion of intravesical treatment (TAR-200). 
Given the prior data from NCT02722538, this study will be stratified by complete vs. incomplete 
resection status, as well as tumor stage (cT2 vs cT3-4a).
Moreover, this Phase 2 clinical study within our bladder portfolio of trials, will provide supportive 
data demonstrating the impact the individual components of TAR-200 and cetrelimab in 
participants with MIBC.
Given the proven benefit of neoadjuvant therapy, prior studies, and potential synergies between 
local and systemic treatment, we postulate the pCR rates and RFS will meet or exceed prior studies.
Biomarker Collection
Biomarker samples will be collected from participants in all cohorts to evaluate the mechanism of 
action of TAR-200 + IV cetrelimab and IV cetrelimab alone or help to explain interindividual 
variability in clinical outcomes or may help to identify population subgroups that respond 
differently to a study treatment.
Biomarker samples may be used to help address emerging issues and to enable the development 
of safer, more effective, and ultimately individualized therapies.
Patient-Reported Outcomes Research
A patient-reported outcome (PRO) is any report coming directly from patients, without 
interpretation by physicians or others, about how they function or feel in relation to a health 
condition and its therapy. PRO instruments are used to measure these patient reports. PROs 
provide a unique perspective on medical therapy, because some effects of a health condition and 
its therapy are known only to patients. Patient-reported outcome instruments capture meaningful 
change in patient-reported health status to assess health-related quality of life (HRQoL) for 
participants treated with TAR-200 and IV cetrelimab (Cohort 1) and IV cetrelimab alone
(Cohort 2). The disease specific PRO captured in this clinical trial is the Functional Assessment 
of Cancer Therapy – Bladder (FACT-Bl). The Patient Global Impression of Severity (PGIS) and 
the Patient Global Impression of Change (PGIC) will also be administered to participants within 
the study to provide anchor-based assessment. In approved countries, these PRO measures will be 
administered to test the hypothesis that treatment with TAR-200 and IV cetrelimab maintains a 
HRQoL as measured by time to symptom deterioration (TSP) of a prespecified meaningful change 
threshold. PRO data will be collected as outlined in the Schedule of Activities (Section 1.3).
Medical Resource Utilization Data Collection
Treatment of MIBC with TAR-200 in combination with systemic IV cetrelimab and systemic IV 
cetrelimab alone may result in lower utilization of medical resources. Exploratory analyses of 
Medical Resource Utilization (MRU) data collected for participants in both treatment groups will 
be performed.

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4.2.1.
Study-Specific Ethical Design Considerations
Potential participants will be fully informed of the risks and requirements of the study and, during 
the study, participants will be given any new information that may affect their decision to continue 
participation. They will be told that their consent to participate in the study is voluntary and may 
be withdrawn at any time with no reason given and without penalty or loss of benefits to which 
they would otherwise be entitled. Only participants who are fully able to understand the risks, 
benefits, and potential AEs of the study, and provide their consent voluntarily will be enrolled.
For the purposes of this study, all references to participants who have provided consent refers to 
the participants and the participant's legal guardian(s) or legally acceptable representative(s) who 
have provided consent.
The total blood volume that will be collected is considered within the normal range allowed for 
this participant population over this time frame. For adult participants, the amount of blood 
collected is less than the American Red Cross (ARC) standard blood donation of 500 mL over 
60 days (ARC 2020) and is aligned with World Health Organization (WHO) blood donation 
guidelines (WHO 2020).
4.3.
Justification for Dose
4.3.1.
TAR-200 Dose Selection
TAR-200 is available in one dose only (containing 225 mg free base equivalents of gemcitabine); 
the TAR-200 which will remain indwelling for up to 21 days (3 weeks) per each dosing cycle. For 
Cohort 1, the first TAR-200 will be removed via flexible or rigid cystoscopy at 
 
and then the second TAR-200 will be placed via the UPC. This removal/replacement procedure 
will be repeated for a 
 
respectively. The fourth TAR-200 will be removed at 
Each TAR-200 releases gemcitabine into the bladder during the indwelling period, with the 
majority being delivered within the first 7 days. TAR-200 maintains therapeutic gemcitabine urine 
concentrations, exceeding the EC90 of many bladder tumor cell lines, in the bladder urine over the 
first 5 to 10 days (Jeon 2011). Studies have demonstrated that prolonged gemcitabine exposure 
increases intracellular concentrations of the active di- and tri- phosphorylated metabolites 
enhancing overall drug potency compared to short duration dosing (Cattel 2006). 
The first dosing regimen (TAR-200-101) evaluated in human studies comprised two 7-day dosing 
cycles with a 14-day recovery period in between dosing cycles. This regimen was found to be well 
tolerated in the initial study participants. 
 
 
 
 
 
 
 
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concentration of gemcitabine remaining in the TAR-200 after 7 days is low, and the rate of release 
of additional gemcitabine at Day 7 is minimal. The safety of 21-day (3 week) dosing cycles has 
been evaluated in 2 completed Phase 1b clinical studies (NCT02720367, NCT03518320) and has 
been generally well tolerated to date based on preliminary data of these studies. A third study, 
TAR-200-103/NCT03404791 is currently ongoing.
As there is only one dose option for TAR-200 there will be no dose modifications of TAR-200. 
Information regarding the management of missed cycles and stopping rules are outlined in 
Section 6.5.1.
4.3.2.
IV Cetrelimab Dose Selection
For this study, Cohort 1 and Cohort 2 will receive IV cetrelimab dosed at 360 mg Q3W for four 
doses, neoadjuvant to RC, which aligns with the dosing frequency of TAR-200. The 360 mg Q3W
IV regimen was selected based on population PK modeling and simulation of cetrelimab, which 
predicted that the steady state predose concentration at steady-state (Ctrough) and maximum serum 
concentration (Cmax) of cetrelimab 
 
 
 
 
The recommended monotherapy dose for cetrelimab is based on clinical activity in the ongoing 
Phase 1 Study 63723283LUC1001. 
 
 
 
 
 
4.4.
End of Study Definition
End of Study Definition
The end of study is considered as approximately 2 years after the last participant receives RC. The 
study can be prematurely ended per Sponsor decision, as outlined in Section 7 and Section 10.3.14.
The final data from the study site will be sent to the Sponsor (or designee) after completion of the 
final participant assessment at that study site, in the time frame specified in the Clinical Trial 
Agreement.
Study Completion Definition
Participant Completion of Study Definition
A participant will be considered to have completed the study if they have completed the treatment 
and follow-up phases or died before the end of the treatment or follow-up phases. Participants who 
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have been lost to follow-up or have withdrawn consent for study participation before the end of 
the follow-up phase will not be considered to have completed the study. 
Participants who prematurely discontinue study treatment for any reason will remain in the study 
and all efforts will be made to continue to follow those participants for assessments/procedures 
outlined in the Follow-Up Phase. However, if a participant develops metastatic disease 
progression, they should be discontinued from the efficacy (imaging) follow up portion of the 
study and continued to be followed for survival status, subsequent anti-cancer therapies, and other 
malignancies per Section 1.3. The only exception to this is when a participant specifically 
withdraws consent for any further contact with him/her or persons previously authorized by 
participant to provide this information. All reasonable efforts should be made to maintain the 
participant on study to ensure accurate assessment of all protocol-specified endpoints. Those 
participants who do prematurely discontinue study treatment for any reason before completion of 
the Treatment Phase will not be considered to have completed the study treatment.
5.
STUDY POPULATION
This study will randomize approximately 160 participants with MIBC. The TURBT resulting in 
pathologic evidence of an initial diagnosis of cT2-T4a MIBC must be within 120 days of 
randomization. The participant must also undergo screening CT/MRI imaging to confirm N0, M0 
disease status (assessed per RECIST 1.1). The screening period for the study will be 
days (refer 
to Schedule of Activities, Section 1.3). Refer to Section 5.4, Screen Failures, for conditions under 
which the repeating of any screening procedures is allowed.
The inclusion and exclusion criteria for enrolling participants in this study are described below. If 
there is a question about these criteria, the Investigator must consult with the appropriate Sponsor
representative and resolve any issues before enrolling a participant in the study.  Waivers are not 
allowed. 
For a discussion of the statistical considerations of participant selection, refer to Section 9.2, 
Sample Size Determination.
5.1.
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
Age
1.
≥18 years (or the legal age of consent in the jurisdiction in which the study is taking place) 
at the time of informed consent.
Type of Participant and Disease Characteristic
2.
Criterion modified per Amendment 2
2.1
Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma (AJCC 
2017) of the bladder. Initial diagnosis must have been within 120 days of 
CC
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randomization date. Participants with variant histologic subtypes are allowed if 
tumor(s) demonstrate urothelial predominance. However, the presence of small cell 
or neuroendocrine variants will make a participant ineligible.
3.
Criterion modified per Amendment 2
3.1
Participants with no residual tumor, or intravesical tumor size of ≤3 cm following 
TURBT are eligible; debulking TURBT for any residual disease is encouraged but 
not mandated. Participants with persistent tumors >3 cm at screening must undergo 
a second debulking, re-staging TURBT. Participants will be ineligible if any 
individual tumor is >3 cm after debulking TURBT.
4.
Criterion modified per Amendment 1
4.1
Deemed eligible for and willing to undergo RC by the attending urologist.
Investigators should refer to Section 10.15, Appendix 15 for guidance on assessing 
cardiac risk via the Adapted Cardiac Risk Index for Pre-Operative Risk (RCRI). 
5
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1
(Section 10.12, Appendix 12, ECOG Performance Status Scale).
6.
Criterion modified per Amendment 1
6.1 Criterion modified per Amendment 2
6.2
Thyroid function tests within normal range or stable on hormone supplementation 
per Investigator assessment. Note: If thyroid stimulating hormone (TSH) is not 
within normal limits, the subject may still be eligible if T3 (either total or free) and 
free T4 are within normal limits. Investigators may consult an endocrinologist for 
participant eligibility assessment in the case of equivocal or marginal tests results.
7.
Criterion modified per Amendment 1
7.1
Criterion modified per Amendment 2:
7.2
Adequate bone marrow, liver, and renal function:
a.
Bone marrow function (without the support of cytokines or erythropoiesis-
stimulating agent in preceding 2 weeks):
i.
Absolute neutrophil count (ANC) ≥1,500/mm3
ii.
Platelet count ≥80,000/mm3
iii.
Hemoglobin ≥9.0 g/dL
b. Liver function:
i.
Total bilirubin ≤1.5xULN OR direct bilirubin ≤ULN for participants with 
total bilirubin levels >1.5xULN (except participants with Gilbert’s 
Syndrome, who must have a total bilirubin <3.0 mg/dL),
ii.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5x 
institutional ULN

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c.
Renal function:
i.
Creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault 
formula (see Section 10.17, Appendix 17)
8.
Criterion modified per Amendment 2:
8.1 Participants must refuse cisplatin-based combination chemotherapy (and understand 
the risk and benefits of doing so) or be deemed ineligible for cisplatin-based 
chemotherapy by meeting at least one of the following criteria:
!
GFR
<60
mL/min/1.73 m2
(assessed using the
CKD-EPI equation)
(see 
Section 10.18, Appendix 18)
!
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≥2 
audiometric hearing loss
!
CTCAE version 5.0 Grade ≥2 peripheral neuropathy
9.
Prior systemic chemotherapy for indications other than urothelial cell carcinoma of the 
bladder is permitted, but interval between this treatment and study enrollment must 
exceed 24 months. All toxicities attributed to prior anti-cancer therapy other than alopecia 
and fatigue must have resolved to Grade 1 (NCI-CTCAE version 5.0) or baseline before 
administration of study treatment. Participants with toxicities attributed to prior 
anticancer therapy which are not expected to resolve and result in long lasting sequelae, 
such as peripheral neuropathy after platinum-based therapy or audiometric hearing loss, 
are ineligible.
10.
All adverse events associated with any prior surgery must have resolved to CTCAE
version 5.0 Grade <2 prior to randomization.
Sex and Contraceptive/Barrier Requirements
11.
Criterion modified per Amendment 1
11.1
Criterion modified per Amendment 2
11.2
Contraceptive use by participants should be consistent with local regulations 
regarding the use of contraceptive methods for participants participating in 
clinical studies (See Section 10.5, Appendix 5: Contraceptive and Barrier 
Guidance). Investigators will advise participants on the options for banking of 
sperm and ova for reproductive conservation. A female participants must agree 
not to be pregnant, breastfeeding, or planning to become pregnant while enrolled 
in this study or within 6 months after the last dose of study treatment.
a.
A female participant must be either of the following (as defined in Section 10.5,
Appendix 5: Contraception and Barrier Guidance):
i.
Not of childbearing potential
ii.
Of childbearing potential and
!
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!
have a sole partner who is vasectomized, or
!
practicing at least 1 highly effective user independent method of 
contraception (see Section 10.5, Appendix 5: Contraception and 
Barrier Guidance).
Participant must agree to continue the above throughout the study and for 
6 months after the last dose of study treatment.
Note: If a participant becomes of childbearing potential after start of the 
study, the participant must comply with point (ii), as described above. 
A female participant must also:
!
agrees to not donate eggs (ova, oocytes, or freeze for future use) for the 
purposes of assisted reproduction during the study and for at least 6 months 
after the last dose of study treatment.
!
not be breastfeeding (including temporarily withholding breastfeeding in 
order to participate in the study) and not planning to become pregnant during 
the study and for at least 6 months after the last dose of study treatment. 
Female participants should consider preservation of eggs prior to study 
treatment as anti-cancer treatments may impair fertility. Investigators will 
advise female participants on the options for banking of ova for reproductive 
conservation.
b.
A male participant must wear a condom (with or without spermicidal 
foam/gel/film/cream/suppository) when engaging in any activity that allows for 
passage of ejaculate to another person during the study and for a minimum of 
6 months after receiving the last dose of study treatment. His female partner, if 
of childbearing potential, must also be practicing a highly effective method of 
contraception (see Section 10.5, Appendix 5: Contraception and Barrier 
Guidance).
If the male participant is vasectomized, he still must wear a condom (with or 
without spermicidal foam/gel/film/cream/suppository), but his female partner is 
not required to use contraception.
A male participant must also:
!
agree to not donate sperm for the purpose of reproduction during the study 
and for a minimum of 6 months after the last dose of study treatment
!
not plan to father a child while enrolled in this study or within 6 months after 
the last dose of study treatment. Male participants should consider 
preservation of sperm prior to study treatment as anti-cancer treatments may 
impair fertility. Investigators will advise male participants on the options for 
banking of sperm for reproductive conservation.
12.
Criterion modified per Amendment 1
12.1
A female participant of childbearing potential must have a highly sensitive 
negative serum (∀-human chorionic gonadotropin [∀-hCG]) or urine test at 

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screening and within 72 hours of the first dose of study treatment and must agree 
to further serum or urine pregnancy tests during the study, that may exceed those 
listed in the Schedule of Activities (Section 1.3).
Informed Consent
13.
Must sign an informed consent form (ICF) (or their legally acceptable representative must 
sign) indicating that the participant understands the purpose of, and procedures required 
for, the study and is willing to participate in the study and agree to store samples when 
applicable.
5.2.
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from 
participating in the study:
Medical Conditions
1.
Criterion modified per Amendment 1:
1.1
Active malignancies (ie, progressing or requiring treatment change in the last 
24 months) other than the disease being treated under study. The only allowed 
exceptions are: 
a.
skin cancer (non-melanoma or melanoma) that is considered completely 
cured.
b.
non-invasive cervical cancer that is considered completely cured.
c.
Localized prostate cancer (N0M0):
!
with a Gleason score of 6, treated may include surgery, radiation, or 
ablation) within the last 24 months or untreated and under active 
surveillance,
!
with a Gleason score of 3+4 that has been treated (may include surgery, 
radiation, or ablation) more than 6 months prior to full study screening 
and considered to have a very low risk of recurrence,
!
or history of localized prostate cancer and receiving androgen 
deprivation therapy and considered to have a very low risk of 
recurrence. 
d.
Breast cancer:
!
adequately treated lobular carcinoma in situ or ductal carcinoma in situ,
!
or history of localized breast cancer and receiving antihormonal agents 
and considered to have a very low risk of recurrence.
e.
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2.
Criterion modified per Amendment 1
2.1
Must not have received prior systemic chemotherapy, targeted small molecule 
therapy, or radiation therapy within 2 weeks prior to starting study treatment 
(treatment exceptions not precluding participants from enrollment are noted in 
the active malignancies exclusion criterion).
3.
Must not have had urothelial carcinoma or histological variant at any site outside of the 
urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) 
is allowable if treated with complete nephroureterectomy more than 24 months prior to 
randomization.
4.
Criterion modified per Amendment 2:
4.1
Participants must not have evidence of cT4b, or N1-3, or M1 disease based on 
central radiology staging (chest, abdomen, and pelvis must be performed using 
CT or MRI) within 42 days prior to randomization.
5.
Presence of any bladder or urethral anatomic feature that, in the opinion of the 
Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200.
6.
Uncontrolled adrenal insufficiency.
7.
A history of clinically significant polyuria with recorded 24-hour urine volumes greater 
than 4,000 mL.
8.
Criterion modified per Amendment 2
8.1
History of uncontrolled cardiovascular disease including any of the following in 
the preceding 3 months- prior to Screening: unstable angina, myocardial 
infarction, ventricular fibrillation, Torsades de Pointes, cardiac arrest, or known 
congestive New York Heart Association Class III-IV heart failure, 
cerebrovascular accident, or transient ischemic attack. History of pulmonary 
embolism or other venous thromboembolism within the preceding 2 months.
9.
Must not have active tuberculosis.
10.
Criterion deleted per Amendment 1
11.
Pyeloureteral tube externalized to the skin is exclusionary. Unilateral nephrostomy tube 
or ureteral stent is permitted as long as it does not interfere with placement or retention 
of TAR-200 in the bladder. Bilateral ureteral stents are exclusionary.
12.
Indwelling catheters are not permitted; however, intermittent catheterization is 
acceptable.

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13.
Criterion modified per Amendment 2:
13.1
Participants with an active, autoimmune disease that has required systemic 
treatment in the past 2 years are excluded. Participants with autoimmune 
disorders not requiring systemic treatment or conditions requiring hormonal 
replacement therapies such as type 1 diabetes mellitus or hypothyroidism are 
permitted to enroll.
14.
Participants must not have clinically significant liver disease that precludes participant 
treatment regimens prescribed on the study (including, but not limited to active viral, 
alcoholic, or other autoimmune hepatitis, cirrhosis, or inherited liver disease).
15.
Criterion modified per Amendment 1:
15.1
Human immunodeficiency virus (HIV) infection, unless the participant has been 
on a stable anti-retroviral therapy regimen for the last 6 months or more and has 
had no opportunistic infections and a CD4 count of >350 in the last 6 months.
16.
Criterion modified per Amendment 2:
16.1
Evidence of active or chronic hepatitis B or C infection (however, participants
with history of hepatitis C infection but normal hepatitis C virus polymerase 
chain reaction test and participants with hepatitis B with positive HBsAg 
antibody are allowed).
17.
Criterion modified per Amendment 2:
17.1
Concurrent urinary tract infection (UTI), defined as a symptomatic infection with 
a positive urine culture with a bacterial count of ≥105 colony forming units 
(CFU)/mL in urine voided from women, or >104 CFU/mL in urine voided from 
men, or in straight-catheter urine from women that cannot be cleared with 
antibiotic therapy.
18.
Criterion deleted per Amendment 2
19.
Evidence of interstitial lung disease or active non-infectious pneumonitis.
20.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active 
infection, unstable angina pectoris, or psychiatric illness/social situations that would 
limit compliance with study requirements.
21.
Criterion modified per Amendment 2:
17.1
Participants with current acute diverticulitis, intra-abdominal abscess, 
gastrointestinal obstruction and abdominal carcinomatosis which are known risk 
factors for bowel perforation, and participants who have a history immune-
mediated colitis.
22.
Criterion deleted per Amendment 2

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Prior/Concomitant Therapy
23.
Not recovered from adverse events due to a previously administered agent.
24.
Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time.
25.
Pelvic radiotherapy administered less than 6 months prior to screening. Participants 
who received radiotherapy ≥6 months prior to screening must demonstrate no 
cystoscopic evidence or symptoms of radiation cystitis.
26.
Criterion modified per Amendment 1:
26.1
Criterion modified per Amendment 2
26.2
Received a live virus vaccine within 30 days of initiation of study treatment.
Inactivated (non-live or non-replicated) vaccines approved or authorized for 
emergency use (eg, Coronavirus Disease 2019 [COVID-19]) are allowed (see 
Section 6.8). (Note: Specifically, for COVID-19 vaccines, please refer to 
Section 10.11, Appendix 11, Study Conduct During a Natural Disaster)
27.
Criterion deleted per Amendment 2
28.
Criterion modified per Amendment 1:
28.1
Active infection requiring systemic intravenous therapy within 14 days prior to 
randomization. See exclusion criterion 17 for information regarding UTI.
29.
Criterion modified per Amendment 1:
29.1
Received intervening intravesical chemotherapy or immunotherapy from the 
time of most recent cystoscopy/TURBT to starting study treatment. Immediate 
post-TURBT single-dose peri-operative intravesical chemotherapy is allowed 
per institutional guidelines in the screening phase. 
30.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or 
anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody, or any other antibody or 
drug specifically targeting T-cell co-stimulation or checkpoint pathways.
31.
Participants with a history of Grade ≥3 toxic effects when using anti-TNF or anti-IL-6 
agents are excluded.
32.
Participants still recovering from toxicity of prior anticancer therapy which was 
received more than 24 months prior to enrollment (except toxicities which are not 
clinically significant such as alopecia, skin discoloration).
33.
Participants who require immunosuppressive medications including but not limited to 
systemic corticosteroid at doses >10 mg/day of prednisone or its equivalence, 
methotrexate, 
cyclosporine, 
azathioprine, 
and 
TNF 
α 
blockers. 
Use 
of 
immunosuppressive medications for the management of immune related adverse 

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events, infusion related reactions, or in participants with contrast allergies is acceptable. 
Use of inhaled, topical, and intranasal corticosteroids are permitted.
34.
Participants with a history of allergy to protein-based therapies and participants with a 
history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-
mediated thrombocytopenia or anemia) are excluded.
35.
Known hypersensitivity to any study component including:
a.
Gemcitabine (or other drug excipients) or chemically-related drugs, 
b.
TAR-200 device constituent materials,
c.
TAR-200 Urinary Placement Catheter materials, 
d.
Cetrelimab excipients or chemically-related drugs
Refer to the TAR-200 IB and cetrelimab IB for complete information on excipients.
Prior/Concurrent Clinical Study Experience
36.
Currently participating or has participated in a study of an investigational agent and 
received study therapy or investigational device within 4 weeks prior to enrollment.
Diagnostic Assessments
37.
Participants with evidence of bladder perforation during diagnostic cystoscopy. 
Participant is eligible if perforation has resolved prior to dosing.
38.
Bladder post-void residual (PVR) volume >350mL at screening after second voided 
urine.
39.
Criterion modified per Amendment 2:
39.1
Participants who have not recovered from the effects of major surgery or 
significant traumatic injury at least 14 days before randomization (TURBT is not 
considered major surgery).
Other Exclusions
40.
Any condition for which, in the opinion of the Investigator, participation would not be 
in the best interest of the participants (eg, compromise the well-being) or that could 
prevent, limit, or confound the protocol-specified assessments.
41.
The participant is unable to comply with the requirements of this protocol, including 
any factors that are likely to affect the participant’s return for scheduled visits and 
follow-up.
NOTE: Investigators should ensure that all study enrollment criteria have been met at screening. 
If a participant's clinical status changes (including any available laboratory results or receipt of 

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additional medical records) after screening but before the first dose of study treatment is given 
such that the participant no longer meets all eligibility criteria, then the participant should be 
excluded from participation in the study. Section 5.4, Screen Failures, describes options for 
retesting. The required source documentation to support meeting the enrollment criteria are noted 
in Section 10.3, Appendix 3, Regulatory, Ethical, and Study Oversight Considerations.
5.3.
Lifestyle Considerations
Potential participants must be willing and able to adhere to the following lifestyle restrictions 
during the course of the study to be eligible for participation:
1.
Refer to Section 6.8, Concomitant Therapy for details regarding prohibited and 
restricted therapy during the study.
2.
Agree to follow all requirements that must be met during the study as noted in the 
Inclusion and Exclusion Criteria (eg, contraceptive requirements).
5.3.1.
Meals and Dietary Restrictions
There are no restrictions in meals or diet required for this study. However, participants in all 
cohorts will be recommended to consume at least 
 
during the study treatment period to allow for adequate urine production.
5.3.2.
Caffeine, Alcohol, and Tobacco
There are no restrictions regarding caffeine, alcohol, or tobacco intake while participating in this 
study.
5.3.3.
Activity
There are no restrictions regarding activity or exercise while participating in this study.
5.4.
Screen Failures
Participant Identification, Enrollment, and Screening Logs
The Investigator agrees to complete a participant identification and enrollment log to permit easy 
identification of each participant during and after the study. This document will be reviewed by 
the Sponsor study site contact for completeness. When available, the Investigator may generate 
screening and enrollment logs directly from IWRS.
The participant identification and enrollment log will be treated as confidential and will be filed 
by the Investigator in the study file. To ensure participant confidentiality, no copy will be made. 
All reports and communications relating to the study will identify participants by participant 
identification and age at initial signed informed consent. In cases where the participant is not 
randomized into the study, the date seen and age at initial signed informed consent will be used.
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Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened 1 time. A participant who is a screen failure may be re-screened no more than one time, 
if in the opinion of the Investigator, the participant would likely meet eligibility if available care 
is provided (eg, blood product provided for low hemoglobin or platelet count) and is deemed an 
appropriate candidate for study participation. Rescreened participants should be assigned the same 
participant number as for the initial screening. A participant who is re-screened is not required to 
sign another ICF if the re-screening occurs within 42 days from the previous ICF signature date. 
If re-screened outside the 
-day screening window, a new participant number must be assigned.
5.5.
Criteria for Temporarily Delaying Administration of Study Treatment
TAR-200 
Dose modifications with TAR-200 can only be achieved by early removal of TAR-200. See the 
TAR-200 Dosing Delay/Discontinuation Criteria in Section 6.5.1 for the conditions under which 
TAR-200 will either not be inserted (delayed) or will be removed and for the conditions under 
which participants will be permanently discontinued from TAR-200 study dosing. If the TAR-200 
is removed, in consultation with the Sponsor, it may be replaced immediately in accordance with 
the protocol 
Beyond 
this will be considered a 
skipped dose and the next dose may occur no sooner than at the next treatment period.
Cetrelimab
Dose delay/interruption is the primary method for managing cetrelimab-related toxicities. 
Toxicities requiring dose delay as well as procedures for delay are outlined in Section 6.5.2.
6.
STUDY TREATMENT AND CONCOMITANT THERAPY
6.1.
Study Treatment(s) Administered
Study treatment administration must be captured in the source documents and the electronic case 
report form (eCRF).
TAR-200 and IV cetrelimab will be manufactured and provided under the responsibility of the 
Sponsor. Refer to current version of the TAR-200 and cetrelimab IBs for a list of excipients in 
each product. The designation of the study treatments administered are provided in the table below.
Designation
Product
Investigational Medicinal Product
TAR-200
Investigational Medicinal Product
Cetrelimab
For a definition of study treatment overdose, refer to Section 6.7, Treatment of Overdose.
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Table 8:
Description of Treatments
Group/Cohort Name
Cohort 1 
Cohort 1 and Cohort 2
Study Treatment Name
TAR-200
IV Cetrelimab
Generic Name
JNJ-17000139
JNJ-63723283
Type
Integral drug-device combination 
product
Drug
Formulation (s)
Intravesical drug delivery system 
Lyophilized or liquid product 
Unit Dose Strength(s)
225 mg gemcitabine per TAR-200
30 mg/ml (for lyophilized product upon 
reconstitution and for liquid formulation)
Dosage Level(s)
1 TAR-200 (225 mg of gemcitabine) per 
3-week dosing cycle
360 mg of cetrelimab given via IV 
infusion per 3-week dosing cycle. 
Dosing Instructions
Intravesical system; inserted 
transurethrally into the bladder using the 
UPC and removed from the bladder 
using endoscopic non-cutting grasping 
forceps and a standard flexible or rigid 
cystoscope (flexible is preferred for the 
removal process)
The reconstituted (lyophilized) product 
solution is further diluted with 0.9% 
sodium chloride injection to make 100 
mL IV solution and given via IV 
infusion.
Route of 
Administration
Intravesical
Intravenous
Use
Experimental
Experimental
Investigational 
Medicinal Product 
(IMP)
Yes
Yes
Non-Investigational 
Medicinal 
Product/Auxiliary 
Medicinal Product 
(NIMP/AxMP)
No
No
Sourcing
Provided by the Sponsor 
Provided by Sponsor
IP Packaging and 
Labeling
Study Treatment will be provided in 
individual participant treatment 
packages. Each treatment package will 
contain the TAR-200 and the UPC. All 
study treatment will not be dispensed in 
child-resistant packaging.
Each individual treatment package will 
contain information and be labeled as 
required per country/territory regulatory 
requirements. Labels must remain 
affixed to the individual treatment 
packages
Study Treatment will be provided in 
individual participant treatment 
packages. Each treatment package will 
consist of 1 vial of lyophilized product.
All study treatment will not be dispensed 
in child-resistant packaging.
Each individual treatment package will 
contain information and be labeled as 
required per country/territory regulatory 
requirements. Labels must remain 
affixed to the individual treatment 
packages.
6.1.1.
TAR-200 Insertion (Cohort 1)
The UPC shaft is placed via the urethra into the bladder with position confirmed by urine return. 
Note: The bladder should not be completely empty of urine when TAR-200 is inserted. TAR-200
is loaded into the UPC shaft. The green stylet is inserted into the clear shaft to advance the 

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TAR-200 through the UPC. The stylet manually advances the device through the UPC. The 
TAR-200 emerges at the exit port as it is being deployed into the bladder lumen. The TAR-200 is 
deployed into the bladder and returns to its original bi-oval form. Figure 3 below portrays a 
benchtop illustration of the TAR-200 insertion procedure.
Figure 3:
Loading and Deployment (Insertion) of TAR-200 using the UPC
Note: The above pictures represent a benchtop illustration of the TAR-200 insertion procedure. Please refer to the 
Instructions for Use (IFU).
A post-insertion cystoscopy is not protocol mandated but may be performed at the discretion of 
the Investigator and is suggested for those utilizing the TAR-200 and UPC for the first time. A 
performed post-insertion cystoscopy would provide a visual assessment of TAR-200 to safeguard 
that the intravesical drug-device combination product is in its bi-oval shape and fully contained 
within the bladder. When placing the UPC, confirm position within the bladder with urine return, 
then block the opening of the catheter to allow urine to remain in the bladder. This creates a space 
within the bladder that may facilitate deployment of TAR-200 within the bladder. Alternatively, 
flexible cystoscopy after insertion of TAR-200 can confirm that it is freely floating within the 
bladder. Consider administering anticholinergics, anticholinergics, nonsteroidal anti-inflammatory 
drugs (NSAIDs), and bladder analgesics such as phenazopyridine, prior to or after TAR-200 
insertion. TAR-200 should not be inserted into an empty bladder. After insertion of TAR-200, the 
participant should be consulted to consume adequate liquids as reduced fluid consumption may 
exacerbate urinary symptoms. 
To mitigate the risk of UTI, participants must receive at least one dose of prophylactic 
periprocedural antibiotics with TAR-200 insertion and/or removal. Complete instructions for 
TAR-200 insertion are provided in the IFU.
Insertion of TAR-200 and administration of IV cetrelimab do not need to occur on the same day 
but should occur no more than 
of each other. The TAR-200 should generally be placed 
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after all other assessments required at that visit. Note that on days in which both TAR-200 and IV 
cetrelimab will be administered, TAR-200 will be inserted at least 
before the start of 
IV cetrelimab infusion or at least 
 the completion of IV cetrelimab infusion.
Complete instructions for TAR-200 insertion and removal are provided in the IFU.
TAR-200 should not be administered less than 14 days after any procedure resulting in traumatized 
urothelium during the biopsy (eg, gross hematuria).
6.1.2.
TAR-200 Removal (Cohort 1)
When the TAR-200 is removed, it may be replaced immediately per protocol or 
 
to allow for the resolution of any adverse event symptoms as assessed by the investigator 
and in consultation with the sponsor. The TAR-200 should generally be removed after all other 
assessments required at that visit and prior to the TAR-200 insertion, if a TAR-200 insertion is 
required at that visit. TAR-200 is to be removed by flexible (preferred) or rigid cystoscopy with the 
use of non-cutting grasping forceps. This must be performed by the Investigator or a trained 
healthcare professional. The TAR-200 should be grasped fully (wireform and tubing) and removed 
from the bladder under direct visualization, not through a cystoscope’s working channel. Complete 
instructions for TAR-200 removal are provided in the IFU. A graphical representation of removal 
is presented in Figure 4. 
Figure 4:
TAR-200 Removal
If safe removal of the product through the urethra with the cystoscope and grasping forceps is not 
possible or not advised, this may require an operative procedure requiring local and/or general 
anesthesia.
Palliative radiation may only be administered after a 10-day gemcitabine washout period following 
removal of the TAR-200. Please refer to the TAR-200 IB for additional details. 
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6.1.3.
Cetrelimab Administration
Cetrelimab (IV) will be dosed on a 
schedule as outlined in the Schedule of Activities
(Section 1.3): until 
or until the participant has disease progression, intolerable toxicity, 
withdraws consent, there is a decision by the Investigator to discontinue study treatment, or the 
study is terminated, whichever occurs first. The dosing of IV cetrelimab may be delayed or skipped
to allow for the resolution of any AE symptoms as assessed by the Investigator and subsequently 
conveyed to the Sponsor. See Section 6.5.2 for Dose Modifications.
For participant comfort, on days in which both TAR-200 and IV cetrelimab will be administered, 
cetrelimab infusion should be completed at least 
 before, or should be started at least 
 after, the insertion of the TAR-200. At the discretion of the Investigator, premedication 
with antihistamines or antipyretics/analgesics may be administered for subsequent infusions if an 
infusion reaction or injection site reaction is observed with IV cetrelimab.
For a definition of study treatment overdose, refer to Section 6.7.
6.2.
Preparation/Handling/Storage/Accountability
TAR-200 (JNJ-17000139) Preparation/Handling/Storage
The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all TAR-200 systems received and any discrepancies are reported to 
Sponsor immediately and resolved before use of TAR-200. TAR-200 must be stored at room 
temperature (15°C to 30°C) in a secure, environmentally controlled, and monitored (manual or 
automated) area with access limited to the Investigator and authorized site staff. Only participants 
enrolled in the study may receive TAR-200 and only documented trained and credentialed
Investigators or designees may insert or remove TAR-200. A single-use, sterile UPC is 
co-packaged with TAR-200 and is used to insert TAR-200 into the bladder. Please refer to the IFU 
for information on TAR-200 insertion and removal. Refer to the IFU for TAR-200 and the UPC 
and the Site Investigational Product and Procedures Manual (SIPPM) for additional information 
and 
stepwise 
guidance 
on 
TAR-200 
preparation, 
handling, 
and 
storage. 
The 
Investigator/institution is responsible for TAR-200 accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition records).
Cetrelimab (JNJ-63723283) Preparation/Handling/Storage
The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all cetrelimab received and any discrepancies are reported to Sponsor
immediately and resolved before use of cetrelimab. Cetrelimab must be stored at refrigerated 
temperatures ranging from 2°C to 8°C and protected from light in a secure, environmentally 
controlled, and monitored (manual or automated) area with access limited to the Investigator and 
authorized site staff. Protection from light is not required during administration. Only participants 
enrolled in the study may receive IV cetrelimab and only documented trained and credentialed 
Investigators or designees may prepare and dose the cetrelimab. Refer to the Investigational 
Product Preparation Instructions (IPPI) or the SIPPM for additional information and stepwise 
guidance on cetrelimab preparation, handling, and storage. The Investigator/institution is 
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responsible for cetrelimab accountability, reconciliation, and record maintenance (ie, receipt, 
reconciliation, and final disposition records).
Accountability of Study Treatment 
The Investigator is responsible for ensuring that all study treatments received at the site are
inventoried and accounted for throughout the study. The study treatment administered to the 
participant must be documented on the treatment administration form. All study treatment will be 
stored and disposed of according to the Sponsor's instructions. Study site personnel must not 
combine contents of the study treatment containers.
Study treatment must be handled in strict accordance with the protocol and the container label,
IFU for TAR-200, IPPI for IV cetrelimab, and must be stored at the study site in a limited-access 
area or in a locked cabinet under appropriate environmental conditions. Unused study treatment 
must be available for verification by the Sponsor's study site monitor during on-site monitoring 
visits or audits. When the study site is an authorized destruction unit and study treatment supplies
are destroyed on-site, this must also be documented on the treatment return form.
Potentially hazardous materials containing hazardous liquids, such as used ampules, needles, 
syringes and vials, should be disposed of immediately in a safe manner and therefore will not be 
retained for study treatment accountability purposes.
Study treatment must be dispensed under the supervision of the Investigator or a qualified member 
of the study site personnel, or by a hospital/clinic pharmacist. Study treatment will be supplied 
only to participants participating in the study. Returned study treatment must not be dispensed 
again, even to the same participant. Study treatment may not be relabeled or reassigned for use by 
other participants. The Investigator agrees neither to dispense the study treatment from, nor store 
it at, any site other than the study sites agreed upon with the Sponsor. Further guidance and 
information for the final disposition of unused study treatment is provided in the IFU for TAR-200,
and IPPI for IV cetrelimab.
6.3.
Measures to Minimize Bias: Randomization and Blinding
Treatment Allocation
Central randomization will be implemented. Participants will be randomly assigned to 1 of 2
treatment groups in a 5:3 ratio based on a computer-generated randomization schedule prepared 
before the study by or under the supervision of the Sponsor. The randomization will be balanced 
in a 5:3 ratio by using randomly permuted blocks and will be stratified by two stratification factors:
!
TURBT results: Visibly complete vs. Incomplete and ≤3 cm
!
Tumor Stage: cT2 vs. cT3-4a (at initial diagnosis)
The interactive web response system (IWRS) will assign a unique treatment code, which will 
dictate the treatment group assignment and matching study drug kits for the participant. The 
requestor must use his or her own user identification and personal identification number when 

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contacting the IWRS and will then give the relevant participant details to uniquely identify the 
participant.
Blinding
As this is an open study, blinding procedures are not applicable.
6.4.
Study Treatment Compliance
TAR-200
TAR-200 will be inserted and removed from the bladder by appropriately trained and credentialed 
Investigators or designees. The date of each insertion and each removal will be recorded in the 
source documents and recorded in the appropriate electronic electronic case report form (eCRF). 
Cetrelimab
Cetrelimab will be administered in the controlled environment of a qualified medical research 
center, under the direct observation of qualified study site personnel. The details of each 
administration will be recorded in the eCRF (including date, start, and stop times of administration, 
and volume infused).
6.5.
Management of Adverse Events and Dose Modification
Any dose/dosage adjustment should be overseen by medically qualified study site personnel 
(principal or sub-Investigator unless an immediate safety risk appears to be present).
6.5.1.
TAR-200
6.5.1.1.
Management of Adverse Events Related to TAR-200 and Procedures
As a prophylactic measure, participants should be instructed to ensure adequate fluid intake for 
improved tolerability. In addition, to mitigate the risk of UTI’s, participants must receive at least 
1 dose of periprocedural prophylactic antibiotics for any TAR-200 insertion and/or removal.
Any AEs related to TAR-200 or procedures should be treated in a timely manner for optimal 
outcome. Urinary symptoms should prompt evaluation Although a negative urine culture is not 
required for insertion of TAR-200, investigators should initiate treatment of symptomatic UTIs in 
a timely manner.
Symptoms including, but not limited to, hematuria, urinary retention, urinary urgency, bladder 
pain, may be treated with anticholinergics, NSAIDS, and bladder analgesics such as
phenazopyridine. A short course of corticosteroids is also permitted. Although a negative urine 
culture is not required for insertion of TAR-200, investigators should initiate treatment of 
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TAR-200 Dose Modification (Cohort 1 only)
The Sponsor should be notified of any TAR-200 drug delays and directly consulted prior to 
discontinuation of TAR-200 at any time during the study. Given the relatively short treatment 
period, attempts to mitigate mild AEs related to urinary complaints should be performed to avoid 
future TAR-200 skipped doses.
There is only one dose option for this study, as TAR-200 is available in one dose only. Dose 
modifications are not permitted due to the nature of TAR-200, except for early removal, delayed 
placement or skipped dose (ie, a missed dosing cycle), or discontinuation of TAR-200.
A skipped dose is defined as a TAR-200 insertion that is not administered 
 
as described in the Schedule of Activities (Section 1.3) and is not due to study treatment 
discontinuation.
Missed dosing cycles are not to be made up or rescheduled during the study. If a dosing cycle is 
missed, the participant would undergo placement of TAR-200 at the next scheduled insertion time, 
if the participant is eligible for continued administration of TAR-200 at that time. For example, if 
TAR-200 is removed early or not inserted due to AEs considered related to TAR-200 or the UPC 
(listed under ‘Study Drug Delay or Removal’ below), the participant could potentially resume the 
study schedule at the next scheduled protocol placement timepoint, assuming the participant no 
longer meets the participant stopping safety criteria at that time.
Participants with skipped TAR-200 dose due to AE which does not return to Grade 1 or baseline
should be evaluated, with Sponsor consultation, for further delayed placement versus permanent 
TAR-200 discontinuation, based on the balance of clinical risk/benefit.
For participants in Cohort 1, at any point during a TAR-200 drug delay or permanent 
discontinuation, IV cetrelimab dosing alone may continue.
For participants in Cohort 1, an end-of-treatment visit should be conducted after both TAR-200 
and IV cetrelimab treatments have been completed or permanently discontinued.
TAR-200 Participant Safety Stopping Criteria (Cohort 1 only)
If a participant discontinues TAR-200 before the end of the TAR-200 Treatment Phase, the 
participant must return for a clinic visit to have the TAR-200 removed.
TAR-200 should not be administered less than 14 days after any procedure resulting in traumatized 
urothelium/biopsy (due to the increased risk of systemic AEs) or until resolution of gross 
hematuria, whichever occurs later.
TAR-200 will either not be placed or will be removed early if the participant experiences any of 
the following (listed under ‘Study Drug Delay or Removal’ below) considered to be related to the 
TAR-200 or the UPC.
TAR-200 Delay or Removal (TAR-200 Treatment Interruption)
TAR-200 must be removed, and further TAR-200 dosing delayed if the following occur:
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6.5.2.2.
Cetrelimab Dose Modification
Dose modification of IV or cetrelimab is not permitted. Before each IV administration of 
cetrelimab, the participant will be evaluated for possible toxicities that may have occurred since 
the previous dose. Laboratory results and general physical status must be reviewed. If immune-
related toxicity has occurred, the criteria outlined in Section 10.9, Appendix 9: Guidelines for 
Management of Immune-Related Adverse Events and Adverse Events of Clinical Interest must be 
followed for management. Treatment with IV cetrelimab may continue unless the criteria for 
discontinuation of study drug (Cetrelimab Discontinuation, see below) are met. The criteria for 
retreatment after improvement/resolution of AEs are outlined in Table 9.
Table 9:
Retreatment Criteria for Cetrelimab
Adverse Event
Requirements Before Cetrelimab Administration
ANC
≥1.0 x 109/L with or without neutrophil growth factors
Platelet count
≥50.0 x 109/L without platelet transfusions, thrombopoietic cytokines, or both
Hemoglobin
≥7.5 g/dL with or without transfusion, erythropoietin, or both
Fasting glucose, if prompted by 
HbA1ca
≤250 mg/dL (13.9 mmol/L)
Hyperthyroidism 
Hypothyroidism
≤Grade 2
AST and ALT
≤3xULN 
Total bilirubin
≤1.5xULN
Rash
≤Grade 2 
≤Grade 1 for bullous dermatoses
Other 
clinically 
significant 
toxicity
Recovery to Grade ≤1 or baseline.
ALT=alanine 
aminotransferase; 
ANC=absolute 
neutrophil 
count; 
AST=aspartate 
aminotransferase; 
HbA1c=hemoglobin A1c; ULN=upper limit of normal
a 
If fasting glucose results are available and meet the retreatment criteria, the HbA1c result does not need to be 
reviewed prior to dosing, but should still be collected.
Cetrelimab Dose Delay
A skipped dose is defined as an IV cetrelimab infusion that is not administered within the study 
window and is not due to study discontinuation. For IV cetrelimab only, a dose interruption is 
when the infusion is stopped before the entire dose has been administered.
Dose delay is the primary method for managing cetrelimab-related toxicities. In the event of a 
toxicity that meets the criteria below or is otherwise considered to be clinically significant by the 
Investigator, treatment of IV cetrelimab will be held and supportive therapy administered as 
clinically indicated. If clinically significant drug-related toxicity is present, treatment should be 
delayed until the toxicity resolves (with or without supportive therapy) to baseline or #Grade 1 
except for fatigue, alopecia, hyperthyroidism, hypothyroidism, and rash (other than bullous 
dermatoses), which require resolution to #Grade 2 for subsequent treatment. Drug-related 
pulmonary toxicity, diarrhea, or colitis must have resolved to baseline. If dose delay of IV 
cetrelimab is beyond the 
, the dose should be delayed until the next protocol-
specified 
 
then the dose will be considered a missed dose. If 
the toxicity does not resolve to Grade≤1 or baseline (or Grade <2 for those mentioned above)
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within 6 weeks of identification of toxicity, (or prior to subsequent IV cetrelimab administration) 
discontinuation of IV cetrelimab is recommended unless agreement to continue dosing is reached 
by the Sponsor’s Medical Monitor or designee and the Investigator. For participants in Cohort 1, 
TAR-200 dosing alone may continue if the Investigator and Sponsor’s Medical Monitor agree. 
The following drug related irAEs will require dose delays:
!
Grade 2 pneumonitis (recurrent Grade 2 pneumonitis, study treatment must be permanently 
discontinued, see Cetrelimab Discontinuation below)
!
Grade 2 or 3 diarrhea or colitis
!
Grade 2 or 3 creatinine elevation
!
Grade ≥2 AST, ALT or total bilirubin increased
!
Symptomatic endocrinopathies (hypophysitis, adrenal insufficiency, and diabetes; excluding 
hypothyroidism and hyperthyroidism)
!
Grade 3 or 4 hyperthyroidism or hypothyroidism
!
Grade 2 uveitis
!
Grade 3 rash or Grade 2 bullous dermatoses
!
Grade 3 of other immune-mediated adverse reactions
The Investigator believes that for treatment-emergent toxicity it is in the best interest of the 
participant to discontinue study treatment.
Cetrelimab Discontinuation 
A participant must discontinue study treatment for any of the following drug-related irAEs:
!
irAEs that persist despite treatment modifications or corticosteroid dosing cannot be reduced 
to #10 mg prednisone or equivalent per day within 6 weeks
!
A treatment-related AE does not resolve to Grade #1 within 6 weeks of the last dose of study 
drug unless otherwise agreed to by the Sponsor’s Medical Monitor and the Investigator based 
on evidence of clinical benefit
!
Grade 4 toxicities (ie, Grade 4 diarrhea or colitis, Grade 4 creatinine elevation, Grade 4 rash) 
except for:
∃
Endocrinopathies that are controlled with replacement hormones
∃
Grade 4 hematologic toxicities that resolve in less than 7 days may not result in study 
treatment discontinuation at the discretion of the treating physician
!
Any non-hematologic study treatment-related event occurs a second time at Grade %3 severity
!
Grade %3 (or recurrent Grade 2) pneumonitis/interstitial lung disease
!
Grade ≥3 elevation of AST or ALT or total bilirubin that does not resolve to Grade ≤1 within 
7 days or is symptomatic
!
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!
Grade %3 infusion-related reactions (IRRs) due to IV cetrelimab
!
Grade %3 uveitis
!
Immune-mediated encephalitis
!
Recurrence of Grade 3 of other immune-mediated adverse reactions 
!
The Investigator believes that for treatment-emergent toxicity it is in the best interest of the 
participant to discontinue IV cetrelimab treatment. Participants may continue TAR-200 for 
those in Cohort 1.
If a participant's study treatment is discontinued, this will not result in automatic withdrawal of the 
participant from the study. Following treatment discontinuation, the participant should proceed to 
the RC Visit if clinically appropriate. Once a participant discontinues treatment with IV cetrelimab, 
the participant may not be retreated with the study drug. For those participants in Cohort 1, if IV 
cetrelimab is permanently discontinued, then treatment with TAR-200 dosing alone may continue 
if the Investigator and Sponsor’s Medical Monitor agree.
Discontinuation of study treatment is described in Section 7.1
6.6.
Continued Access to Study Treatment After the End of the Study
Given that radical cystectomy will preclude future TAR-200 placement, continued access to either 
study drug is not applicable.
6.7.
Treatment of Overdose
In the event of an overdose, the Investigator should:
!
Contact the Sponsor’s Medical Monitor immediately.
!
Evaluate the participant to determine, in consultation with the Sponsor’s Medical Monitor, 
whether study treatment must be interrupted or whether the dose should be reduced.
!
Closely monitor the participant for AE/serious AE (SAE) and laboratory abnormalities until 
resolution.
!
Obtain a serum sample for PK analysis after last dose of study treatment if requested by the 
medical monitor (determined on a case-by-case basis).
!
Document the quantity of the excess dose as well as the duration of the overdosing in the 
eCRF.
Discussions of overdose for each study treatment are discussed in following subsections below. 
TAR-200
Due to the nature of TAR-200 administration, overdoses are not considered to be a potential risk 
for TAR-200 in this study. 
Urothelial carcinoma, specifically transitional cell carcinoma of the upper and lower genitourinary 
tract, has demonstrated meaningful responsiveness to deoxycytidine analogues. Gemcitabine, 
delivered systemically or locally, is an effective treatment of metastatic and local transitional cell 

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carcinoma of the upper and lower genitourinary tract, respectively. There has been broad human 
experience with high dose (>2 g/100-mL normal saline) intravesical gemcitabine instillations in 
the management of participants with NMIBC. Minimal systemic absorption occurs through the 
bladder and safety has been documented in both once- and twice-weekly dosing regimens, in 
addition to long-term maintenance regimens.
Intravesical instillations of chemotherapeutic agents, including gemcitabine, are frequently used 
in the treatment of NMIBC. However, intravesical gemcitabine delivery is currently limited by: 
(1) the logistics of frequent dose delivery; (2) the short bladder dwell time; and (3) morbidity 
following a high-dose bladder administration (2 g over one to two hours).
TAR-200 continuously delivers gemcitabine at an average of 
 over the first seven days 
(with 
 expected to be released daily after Day 7) for a maximum of 225 mg, a dose 
that is significantly less than the doses used in standard gemcitabine instillations today. Given this 
low total payload dose within TAR-200, even in the event of a dose dumping, wherein the entire 
drug load is released into the participant urine at one time, this dose would be significantly less 
than the typical intravesical gemcitabine instillation doses traditionally employed. Finally, 
participant voiding of the bladder urine upon the subsequent voiding cycle would eliminate this 
gemcitabine volume from the participant’s bladder, limiting the dwell time of this drug load.
Cetrelimab
There are no human or animal data regarding overdose of cetrelimab. Treatment of overdose of
cetrelimab should consist of general supportive care. There is no known specific antidote for 
overdose with cetrelimab.
6.8.
Concomitant Therapy
Any medication (including over-the-counter or prescription medicines, vitamins, or herbal 
supplements), therapy (including palliative procedures), or vaccine that the participant is receiving 
at the time of signed initial informed consent or that the participant receives during the study must 
be recorded along with:
!
Indication for use
!
Dates of administration including start and end dates, if available
!
Dosage information including route of administration, dose, and frequency
Prophylactic antibiotics should be administered at time of TAR-200 insertion and/or removal to 
reduce the risk of procedure related UTI. Additionally, the use of thromboprophylaxis is strongly 
recommended perioperatively for radical cystectomy per local guidelines. Details pertaining to the 
type of thromboprophylaxis and duration of use should be recorded in the eCRF.
Concomitant therapies, Relevant Procedures (including genitourinary events and procedures), and 
Healthcare encounters must be recorded throughout the study, beginning with signed initial
informed consent and through the Week 108 Follow-up visit. Concomitant therapies should also 
be recorded in conjunction with new or worsening serious adverse events that meet the criteria 
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outlined in Serious Adverse Events in Section 8.9.1, Time Period and Frequency for Collecting 
Adverse Event and Serious Adverse Event Information.
All therapies (prescription or over-the-counter medications, including vaccines, vitamins, herbal 
supplements; non-pharmacologic therapies such as electrical stimulation, acupuncture, special 
diets, exercise regimens, or other specific categories of interest) different from the study treatment 
must be recorded in the eCRF.
The Sponsor must be notified in advance (or as soon as possible thereafter) of any instances in 
which prohibited therapies are administered.
Permitted Medications
Throughout the study, Investigators may prescribe concomitant medications or treatments 
(including nutritional support, correction of metabolic disorders, optimal symptom control, and 
pain management) deemed necessary to provide adequate supportive care. Participants may 
continue the use of bisphosphonates or denosumab for bone disease. Concurrent use of hormones 
for noncancer related conditions (eg, insulin for diabetes and hormone replacement therapy) is 
acceptable. Concomitant medications (eg, acetaminophen/paracetamol or diphenhydramine) 
deemed necessary by the Investigator to provide adequate prophylaxis and management of IRR 
are allowed.
In addition, the following medications may be administered during the study:
!
Standard 
supportive 
care 
therapies 
(antiemetics, 
antidiarrheals, 
anticholinergics, 
antispasmodics, antipyretics, antihistamines, analgesics, antibiotics and other antimicrobials, 
histamine receptor [H2] antagonists or proton pump inhibitors, and other medications intended 
to treat symptoms or signs of disease) as clinically indicated, according to institutional 
standards and as deemed necessary by the Investigator.
!
Documented infectious complication should be treated with oral or IV antibiotics or other 
anti-infective agents as considered appropriate by the treating Investigator for a given 
infectious condition, according to standard institutional practice.
!
Growth factor support for the management of treatment-emergent hematological toxicity as 
recommended according to National Comprehensive Cancer Network/European Organization 
for Research and Treatment of Cancer (NCCN/EORTC) guidelines.
Prohibited Medications
The following medications are prohibited during the study. The Sponsor must be notified in 
advance (or as soon as possible thereafter) of any instances in which prohibited therapies are 
administered.
!
Concurrent experimental or investigational therapy.
!
Concurrent anti-neoplastic agents [eg, chemotherapy, anticancer immunotherapy other than 
cetrelimab or hormonal therapy (hormone replacement therapy is acceptable)]; however, 
supportive care agents, including denosumab, bisphosphonates, and hormonal agents are 

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allowed. Also, Androgen Deprivation Therapy (ADT) for prostate cancer or antihormonal 
therapy for breast cancer (see Section 5.2) are permitted to be continued. 
!
Other immunosuppressant agents, including, but not limited to: systemic corticosteroids at 
doses exceeding 10 mg per day of prednisone or its equivalent, methotrexate, azathioprine, 
and tumor necrosis factor α (TNF-α) blockers, should not be given while the patient is on 
study treatment. Use of immunosuppressive medications for the management of immune-
related AEs, IRRs, or in participants with contrast allergies is acceptable. In addition, use of 
inhaled, topical, local, and intranasal corticosteroids is permitted.
!
Vaccinations with live vaccines within 30 days of the initiation of study treatment, during 
study treatment, and for 90 days following completion of study treatment (non-live or 
non-replicating vaccines such as annual inactivated influenza, COVID-19, or monkeypox
vaccine are allowed). (Note: Specifically, for COVID-19 vaccines, please refer to 
Section 10.11, Appendix 11, Study Conduct During a Natural Disaster)
!
Medications, treatments, or procedures that are exclusionary for entry in the study should not 
be introduced during treatment. Please see Section 5.1, Inclusion Criteria and Section 5.2, 
Exclusion Criteria for those therapies which would preclude study participation
The Sponsor must be notified in advance (or as soon as possible thereafter) of any instances in 
which prohibited therapies are administered.
Possible Drug-Drug Interactions
No drug-drug interaction studies have been conducted by Sponsor to date. No drug-drug 
interactions studies are discussed in the prescribing information for gemcitabine (Gemzar US 
Prescribing Information 2019; Gemzar Summary of Product Characteristics 2019). A case was 
reported of increased international normalized ratio (INR) values and hematomas subsequent to 
the concomitant administration of warfarin and intravesical gemcitabine in a 90-year-old man with 
BCG-unresponsive bladder cancer (Kurtzhalts 2016). The participant had started warfarin one 
month prior to starting intravesical gemcitabine (2 g, administered once weekly). During the first 
five cycles of gemcitabine, critically elevated INRs resulting in hospitalization were reported. 
Warfarin was discontinued, and enoxaparin was initiated after the hematomas resolved and 
hemoglobin stabilized (Refer to the TAR-200 IB).
Gemcitabine may potentiate the effects of antithrombotic medications (thrombolytics, 
anticoagulants, and anti-platelet agents); therefore, Investigators should monitor participants who 
are administered these medications closely for risks of increased bleeding.
No preclinical or clinical studies that examine the interaction between cetrelimab and other 
products have been conducted (Refer to the cetrelimab IB).
The main toxicities of cetrelimab and TAR-200 are non-overlapping.
6.8.1.
Rescue Medication
There are no prespecified rescue medications in this study. All concomitant rescue medications, 
treatments, and procedures should be documented in the eCRF.

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7.
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1.
Discontinuation of Study Treatment
A participant's study treatment must be discontinued if:
!
The participant withdraws consent to receive study treatment
!
Any clinical AE, laboratory abnormality or intercurrent illness which the Investigator believes 
that for safety reasons or tolerability reasons (eg, adverse event) it is in the best interest of the 
participant to discontinue study treatment. 
!
The Investigator believes that for safety reasons or tolerability reasons (eg, due an AE, 
laboratory abnormality or intercurrent illness) it is in the best interest of the participant to 
discontinue study treatment.
!
The participant becomes pregnant
!
Noncompliance with study treatment or schedule.
!
Participant develops clinical symptoms or disease progression that precludes RC surgery
!
Participant develops metastatic disease (as assessed by RECIST 1.1 criteria)
!
The Sponsor closes the study.
∃
The Sponsor reserves the right to close the study or close the study site at any time for 
any reason at the sole discretion of the Sponsor (eg, in case of unacceptable risk, 
intolerable toxicity, or change in the risk/benefit profile); this might include recurrence 
of adverse events of which character, severity, or frequency is new in comparison to the 
existing risk profile. Also, data derived from other clinical or toxicology studies, which 
negatively influence the risk/benefit assessment, might cause discontinuation or 
termination of the study.
Participants that develop the following should continue within the efficacy (imaging) Follow-up 
Phase of the study:
!
Clinical symptoms or pelvic nodal disease that precludes RC surgery
!
Evidence of pelvic nodal disease following RC surgery
Participants that develop metastatic disease progression should be discontinued from further 
efficacy (imaging) follow-up and continue to be followed for survival status, subsequent anti-
cancer therapies, and other malignancies.
If a participant permanently discontinues study treatment for any reason before the end of the
Treatment Phase, the participant must commit to a clinic visit to have the TAR-200 removed. All 
efforts will be made to continue to follow participants in the Follow-up Phase of the study until 
the participant meets discontinuation criteria in Section 7.2. The primary reason for study treatment 
discontinuation will be clearly documented in the participant’s medical record and recorded in the 
eCRF. Study drug assigned to the participant who discontinued study drug may not be assigned to 
another participant. Additional participants will not be entered to account for those participants 
who discontinue study treatment.

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!
The Investigator must document whether the participant is withdrawing from taking the study 
drug only or withdrawing from taking the study drug, attending future visits, and participating 
in future assessments.
!
Efforts will be made to continue follow-up of participants who withdraw prematurely, 
especially with respect to disease progression and survival through Week 108 post RC as 
described in the Schedule of Activities (Section 1.3).
!
Efforts will be made to undergo protocol-specified follow-up of any ongoing AEs and SAEs.
7.2.
Discontinuation from Efficacy (Imaging) Follow-up
A participant should be discontinued from efficacy (CT/MRI) imaging follow-up if:
!
Participant develops metastatic disease (as assessed by RECIST 1.1 criteria)
∃
Note that participants should continue to be followed for survival status through 
End of Study Visit.
7.3.
Participant Discontinuation/Withdrawal From the Study
A participant will be withdrawn from the study for any of the following reasons:
!
Lost to follow-up
!
Withdrawal of consent
If a participant withdraws before study completion, the reason for withdrawal is to be documented 
in the eCRF and in the source document. If the reason for withdrawal from the study is withdrawal 
of consent, then no additional assessments are allowed.
Withdrawal of Consent
A participant declining to return for scheduled visits does not necessarily constitute withdrawal of 
consent. Alternate follow-up mechanisms that the participant agreed to when signing the consent 
form apply (eg, consult with family members, contacting the participant’s other physicians, 
medical records, database searches, use of locator agencies at study completion) as local 
regulations permit.
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 as described above. This is expected to be uncommon occurrence for this study.
!
If a participant in Cohort 1 withdraws from the study, he/she must return to the site for 
TAR-200 removal (if applicable).
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. If a participant 
withdraws from the study, he/she may request destruction of any samples taken and not tested, and 
the Investigator must document this in the site study record.

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When a participant withdraws before study completion, the reason for withdrawal is to be 
documented in the eCRF and in the source document. If the reason for withdrawal from the study 
is withdrawal of consent, then no additional assessments are allowed.
Prior to a participant withdrawing consent for follow-up, the investigator must offer the participant 
an opportunity for one of the alternative reduced follow-up mechanisms described below.
Circumstances for Reduced Follow-up
In the situation where a participant may be at risk for withdrawal of consent and is unable to return 
for scheduled visits at the protocol-defined frequency, the investigator may consider options for 
reduced follow-up. These may include (as local regulations permit):
!
Less frequent clinical visits
!
Telephone, email, letter, social media, fax, or other contact with:
∃
participant
∃
relatives of the participant
∃
participant’s physicians (general or specialist)
!
Review of any available medical records
Details regarding these contacts must be properly documented in source records including 
responses by participants.
7.3.1.
Withdrawal From the Use of Research Samples
Withdrawal From the Use of Samples in Future Research
The participant may withdraw consent for use of samples for research (refer to Long-Term 
Retention of Samples for Additional Future Research in Section 10.3, Appendix 3, Regulatory, 
Ethical, and Study Oversight Considerations). In such a case, samples will be destroyed after they 
are no longer needed for the clinical study. Details of the sample retention for research are 
presented in the main ICF. 
7.4.
Lost to Follow-up
To reduce the chances of a participant being deemed lost to follow-up, prior to randomization
attempts should be made to obtain contact information from each participant, eg, home, work, and 
mobile telephone numbers and email addresses for both the participant as well as appropriate 
family members.
A participant will be considered lost to follow-up if the participant repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. A participant cannot be deemed 
lost to follow-up until all reasonable efforts made by the study site personnel to contact the 
participant are deemed futile. The following actions must be taken if a participant fails to return to 
the study site for a required study visit:

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!
The study site personnel must attempt to contact the participant to reschedule the missed visit 
as soon as possible, to counsel the participant on the importance of maintaining the assigned 
visit schedule, to ascertain whether the participant wishes to or should continue in the study.
!
Before a participant is deemed lost to follow up, the Investigator or designee must make every 
reasonable effort to regain contact with the participant (where possible, 3 telephone calls, 
e-mails, text-message, 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 records.
!
Should the participant continue to be unreachable, they will be considered to have withdrawn 
from the study.
!
Site personnel, or an independent third party, will attempt to collect the vital status of the 
participant within legal and ethical boundaries for all participants randomized, including those 
who did not get study treatment. Public sources may be searched for vital status information. 
If vital status is determined as deceased, this will be documented, and the participant will not 
be considered lost to follow-up. Sponsor personnel will not be involved in any attempts to 
collect vital status information.
Should a study site close, eg, for operational, financial, or other reasons, and the Investigator
cannot reach the participant to inform them, their contact information will be transferred to another 
study site.
7.5.
Death
If it is determined that the participant has died, the site will use permissible local methods to 
determine the date and cause of death. Any information regarding the participant’s death, including 
cause and date of death, will be entered into the applicable eCRF.
8.
STUDY ASSESSMENTS AND PROCEDURES
Please refer to Section 1.3, Schedule of Activities.
Overview
The Schedule of Activities summarizes the frequency and timing of assessments applicable to this 
protocol. If multiple assessments are scheduled for the same timepoint, it is recommended that 
procedures be performed in the following sequence: PROs, electrocardiograms (ECGs), vital 
signs, and any type of blood draw last. Blood collections for pharmacokinetic and immunogenicity 
assessments should be kept as close to the specified time as possible. Assessments and procedures 
should be completed on the day indicated (± window indicated). At the Week 6 visit, imaging 
should be performed prior to dosing.
In Cohort 1, placement of TAR-200 and administration of IV cetrelimab, respectively, do not need 
to occur on the same day but should occur within 
and no more than 
 of each 
other. At times when both TAR-200 and IV cetrelimab are administered on the same day, TAR-200 
should be provided at least
 before the start of IV cetrelimab infusion or cetrelimab 
injection or 
fter the IV or cetrelimab administration is completed. If one 
treatment is held, the other may still be administered in consultation with the Sponsor. Actual dates 
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and times of assessments will be recorded in the source documentation and eCRF. All PRO 
assessments should be conducted/completed before any tests, procedures, or other consultations to 
prevent influencing participant responses. Refer to the PRO completion guidelines for instructions 
on the administration of electronic patient-reported outcome(s) (ePROs). MRU data will also be 
collected. Refer to Section 8.14, Healthcare Resource Utilization for details.
Home Health Care and Telehealth Visits
Home health care and telehealth visits may be implemented by or with approval from the Sponsor 
and per the clinical judgment of the Investigator, for certain circumstances when warranted where 
feasible and permissible by local policy, regulations (as applicable) and for participants for whom 
there is no safety concern.
Study procedures such as participant reconsent; ECOG assessment; AE and concomitant 
medication reporting; review of body systems; and collection of information on the participant’s 
current health status may be performed with home health care and telehealth visits. 
Protocol-specified laboratory assessments for efficacy and safety may be collected during home 
health care visits. All assessments should be followed with in-person examination, as applicable.
For samples analyzed at local laboratories, it is important to ensure appropriate documentation of 
laboratory reference ranges. Source documentation and, if applicable, the appropriate case report 
forms should be completed and should detail how each assessment was collected (eg, remote 
versus on-site, central versus local laboratory [if applicable], and vital signs taken at home by 
delegated in-home nursing) may be performed with home health care and telehealth visits. 
Protocol-specified laboratory assessments for efficacy and safety may be collected during home 
health care visits.
All screening evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria. The Investigator will maintain a screening log to record details of all 
participants screened and to confirm eligibility or record reasons for screening failure. See 
Section 5.4 for information on screen failures.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the eCRF or laboratory 
requisition form. If blood samples are collected via an indwelling cannula, an appropriate amount 
(1 mL) of serosanguineous fluid slightly greater than the dead space volume of the lock will be 
removed from the cannula and discarded before each blood sample is taken. After blood sample 
collection, the cannula will be flushed with 0.9% sodium chloride, United States Pharmacopeia 
(USP) (or equivalent) or sodium heparin of 10 U/mL and charged with a volume equal to the dead 
space volume of the lock. If a mandarin (obturator) is used, blood loss due to discard is not 
expected.
Refer to the Schedule of Activities (Section 1.3) for the timing and frequency of all sample 
collections.

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The actual dates and times of sample collection must be recorded in the eCRF or laboratory 
requisition form. Instructions for the collection, handling, storage, and shipment of samples are 
found in the Laboratory Manual that will be provided. Collection, handling, storage, and shipment 
of samples must be under the specified, and where applicable, controlled temperature conditions 
as indicated in the Laboratory Manual.
Study-Specific Materials
The Investigator will be provided with the following supplies:
!
Study Protocol
!
Investigator’s Brochure for cetrelimab and TAR-200
!
TAR-200 IFU
!
Cetrelimab IPPI
!
Pharmacy manual/study SIPPM
!
Combination Products Instructions for Use Manual
!
Laboratory manual
!
CTCAE Version 5.0
!
PRO questionnaire and ePRO completion guidelines
!
Tablet for onsite ePRO completion
!
ePRO Completion Guidelines
!
Electronic clinical outcome assessment Manual
!
RECIST guidelines Version 1.1
!
IVRS/IWRS Manual 
!
eDC Manual
!
Participant Wallet cards
8.1.
Screening
During the Screening Phase, all participants who have qualified for enrollment will consent to the 
study by signing the ICF. For Cohort 1 and Cohort 2, the Screening Phase includes the interval 
between signing the ICF and the day the participant is randomly assigned to either cohort. The full
Screening Phase should not exceed 42 days. Assessments that are required to demonstrate 
eligibility may be performed over the course of multiple days during the screening process.
Screening imaging and cystoscopy should be completed as soon as possible following the 
participant’s signing of the informed consent. The participant should be screen failed if, upon 
imaging central read, the participant is confirmed to have nodal or metastatic disease.
A screening cystoscopy is required within 
days prior to randomization if participant is referred 
from outside institution. This is performed to assess the bladder burden of disease, to ensure that 
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no underlying anatomical abnormality is found that could prevent safe placement, indwelling use, 
or removal of TAR-200, to assess for abnormal urothelium that would preclude participation, and 
to determine the presence of any residual tumors >3 cm. The diagnostic TURBT may be sufficient 
for screening cystoscopy assessment if performed within 42 days of randomization, performed by 
study Investigator, and tumor size is documented as ≤3 cm. Eligible participants may have either 
completely or partially resected tumors (≤3 cm) if the treating urologist attempted maximal 
resection. If tumor is >3 cm on the assessment cystoscopy, a debulking re-TURBT must be 
performed prior to randomization. Tumors larger than 3 cm in greatest diameter following 
debulking TURBT during screening will result in the participant’s screen failure. Randomization
is to occur once the initial diagnostic TURBT histopathology and imaging confirms cT2-T4a N0, 
M0 urothelial carcinoma by local pathology and central radiographic evaluation. Local pathology 
interpretations will be confirmed centrally. Participants should receive initial dosing of study 
treatment within 7 days following randomization.
Procedures conducted as part of the participant’s routine clinical management (eg, blood count, 
disease assessment, and cystoscopy) and obtained before signing the ICF may be used for 
screening purposes provided the procedure meets the protocol-defined criteria and has been 
performed within the time frame of the study (see Section 1.3). All information associated with 
eligibility requirements must be entered onto the appropriate eCRF. Requirements for biopsy 
specimens for histologic assessment for diagnosis are provided in Section 8.7.1. The participant’s 
previous anticancer therapies and TURBT details, the dose and timing of administrations, and the 
participant’s responses to each therapy will be collected and recorded in source documents and the 
eCRF. Tests with results that fail eligibility requirements may be repeated once during screening 
if the Investigator believes that these results are in error. For screening assessments that are 
repeated, the most recent available results before initiation of study drug will be used to determine 
participant eligibility.
The PVR will be measured at the Screening Visit per the study site’s standard of care method 
(ie, bladder scan, catheterization). At the Screening Visit, participants with a bladder PVR 
>350 mL after an attempted second voiding will be excluded from the study. 
Results from the screening evaluations will be reviewed to confirm participant eligibility before 
randomization.
Please refer to Schedule of Activities (Section 1.3) for all screening procedures and activities.
8.2.
Treatment
The Treatment Phase for Cohorts 1 and 2 will begin following a 5:3 random assignment into the 
study. Treatment may continue until the participant experiences discontinuation events noted in 
Section 7.1. During study visits, all ePRO assessments should be conducted and completed before 
any other tests, procedures, or consultations to prevent influencing participant perceptions.
All scheduled non-dosing assessments should be completed prior to dosing of any therapy. 
Assessments and procedures should be completed on the day indicated (± window indicated); if 

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this is not possible because of a weekend, holiday, or emergency, the assessment or procedure 
should be completed within 72 hours of the scheduled day.
Cohort 1: Administration of IV cetrelimab and the placement of TAR-200 do not need to occur 
on the same day; however, should occur within 
 and no more than 
 of each other. 
At times when both TAR-200 and IV cetrelimab are administered on the same day, TAR-200
should be provided at least 
 before the start of cetrelimab IV infusion OR at least 
after the infusion is completed. If one treatment is held, the other may still be 
administered in consultation with the Sponsor.
Cetrelimab administration will take place every three weeks for four consecutive cycles on study 
per the Schedule of Activities (Section 1.3).
Cohort 1 and Cohort 2: The first infusion of IV cetrelimab should be administered over 60 (±10) 
minutes. In the absence of infusion-related reactions, subsequent infusions may be administered 
intravenously over 30 minutes (but not less than 25 minutes). Study drug is to be administered 
under the supervision of qualified site staff. For the first infusion, vital signs should be monitored 
before the start of the infusion, during infusion, at the end of infusion (+10 minutes), and 2 hours 
(±15 min) after the completion of infusion. After the completion of the first infusion, the 
participant may be discharged if considered clinically stable and all other study procedures have 
been completed. During subsequent infusions of cetrelimab, vital signs should be monitored before 
the start of the infusion. 
Cohort 1 and Cohort 2: Dose modification of cetrelimab is not permitted. Dose delay is the 
primary method for managing cetrelimab-related toxicities (see Section 6.5 Dose Modifications). 
), then the dose 
will be considered a missed dose. Administration may resume at the next planned dosing date if 
participant meets requirements to resume treatment.
Cohort 1: TAR-200 insertion will take place Q3W four times on the study (Week 0, Day 1 and
then at Weeks 3, 6, and 9). The TAR-200 kit includes the TAR-200 device and UPC (Inserter). 
Participants will undergo insertion of TAR-200 into the bladder using the provided UPC in 
accordance with the IFU. All Investigators or healthcare professional designees must have training 
completed and documented in accordance with TAR-200 training guidelines and be trained prior 
to performing their first TAR-200 insertion. Only one TAR-200 may be contained in the bladder 
at any given time.
Cohort 2: Cetrelimab alone will be dosed approximately every 21 days for four consecutive 
cycles, with cycles starting at Week 0, Day 1. Subsequent doses will be administered at Weeks 3, 
6, and 9.
Cohort 1 and Cohort 2- Early Disease Progression: The Investigator will assess response to 
treatment at the Week  Visit using radiographic imaging (CT/MRI), which will be reviewed 
locally and centrally. For participants who are determined by Investigator to have metastatic 
progression (M1a or b), or who do not undergo RC, further study treatment will be discontinued.
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If a participant develops imaging consistent with pelvic nodal disease, further treatment (inclusive 
of radical cystectomy) and/or percutaneous biopsy should proceed at Investigator’s discretion. In 
cases of discordance or equivocal findings, additional imaging may be obtained at Investigator’s 
discretion to adjudicate; these cases must be discussed with Sponsor.
Cohort 1 and Cohort 2 - Radical Cystectomy: Participants should proceed to RC at Week 
 
(or up to 3 weeks [21 days] after the Week
visit, if clinically indicated), regardless of any dosing 
delays or missed doses that may occur during the study. All participants should undergo pre-
operative cardiac and risk stratification prior to RC per institutional guidelines. Please refer to 
detailed instructions for the collection, processing, storage, and shipment of samples as provided 
in the Central Laboratory Manual. Radical cystectomy outside of the protocol-specified 
timeframes is at the Investigator’s discretion. 
For participants in Cohort 1, TAR-200 will be removed at 
). RC may be 
performed on the same day or within 3 weeks (21 days) after the Week 
 visit.
Any pre-operative assessments specifically for the preparation of the RC procedure, 
intra-operative care, and post-operative hospitalization and recovery care should be according to 
institutional standard of care. 
Follow-up Visits: No restrictions are placed on adjuvant therapy after RC. Following the RC, all 
participants will have a safety follow-up visit 4 weeks (one month) following the RC surgery. 
Additionally, participants will have follow-up study visits at Weeks 8, 12, and then every 12 weeks 
through Week 108 post RC (eg, Weeks 24, 36, 48, 60, 72, 84, 96, 108 [End of Study]).
Unscheduled visits may occur throughout the study at the discretion of the Investigator and for
clinical necessity.
8.3.
Follow-up Phase
For participants who complete the Treatment Phase of the study, including radical cystectomy 
surgery, the participant will proceed to the follow up phase of the trial. This Follow-up Phase 
includes the Week 4, 8, and 12 post RC visits with subsequent disease status visits assessed every 
12 weeks through Week 108 post RC. For participants with metastatic progression following study 
treatment, other malignancies, and subsequent anti-cancer therapies will be collected in the eCRF, 
and these participants will continue to be followed for survival status until death, withdrawal of 
consent, or the end of the study, whichever occurs first. Participants with locoregional pelvic 
recurrence should continue efficacy evaluations (imaging) per the Schedule of Activities 
(Section 1.3). All drug-related serious adverse events beyond 100 days after last dose of study drug 
should be collected while participants are in study follow-up phase. 
8.4.
Overall Survival
Overall Survival status will also be determined and collected in the eCRF until death, withdrawal 
of consent, or the end of the study, whichever occurs first. This may be obtained via telephone 
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with the participant or the participant’s family or friends, if approved by the participant in the ICF, 
or by any means applicable by local laws and regulations.
8.5.
End of Study Visit
For each participant, the study is considered completed after the participant completes the 
Week 108 post RC (End of Study Visit). Additionally, they will be considered completed if they 
have died before the end of the study, have not been lost to follow-up, or have not withdrawn 
consent for study participation before the end of the study as defined above.
8.6.
Unscheduled Visits
Clinic visits not described in the schedule of assessments may be performed at any time as 
clinically indicated. Results of assessments performed at these visits will be entered as 
“unscheduled” visits in the eCRF.
8.7.
Efficacy Assessments
8.7.1.
Disease Assessments
8.7.1.1.
TURBT Biopsies, Cystoscopy, and Radical Cystectomy Pathology
!
Initial diagnostic TURBT specimens will be sent for central pathologic review. 
!
A screening cystoscopy is required within the 
-day screening period to determine the 
presence of any residual tumor >3 cm. The diagnostic TURBT may be sufficient for screening 
cystoscopy assessment if all three criteria are met: 1) performed within 42 days of 
randomization, 2) performed by study Investigator, and 3) the residual tumor size at that time 
is documented as ≤3 cm. For participants referred from outside the institution, a repeat 
screening cystoscopy is required.
!
Procedures conducted as part of the participant’s routine clinical management 
(eg, cystoscopy) and obtained before signing the ICF may be used for screening purposes 
provided the procedure meets the protocol-defined criteria and has been performed within the 
time frame of the study (see Section 1.3).
!
All efforts should be made to resect multifocal tumors to visual completion. If screening 
cystoscopy demonstrates any residual mucosal disease, debulking TURBT is encouraged to 
attain complete resection, but not mandated if all individual residual tumors are <3 cm.
!
If the total size of an individual, residual tumor exceeds 3 cm, it must undergo re-resection 
(re-TURBT) for entry into the study.
!
All screening assessments should be performed within the screening period of 
days prior 
to randomization.
!
All initial, diagnostic TURBT specimens will be collected and shipped to the central 
laboratory for a central histopathologic review per the Pathology Charter.
!
All debulking, completion TURBT specimens will be evaluated by local site pathology.
!
Participants that develop metastatic disease (as assessed per RECIST 1.1) prior to RC, will be 
taken off protocol treatment and discontinued from the efficacy (imaging) follow-up.
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!
If a participant develops imaging consistent with pelvic nodal disease, radical cystectomy 
and/or percutaneous biopsy should proceed at Investigator’s discretion.  
!
The radical cystectomy specimen will be processed and reviewed by local site pathology. 
Pathology material will then be collected and shipped to the central laboratory for central 
histopathologic review per the Laboratory Manual and will form the basis of primary outcome 
measure of complete response (CR).
Refer to the Laboratory Manual for instruction on sample handling.
8.7.1.2.
Computed Tomography/Magnetic Resonance Imaging (CT/MRI)
The CT/MRI with contrast to include the chest, abdomen, and pelvis:
!
A CT/MRI should be performed at screening, Week 
on treatment, Week 
post RC, and 
then every 
 weeks thereafter up to Week 108 (End of Study). Please also refer to Section 1.3
for time points that CT/MRI should be performed. In the case of abdominopelvic imaging 
with MR, chest imaging should be obtained, per Investigator discretion, and further clarified 
below. The same scanning parameters will be used throughout the study and should be in 
accordance with the Imaging Manual. All per-protocol imaging (CT/MRI) must be 
read/confirmed centrally. Additionally, the time window for all on-study CT/MRI imaging 
throughout the study is +/- 7 days. Eligibility is determined by central read of CT/MRI at 
screening. All on-study treatment decisions should be based on the Investigator’s assessment 
of the CT/MRI images and not on the central review. In cases of discordance between local 
and central review of CT/MRI images, the Investigator should consult with Sponsor for 
support.
!
The participant’s hydration should be handled per local institutional policy.
Incidental Findings: The Investigator is responsible for following up on the participant per their 
institutional standard of care for incidental findings on CT. The responsibilities of the imaging 
core laboratory, if any, with respect to incidental findings will be defined in the Imaging Charter.
Off-study CTs: Off-study imaging is defined as imaging that is not performed for the purpose of 
evaluation of disease progression or response for this study and/or consists of a modality and/or 
anatomy that is not study specific. 
Alternative Imaging: The preferred imaging modality is the contrast-enhanced CT of the chest 
abdomen, and pelvis (ie, the full body CT) and this modality should be used consistently 
throughout the study if there are no contraindications. However, in participants who are unable to 
undergo contrast-enhanced CT, alternative imaging may be used. If contrast-enhanced CT of the 
chest, abdomen, and pelvis is not possible, the following alternative methods, may be used, in 
order of preference:
1) Non-contrast CT of chest with contrast-enhanced MRI of abdomen and pelvis
2) Non-contrast CT of chest with non-contrast MRI of abdomen and pelvis
3) Non-contrast CT of chest, abdomen, and pelvis
Additional information will be provided in the Imaging Manual.
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Magnetic Resonance Imaging Conditional Compatibility (Applicable Only for Participants 
on Treatment with TAR-200 [Within Cohort 1])
TAR-200 is Magnetic Resonance conditional. A participant with TAR-200 can be scanned safely 
in a Magnetic Resonance system under the following conditions: 
!
Static magnetic field of 1.5-Tesla and 3-Tesla, only.
!
Maximum spatial gradient magnetic field of 3000 Gauss/cm or less.
!
Maximum magnetic resonance system reported, whole body averaged specific absorption rate 
of 2-W/kg for 15 minutes of scanning in the Normal Operating Mode of operation for the 
magnetic resonance system. 
!
Under the scan conditions defined, TAR-200 is expected to produce a maximum temperature 
rise of 2.0° C after 15 minutes of continuous scanning.
Additional information will be provided in the Imaging Manual. PET/CT may be utilized only in 
the screening phase, with the non-contrast CT phase serving as the baseline CT scan for future CT 
imaging comparisons. PET/CT is not permitted as an imaging modality on-study, during the 
treatment and follow-up phases, in order to maintain imaging fidelity and consistency throughout 
the study.
8.7.2.
Response Assessments
8.7.2.1.
TURBT Biopsies, Cystoscopy, and Radical Cystectomy Pathology
TURBT/Biopsy: Participants will have undergone an initial diagnostic TURBT resulting in 
pathologic diagnosis of cT2-T4a MIBC to initiate study enrollment. Pathology will be based upon 
the American Joint Committee on Cancer (AJCC) Bladder Cancer Staging nomenclature 
(AJCC 2017). The initial TURBT must be completed within 120 days of randomization. The 
biopsy specimen (accompanied by a pathology report) will be sent to a central pathology vendor 
for review and confirmation of tumor stage. A debulking re-TURBT must be completed if 
individual residual tumor volume exceeds 3 cm. A debulking re-TURBT is encouraged if there is 
residual mucosal disease ≤3 cm.
All debulking, re-TURBT specimens will be evaluated by local site pathology and are not required 
to be sent to the central pathology vendor.
Cystoscopy: A cystoscopy is required during screening to determine the presence of any residual 
tumor >3 cm within the 
-day screening period. The diagnostic TURBT may be sufficient for 
screening cystoscopy assessment if performed within 42 days of randomization it is performed by 
study Investigator, and the residual post-TURBT tumor size is documented as ≤3 cm.
For participants in Cohort 1: Visual assessment of the bladder urothelium and known tumor site(s)
will be performed at each placement/removal of TAR-200.
For participants in Cohort 2: There are no additional protocol-specified cystoscopic assessments 
beyond screening, however, cystoscopy may be performed at Week  if clinically indicated.
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Radical Cystectomy: The primary outcome assessment will be the rate of pCR within the bladder 
as well as analysis of residual tumor stage, ypTa, ypTis, ypT1-ypT4 will be performed as an 
outcome assessment for Cohort 1 and Cohort 2. The extent of nodal disease involvement after RC 
will be based upon the AJCC Bladder Cancer Staging nomenclature (AJCC 2017). Adjuvant or 
subsequent anti-cancer treatments will be documented within the eCRF and participants will 
continue per protocol study follow up visits. Participants with pelvic nodal disease at RC will be 
followed for efficacy assessments. Participants with metastatic disease noted at the time of RC, or 
at any time point, will be discontinued from the efficacy (imaging) follow-up. Participants should 
be followed for survival status.
8.7.2.2.
Imaging
Classification of Disease Progression via Nodal or Metastatic Disease
The presence of radiographic nodal and metastatic disease involvement will be assessed at 
participant screening, Week
 and during post RC follow up visits (every 
 weeks) through 
Week 108 (End of Study Visit). Additionally, radiographic response to treatment will be 
determined during on-study timepoints and will be based upon the AJCC Bladder Cancer Staging 
nomenclature (AJCC 2017).
!
All imaging will be performed for assessment of response and read/confirmed with central 
radiology review. 
!
At Week , if a participant develops imaging consistent with pelvic nodal disease, radical 
cystectomy and/or percutaneous biopsy should proceed at Investigator’s discretion.  
!
If participants develop metastatic disease (as assessed per RECIST 1.1) prior to RC, they 
should be taken off protocol study treatment and discontinued from the efficacy (imaging) 
follow-up.
!
If local progression is suspected from cystoscopy or based on clinical signs, participant should 
proceed with immediate RC if clinically indicated.
!
At post RC follow-up imaging assessment timepoints, if distant metastatic progression is 
confirmed, the participant should be discontinued from further imaging assessments and 
continued to be followed for survival status, subsequent anti-cancer therapies, and other 
malignancies. Participants with locoregional pelvic recurrence should continue efficacy 
evaluations (imaging) per the Schedule of Activities (Section 1.3).
8.7.3.
Overall Response Assessment
Overall response will be determined by findings radical cystectomy. The response assessments are 
presented for participants in Table 10.
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Table 10:
Overall Response Assessments after Radical Cystectomy
Bladder Disease
Lymph Node Disease
Overall 
Response
No evidence of intravesical disease 
pathologically (ypT0)
No evidence of pathologic nodal 
involvement
pCR
No evidence of intravesical disease 
pathologically (ypT0)
Evidence of new pathologic nodal disease
PD
Downstaged intravesical disease (<ypT2)
No evidence of pathologic nodal 
involvement
pPR
Downstaged intravesical disease (<ypT2)
Evidence of new pathologic nodal disease
PD
Increased burden of intravesical disease 
pathologically relative to clinical stage
No evidence of pathologic nodal 
involvement
PD
Increased burden of intravesical disease 
pathologically relative to clinical stage
Evidence of new pathologic nodal disease
PD
No change in intravesical disease
No evidence of pathologic nodal 
involvement
Stable disease
No change in intravesical disease
Evidence of new pathologic nodal disease
Stable disease
Abbreviations: pCR=pathologic complete response; PD=progressive disease; pPR=pathologic.
8.7.4.
Patient-Reported Outcomes
Patient-Reported Outcomes Assessments
Patient-reported outcomes measures will be collected at the times specified in the Schedule of 
Activities (Section 1.3). All PROs should be administered prior to other assessments. 
The disease specific PRO captured in this clinical trial is the FACT-Bl (Section 10.6, Appendix 6, 
PRO Questionnaires [FACT-Bl]). PGIS (Section 10.7, Appendix 7, PRO Questionnaires [PGIS]) 
and PGIC (10.8, Appendix 8, PRO Questionnaires [PGIC]) are single-item questionnaires that 
provide an anchor-based comparison for the FACT-Bl.
The PGIS and PGIC should be administered prior to other PRO assessments. The PGIC will not 
be administered at the first visit because it captures change. The PRO instrument will be provided 
in the local language in accordance with local guidelines.
8.8.
Safety Assessments
8.8.1.
Specification of Safety Parameters
Safety assessments will be based on medical review of adverse event reports and the results of 
vital sign measurements, 12-lead ECG, physical examinations, clinical laboratory tests,
cystoscopic examination, ADA assessments, concomitant treatments/procedures, and other safety 
evaluations at specified time points as described in the Schedule of Activities (Section 1.3). All 
AEs will be reported from the time of the informed consent form signature to the end of the 
100-day safety follow-up visit. All drug-related SAEs beyond 100 days after last dose of study 
treatment must be reported for participants during the Follow-up Phase. The Sponsor will evaluate 
any safety information that is spontaneously reported by an investigator beyond the time frame 
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In the event that a participant complains of unexpected fever, shortness of breath/dyspnea, or dry 
cough, a thorough evaluation for interstitial pneumonitis is recommended per institution standard 
of care.
Details regarding the internal Data Review Committee are provided in Committees Structure in 
Section 10.3, Appendix 3, Regulatory, Ethical, and Study Oversight Considerations.
Adverse events will be reported and followed by the Investigator as specified in Section 8.9, 
Adverse Events, Serious Adverse Events, and Other Safety Reporting, and Section 10.4, 
Appendix 4, Adverse Events, Serious Adverse Events, Product Quality Complaints, and Other 
Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-Up, and 
Reporting.
Any clinically relevant changes occurring during the study must be recorded on the Adverse Event 
section of the eCRF.
Any clinically significant abnormalities or toxicities persisting at the end of the study/early 
withdrawal will be followed by the Investigator until resolution or until a clinically stable condition 
is reached.
The study will include the following evaluations of safety and tolerability according to the time 
points provided in the Schedule of Activities.
8.8.2.
Immune-Mediated Adverse Events
Every AE must be assessed by the Investigator regarding whether it is considered 
immune-mediated. For events which are potentially immune-mediated, additional information will 
be collected on the participant’s eCRF. Immune-mediated AEs are AEs consistent with an 
immune-mediated mechanism or immune-mediated component for which non-inflammatory 
etiologies (eg, infection or tumor progression) have been ruled out. Immune-mediated AEs can 
include events with an alternate etiology, which were exacerbated by the induction of 
autoimmunity. Information supporting the assessment will be collected on the participant’s eCRF.
8.8.3.
Physical Examinations
A complete physical examination including head, ears, eyes, nose, throat and neck, cardiovascular, 
abdomen, musculoskeletal, skin, and genitourinary systems will be performed at the 
Screening Visit. Height is assessed at the Screening Visit only. A targeted physical examination 
must be conducted at every disease assessment visit, and as clinically indicated throughout the 
study. Weight will be assessed at each study visit. The Investigator must review physical 
examination results and record any clinically relevant changes occurring during the study in the 
medical history or adverse event section of the eCRF.

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8.8.4.
Vital Signs
Vital signs will be assessed per the Schedule of Activities (Section 1.3). Blood pressure (systolic 
and diastolic), heart rate, respiratory rate, and temperature will be assessed. The Investigator must 
review vital signs results and record any clinically relevant changes occurring during the study in 
the adverse event section of the eCRF.
8.8.5.
Electrocardiograms
12-lead electrocardiograms will be performed as specified in the Schedule of Activities 
(Section 1.3). Additional ECGs may be performed as clinically indicated. The participant should 
rest in a supine position for at least 5 minutes before ECG recording and should refrain from talking 
or moving the arms or legs. The 12-lead ECG recorder device used should have been recently 
serviced and calibrated. The Investigator will comment on the clinical relevance and document 
this in the eCRF (along with details of clinically significant findings).
8.8.6.
Clinical Safety Laboratory Assessments
Blood samples for serum chemistry and hematology will be collected as noted in Section 10.2,
Appendix 2, Clinical Laboratory Tests. More frequent clinical laboratory tests may be performed, 
as indicated by the overall clinical condition of the participant and for abnormalities that warrant 
more frequent monitoring. The Investigator must review the laboratory results, document this 
review, and record any clinically relevant changes occurring during the study in the adverse event 
section of the eCRF. The laboratory reports must be filed with the source documents.
Prior to dosing, laboratory tests are to be completed per the protocol schedule of activities
(Section 1.3). The laboratory tests will be performed by the local laboratory. The Investigator must 
review the laboratory results, document this review, and record any clinically relevant changes 
occurring during the study in the adverse event section of the eCRF.
Laboratory certificates or accreditation and normal ranges of the laboratory facility at the site must 
be submitted to the Sponsor before the screening of any participant at the site. If the participant 
has the laboratory assessments conducted at a laboratory facility other than the one associated with 
the investigational site, the Investigator must submit to the Sponsor laboratory certificates or 
accreditation and normal ranges for that facility as well. The laboratory reports must be filed with 
the source documents. Required laboratory evaluations are detailed in Section 10.2, Appendix 2, 
Clinical Laboratory Tests.
8.8.7.
Pregnancy Testing
Pre-dose urine or serum samples will be obtained for β-hCG pregnancy testing in participants of 
childbearing potential at time points indicated in the Schedule of Activities (Section 1.3) and as 
required per local regulations. Participants who are not of documented childbearing potential do 
not require a pregnancy test (Section 10.5). Potential childbearing status will be confirmed and 
documented pre- and if appropriate, post RC. Additional serum or urine pregnancy tests may be 
performed, as determined necessary by the investigator or required by local regulation, to establish 
the absence of pregnancy at any time during the participation in the study.

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Pregnancy tests will be performed to establish the absence of pregnancy at any time during the 
participant's participation in the study. If a urine pregnancy test is positive, it will be repeated with
serum pregnancy test. The study treatment will be provided only upon confirmation of negative 
pregnancy test.
8.8.8.
ECOG Performance Status
The ECOG performance status grade will be determined as part of screening evaluations, during 
disease assessment visits, and as clinically indicated throughout the study. The scoring information 
is provided in Section 10.12, Appendix 12, ECOG Performance Status Scale.
8.9.
Adverse Events, Serious Adverse Events, and Other Safety Reporting
Timely, accurate, and complete reporting and analysis of safety information, including AEs, SAEs, 
Product Quality Complaints (PQCs), and Device Deficiencies from clinical studies are crucial for 
the protection of participants, Investigators, and the Sponsor, and are mandated by regulatory 
agencies worldwide. The Sponsor has established Standard Operating Procedures in conformity with 
regulatory requirements worldwide to ensure appropriate reporting of safety information; all clinical 
studies conducted by the Sponsor or its affiliates will be conducted in accordance with those 
procedures. Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally acceptable representative) for the duration of the study.
Further details on AEs, SAEs, and PQC can be found in Section 10.4, Appendix 4: Adverse 
Events, Serious Adverse Events, Product Quality Complaints, and Other Safety Reporting: 
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting.
Further details on Device Deficiencies (related to the UPC) can be found in Section 10.10,
Appendix 10 (Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse 
Device Effects, Unanticipated Serious Adverse Device Effects, and Device Deficiencies: 
Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting in Medical 
Device Studies).
8.9.1.
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information
All Adverse Events
All AEs and special reporting situations, whether serious or non-serious, will be reported from the 
time a signed and dated study ICF is obtained until 100 days after the participant's last dose of 
study treatment or before the start of subsequent anticancer therapy. If a participant begins a new 
systemic anti-cancer therapy, the AE reporting period for non-SAEs ends at the time the new 
treatment is started. All drug-related SAEs beyond 100 days after last dose of study treatment 
should be reported for all cohorts while participants are in the study Follow-up Phase. The Sponsor
will evaluate any safety information that is spontaneously reported by an Investigator beyond the 
time frame specified in the protocol.
For this study, all device-related safety reporting will be done according to local legislation.

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Serious Adverse Events, PQCs, and Device Deficiencies
All SAEs, as well as PQCs and Device Deficiencies, occurring during the study must be reported 
to the appropriate Sponsor contact person by study site personnel immediately, without undue 
delay but no later than 24 hours of their knowledge of the event as required by local regulations.
Serious adverse events, including those spontaneously reported to the Investigator within 100 days 
after the last dose of study treatment, must be reported using the Serious Adverse Event Form.
Any SAE occurring after the end of the study period must be promptly reported if a causal 
relationship to the investigational drug is suspected. The Sponsor will evaluate any safety 
information that is spontaneously reported by an Investigator beyond the time frame specified in 
the protocol.
Information regarding SAEs will be transmitted to the Sponsor using the Serious Adverse Event 
Form and Safety Report Form of the eCRF, which must be completed and reviewed by a physician 
from the study site and transmitted to the Sponsor immediately without undue delay or within 24 
hours of the event as required by local regulations. The initial and follow-up reports of an SAE
should be transmitted electronically or by facsimile (fax). Telephone reporting should be the 
exception and the reporter should be asked to complete the appropriate form(s) first. Device 
Deficiencies of the UPC and PQCs associated with TAR-200 will be reported on the PQC form.
8.9.2.
Method of Detecting Adverse Events and Serious Adverse Events
Care will be taken not to introduce bias when detecting AEs or SAEs. Open-ended and nonleading 
verbal questioning of the participant is the preferred method to inquire about AE occurrence.
Solicited Adverse Events
Solicited AEs are predefined local and systemic events for which the participant is specifically 
questioned.
Unsolicited Adverse Events
Unsolicited AEs are all AEs for which the participant is not specifically questioned.
8.9.3.
Follow-up of Adverse Events and Serious Adverse Events, PQCs, and 
Device Deficiencies
The Investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and evaluations as medically indicated to elucidate the nature and causality of the AE, SAE, PQC
or Device Deficiency as fully as possible. This may include additional laboratory tests or 
investigations, histopathological examinations, or consultation with other health care 
professionals.
Adverse events and the special reporting situation of pregnancy, will be followed by the 
Investigator as specified in Section 10.4, Appendix 4, Adverse Events, Serious Adverse Events, 
Product Quality Complaints, and Other Safety Reporting: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting.

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8.9.4.
Regulatory Reporting Requirements for Serious Adverse Events and 
Anticipated Events
The Sponsor assumes responsibility for appropriate reporting of AEs to the regulatory authorities. 
The Sponsor will also report to the Investigator (and the head of the investigational institute where 
required) all suspected unexpected serious adverse reactions (SUSARs). The Investigator (or 
Sponsor where required) must report SUSARs to the appropriate Independent Ethics 
Committee/Institutional Review Board (IEC/IRB) that approved the protocol unless otherwise 
required and documented by the IEC/IRB.
An anticipated event is an AE that commonly occurs in the study population independent of 
exposure to the drug under investigation. Please refer to Anticipated Events (US only),
Section 10.16, Appendix 16 for a list of anticipated events. Please note that the list of anticipated 
events is pertinent for SUSAR reporting to the US FDA, US-based IECs/IRBs and Investigators
only (refer to Section 10.16, Appendix 16 for further background and details). All SAEs reported 
from study sites will be reviewed and assessed case by case by the Sponsor.
8.9.5.
Pregnancy
All initial reports of pregnancy in female participants or partners of male participants must be 
reported to the Sponsor by the study site personnel within 24 hours of their knowledge of the event 
using the appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg, 
spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are 
considered SAEs and must be reported using an SAE reporting form. Any participant who becomes 
pregnant during the study must discontinue further study treatment.
Because the effect of the study drugs on sperm is unknown, pregnancies in partners of male 
participants included in the study will be reported as noted above.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the 
infant will be requested.
8.9.6.
Adverse Events of Special Interest
There are no AEs of special interest for TAR-200 or cetrelimab for this protocol.
8.9.7.
Disease-related Events and Disease-related Outcomes Not Qualifying 
as Adverse Events or Serious Adverse Events
All events that meet the definition of a serious adverse event will be reported as serious adverse 
events, regardless of whether they are protocol-specific assessments.
Expected progression of disease, which is part of the natural course of the disease under study, 
should not be considered or reported as an adverse event (or serious adverse event).
However, if determined by the investigator to be more likely related to the study treatment, 
protocol design, or protocol procedures than being expected from the underlying disease, the 
treatment-invoked progression (ie the treatment-invoked signs/symptoms of such progression) 

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should be reported per the usual reporting requirements (refer to Adverse Event Definitions and 
Classifications in Section 10.4, Appendix 4: Adverse Events, Serious Adverse Events, Product 
Quality Complaints, and Other Safety Reporting: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting). 
Death that is attributed by the investigator explicitly to progression of disease should not be 
considered nor reported as an adverse event (or serious adverse event). Progression of disease and 
death due to disease progression should be documented on the appropriate eCRF forms (eg, the 
Disease Progression form and the Death form).
Signs or symptoms of disease progression that are of clinical significance, such as spinal cord 
compression, bony metastasis, vena cava superior syndrome, major vessel rupture, renal
obstruction or organ failure, should be documented on the appropriate eCRF forms (eg, the 
Symptomatic Progression Form).
8.9.8.
Product Quality Complaints and Medical Device Deficiencies
All PQC related to IV cetrelimab and TAR-200 as well as Device Deficiencies related to the UPC 
(including malfunction, use errors, or inadequacy in information supplied by the manufacturer) 
shall be documented and reported by the Investigator on the PQC reporting form (see Sections
10.4 [for TAR-200 and IV cetrelimab] and 10.10 [for the UPC]) and will be reviewed by the 
Investigator and Sponsor and reported in accordance with local legislation (see Section 10.10). If 
a PQC or Device Deficiency is reported, the TAR-200, cetrelimab, or UPC (for Device 
Deficiencies), respectively, must be retained under the correct storage conditions until a shipment 
request is received from the Sponsor. Please refer to the IFU for additional instructions.
NOTE: If an AE/SAE is reported as a consequence of Device Deficiency, follow the processes 
outlined in Section 8.9, Adverse Events, Serious Adverse Events, and Other Safety Reporting and 
Section 10.10, Appendix 10: Adverse Events, Adverse Device Effects, Serious Adverse Events, 
Serious Adverse Device Effects, Unanticipated Serious Adverse Device Effects, and Device 
Deficiencies: Definition and Procedures for Recording, Evaluating, Follow-up, and Reporting in 
Medical Device) of the protocol.
8.10.
Pharmacokinetics
Samples collected will be used to evaluate the PK of cetrelimab and TAR-200. Serum collected 
for PK may additionally be used to evaluate safety or efficacy aspects that address concerns arising 
during or after the study period. Genetic analyses will not be performed on these serum samples. 
Participant confidentiality will be maintained.
8.10.1.
Evaluations
Sparse Urine PK Samples for Gemcitabine and dFdU Analysis (Cohort 1 Only)
One single collection of urine samples will be collected from participants within 24 hours pre-dose 
at Week 0 Visit. One pooled 24-hr cumulative urine collection will be collected from participants 
anytime between Days 2 to 7 following TAR-200 insertion on either Week 
 and the urine 
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output of this 24-hr pooled urine collection will also be recorded. The 2 to 7 days sampling window 
is selected based on prior PK information from gemcitabine release from TAR-200, in which there 
is an approximate 1-day delay in drug release. Limited drug release occurs after the 7th indwelling 
day of TAR-200.
Detailed instructions for the collection, processing, storage, and shipment of samples are provided 
in the Laboratory Manual. The exact collection date and time of sampling must be recorded in the 
laboratory requisition form/source documentation and/or eCRF.
The final post placement sample collection days will be determined at the study participant and 
Investigator’s discretion. These sparse samples will be collected for assessment of gemcitabine 
and dFdU concentrations in urine (also see Table 3). The 20 participants in Cohort 1 in the serial 
urine sampling are not required to complete the Week 0 and 
sparse timepoints as the
serial urine sampling will meet these requirements.
Serial Urine PK Samples for Gemcitabine and dFdU Analysis (Cohort 1 Only)
!
Serial urine samples for gemcitabine and dFdU levels will also be collected according to the 
following schedule (also see Table 4) in up to 20 participants in Cohort 1. If participants have 
a documented sufficient rationale for not participating in this serial urine sampling, it will not 
preclude them from screening for the study.
!
Within 24 hours pre-dose at Week 0 (one single collection).
!
Beginning at Week 0, on all days from Day 1 through Day 5 and Day 8 through Day 12 (one 
pooled 24-hr cumulative urine collection per day). 
!
Beginning at Week 
 on all days from Day 1 through Day 5 and Day 8 through Day 12
(one pooled 24-hr cumulative urine collection per day).
Daily urine output over this sampling period in these approximately 20 participants will also be 
collected to demonstrate any correlation between a participant’s gemcitabine urine concentrations 
and daily urine output.
Detailed instructions for the collection, processing, storage and shipment of samples are provided 
in the Laboratory Manual. The exact collection date and time of sampling must be recorded in the 
laboratory requisition form/source documentation and/or eCRF.
Plasma PK Samples for Gemcitabine and dFdU Analysis (Cohort 1 Only)
Blood samples will be collected from participants at the following 2 time points (which coincide 
with sparse urine PK time points) as presented in Table 5:
!
Within 24 hours pre-dose at Week 0 Visit (required) 
!
Anytime between Days 2 to 7, following TAR-200 insertion on either Week
The exact collection date and time of sampling must be recorded in the laboratory requisition 
form/source documentation and/or eCRF.
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Serum PK Samples for IV Cetrelimab (Cohort 1 only)
!
Blood for the assessment of cetrelimab serum PK, including minimum concentration (Cmin) 
(pre-infusion) and Cmax (End -of -Infusion [EOI]) will be collected at the time points specified 
in Table 6 (Serum Pharmacokinetics for Cetrelimab). All pre-infusion trough samples should 
be drawn within 30 minutes and before cetrelimab infusion. Blood samples should be obtained 
from the arm contralateral to the arm where cetrelimab is infused. The exact dates and times 
of dosing and blood samples must be recorded accurately. Additional details are provided in 
the Laboratory Manual. 
The exact collection date and time of blood sampling must be recorded in the laboratory requisition 
form/source documentation and/or eCRF.
8.10.2.
Analytical Procedures
Venous blood samples will be collected for measurement of serum concentrations of cetrelimab
and the generation of antibodies to cetrelimab using validated immunoassay methods.
Plasma and urine samples will be analyzed to determine concentrations of gemcitabine and dFdU 
using validated liquid chromatography/tandem mass spectrometry (LC/MS) methods by or under 
the supervision of the Sponsor.
If required, some plasma, serum, and urine samples may be analyzed to document the presence of 
circulating metabolites using a qualified research method. In addition, plasma, serum, and urine
PK samples may be stored for future analysis of the metabolite profile.
Additional information about the collection, handling, and shipment of biological samples can be 
found in the Laboratory Manual.
8.11.
Genetics and Pharmacogenomics
Genetics and pharmacogenomics are not evaluated in this study.
8.12.
Biomarkers
Biomarker samples will be collected to evaluate the mechanism of action of TAR-200 in 
combination with cetrelimab in participants with muscle-invasive urothelial carcinoma. Samples 
may help to identify population subgroups that respond differently to TAR-200 in combination 
with cetrelimab.
Tissue for Immune Biomarkers and Molecular Subtyping and Mutational Profiling
Tissue collected on study will be used to assess the immune marker status and identify the 
molecular subtype of participants’ tumors, as well as identify changes in the tumor in response to 
treatment with TAR-200 in combination with IV cetrelimab. If participants demonstrate 
progression, a tissue sample should be collected for biomarker analysis.
The following analyses may be performed:
!
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!
RNA sequencing on tumor specimens to conduct molecular subtyping and to evaluate changes 
after treatment. Whole exome sequencing may also be performed on the TURBT specimen.
!
DNA mutation profiling to explore molecular markers of response and resistance. 
Circulating Biomarkers 
Blood samples for circulating tumor DNA (ctDNA)should be collected pre-dose and at timepoints 
specified in the Schedule of Activities (Section 1.3).
Circulating Tumor DNA
Blood and urine for analysis of ctDNA will be collected at multiple time points on study. Analysis 
of ctDNA offers the potential of a non-invasive method to track response to treatment by 
monitoring changes in target ctDNA levels over time and assess correlation with clinical 
responses. As such, measuring ctDNA levels will be assessed as a non-invasive disease 
surveillance approach and evaluated as a pharmacodynamic marker of response. Additionally, 
collection of blood or urine samples may be used to identify the emergence of potential markers 
of resistance.
Additional cancer relevant biomarkers may also be obtained from assessing DNA, RNA, protein, 
and serum soluble factors in blood, urine and tissue samples collected on the study to better 
understand the disease and mechanisms of response or resistance to TAR-200 in combination with 
cetrelimab.
The timing of biomarker collections may be modified during the study based on emerging data, 
however the number or volume of biomarker sampling will not increase.
Residual samples of blood or tissue for biomarker analysis may be stored for up to 15 years for 
additional research.
Detailed instructions for the collection, processing, storage, and shipment of samples are provided 
in the Study Reference Manual.
Stopping Analysis
Biomarker analyses are dependent upon the availability of appropriate biomarker assays and 
clinical response rates. Biomarker analysis may be deferred or not performed, if during or at the 
end of the study, it becomes clear that the analysis will not have sufficient scientific value for 
biomarker evaluation, or if there are not enough samples or responders to allow for adequate 
biomarker evaluation. In the event the study is terminated early or shows poor clinical efficacy, 
completion of biomarker assessments is based on justification and intended utility of the data.
Additional Collections
If it is determined at any time before study completion that additional material is needed from a 
formalin-fixed, paraffin-embedded tumor sample for the successful completion of the protocol-
specified analyses, the Sponsor may request that additional material be retrieved from existing 
samples. Also, based on emerging scientific evidence, the Sponsor may request additional material 

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from previously collected tumor samples during or after study completion for a retrospective 
analysis. In this case, such analyses would be specific to research related to the study treatment(s) 
or diseases being investigated.
8.13.
Immunogenicity Assessments
Serum Immunogenicity Samples for Cetrelimab (Cohort 1 and Cohort 2)
!
Blood samples will be collected, and serum will be analyzed for antibodies to cetrelimab,
using a validated immunoassay for ADA analysis at the timepoints specified in Table 7. The 
incidence of anti-cetrelimab antibodies will be summarized for all participants who receive at 
least 1 dose of IV cetrelimab and have appropriate samples for detection of antibodies to IV
cetrelimab (ie, participants with at least 1 sample obtained after their first dose of cetrelimab).
!
All pre-infusion samples should be drawn within 30 minutes before infusion of IV cetrelimab. 
If drug was administered via a central venous catheter, sample collection for PK should be
from a different site. Blood samples will be processed to obtain serum for measurement of 
cetrelimab concentration by a validated analytical method by the Sponsor. Additional details 
are provided in the Laboratory Manual. The exact date and time of sample collections must
be recorded on the appropriate eCRF. 
The exact collection date and time of blood sampling must be recorded in the laboratory requisition 
form/source documentation and/or eCRF.
8.14.
Medical Utilization and Health Economics
Medical resource utilization and health economics data, associated with medical encounters, will 
be collected in the eCRF by the Investigator and study site personnel for all participants throughout 
the study. Protocol-mandated procedures, tests, and encounters are excluded. The data collected 
may be used to conduct exploratory economic analyses and will include:
!
Number and duration of medical care encounters, including surgeries, and other selected 
procedures (inpatient and outpatient)
!
Duration of hospitalization (total days length of stay, including duration by wards; 
eg, intensive care unit)
!
Number and character of diagnostic and therapeutic tests and procedures
!
Outpatient medical encounters and treatments (including physician or emergency room visits, 
tests and procedures, and medications)
9.
STATISTICAL CONSIDERATIONS
Statistical analysis will be done by the Sponsor or under the authority of the Sponsor. A general 
description of the statistical methods to be used to analyze the efficacy and safety data is outlined 
below. Specific details will be provided in the Statistical Analysis Plan.
9.1.
Statistical Hypotheses
The statistical hypothesis is that the combination of TAR-200 + IV cetrelimab (Cohort 1) will lead 
to a pCR rate 
 or greater (against a hurdle rate of 
), and the IV cetrelimab alone (Cohort 2)
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will lead to a pCR rate 
or greater (against a hurdle rate of 
). There is no formal statistical 
hypothesis testing for the comparison between the 2 cohorts. 
9.2.
Sample Size Determination
This study will randomize approximately 160 participants in a 5:3 randomization ratio to receive 
TAR-200 + IV cetrelimab (n=100) or IV cetrelimab alone (n=60).
This sample size determination utilizes a Bayesian approach with Beta(0.5,0.5) as the prior 
distribution and Beta(0.5+m, 0.5+n-m) as the posterior distribution for the pCR rate, where m is the 
observed number of participants with pCR and n is the total number of participants. Assuming a pCR 
rate of 
for TAR-200 + IV cetrelimab (Cohort 1), 100 participants will provide over 90% 
probability to have the lower limit of the 80% credible interval exceeding 
 pCR rate (or about 
80% probability of exceeding 
 pCR rate). Assuming a pCR rate of 
 for the IV cetrelimab 
alone (Cohort 2), 60 participants will provide about 65% probability to have the lower limit of the 
80% credible interval exceeding
pCR rate.
9.3.
Participant for Analysis Sets
For purposes of analysis, the following populations are defined:
Analysis Sets
Description
Enrolled
All participants who signed Informed Consent Form (ICF)
Randomized
All participants who were randomized in the study
Treated
All participants who receive at least 1 dose of any study treatment
Evaluable
All participants who receive at least 1 dose of any study treatment, undergo RC and have 
adequate disease assessment at the RC
9.4.
Statistical Analyses
The statistical analysis plan will include a more technical and detailed description of the statistical 
analyses described in this section. This section is a summary of the planned statistical analyses of 
the most important endpoints including primary and key secondary endpoints.
9.4.1.
General Considerations
This study is being performed to assess safety, efficacy, and tolerability of 4 consecutive dosing 
cycles of TAR-200 + IV cetrelimab, and IV cetrelimab alone (monotherapy) neoadjuvant to radical 
cystectomy. A side-by-side descriptive summary of efficacy will be provided to illustrate the 
contribution of TAR-200 to the efficacy of the combination therapy.
9.4.2.
Primary Endpoint
Primary Estimand
!
Population: participants with muscle-invasive urothelial carcinoma of the bladder who are 
scheduled for radical cystectomy and are ineligible for or refusing platinum-based 
neoadjuvant chemotherapy
!
Variable: pCR or ypT0N0, at the radical cystectomy
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!
Study Treatment: TAR-200 + IV cetrelimab, or IV cetrelimab alone
!
Intercurrent event: subsequent therapy. Hypothetical Strategy: Response after this intercurrent 
event will not be considered as a response
!
Summary: pCR rate at the radical cystectomy
The primary endpoint, pCR rate, is defined as the proportion of participants with a pCR which will 
be derived from analysis of a RC bladder specimen.
The point estimate of pCR rate and the corresponding 2-sided 80% credible interval (CrI) will be 
calculated for each cohort. The 80% CrI will be symmetric (ie, 10% for each tail) and be calculated 
utilizing a Bayesian approach with Beta(0.5, 0.5) as prior distribution and Beta(0.5+m, 0.5+n-m) 
as the posterior distribution for the pCR rate, where m is the observed number of participants with 
pCR and n is the total number of participants. Additionally, 95% exact confidence interval will 
also be calculated for each cohort based on binomial distribution.
Dynamic borrowing external data from similar PD-1/PD-L1 treatments in the similar disease 
population may be explored to support the primary analysis.
9.4.3.
Secondary Endpoint(s)
Recurrence-free survival (RFS) will be determined in participants receiving TAR-200 + IV 
cetrelimab (Cohort 1) and IV cetrelimab alone (Cohort 2). Recurrence-free survival is defined as the 
time from first dose of any study treatment to first radiologic (as assessed by RECIST 1.1 criteria) 
or histologic evidence of nodal or metastatic disease or death due to any cause. For participants who 
are free from RFS event, data will be censored at the last study disease assessment.
The distribution of RFS will be estimated for each cohort using Kaplan-Meier method.
9.4.4.
Exploratory Endpoint(s)
Overall survival (OS) will be determined in participants receiving TAR-200 + IV cetrelimab
(Cohort 1), and IV cetrelimab alone (Cohort 2) OS is defined as the time from first dose of any 
study treatment to death. The distribution of OS will be estimated for each cohort using Kaplan-
Meier method.
Pathologic overall response (pOR) will be determined in participants receiving TAR-200 + IV 
cetrelimab (Cohort 1), and IV cetrelimab alone (Cohort 2). Pathologic overall response (pOR) will 
be determined by composite evaluation of local disease in the bladder and evaluation of nodal and 
metastatic disease as defined above. pOR rate is defined as the proportion of participants with 
either pCR or pPR. The response assessments are presented for participants who are N0 at the start 
of the study in Table 10. The pOR rate will be tabulated together with its 95% exact confidence 
interval. In addition, the number and percentage of participants in each response category will be
tabulated.

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The TSP will be determined in participants receiving TAR-200 + IV cetrelimab and IV cetrelimab
alone. The TSP defined as the time from first dose of any study treatment to documentation of any 
of the following (whichever occurred earlier):
!
Progression of pain or worsening of disease-related symptoms requiring initiation of a new 
systemic anticancer therapy
!
Development of clinically significant symptoms due to locoregional tumor progression 
requiring surgical treatment or radiation therapy.
!
Development of symptomatic deterioration on the basis of global deterioration of health 
status.
The distribution of TSP will be estimated for each cohort using Kaplan-Meier method.
9.4.5.
Safety Analyses
All safety analyses are to be performed on data from the All Treated Analysis Set. The baseline value 
for safety assessment is defined as the value collected at the time closest to, but prior to, the start of 
either TAR-200 or IV cetrelimab. Safety evaluations include the incidence, severity, and type of 
adverse events, clinically significant changes in the participant’s physical examination findings, vital 
signs measurements, and clinical laboratory results. Exposure to investigational product and reasons 
for discontinuation of study treatment will be tabulated. Adverse events will be summarized by 
system organ class, preferred term, and worst grade experienced by the participant.
Adverse Events
The verbatim terms used in the eCRF by Investigators to identify AEs will be coded using the 
Medical Dictionary for Regulatory Activities (MedDRA). Any AE occurring at or after the initial 
administration of study treatment through the day of last dose plus 100 days or that is a 
consequence of a pre-existing condition that has worsened since baseline is considered to be 
treatment-emergent. All reported treatment-emergent AEs which occur within 100 days after last 
dose of study treatment will be included in the analysis. Serious Adverse Events, if considered 
related to study treatment, occurring more than 100 days after the last dose of study treatment
should also be reported. For each AE, the percentage of participants who experience at least 
1 occurrence of the given event will be summarized by treatment group.
Summaries, listings, datasets, or participant narratives may be provided, as appropriate, for those 
participants who die, who discontinue treatment due to an AE, or who experience a severe or a 
SAE.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test. Descriptive statistics will be 
calculated for laboratory analytes at baseline and at each scheduled timepoint. Parameters with 
predefined NCI-CTCAE toxicity grades will be summarized. Change from baseline to the worst 
grade experienced by the participant during the study will be provided as shift tables.

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Electrocardiogram
Electrocardiogram data will be summarized by ECG parameter. Descriptive statistics will be 
calculated at baseline and for observed values and changes from baseline at each scheduled time 
point. 
The ECG variables that will be analyzed are heart rate, PR interval, QRS interval, QT interval, and 
corrected QT (QTc) interval using the following correction methods: QT corrected according to 
Fridericia's formula (QTcF).
Descriptive statistics of QTc intervals and changes from baseline will be summarized at each 
scheduled time point. The percentage of participants with QTc interval >450 milliseconds, 
>480 milliseconds, or >500 milliseconds will be summarized, as will the percentage of participants 
with QTc interval increases from baseline >30 milliseconds or >60 milliseconds.
Vital Signs
Vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic 
and diastolic) will be summarized descriptively.
9.4.6.
Other Analyses
Pharmacokinetic Analyses
TAR-200:
Urine and plasma concentration of gemcitabine and dFdU, and urine amount of gemcitabine and 
dFdU will be listed (for both sparse and serial urine PK and plasma PK) and summarized (for serial 
urine PK only) at each timepoint using descriptive statistics (arithmetic mean, standard deviation 
[SD], coefficient of variation [CV], geometric mean, geometric CV, median, minimum, and 
maximum). All concentrations below the lowest quantifiable concentration or missing data will be 
labeled as such in the concentration and amount data presentation. For serial urine PK, PK 
parameters will be listed and summarized using descriptive statistics. Concentrations below the 
lowest quantifiable concentration will be treated as zero in the summary statistics and for the 
calculation of PK parameters. All participants and samples excluded from the analysis will be 
clearly documented in the study report. Details of the analyses will be described in the Clinical 
Pharmacology Analysis Plan.
If feasible, population PK analysis of urine and plasma concentration-time data of TAR-200 may 
be performed using nonlinear mixed-effects modeling. Data may be combined with those of other 
selected studies to support a relevant structural model. Available baseline participant 
characteristics (demographics, laboratory variables, genotypes, race, etc.) will be tested as 
potential covariates affecting PK parameters. Details will be given in a population PK analysis 
plan and the results of the population PK analysis will be presented in a separate report.

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Cetrelimab:
Cetrelimab concentrations will be summarized by cohort and at each timepoint using descriptive 
statistics (arithmetic mean, SD, CV, geometric mean, geometric CV, median, minimum, and 
maximum) and figures. All concentrations below the lowest quantifiable concentration or missing 
data will be labeled as such in the concentration data presentation. Concentrations below the lowest 
quantifiable concentration will be treated as zero in the summary statistics and for the calculation 
of PK parameters. All participants and samples excluded from the analysis will be clearly 
documented in the study report.
If feasible, population PK analysis of serum concentration-time data of cetrelimab may be 
performed using nonlinear mixed-effects modeling. Data may be combined with those of other 
selected studies to support a relevant structural model. Available baseline participant 
characteristics (demographics, laboratory variables, genotypes, race, etc.) will be tested as 
potential covariates affecting PK parameters. Details will be given in a population PK analysis 
plan and the results of the population PK analysis will be presented in a separate report.
Biomarkers Analyses
Associations between baseline levels and changes from baseline in select markers and clinical 
response will be explored.
Results of exploratory biomarker analyses may be presented in a separate report. Planned 
biomarker analyses may be deferred if emerging study data show no likelihood of providing useful 
scientific information.
Immunogenicity Analyses
The incidence of anti-cetrelimab antibodies will be summarized for all participants who receive at 
least 1 dose of cetrelimab and have appropriate samples for detection of antibodies to cetrelimab 
(ie, participants with at least 1 sample obtained after their first dose of cetrelimab). A listing of 
participants who are positive for antibodies to cetrelimab will be provided. The maximum titers of 
antibodies to cetrelimab will be summarized for participants who are positive for antibodies to 
cetrelimab by cohort. Other immunogenicity analyses may be performed to further characterize 
the immune responses that are generated.
Pharmacokinetic/pharmacodynamic Analyses
Pharmacokinetic/pharmacodynamic models may be explored to understand and characterize the 
exposure-response relationship for key efficacy, safety, and pharmacodynamic/biomarker data 
parameters, to detect the influence of covariates, and to identify inter-individual variability in 
response. The details will be provided in a separate analysis plan and the results of the analyses 
will be summarized in a separate report.
Patient-Reported Outcomes Assessments
Results for FACT-Bl data will be summarized descriptively for participants who receive at least 
1 dose of study treatment and have at least 1 evaluable postbaseline measurement by treatment 

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group and study visit. Each multi-item scale and individual item will be summarized using count 
and percent. 
The change of FACT-Bl from baseline will also be assessed. The meaningful clinical important 
difference will be assessed with an anchor-based method utilizing the PGIC and PGIS. A 
supplemental PRO Statistical Analysis Plan may be provided to describe analyses.
Time to worsening in FACT-Bl total score and individual scales will be analyzed using a 
Kaplan-Meier method and stratified Cox proportional hazard model. Additional analysis may be 
done, if appropriate. Analysis details will be included in the Statistical Analysis Plan. 
The PRO and AE data will not be reconciled with one another. Only PRO data will be used to 
conduct these analyses.
Healthcare Resource Utilization and Health Economics Analyses
Healthcare resource utilization and health economics will be descriptively summarized by cohort.
9.5.
Interim Analysis (Cohort 1 and Cohort 2)
Two interim analyses are planned. The first interim analysis (IA1) will be conducted after 
 
participants in total (ie, approximately 
in Cohort 1 and approximately 
in Cohort 2) complete 
the RC and have the disease assessment of pCR at RC. The second interim analysis (IA2) will be
after approximately 
participants in total (ie, approximately 
 Cohort 1 and approximately 
 in Cohort 2) complete the RC and have the disease assessment of pCR at RC. The analyses will
utilize the Bayesian approach described in Section 9.4.2
At IA1, the cetrelimab cohort may be stopped for futility if the posterior probability of pCR rate 
 is greater than 80%, ie, the number of participants with pCR is
. The criteria ensure at 
least 60% probability of early termination for futility if the true pCR rate for the cetrelimab cohort 
is less than 
At IA2, the cetrelimab cohort may be stopped for futility if the posterior probability of pCR rate 
is greater than 80%, ie, the number of participants with pCR is 
 Similarly, an early 
success may be declared for the TAR-200 and cetrelimab cohort if the posterior probability of pCR 
rate 
is greater than 80%, ie, the number of participants with pCR is 
 The criteria ensure 
at least 71% probability of early termination for futility if the true pCR rate for the cetrelimab 
cohort is less than 
, or 71% probability of early success for the combination if the true pCR 
rate for the combination cohort is greater than 
IDMC will be established to review interim data. Specific details will be outlined in the IDMC 
Charter.
CC
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10.
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1.
Appendix 1: Abbreviations and Definitions
ADA
anti-drug antibody
AE
adverse events
AJCC
American Joint Committee on Cancer
ALP
Alkaline phosphatase
ALT
alanine aminotransferase 
ANC
absolute neutrophil count
AST
aspartate aminotransferase 
AUA
American Urological Association
AUCtau
area under the curve for 1 dosing interval 
β-hCG
β-human chorionic gonadotropin
Cavg
observed mean maximum serum concentration
CFU
colony forming units
Cmax
maximum serum concentration
CR
complete response
CRC
colorectal cancer
CrI
credible interval
CT
computed tomography
Ctrough
predose concentration at steady-state
dFdU
2′,2′-difluorodeoxyuridine
EAU
European Association of Urology
ECG
Electrocardiogram
eCRF
electronic case report form(s)
eDC
electronic data capture
EORTC
European Organization for Research and Treatment of Cancer
ECOG
Eastern Cooperative Oncology Group
FACT-Bl
Functional Assessment of Cancer Therapy – Bladder
FDA
Food and Drug Administration
FOIA
Freedom of Information Act
GCP
Good Clinical Practice
GGT
Gamma-glutamyltransferase 
HCV
hepatitis C
HIV
human immunodeficiency virus
HNT
human nucleoside transporter
HRQoL
health-related quality of life
MRU
Medical resource utilization
IA
interim analysis
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Council for Harmonisation
IDMC
Independent Data Monitoring Committee
IEC
Independent Ethics Committee
IFU
instructions for use
IHC
Immunohistochemistry
IMP
Investigational Medicinal Product
INR
international normalized ratio
IPPI
Investigational Product Preparation Instructions
irAE
immune-related adverse event
IRB
Institutional Review Board
IRR
infusion-related reactions
IWRS
interactive web response system
IV
Intravenous
mAb
monoclonal antibody

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MedDRA
Medical Dictionary for Regulatory Activities
MIBC
Muscle Invasive Bladder Cancer
MRI
magnetic resonance imaging
NCCN
National Comprehensive Cancer Network
NMIBC
Non-muscle Invasive Bladder Cancer
NSAIDs
anticholinergics, nonsteroidal anti-inflammatory drugs
NSCLC
non-small cell lung cancer
ORR
overall response rate
OS
overall survival
pCR
pathologic complete response
PD-1
programmed-cell death protein 1
PD-L1
programmed-cell death ligand 1
PD-L2
programmed-cell death ligand 2
PGIC
Patient Global Impression of Change
PGIS
Patient Global Impression of Severity
PK
pharmacokinetic(s)
POCBP
Participants of Childbearing Potential
pOR
pathologic overall response
pPR
pathologic partial response
PQC
Product Quality Complaint
PRO (ePRO)
patient-reported outcome(s) (paper or electronic as appropriate for this study)
PVR
Post-Void Residual 
Q2W
once every 2 weeks
Q3W
once every 3 weeks
Q4W
once every 4 weeks
QoL
Quality of Life
RBC
red blood cell
RC
radical cystectomy
RCRI
Revised Cardiac Risk Index
RFS
recurrence-free Survival
RP2Ds
recommended Phase 2 dose(s)
SAE
serious adverse event
SC
subcutaneous
SD
standard deviation
SIPPM
Site Investigational Product and Procedures Manual
SUSAR
suspected unexpected serious adverse reaction
TGF-β
transforming growth factor beta
TSP
time to symptom deterioration
TURBT
transurethral resection of bladder tumor
ULN
upper limit of normal
UPC
Urinary Placement Catheter
UTI
urinary tract infection
WBC
white blood cell
WHO
World Health Organization
Definitions of Terms
Electronic Source 
System
Contains data traditionally maintained in a hospital or clinic record to document medical 
care or data recorded in an eCRF as determined by the protocol. Data in this system may 
be considered source documentation.
PRO
Reports directly from the participant without interpretation by clinician or anyone else

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10.3.
Appendix 3: Regulatory, Ethical, and Study Oversight Considerations
10.3.1.
Regulatory and Ethical Considerations
Investigator Responsibilities
The Investigator is responsible for ensuring that the study is performed in accordance with the 
protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable regulatory and 
country- or territory-specific requirements.
Good Clinical Practice is an international ethical and scientific quality standard for designing, 
conducting, recording, and reporting studies that involve the participation of human participants. 
Compliance with this standard provides public assurance that the rights, safety, and well-being of 
study participants are protected, consistent with the principles that originated in the Declaration of 
Helsinki, and that the study data are credible.
Protocol Clarification Communications
If text within a final approved protocol requires clarification (eg, current wording is unclear or 
ambiguous) that does not change any aspect of the current study conduct, a protocol clarification 
communication (PCC) may be prepared. The PCC Document will be communicated to the 
Investigational Site, Site Monitors, Local Trial Managers (LTMs), Clinical Trial Managers 
(CTMs), and/or Contract Research Organizations (CROs) who will ensure that the PCC 
explanations are followed by the investigators.
The PCC Document may be shared by the sites with Independent Ethics Committees/Institutional 
Review Boards (IECs/IRBs) per local regulations.
The PCC Documents must NOT be used in place of protocol amendments, but the content of the 
PCC Document must be included in any future protocol amendments.
Protocol Amendments
Neither the Investigator nor the Sponsor will modify this protocol without a formal amendment by 
the Sponsor. All protocol amendments must be issued by the Sponsor, and signed and dated by the 
Investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or 
when the relevant competent authority has raised any grounds for non-acceptance, except when 
necessary to eliminate immediate hazards to the participants, in which case the amendment must 
be promptly submitted to the IEC/IRB and relevant competent authority. Documentation of 
amendment approval by the Investigator and IEC/IRB must be provided to the Sponsor. When the 
change(s) involve only logistic or administrative aspects of the study, the IEC/IRB (where 
required) only needs to be notified.
During the course of the study, in situations where a departure from the protocol is unavoidable, 
the Investigator or other physician in attendance will contact the appropriate Sponsor
representative listed in the Contact Information page(s), which will be provided as a separate 
document. Except in emergency situations, this contact should be made before implementing any 
departure from the protocol. In all cases, contact with the Sponsor must be made as soon as possible 

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to discuss the situation and agree on an appropriate course of action. The data recorded in the eCRF 
and source documents will reflect any departure from the protocol, and the source documents will 
describe this departure and the circumstances requiring it.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities 
in each respective country/territory, if applicable. A study may not be initiated until all local 
regulatory requirements are met.
Required Prestudy Documentation
The following documents must be provided to the Sponsor before shipment of study treatment to 
the study site:
!
Protocol and amendment(s), if any, signed and dated by the principal Investigator
!
A copy of the dated and signed (or sealed, where appropriate per local regulations), written 
IEC/IRB approval of the protocol, amendments, ICF, any recruiting materials, and if 
applicable, participant compensation programs. This approval must clearly identify the 
specific protocol by title and number and must be signed (or sealed, where appropriate per 
local regulations) by the chairman or authorized designee.
!
Name and address of the IEC/IRB, including a current list of the IEC/IRB members and their 
function, with a statement that it is organized and operates according to GCP and the 
applicable laws and regulations. If accompanied by a letter of explanation, or equivalent, from 
the IEC/IRB, a general statement may be substituted for this list. If an Investigator or a 
member of the study site personnel is a member of the IEC/IRB, documentation must be 
obtained to state that this person did not participate in the deliberations or in the vote/opinion 
of the study.
!
Regulatory authority approval or notification, if applicable
!
Signed and dated statement of Investigator (eg, Form FDA 1572), if applicable
!
Documentation of Investigator qualifications (eg, curriculum vitae)
!
Completed Investigator financial disclosure form from the principal Investigator, where 
required
!
Signed and dated clinical trial agreement, which includes the financial agreement
!
Any other documentation required by local regulations
The following documents must be provided to the Sponsor before enrollment of the first 
participant:
!
Completed Investigator financial disclosure forms from all sub-Investigators
!
Documentation of sub-Investigator qualifications (eg, curriculum vitae)
!
Name and address of any local laboratory conducting tests for the study, and a dated copy of 
current laboratory normal ranges for these tests, if applicable

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!
Local 
laboratory 
documentation 
demonstrating 
competence 
and 
test 
reliability 
(eg, accreditation/license), if applicable
Independent Ethics Committee or Institutional Review Board
Before the start of the study, the Investigator (or Sponsor where required) will provide the IEC/IRB 
with current and complete copies of the following documents (as required by local regulations):
!
Final protocol and, if applicable, amendments
!
Sponsor-approved ICF (and any other written materials to be provided to the participants)
!
IB (or equivalent information) and amendments/addenda
!
Sponsor-approved participant recruiting materials
!
Information on compensation for study-related injuries or payment to participants for 
participation in the study, if applicable
!
Investigator's curriculum vitae or equivalent information (unless not required, as documented 
by the IEC/IRB)
!
Information regarding funding, name of the Sponsor, institutional affiliations, other potential 
conflicts of interest, and incentives for participants
!
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after the IEC/IRB has given full approval of the final protocol, 
amendments (if any, excluding the ones that are purely administrative, with no consequences for 
participants, data or study conduct, unless required locally), the ICF, applicable recruiting 
materials, and participant compensation programs, and the Sponsor has received a copy of this 
approval. This approval letter must be dated and must clearly identify the IEC/IRB and the 
documents being approved.
During the study the Investigator (or Sponsor where required) will send the following documents 
and updates to the IEC/IRB for their review and approval, where appropriate:
!
Protocol amendments (excluding the ones that are purely administrative, with no 
consequences for participants, data or study conduct)
!
Revision(s) to ICF and any other written materials to be provided to participants
!
If applicable, new or revised participant recruiting materials approved by the Sponsor
!
Revisions to compensation for study-related injuries or payment to participants for 
participation in the study, if applicable
!
New edition(s) of the IB and amendments/addenda
!
Summaries of the status of the study at intervals stipulated in guidelines of the IEC/IRB (at 
least annually)
!
Reports of AEs that are serious, unlisted/unexpected, and associated with the study treatment

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!
New information that may adversely affect the safety of the participants or the conduct of the 
study
!
Deviations from or changes to the protocol to eliminate immediate hazards to the participants
!
Report of deaths of participants under the Investigator's care
!
Notification if a new Investigator is responsible for the study at the site
!
Development Safety Update Report and Line Listings, where applicable
!
Any other requirements of the IEC/IRB
For all protocol amendments (excluding the ones that are purely administrative, with no 
consequences for participants, data or study conduct), the amendment and applicable ICF revisions 
must be submitted promptly to the IEC/IRB for review and approval before implementation of the 
change(s).
At least once a year, the IEC/IRB will be asked to review and reapprove this study, where required.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB about 
the study completion (if applicable, the notification will be submitted through the head of 
investigational institution).
Country/Territory Selection
This study will only be conducted in those countries/territories where the intent is to launch or 
otherwise help ensure access to the developed product if the need for the product persists, unless 
explicitly addressed as a specific ethical consideration in Section 4.2.1, Study-Specific Ethical 
Design Considerations.
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.1.
10.3.2.
Financial Disclosure
Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial 
information in accordance with local regulations to allow the Sponsor to submit complete and 
accurate financial certification or disclosure statements to the appropriate regulatory authorities. 
Investigators are responsible for providing information on financial interests during the course of 
the study and for 1 year after completion of the study.
Refer to Required Pre-study Documentation (above) and contracts for details on financial 
disclosure.
10.3.3.
Informed Consent Process
Each participant (or a legally acceptable representative) must give written consent according to 
local requirements after the nature of the study has been fully explained. The ICF(s) must be signed 
before performance of any study-related activity. The ICF(s) that is/are used must be approved by 
both the Sponsor and by the reviewing IEC/IRB and be in a language that the participant can read 

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and understand. The informed consent should be in accordance with principles that originated in 
the Declaration of Helsinki, current ICH and GCP guidelines, applicable regulatory requirements, 
and Sponsor policy.
Before enrollment in the study, the Investigator or an authorized member of the study site
personnel must explain to potential participants or their legally acceptable representatives the aims, 
methods, reasonably anticipated benefits, and potential hazards of the study, and any discomfort 
participation in the study may entail. Participants will be informed that their participation is 
voluntary and that they may withdraw consent to participate at any time. They will be informed 
that choosing not to participate will not affect the care the participant will receive for the treatment 
of his or her disease. Participants will be told that alternative treatments are available if they refuse 
to take part and that such refusal will not prejudice future treatment. Finally, they will be told that 
the Investigator will maintain a participant identification register for the purposes of long-term 
follow up if needed and that their records may be accessed by health authorities and authorized
Sponsor personnel without violating the confidentiality of the participant, to the extent permitted 
by the applicable law(s) or regulations. By signing the ICF the participant or legally acceptable 
representative is authorizing such access, which includes permission to obtain information about 
his or her survival status. It also denotes that the participant agrees to allow his or her study 
physician to recontact the participant for the purpose of obtaining consent for additional safety 
evaluations, and subsequent disease-related treatments, if needed.
The participant (or legally acceptable representative) will be given sufficient time to read the ICF 
and the opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of either the participant's or his or her legally 
acceptable representative's personally dated signature. After having obtained the consent, a copy 
of the ICF must be given to the participant.
A participant who is rescreened is not required to sign another ICF if the rescreening occurs within 
42 days from the previous ICF signature date.
If the participant or legally acceptable representative is unable to read or write, an impartial witness 
must be present for the entire informed consent process (which includes reading and explaining all 
written information) and must personally date and sign the ICF after the oral consent of the 
participant or legally acceptable representative is obtained.
10.3.4.
Data Protection
Privacy of Personal Data
The collection and processing of personal data from participants enrolled in this study will be 
limited to those data that are necessary to fulfill the objectives of the study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. Appropriate 
technical and organizational measures to protect the personal data against unauthorized disclosures 
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place. 

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Sponsor personnel whose responsibilities require access to personal data agree to keep the identity 
of participants confidential.
The informed consent obtained from the participant (or his or her legally acceptable representative)
includes explicit consent for the processing of personal data and for the Investigator/institution to 
allow direct access to his or her original medical records (source data/documents) for study-related 
monitoring, audit, IEC/IRB review, and regulatory inspection. This consent also addresses the 
transfer of the data to other entities and to other countries/territories.
The participant has the right to request through the Investigator access to his or her personal data 
and the right to request rectification of any data that are not correct or complete. Reasonable steps 
will be taken to respond to such a request, taking into consideration the nature of the request, the 
conditions of the study, and the applicable laws and regulations.
Exploratory biomarker, PK, and immunogenicity research is not conducted under standards 
appropriate for the return of data to participants. In addition, the Sponsor cannot make decisions 
as to the significance of any findings resulting from exploratory research. Therefore, exploratory 
research data will not be returned to participants or Investigators, unless required by law or local 
regulations. Privacy and confidentiality of data generated in the future on stored samples will be 
protected by the same standards applicable to all other clinical data.
10.3.5.
Long-Term Retention of Samples for Additional Future Research
Samples collected in this study may be stored for up to 15 years (or according to local regulations) 
for additional research. Samples will only be used to understand cetrelimab and TAR-200, to 
understand urothelial cancer, to understand differential drug responders, and to develop 
tests/assays related to cetrelimab, TAR-200, and urothelial cancer. The research may begin at any 
time during the study or the post-study storage period. 
Stored samples will be coded throughout the sample storage and analysis process and will not be 
labeled with personal identifiers. Participants may withdraw their consent for their samples to be 
stored for research (refer to Section 7.3.1, Withdrawal From the Use of Research Samples).
10.3.6.
Committees Structure
Independent Data Monitoring Committee (IDMC)
An IDMC of at least 2 medical experts in the relevant therapeutic area and at least 1 statistician 
will be established to monitor data on an ongoing basis to ensure the safety of the participants 
enrolled in this study. The committee membership responsibilities, authorities, and procedures will 
be documented in the IDMC Charter. The safety review will focus on deaths, study drug 
discontinuations, SAEs, Grade ≥3 events, and emerging safety data. Based on the results from 
these scheduled safety review meetings, the IDMC chair may request more frequent monitoring. 
Until the first IDMC review, all deaths, study drug discontinuations and SAEs will be reviewed 
by the Sponsor’s medical monitor on an ongoing basis to identify safety concerns, and the IDMC 
will be informed of any new potential signals. The committee will meet periodically to review 

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interim data. After the review, the IDMC will make recommendations regarding the continuation 
of the study.
10.3.7.
Publication Policy/Dissemination of Clinical Study Data
All information, including but not limited to information regarding or the Sponsor's operations 
(eg, patent application, formulas, manufacturing processes, basic scientific data, prior clinical data, 
formulation information) supplied by the Sponsor to the Investigator and not previously published, 
and any data, including biomarker research data, generated as a result of this study, are considered 
confidential and remain the sole property of the Sponsor. The Investigator agrees to maintain this 
information in confidence and use this information only to accomplish goals of this study and will 
not use it for other purposes without the Sponsor's prior written consent.
The Investigator understands that the information developed in the study will be used by the 
Sponsor in connection with the continued development of TAR-200 and cetrelimab, and thus may 
be disclosed as required to other clinical Investigators or regulatory agencies. To permit the 
information derived from the clinical studies to be used, the Investigator is obligated to provide 
the Sponsor with all data obtained in the study.
The results of the study will be reported in a Clinical Study Report generated by the Sponsor and 
will contain data from all study sites that participated in the study as per protocol. Recruitment 
performance or specific expertise related to the nature and the key assessment parameters of the 
study will be used to determine a coordinating Investigator for the study. Results of biomarker 
analyses performed after the Clinical Study Report has been issued will be reported in a separate 
report and will not require a revision of the Clinical Study Report. 
Study participant identifiers will not be used in the publication of results. Any work created in 
connection with performance of the study and contained in the data that can benefit from copyright 
protection (except any publication by the Investigator as provided for below) shall be the property 
of the Sponsor as author and owner of copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal 
Editors (ICMJE) guidelines, the Sponsor shall have the right to publish such primary (multicenter) 
data and information without approval from the Investigator. The Investigator has the right to 
publish study site-specific data after the primary data are published. If an Investigator wishes to 
publish information from the study, a copy of the manuscript must be provided to the Sponsor for 
review at least 60 days before submission for publication or presentation. Expedited reviews will 
be arranged for abstracts, poster presentations, or other materials. If requested by the Sponsor in 
writing, the Investigator will withhold such publication for up to an additional 60 days to allow for 
filing of a patent application. If issues arise regarding scientific integrity or regulatory compliance, 
the Sponsor will review these issues with the Investigator. The Sponsor will not mandate 
modifications to scientific content and does not have the right to suppress information. For 
multicenter study designs and sub-study approaches, secondary results generally should not be 
published before the primary endpoints of a study have been published. Similarly, Investigators 
will recognize the integrity of a multicenter study by not submitting for publication data derived 

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from the individual study site until the combined results from the completed study have been 
submitted for publication, within 18 months after the study end date, or the Sponsor confirms there 
will be no multicenter study publication. Authorship of publications resulting from this study will 
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations 
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which 
state that the named authors must have made a significant contribution to the conception or design 
of the work; or the acquisition, analysis, or interpretation of the data for the work; and drafted the 
work or revised it critically for important intellectual content; and given final approval of the 
version to be published; and agreed to be accountable for all aspects of the work in ensuring that 
questions related to the accuracy or integrity of any part of the work are appropriately investigated 
and resolved.
Registration of Clinical Studies and Disclosure of Results
The Sponsor will register and disclose the existence of and the results of clinical studies as required 
by law. The disclosure of the final study results will be performed after the end of study to ensure 
the statistical analyses are relevant.
10.3.8.
Data Quality Assurance
Data Quality Assurance/Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified 
Investigators and appropriate study sites, review of protocol procedures with the Investigator and 
study site personnel before the study, periodic monitoring visits by the Sponsor, and direct 
transmission of clinical laboratory data from a central laboratory into the Sponsor's data base. 
Written instructions will be provided for collection, handling, storage, and shipment of samples. 
Guidelines for eCRF completion will be provided and reviewed with study site personnel before 
the start of the study.
The Sponsor will review the eCRF for accuracy and completeness during on-site monitoring visits 
and after transmission to the Sponsor; any discrepancies will be resolved with the Investigator or 
designee, as appropriate. After upload of the data into the study database they will be verified for 
accuracy and consistency with the data sources.
10.3.9.
Case Report Form Completion
Case report forms are prepared and provided by the Sponsor for each participant in electronic 
format. All data relating to the study must be recorded in the CRF. All eCRF entries, corrections, 
and alterations must be made by the Investigator or authorized study site personnel. The 
Investigator must verify that all data entries in the eCRF are accurate and correct.
The study data will be transcribed by study site personnel from the source documents onto an 
eCRF, if applicable. Study-specific data will be transmitted in a secure manner to the Sponsor.

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Worksheets may be used for the capture of some data to facilitate completion of the eCRF. Any 
such worksheets will become part of the participant's source documents. Data must be entered into 
the eCRF in English. The eCRF must be completed as soon as possible after a participant visit and 
the forms should be available for review at the next scheduled monitoring visit.
All participative measurements (eg, pain scale information or other questionnaires) will be 
completed by the same individual who made the initial baseline determinations whenever possible.
If necessary, queries will be generated in the electronic data capture (eDC) system. If corrections 
to an eCRF are needed after the initial entry into the eCRF, this can be done in either of the 
following ways:
!
Investigator and study site personnel can make corrections in the eDC system at their own 
initiative or as a response to an auto query (generated by the eDC system).
!
Sponsor or Sponsor delegate can generate a query for resolution by the Investigator and study 
site personnel.
10.3.10.
Source Documents
At a minimum, source documents consistent in the type and level of detail with that commonly 
recorded at the study site as a basis for standard medical care must be available for the following: 
participant identification, eligibility, and study identification; study discussion and date of signed 
informed consent; dates of visits; results of safety and efficacy parameters as required by the 
protocol; record of all AEs and follow-up of AEs; concomitant medication; treatment
receipt/dispensing/return records; study treatment administration information; and date of study 
completion and reason for early discontinuation of study treatment or withdrawal from the study, 
if applicable. 
The author of an entry in the source documents should be identifiable. Given that patient-reported 
outcomes (PROs) are reports of a patient's health condition that come directly from the patient, 
without interpretation by a clinician or anyone else, the responses to PRO measures entered by 
trial participants into source records cannot be overridden by site staff or Investigators.
Specific details required as source data for the study and source data collection methods will be 
reviewed with the Investigator before the study and will be described in the monitoring guidelines 
(or other equivalent document).
The following data will be recorded directly into the eCRF and will be considered source data:
!
Race
!
History of all nicotine use, eg, cigarettes (including e-cigarettes or the equivalent of e-
cigarettes), cigars, chewing tobacco, patch, gum
!
Blood pressure and pulse/heart rate 
!
Height and weight

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!
Details of physical examination
!
Investigator-completed scales and assessments, PRO, Health Economics data
The minimum source documentation requirements for Section 5.1, Inclusion Criteria and 
Section 5.2, Exclusion Criteria that specify a need for documented medical history are as follows:
!
Referral letter from treating physician or
!
Complete history of medical notes at the site
!
Discharge summaries
Inclusion and exclusion criteria not requiring documented medical history must be verified at a 
minimum by participant interview or other protocol required assessment (eg, physical 
examination, laboratory assessment) and documented in the source documents.
An eSource system may be utilized, which contains data traditionally maintained in a hospital or 
clinic record to document medical care (eg, electronic source documents) as well as the clinical 
study-specific data fields as determined by the protocol. This data is electronically extracted for 
use by the Sponsor. If eSource is utilized, references made to the eCRF in the protocol include the 
eSource system but information collected through eSource may not be limited to that found in the 
eCRF.
10.3.11.
Monitoring
The Sponsor will use a combination of monitoring techniques central, remote, or on-site 
monitoring to monitor this study.
The Sponsor will perform on-site monitoring visits as frequently as necessary. The monitor will 
record dates of the visits in a study site visit log that will be kept at the study site. The first post-
initiation visit will be made as soon as possible after enrollment has begun. At these visits, the 
monitor will compare data entered into the eCRF with the source documents (eg, 
hospital/clinic/physician’s office medical records); a sample may be reviewed. The nature and 
location of all source documents will be identified to ensure that all sources of original data 
required to complete the eCRF are known to the Sponsor and study site personnel and are 
accessible for verification by the Sponsor study site contact. If electronic records are maintained 
at the study site, the method of verification must be discussed with the study site personnel. 
Direct access to source documents (medical records) must be allowed for the purpose of verifying 
that the recorded data are consistent with the original source data. Findings from this review will 
be discussed with the study site personnel. The Sponsor expects that, during monitoring visits, the 
relevant study site personnel will be available, the source documents will be accessible, and a 
suitable environment will be provided for review of study-related documents. The monitor will 
meet with the Investigator on a regular basis during the study to provide feedback on the study 
conduct.

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In addition to on-site monitoring visits, remote contacts can occur. It is expected that during these 
remote contacts, study site personnel will be available to provide an update on the progress of the 
study at the site.
Central monitoring will take place for data identified by the Sponsor as requiring central review.
10.3.12.
On-Site Audits
Representatives of the Sponsor's clinical quality assurance department may visit the study site at 
any time during or after completion of the study to conduct an audit of the study in compliance 
with regulatory guidelines and company policy. These audits will require access to all study 
records, including source documents, for inspection. Participant privacy must, however, be 
respected. The Investigator and study site personnel are responsible for being present and available 
for consultation during routinely scheduled study site audit visits conducted by the Sponsor or its 
designees. 
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part 
of a national GCP compliance program or to review the results of this study in support of a 
regulatory submission. The Investigator should immediately notify the Sponsor if he or she has 
been contacted by a regulatory agency concerning an upcoming inspection.
10.3.13.
Record Retention
In compliance with the ICH/GCP guidelines, the Investigator/institution will maintain all eCRF 
and all source documents that support the data collected from each participant, as well as all study 
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical 
Trial, and all study documents as specified by the applicable regulatory requirement(s). The 
Investigator/institution will take measures to prevent accidental or premature destruction of these 
documents.
Essential documents must be retained until at least 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or contemplated marketing applications 
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
development of the investigational product. These documents will be retained for a longer period 
if required by the applicable regulatory requirements or by an agreement with the Sponsor. It is 
the responsibility of the Sponsor to inform the Investigator/institution as to when these documents 
no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will accept 
the responsibility. The Sponsor must be notified in writing of the name and address of the new 
custodian. Under no circumstance shall the Investigator relocate or dispose of any study documents 
before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator/institution must permit access to such reports.

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10.3.14.
Study and Site Start and Closure
First Act of Recruitment
The first site open is considered the first act of recruitment and it becomes the study start date.
Study/Site Termination
The Sponsor 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 IEC/IRB 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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10.4.
Appendix 4: Adverse Events, Serious Adverse Events, Product Quality 
Complaints, and Other Safety Reporting: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting
10.4.1.
Adverse Event Definitions and Classifications
Adverse Event
An AE is any untoward medical occurrence in a clinical study participant administered a 
pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have 
a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended 
sign (including an abnormal finding), symptom, or disease temporally associated with the use of a 
medicinal (investigational or non-investigational) product, whether or not related to that medicinal 
(investigational or non-investigational) product. (Definition per International Council for
Harmonisation [ICH])
This includes any occurrence that is new in onset or aggravated in severity or frequency from the 
baseline condition, or abnormal results of diagnostic procedures, including laboratory test 
abnormalities.
Note: The Sponsor collects AEs starting with the signing of the ICF (refer to All Adverse Events
under Section 8.9.1, Time Period and Frequency for Collecting Adverse Events and Serious 
Adverse Events Information, for time of last AE recording).
All adverse events, regardless of seriousness, severity, or presumed relationship to study treatment, 
must be recorded using medical terminology in the source document and the eCRF. Whenever 
possible, diagnoses should be given when signs and symptoms are due to a common etiology (eg, 
cough, runny nose, sneezing, sore throat, and head congestion should be reported as "upper 
respiratory infection"). Investigators must record in the eCRF their opinion concerning the 
relationship of the adverse event to study therapy. All measures required for adverse event 
management must be recorded in the source document and reported according to sponsor 
instructions. For combination products with a device constituent, AEs include those resulting from 
insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, 
or any malfunction of the device. It includes any AE resulting from use error or from intentional 
misuse of the investigational device.
Serious Adverse Event
A SAE based on ICH and EU Guidelines on Pharmacovigilance for Medicinal Products for Human 
Use is any untoward medical occurrence that at any dose:
!
Results in death
!
Is life-threatening
(The participant was at risk of death at the time of the event. It does not refer to an event that 
hypothetically might have caused death if it were more severe.)
!
Requires inpatient hospitalization or prolongation of existing hospitalization

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!
Results in persistent or significant disability/incapacity
!
Is a congenital anomaly/birth defect
!
Is a suspected transmission of any infectious agent via a medicinal product
!
Is Medically Important*
Note: Events that do not qualify as an AE cannot be reported as a SAE, even if the conditions for 
seriousness are met. In particular, this is the case for events due to disease progression leading to 
death, hospitalization, etc.
*Medical and scientific judgment should be exercised in deciding whether expedited reporting is 
also appropriate in other situations, such as important medical events that may not be immediately 
life threatening or result in death or hospitalization but may jeopardize the participant or may 
require intervention to prevent one of the other outcomes listed in the definition above. These 
should usually be considered serious.
Unlisted (Unexpected) Adverse Event/Reference Safety Information
An AE is considered unexpected if the nature or severity is not consistent with the applicable 
product reference safety information. For TAR-200 and cetrelimab, the expectedness of an AE
will be determined by whether or not it is listed in the IB.
10.4.2.
Attribution Definitions
Assessment of Causality
The causal relationship to study treatment is determined by the Investigator. The following 
selection should be used to assess all AEs.
Related
There is a reasonable causal relationship between study treatment administration and the AE.
Not Related
There is not a reasonable causal relationship between study treatment administration and the AE.
The term "reasonable causal relationship" means there is evidence to support a causal relationship.
10.4.3.
Severity Criteria
An assessment of severity grade will be made by the Investigator according to the National Cancer 
Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 5.0). 
Any adverse events or serious adverse events not listed in the NCI-CTCAE Version 5.0 should be 
evaluated for severity/intensity by using the standard grades as follows:

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Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated.
!
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental ADL*.
!
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care ADL**.
!
Grade 4 Life-threatening consequences; urgent intervention indicated.
!
Grade 5 Death related to AE.
Activities of Daily Living (ADL)
!
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc.
!
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, 
taking medications, and not bedridden.
The Investigator must use clinical judgment in assessing the severity of events not directly 
experienced by the participant (eg, laboratory abnormalities).
10.4.4.
Special Reporting Situations
Safety events of interest on a Sponsor study drug in an interventional study that may require 
expedited reporting or safety evaluation include, but are not limited to:
!
Overdose of a Sponsor study treatment
!
Suspected abuse/misuse of a Sponsor study treatment
!
Accidental or occupational exposure to a Sponsor study treatment
!
Any failure of expected pharmacologic action (ie, lack of effect if used according to the local 
label) of a Sponsor study treatment (to be reported as a PQC for marketed products)
!
Unexpected therapeutic or clinical benefit from use of a Sponsor study treatment
!
Medication error, intercepted medication error, or potential medication error involving a 
Johnson & Johnson medicinal product (with or without patient exposure to the Johnson & 
Johnson medicinal product, eg, product name confusion, product label confusion, intercepted 
prescribing or dispensing errors)
!
Exposure to a Sponsor study treatment from breastfeeding
Special reporting situations should be recorded in the eCRF. Any special reporting situation that 
meets the criteria of an SAE should be recorded on the SAE page of the eCRF.

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10.4.5.
Procedures
All Adverse Events
All AEs, regardless of seriousness, severity, or presumed relationship to study treatment, must be 
recorded using medical terminology in the source document and the eCRF. Whenever possible, 
diagnoses should be given when signs and symptoms are due to a common etiology (eg, cough, 
runny nose, sneezing, sore throat, and head congestion should be reported as "upper respiratory 
infection"). Investigators must record in the eCRF their opinion concerning the relationship of the 
AE to study therapy. All measures required for AE management must be recorded in the source 
document and reported according to Sponsor instructions.
Anticipated events will be recorded and reported as described in Anticipated Events (US only),
Section 10.16, Appendix 16.
For all studies with an outpatient phase, including open-label studies, the participant must be 
provided with a "wallet (study) card" and instructed to carry this card with them for the duration 
of the study indicating the following: 
!
Study number
!
Statement, in the local language(s), that the participant is participating in a clinical study
!
Investigator's name and 24hour contact telephone number
!
Local Sponsor's name and 24-hour contact telephone number (for medical personnel only)
!
Site number
!
Participant number
Serious Adverse Events
All SAEs that have not resolved by the end of the study, or that have not resolved upon the 
participant's discontinuation from the study, must be followed until any of the following occurs:
!
The event resolves
!
The event stabilizes
!
The event returns to baseline, if a baseline value/status is available
!
The event can be attributed to agents other than the study treatment or to factors unrelated to 
study conduct
!
It becomes unlikely that any additional information can be obtained (participant or health care 
practitioner refusal to provide additional information, lost to follow-up after demonstration of 
due diligence with follow-up efforts)
Any event requiring hospitalization (or prolongation of hospitalization) that occurs during 
participation in the study must be reported as an SAE, except hospitalizations for the following:

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!
Hospitalizations not intended to treat an acute illness or AE (eg, social reasons such as pending 
placement in long-term care facility)
!
Surgery or procedure planned before entry into the study (must be documented in the eCRF). 
Note: Hospitalizations that were planned before the signing of the ICF, and where the 
underlying condition for which the hospitalization was planned has not worsened, will not be 
considered SAEs. Any AE that results in a prolongation of the originally planned 
hospitalization is to be reported as a new SAE.
!
For convenience the Investigator may choose to hospitalize the participant for the duration of 
the treatment period.
Expected progression of disease, which is part of the natural course of the disease under study,
should not be considered an AE (or SAE). However, if determined by the Investigator to be more 
likely related to the study treatment, protocol design, or protocol procedures, than the underlying 
disease, the clinical signs or symptoms of progression and the possibility that the study intervention 
is enhancing disease progression, should be reported per the usual reporting requirements. In this 
latter case, these will be reported if they fulfill the SAE definition (refer to Adverse Event 
Definitions and Classifications in Section 10.4, Appendix 4: Adverse Events, Serious Adverse 
Events, Product Quality Complaints, and Other Safety Reporting: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting).
Information regarding SAEs will be transmitted to the Sponsor using an SAE reporting form and 
Safety Report Form of the eCRF, which must be completed and reviewed by a physician from the 
study site, and transmitted in a secure manner to the Sponsor personnel immediately, without 
undue delay or within 24 hours after being made aware of the event, as required by local 
regulations. The initial and follow-up reports of an SAE should be transmitted in a secure manner 
electronically or by facsimile (fax). Telephone reporting should be the exception and the reporter 
should be asked to complete the appropriate form(s) first.
10.4.6.
Product Quality Complaint Handling
Definition
A PQC is defined as any suspicion of a product defect related to manufacturing, labeling, or 
packaging, ie, any dissatisfaction relative to the identity, quality, durability, reliability, or
performance of a distributed product, including its labeling, drug delivery system, or package 
integrity. A PQC may have an impact on the safety and efficacy of the product. In addition, it 
includes any technical complaints, defined as any complaint that indicates a potential quality issue 
during manufacturing, packaging, release testing, stability monitoring, dose preparation, storage 
of the product or the drug delivery system. This definition includes any PQC related to a device 
constituent in a drug-device combination product, including those used in the administration of the 
study intervention or the comparator. All PQCs related to TAR-200 and IV cetrelimab shall be 
documented and reported by the Investigator on the PQC reporting form (see Section 10.10) and 
will be reviewed by the Investigator and Sponsor and reported in accordance with local legislation 
(see Section 10.10).

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For additional information regarding Device Deficiencies related to the UPC, please see 
Section 10.10. 
Procedures
All initial PQCs must be reported to the Sponsor using the PQC form by the study site personnel 
immediately, without undue delay or within 24 hours after being made aware of the event, as 
required by local regulations.
A sample of the suspected product should be maintained under the correct storage conditions, per 
institutional guidelines, until a shipment request is received from the Sponsor.
10.4.7.
Contacting Sponsor Regarding Safety, Including Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted 
regarding safety issues, PQCs, or questions regarding the study are listed in the Contact 
Information page(s), which will be provided as a separate document.

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10.5.
Appendix 5: Contraceptive and Barrier Guidance
Participants must follow contraceptive measures as outlined in Section 5.1, Inclusion Criteria. Pregnancy 
information will be collected and reported as noted in Section 8.9.5, and Pregnancy, and Section 10.4,
Appendix 4 (Adverse Events, Serious Adverse Events, Product Quality Complaints, and Other 
Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up, and 
Reporting).
Definitions
Participants of Childbearing Potential
A participant is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below).
Participants Not of Childbearing Potential
!
premenarchal
A premenarchal state is one in which menarche has not yet occurred.
!
postmenopausal
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 
A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL) in the postmenopausal range 
may be used to confirm a postmenopausal state in female participants not using hormonal 
contraception or hormonal replacement therapy (HRT), however in the absence of 12 months of 
amenorrhea, 
a 
single 
FSH 
measurement 
is 
insufficient.
If there is a question about menopausal status in female participants on HRT, the female participant
will be required to use one of the non-estrogen-containing hormonal highly effective contraceptive 
methods if she wishes to continue HRT during the study.
!
permanently sterile (for the purpose of this study)
∃
Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral 
oophorectomy.
∃
Has congenital abnormalities resulting in sterility.
Note: If the childbearing potential changes after start of the study eg, a premenarchal female participant 
experiences menarche) or the risk of pregnancy changes (eg, a female participant who is not heterosexually 
active becomes active), a female participant must begin a highly effective method of contraception, as 
described throughout the inclusion criteria.
If reproductive status is questionable, additional evaluation should be considered.
Contraceptive (birth control) use by male or female participants must be consistent with local regulations 
regarding the acceptable methods of contraception for those participating in clinical studies.
Typical use failure rates may differ from those when used consistently and correctly. Use must be 
consistent with local regulations regarding the use of contraceptive methods for participants in 
clinical studies.

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Examples of Contraceptivesa
1. HIGHLY EFFECTIVE METHODS (Failure rate of <1% per year when used consistently and 
correctly.)
1.1. USER INDEPENDENT - Highly Effective Methods.
!
Implantable progestogen-only hormone contraception associated with inhibition of ovulationb
!
Intrauterine device (IUD)
!
Intrauterine hormone-releasing system (IUS)
!
Tubal closure (eg, bilateral tubal occlusion, bilateral tubal ligation)
!
Azoospermic partner (Vasectomized or due to medical cause)
(Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual 
partner of the female of childbearing potential and the absence of sperm has been confirmed. If not, 
additional highly effective method(s) of contraception should be used. Spermatogenesis cycle is 
approximately 74 days.)
1.2. USER DEPENDENT - Highly Effective Methods
!
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition 
of ovulation
∃
oral
∃
intravaginal
∃
transdermal
∃
injectable
!
Progestogen-only hormone contraception associated with inhibition of ovulationb
∃
oral
∃
injectable
!
Sexual abstinence
(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 treatment. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle 
of the participant.)
a
Typical use failure rates may differ from those when used consistently and correctly. Use must 
be consistent with local regulations regarding the use of contraceptive methods for participants 
in clinical studies.
Pregnancy During the Study
All initial reports of pregnancy in female participants or partners of male participants must be reported to 
the Sponsor by the study-site personnel within 24 hours of their knowledge of the event using the 
appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal 
death, stillbirth, congenital anomalies, ectopic pregnancy) are considered serious adverse events and must 
be reported using the Serious Adverse Event Form. Any participant who becomes pregnant during the study 
must be promptly withdrawn from the study and discontinue further study treatment. 

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Because the effect of the study drugs on sperm is unknown, pregnancies in partners of male participants 
included in the study will be reported as noted above.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the infant 
will be required. Follow-up information may continue to be collected up to 12 months after the birth of a 
baby, if a congenital anomaly or significant medical condition is diagnosed at birth.

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10.7.
Appendix 7: PRO Questionnaires (PGIS)
Patient Global Impression of Severity (PGIS) of Cancer
Considering all aspects of your bladder cancer symptoms right now, would you say your 
bladder cancer symptoms are:  (Please select one response)
 1. None
 2. Mild 
 3. Moderate 
 4. Severe 
 5. Very Severe 

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10.8.
Appendix 8: PRO Questionnaires (PGIC)
Patient Global Impression of Change (PGIC) of Cancer
Compared to when you received the first treatment in this study, how has your cancer changed? 
(Please select one response)
 1. A lot better now
 2. Moderately better now
 3. A little better now
 4. Neither better, nor worse (no change)
 5. A little worse now
 6. Moderately worse now
 7. A lot worse now

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10.9.
Appendix 9: Guidelines for Management of Immune-Related Adverse 
Events and Adverse Events of Clinical Interest
Therapy with immuno-oncology agents such as cetrelimab can lead to specific irAEs that differ in 
nature, severity and duration as compared to AEs caused by agents with a different mode of action. 
Early recognition and management of these irAEs may mitigate more severe/subsequent toxicity. 
However, differential diagnoses including non-inflammatory etiologies as well as the impact of 
the underlying malignant disease and/or concomitant medication should be evaluated according to 
standard medical practice. 
Management algorithms have been developed to assist Investigators in assessing and managing 
specific irAEs following administration of nivolumab (Nivolumab SmPC; Nivolumab USPI) and 
pembrolizumab (Pembrolizumab SmPC; Pembrolizumab USPI). These guidelines are presented 
below and should be followed for cetrelimab. In addition to the management algorithms provided 
in following sections, it is recommended that irAEs are managed according to the general treatment 
guidelines outlined for ipilimumab (Ipilimumab USPI). These guidelines recommend the 
following:
1.
Participants should be evaluated to identify any alternative etiology.
2.
In the absence of a clear alternative etiology, all events of an inflammatory nature should be 
considered immune related.
3.
Symptomatic and topical therapy should be considered for low-grade events.
4.
Systemic corticosteroids should be considered for a persistent low-grade event or for a severe 
event.
5.
More potent immunosuppressives should be considered for events not responding to systemic 
corticosteroids (eg, anti-TNF agents or mycophenolate).
If delaying the dose is necessary to ameliorate a toxicity, follow the guidance in Section 6.5.
NCI-CTCAE (Version 5.0) guidelines for severity grading and management of cytokine release 
syndrome are provided in Section 10.13, Appendix 13. There is no expectation of immune related 
adverse events due to TAR-200 or the combination, based on prior Phase 1b data, as detailed in 
the IB. 
10.9.1.
Gastrointestinal Adverse Events
Diarrhea and colitis have been observed in participants receiving anti-PD-1 therapies. Early 
recognition and treatment of diarrhea and colitis are critical to their management. Participants
should be advised to seek immediate medical evaluation if they develop new-onset diarrhea, blood 
in stool, or severe abdominal pain or if they have worsening of baseline diarrhea. In participants
with pre-existing diverticulosis and/or diverticulitis receiving concomitant medication with 
corticosteroids, NSAIDs, and opioid analgesics together with anti-PD-1 therapies, diverticular 
perforation has been observed. Management of immune-related gastrointestinal AEs is provided 
in Table 11.

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10.10.
Appendix 10: Adverse Events, Adverse Device Effects, Serious 
Adverse Events, Serious Adverse Device Effects, Unanticipated 
Serious Adverse Device Effects, and Device Deficiencies: Definition 
and Procedures for Recording, Evaluating, Follow-up, and Reporting 
in Medical Device
!
The safety reporting procedures described in this Appendix apply to the UPC used for the 
insertion of TAR-200 into the bladder (See Section 6.1.1, TAR-200 Insertion).
!
The Investigator should distinguish whether the (S)AEs and (S)ADEs, as well as Device 
Deficiencies, are due to the procedure, ie, TAR-200 (gemcitabine) insertion and removal, or 
the UPC. An AE/ADE can be related both to the procedure and the investigational device.
!
The definitions and procedures detailed in this appendix are in accordance with ISO 14155 
and European Medical Device Regulation (MDR) 2017/745 for clinical device research (if 
applicable).
!
Both the Investigator and the Sponsor will comply with all local and regional medical device 
reporting requirements.
10.10.1.
Definitions (UPC Only)
Adverse Event 
(AE)
An AE is defined as any untoward medical occurrence, unintended disease 
or injury or any untoward clinical signs, including abnormal laboratory 
finding, in participants, users or other persons, in the context of a clinical 
investigation, whether or not related to the investigational device. This 
definition includes events that are anticipated as well as unanticipated 
events. This definition includes events occurring in the context of a clinical 
investigation related to the investigational device, the comparator or the 
procedures involved.
Adverse Device 
Effect (ADE)
An ADE is defined as an AE related to the use of an investigational medical 
device. This definition includes any AEs resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device as well 
as any event resulting from use error or from intentional misuse of the 
investigational medical device.
Serious Adverse 
Event (SAE)
Any AE that: 
!
Led to death
!
Led to serious deterioration in the health of the participant, that resulted 
in any of the following:
∃
Life-threatening illness or injury. The term ‘life-threatening' in the 
definition of serious refers to an event in which the participant was 
at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more 
severe.

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presence of confounding factors, such as concomitant medication/treatment, the natural history 
of the underlying disease, other concurrent illness or risk factors shall also be considered.
Each SAE will be classified according to four different levels of causality. The Sponsor and the 
Investigators will use the following definitions to assess the relationship of the SAE to the 
investigational device, the comparator or the investigational procedure.
!
Not related: Relationship to the device, comparator or procedures can be excluded when:
∃
the event has no temporal relationship with the use of the investigational device, or the 
procedures related to application of the investigational device;
∃
the SAE does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible;
∃
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible and reintroduction of its use (or increase 
of the level of activation/exposure), do not impact on the SAE;
∃
the event involves a body-site or an organ that cannot be affected by the device or 
procedure;
∃
the SAE can be attributed to another cause (eg, an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors);
∃
the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable;
In order to establish the non-relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the SAE.
!
Possible: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely. Alternative causes 
are also possible (eg, an underlying or concurrent illness/ clinical condition or/and an effect 
of another device, drug or treatment). Cases where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible.
!
Probable: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be reasonably 
explained by another cause.
!
Causal Relationship: The SAE is associated with the investigational device, comparator 
or with procedures beyond reasonable doubt when:
∃
the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures;
∃
the event has a temporal relationship with investigational device use/application or 
procedures;
∃
the event involves a body-site or organ that
o
the investigational device or procedures are applied to;
o
the investigational device or procedures have an effect on;

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Status: Approved,  Date: 20 April 2023
10.11. Appendix 11: Study Conduct During a Natural Disaster
GUIDANCE ON STUDY CONDUCT DURING THE COVID-19 PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on 
the conduct of this clinical study due to, for example, self-isolation/quarantine by participants and 
study-site personnel; travel restrictions/limited access to public places, including hospitals; study 
site personnel being reassigned to critical tasks. 
In alignment with recent health authority guidance, the Sponsor is providing options for study 
related participant management in the event of disruption to the conduct of the study. This guidance 
does not supersede any local or government requirements or the clinical judgement of the 
Investigator to protect the health and well-being of participants and site staff. If, at any time, a 
participant’s safety is considered to be at risk, study treatment will be discontinued, and study 
follow-up will be conducted.
Scheduled visits that cannot be conducted in person at the study site will be performed to the extent 
possible remotely/virtually or delayed until such time that on-site visits can be resumed. At each 
contact, participants will be interviewed to collect safety data. Key efficacy endpoint assessments 
should be performed if required and as feasible. Participants will also be questioned regarding 
general health status to fulfill any physical examination requirement. 
Every effort should be made to adhere to protocol-specified assessments for participants on study 
treatment, including follow up. Modifications to protocol-required assessments may be permitted 
via COVID-19 Appendix after consultation with the participant, Investigator, and the Sponsor. 
Missed assessments/visits will be captured in the clinical trial management system for protocol 
deviations. Discontinuations of study treatments and withdrawal from the study should be 
documented with the prefix “COVID-19-related” in the electronic case report form (eCRF). 
The Sponsor will continue to monitor the conduct and progress of the clinical study, and any 
changes will be communicated to the sites and to the health authorities according to local guidance.  
If a participant has tested positive for COVID 19, the Investigator should contact the Sponsor’s 
responsible medical officer to discuss plans for study treatment and follow-up. Modifications made 
to the study conduct as a result of the COVID-19 pandemic should be summarized in the clinical 
study report.
Guidance specific to this protocol:
!
Regarding the COVID-19 vaccination, considering the risk-benefit for cancer patients the 
Sponsor will support the clinical decision of the Investigator for the individual participant 
based on Institutional Standard Guidelines. The Sponsor requests that all COVID-related 
participant interventions including COVID-19 vaccinations be appropriately captured in the 
clinical trial forms and documents.

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!
Missed assessments or change to protocol assessments will be documented in the source 
documentation and in the case report form. All study conduct performed outside of the 
protocol should be documented in the source documentation. 
!
If a site visit is not feasible, the Investigator may discuss with the Sponsor other mechanisms 
for the participant to receive study drug (eg, direct to participant shipment, obtain from another 
Investigative Site participating in the study). Any change in dispensing study drug must be 
documented in the source documentation and eCRF.
!
Safety assessments may be conducted at a local facility after discussion with the Sponsor.
!
Critical laboratory tests, imaging or other diagnostic tests may be done at an 
authorized/certified (as legally required nationally) local laboratory or clinical facility. A copy 
of the laboratory report must be reviewed by the Investigator and retained, along with the 
reference ranges, for the source documentation and provided with the eCRF.

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10.12. Appendix 12: ECOG Performance Status Scale
Grade 
ECOG Performance Status Grade
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature, eg, light housework, office work
2
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and 
about more than 50% of waking hours
3
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5
Dead
Reference: Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative 
Oncology Group. Am J Clin Oncol. 1982;596:649-655.

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10.15. Appendix 15: Cardiovascular Risk Assessment Prior to Study Enrollment 
and Prior to Radical Cystectomy
The individual cardiovascular risk of each study participant must be assessed during the screening 
period prior to enrollment to the study. Participants undergoing radical cystectomy are at a high 
risk for cardiovascular and thromboembolic events. Participants can only be enrolled when the risk 
assessment has been performed and all subsequent steps for diagnostic procedures and medical 
clearance have been conducted as outlined below, which needs to be documented. 
In addition, the cardiovascular risk of each study participant must be reassessed prior to radical 
cystectomy (RC) as outlined in the Schedule of Activities: ie, at approximately 1-3 weeks prior to 
the anticipated RC date. Diagnostic assessment and subsequent steps for diagnostic procedures 
and medical clearance prior to surgery must be conducted and documented. If a participant is 
assessed as not eligible for RC, surgery must be delayed until medical clearance is obtained. If 
medical clearance cannot be achieved, the participant should continue on study, but the 
Investigator might decide to adjust the treatment plan for a participant and consider alternative 
treatment options. In such cases, the Investigator should contact the Sponsor to agree on next steps. 
To assess the cardiovascular risk of participants
prior to enrollment in this study 
(17000139BLC2002) and the actual cardiac risk prior to RC, the formula outlined below adapted 
from the revised Cardiac Risk Index for Pre-Operative Risk (RCRI) should be used to calculate 
participants’ point values reflecting the individual cardiovascular risk. The revised RCRI 
accurately stratifies participants based on their individualized risk prior to surgery. 
Assessment of Individual Cardiovascular Risk
Risk Factor
Description
Points
History of ischemic heart disease
!
History of myocardial infarction
!
Electrocardiogram with pathological Q waves
!
History of positive exercise test
!
Current chest pain considered due to myocardial 
ischemia/angina
!
Use of nitrate therapy
!
History of coronary artery disease 
!
Prior percutaneous coronary intervention
!
Prior coronary artery bypass surgery
+1
History of congestive heart failure
!
Pulmonary edema, bilateral rales or S3 gallop
!
Paroxysmal nocturnal dyspnea
!
Chest x-ray showing pulmonary vascular redistribution
+1
History of cerebrovascular disease
!
Prior transient ischemic attack
!
Past stroke
+1
History of cardiac valvular disease
!
Aortic stenosis
+1
Other risk factorsa
!
Peripheral arterial disease 
!
Atrial fibrillation or other cardiac arrythmia
+1
Pre-operative treatment with insulin
+1
Pre-operative creatinine >2.0 mg/dL
(176.8 μmol/L)
+1
a
Only risk factors listed specifically on the RCRI form should be counted in risk assessment. Any other risk 
factors such as hypertension, hyperlipidemia, obesity, smoking, diabetes, etc, will not be included in the RCRI 
however, these factors should be taken under consideration for monitoring cardiac safety throughout the trial.

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Interpretation of Risk Assessment and Next Steps for Assessment
Revised Cardiac Risk 
Index Score/Points*
Next steps during the study 
(17000139BLC2002) screening period
Next steps prior to RC
0
No additional diagnostic work-up 
Standard pre-operative surgical and 
anesthesiology assessment; subsequent 
diagnostic procedures and clearance for 
cardiac risk factors prior to surgery 
depending on results of pre-operative 
assessment
≥1
Medical consultation prior to 
enrollment and assessment for 
eligibility for RC
Medical consultation prior to surgery; 
subsequent diagnostic procedures and 
medical clearance prior to surgery 
depending on results of pre-operative 
assessment.
* Any changes in risk factors between study entry and date of RC should prompt re-evaluation.

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10.16. Appendix 16: Anticipated Events (US Only)
Purpose
This appendix only applies to the reporting of anticipated events by the Sponsor to the US FDA, 
and US-based Investigators and IECs/IRBs. The intent of this appendix is to minimize the 
submission of a multitude of uninformative IND safety reports to these recipients.
Background
The FDA acknowledges that certain AEs can be anticipated to occur commonly in the study 
population regardless of drug exposure. Anticipated events may occur as a consequence of (a) the 
underlying disease or condition under investigation, (b) characteristics of the study population (eg, 
age), or (c) the background treatment regimen. Although serious anticipated events may meet the 
definition of unexpected (ie, SUSARs), because they are deemed related and not listed in the IB, 
they do not warrant expedited reporting as individual cases, or even in aggregate if the incidence 
is consistent with the expected background rates in the study population. The anticipated events 
list is developed prior to the start of a study. A dedicated Anticipated Events Safety Monitoring 
Plan (ASMP) is developed to establish prespecified thresholds that would trigger a review of the 
aggregated unblinded anticipated event by the Sponsor’s Safety Assessment Committee (SAC).
Sponsor’s Safety Assessment Committee (SAC) 
The Sponsor’s SAC is an established safety committee, independent of the study team, that 
performs reviews of prespecified anticipated events that have met the prespecified threshold at an 
aggregate level. The SAC will meet to determine whether there is a reasonable possibility that an 
anticipated event is related to the study treatment. The SAC will consider in its analysis all relevant 
drug development data, in addition to the clinical study data. If an anticipated event is determined 
to occur more frequently in the experimental arm(s) of the study and there is a reasonable 
possibility that the anticipated event could be drug-related, the Sponsor will prepare an aggregate 
safety report for reporting of these events to FDA and US-based IRBs/ECs and Investigators.
SAE Reporting
This US-specific process does not impact the requirement for SAE reporting by investigators to 
the Sponsor. All AEs will be recorded by the investigator in the eCRF regardless of whether 
considered to be anticipated events and will be reported to the sponsor as described in Section 8.9. 
Anticipated Events for the Study
The below list includes adverse events that are commonly anticipated for the disease stage, study 
population and background treatment:

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10.17. Appendix 17: Cockcroft-Gault Formula – Calculated and Measured 
Creatinine Clearance
To calculate the subject’s creatinine clearance (CrCl), use the following Cockcroft-Gault 
formula:
CrCl = (140 - age [in years]) x weight (kg)
(x 0.85 for females)
(72 x serum creatinine [mg/dL])
If the serum creatinine is obtained using the International System of Units (SI) (ie, micromol/L), 
use the following formula to convert SI units to conventional (mg/dL) units (Manual of 
Laboratory and Diagnostic Tests, 2004):
•
serum creatinine (micromol/L) divided by 88.4 = serum creatinine (mg/dL)
Source: Cockcroft and Gault 1976

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10.18. Appendix 18: CKD-EPI Creatinine Equation (2021)
Formula
Expressed as a single equation:
eGFR =
142*
min(standardized Scr/K, 1)α *
max(standardized Scr/K, 1)-1.200 *
0.9938Age *
1.012 [if female]
Abbreviations / Units
eGFR (estimated glomerular filtration rate) = mL/min/ 1.73 m2
Scr (serum creatinine) = mg/dL
K = 0.7 (females) or 0.9 (males)
α = -0.241 (females) or -0.302 (males)
min = indicates the minimum of Scr/K or 1
max = indicates the maximum of Scr/K or 1
Source: https://www.kidney.org/professionals/kdoqi/gfr_calculator/formula

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
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Status: Approved,  Date: 20 April 2023
10.19. Appendix 19: Protocol Amendment History
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the Table of Contents (TOC). 
Amendment 1 (19 September 2022)
Overall Rationale for the Amendment: The primary focus of the protocol amendment was to clarify 
guidance on the clinical management of TAR-200 related adverse events, including drug delays 
and discontinuations. In addition, updates were made to harmonize shared protocol elements 
within the protocol and across SunRISe protocols for the TAR-200/cetrelimab program. 
Section Number
and Name
Description of Change
Brief Rationale
1.1 Synopsis, Benefit-Risk 
Assessment
Added summary of benefit-risk assessment.  
To provide a comprehensive 
synopsis and align with latest 
guidance and sponsor template. 
1.1 Synopsis, Safety 
Evaluations 
Added information regarding collection of 
adverse events throughout the study and 
description of safety oversight including 
IDMC. 
To provide a comprehensive 
synopsis and align with latest 
guidance and sponsor template. 
1.1 Synopsis
2 Introduction
Updated investigational product descriptions 
including the intravesical system and urinary 
placement catheter/inserter.
This change was made to align 
product language across study 
documentation. 
1.1 Synopsis
Added descriptions for IV cetrelimab PK and 
immunogenicity.
To rectify an inadvertent 
omission.
1.2 Schema
Study Schema replaced with granular version 
indicating treatment visit follow-ups
Clarification.
1.3 Schedule of Activities, 
Table 1 and Table 2 
3. Objectives
Added PROs at Week 
in the Schedule of 
Activities.
Modified 
the 
corresponding 
endpoint: 
“Change in sub-scale and total scores from 
baseline through Week 
of study drug 
treatment.”
To ensure PROs are assessed 
through the end of study 
treatment. 
1.3 Schedule of Activities, 
Table 1 and Table 2
5.1 Inclusion Criteria
10.15 Appendix 15
Added a cardiac risk assessment at Screening 
and at approximately 1-2 weeks prior to the 
anticipated radical cystectomy (RC) date.
Modified Criterion 4 (to Criterion 4.1) to 
indicate that: “Investigators should refer to 
Appendix 15 for guidance on assessing cardiac 
risk via the Adapted Cardiac Risk Index for 
Pre-Operative Risk (RCRI).”
Added Section 10.15 Appendix 15 to provide 
guidance on assessing cardiac risk criteria.
To ensure proper screening of 
cardiac risk factors in order to 
determine study treatment 
eligibility and confirm cardiac 
clearance prior to the 
anticipated RC date.
1.3 Schedule of Activities, 
Table 1 and Table 2
Information 
on 
Relevant 
Procedures 
(including GU events and procedures) to be 
collected during Screening.
To ensure information on 
Relevant Procedures (including 
GU events and procedures) is 
collected from the time of 
initial signed informed consent 
as specified in Section 6.8.
C
CI
CCI

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Section Number
and Name
Description of Change
Brief Rationale
1.3 Schedule of Activities, 
Table 1 and Table 2
Urine biomarker collections footnote clarified 
and collections marked at Screening and the 
RC visit: 
“Urine 
sample 
collection 
must 
occur 
immediately prior to TURBT or RC, as 
applicable.”
Biomarkers in blood collections clarified: 
removed 
“plasma 
ctDNA” 
and 
added 
collections at Screening and RC visit.
To ensure proper biomarker 
collections are performed.
1.1 Synopsis
1.3 Schedule of Activities, 
Table 3
Clarified that: “Participants in the serial urine 
PK sampling are not required to complete the 
Week 0 and Week 
sparse timepoints”
Clarification.
1.3 Schedule of Activities, 
Table 1 and Table 2; 4.4 End 
of Study Definition
Added long-term follow-up activities: 
subsequent anti-cancer therapies & other 
malignancies, which are to be completed 
every 
 weeks beginning after a participant
discontinues from treatment and/or disease 
assessment follow up visits until end of study.
To ensure comprehensive 
follow-up phase assessments 
are performed.
1.3 Schedule of Activities, 
Table 1 and Table 2
5.2 Exclusion Criteria 
Criterion 15
Added HIV, Hepatitis B (HBsAg), and 
Hepatitis C serology testing to screening.
Removed the word “known” from exclusion 
criterion 15 (to 15.1) as testing for HIV will be 
required at screening. 
This change was made to
ensure participants who are 
eligible as prescribed in the 
protocol to enter
the study with HIV or
Hepatitis B or C.
1.3 Schedule of Activities, 
Table 1 and Table 2
Separated 
laboratory 
tests 
including 
coagulation, urinalysis, and urine culture and 
added appropriate notes from the respective 
sections of the protocol. 
This change was made to 
clarify timing and 
requirements for each 
laboratory test. 
1.3 Schedule of Activities, 
Table 1 and Table 2
Changed serum pregnancy to urine pregnancy 
to occur within 72 hours of first dosing. 
Eliminated redundant testing. 
1.3 Schedule of Activities, 
Table 1 and Table 2
Updated the window for screening labs from 
14 days to 30 days of Week 0.  
This change was made to 
reduce participant burden 
during screening process.  
3. Objectives
Removed PK exploratory objective:
“To 
explore 
gemcitabine 
and 
2’,2’-
difluorodeoxyuridine (dFdU) concentrations 
in biopsied tissue.”
PK assessments of gemcitabine 
and 2’,2’-difluorodeoxyuridine 
(dFdU) concentrations in 
biopsied tissue will not be 
performed on this study.
3. Objectives
Modified definitions for RFS, OS, TSP to start 
from the “date of first dose of any study 
treatment”
Clarification.
3. Objectives
Clarified 
PK 
and/or 
immunogenicity 
exploratory objectives related to gemcitabine 
and cetrelimab as follows:
!
To evaluate the PK of gemcitabine 
(TAR-200) and major metabolite 
dFdU in urine and plasma following 
administration of TAR-200 in 
combination with IV cetrelimab 
Clarification.
CCI
C
CI

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Section Number
and Name
Description of Change
Brief Rationale
(Cohort 1) in combination with 
cetrelimab
!
To 
evaluate 
the 
PK 
and 
immunogenicity of cetrelimab in 
serum following administration of 
TAR-200 in combination with IV 
cetrelimab (Cohort 1)
and IV 
cetrelimab alone (Cohort 2)
3. Objectives
Removed the following endpoint:
Cetrelimab and other derivative biproducts 
concentrations in plasma
Concentrations of derivative 
biproducts are not applicable 
for cetrelimab.
4.1 Overall Design
Added language to allow for enrollment in 
countries beyond the planned sample size.
To ensure adequate 
representation of the country in 
the study.
1.3 Schedule of Activities, 
Table 1 and Table 2
6.1.1 TAR-200 Insertion
8.9 Adverse Events, Serious 
Adverse Events, and Other 
Safety Reporting
8.9.1 Time Period and 
Frequency for Collecting 
Adverse Event and Serious 
Adverse Event Information
8.9.3 Follow-up of Adverse 
Events and Serious Adverse 
Events
8.9.8 Product Quality 
Complaints and Medical 
Device Deficiencies
9.4.5 Safety Analyses
10.4.6 Product Quality 
Complaint Handling
10.4.7 Contacting Sponsor 
Regarding Safety, Including 
Product Quality
Added further clarifications to the definition 
of PQC related to a device constituent in a 
combination product and device deficiencies, 
clarifying attribution definitions and device 
safety reporting requirements for TAR-200 
versus the UPC. 
Added that SAEs should be reported without 
“undue delay” in addition to existing text. 
Incorporated medical device specific 
appendix to address adverse events and 
device deficiencies associated with the 
urinary placement catheter. 
This change was made to 
address collection and 
reporting of device 
deficiencies related to the 
urinary placement catheter. 
This appendix was previously 
provided as a stand-alone 
document and has now been 
incorporated into the main 
protocol. 
10.10 Medical Device 
Adverse Events, Adverse 
Device Effects, Serious 
Adverse Events, Serious 
Adverse Device Effects, 
Unanticipated Serious 
Adverse Device Effects, and 
Device Deficiencies: 
Definition and Procedures for 
Recording, Evaluating, 
Follow-up, and Reporting in 
Medical Device

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Section Number
and Name
Description of Change
Brief Rationale
1.3 Schedule of Activities, 
Table 1 and Table 2
Added that overall survival may be obtained 
via telephone during the follow up phase. 
This change was added to 
expand methods of obtaining 
survival status. 
4.4 End of Study Definition
Relocated text from Section 7.3 to Section 4.4 
describing that should a participant 
discontinue treatment prematurely for any 
reason, all efforts will be made to continue 
follow up procedures and assessments. 
This change was made to 
clarify assessments for 
participants who discontinue 
treatment prematurely. 
6.1 Study Treatment(s) 
Administered 
Added description of study treatments and 
their associated designation. 
This change was made to 
clarify the regulatory status of 
the study treatments and to 
align with the current Sponsor 
template. 
6.5.1 TAR-200 Participant 
Stopping Safety Criterion
Required 
Sponsor 
notification 
and 
consultation for any TAR-200 drug delays and 
discontinuations.
Provided specific details for management of 
TAR-200 drug delay due to an adverse event
(AE) during the induction period (Week 0 to 
Week 12) as well as for participants who have 
achieved complete response (CR).
Added information/term on skipped dose. 
Streamlined criteria for TAR-200 drug delay 
or removal.
To clarify guidance on the 
clinical management of 
TAR-200 related AEs, 
including drug delays and 
discontinuations. 
6.5.1 TAR-200 Participant 
Stopping Safety Criterion
Removed Hy’s law as a criterion for 
TAR-200 discontinuation: “ALT or AST 
>3xULN and Total bilirubin >2xULN 
without evidence of cholestasis 
(ALP>2xULN) and no other medical 
explanation. Note that this specific category 
of drug discontinuation criteria used ULN 
rather than CTCAE grade for definition”
To rectify an inadvertent 
inclusion of a discontinuation 
criterion applicable for 
cetrelimab only.
1.3 Schedule of Activities, 
Table 1 and Table 2
6.1.1 TAR-200 Insertion
Added statement/note:
“To mitigate the risk of UTI’s, participants 
must 
receive 
at 
least 
one 
dose 
of 
periprocedural prophylactic antibiotics for any 
intravesical study procedures”
This statement was added to 
ensure patient safety associated 
with study procedures. 
2
Introduction
6.1.1 TAR-200 Insertion
Added clarifying statement that the TAR-200 
is 
freely 
mobile/floating 
within 
the 
urine/bladder. 
This statement was added to 
clarify the position of the 
TAR-200 while indwelling. 
Introduction
2.2.3 Combination Therapy
4.3 Justification for Dose
6.7 Treatment of Overdose
Removed product details considered company 
confidential information. 
This change was made to 
protect confidential 
information. 
3 Objectives
9.4.4 Exploratory Endpoints
Added exploratory objective to determine time 
to symptomatic progression in participants 
receiving TAR-200 in combination with 
cetrelimab versus cetrelimab alone.
This change was made to 
enable evaluation of time to 
symptomatic progression 
between the treatment groups. 

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Section Number
and Name
Description of Change
Brief Rationale
5.1 Inclusion Criteria, 
Criterion 6
Modified Criterion 6 (to 6.1) to indicate that an 
endocrinologist can be consulted in the case of 
unequivocal or marginal thyroid function tests. 
This change was made to 
clarify eligibility of 
participants with unequivocal 
or marginal thyroid function 
tests. 
5.1 Inclusion Criteria, 
Criterion 7
Modified Criterion 7 (to 7.1) to increase bone 
marrow and renal function requirements 
including absolute neutrophil count (from 
≥1,000/mm3 to ≥1,500/mm3), platelet count 
(from 
≥75,000/mm3
to 
≥80,000/mm3, 
hemoglobin (from ≥8.0 g/dL to ≥9.0 g/dL) and 
creatine clearance (from ≥40 ml/min to ≥30 
ml/min).
This change was made to 
enhance participant safety by 
ensuring adequate bone 
marrow and renal function at 
the time of enrollment. 
5.1 Inclusion Criteria,   
Criteria 11 and 12
10.5 Contraceptive and Barrier 
Guidance
Updated Criterion 11 (to 11.1) and Criterion 
12 (to 12.1) related to contraception and 
reproduction to align with the latest sponsor 
template including gender terminology.  
Updated contraception guidance replacing the 
term 
woman 
to 
female 
and 
removed 
duplicative information previously captured in 
inclusion criteria. 
This change was made to align 
with latest guidance and 
sponsor template.
This change was made to align 
to the latest Sponsor template. 
5.2 Exclusion Criteria, 
Criterion 1
Updated Criterion 1 (to 1.1) to remove “treated 
within the last 24 months” from skin cancer 
and cervical cancer exceptions.
This change was made to 
provide clarity on exceptions 
to exclusion criterion. 
5.2 Exclusion Criteria, 
Criterion 2
Updated Criterion 2 (to 2.1) to change window 
for past systemic chemotherapy from 2 years 
to 2 weeks prior to start of study treatment. 
This was an error. 
5.2 Exclusion Criteria, 
Criterion 10
Removed Criterion 10 regarding allogenic 
tissue/solid organ transplant. 
This exclusion criterion is not 
necessary in this patient 
population and is redundant as 
participants on 
immunosuppressive therapy 
are excluded per exclusion 
criterion 33.
5.2 Exclusion Criteria, 
Criterion 26
Clarified that live virus vaccine within 30 days 
of “initiation” of study treatment is required
Clarification
5.2 Exclusion Criteria, 
Criterion 28
Updated Criterion 28 (to 28.1) to add cross 
reference to UTI exclusion criterion (criterion 
17).
This change was made to 
provide clarification regarding 
UTI at the time of enrollment.
5.2 Exclusion Criteria, 
Criterion 29
Updated Criterion 29 (to 29.1) to allow from 
immediate post-TURBT single dose peri-
operative intravesical chemotherapy in the 
screening phase. 
This change was made to align 
with standard of care during 
the screening phase/prior to 
study enrollment. 
6.1 Study Treatment(s) 
Administered
Added details on the 360 mg/vial liquid 
formulation 
product 
for 
IV 
cetrelimab 
expected fourth quarter (Q4) 2022.
To update IV cetrelimab 
description to include details 
on the liquid formulation 
product. 
6.1.1 TAR-200 Insertion
Added subheading for TAR-200 Insertion 
This section was updated to 
provide more information 
regarding the post-insertion 
cystoscopy procedure.

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Section Number
and Name
Description of Change
Brief Rationale
Added guidance on performing a 
post-insertion cystoscopy following TAR-200 
insertion. 
6.1.2 TAR-200 Removal
Added subheading for a TAR-200 Removal
Added section/instructions regarding the 
TAR-200 removal procedure. 
This section was added to 
provide complete information 
regarding all study procedures. 
6.5.1 TAR-200, TAR-200 
Missed Dosing Cycles (Cohort
1 only)
Added definition of skipped dose. 
To provide clarity regarding a 
skipped dose. 
6.6 Continued Access to Study 
Treatment After the End of the 
Study
Added rationale for lack of access to study 
drug after the end of the study (ie, due to RC). 
To provide clarity on the 
rationale for not providing 
study drug after the end of the 
study. 
6.8 Concomitant Therapy, 
Prohibited Medications
Added that participants should not receive a 
live vaccination while on study treatment and 
within 90 days of completion of study 
treatment. 
This change was made to 
ensure participant safety. 
7.1 Discontinuation of Study 
Treatment
Added clarifying statement that participants 
who permanently discontinue with TAR-200 
indwelling must return for removal and EOT 
visit.
This change was made to 
ensure participant safety. 
7.3 Participant 
Discontinuation/Withdrawal 
From the Study
Circumstances for Reduced Follow-up added.
To provide options for 
alternative follow-up 
mechanisms.
8.7.2.1 TURBT Biopsies, 
Cystoscopy, and Radical 
Cystectomy Pathology
Added that in Cohort 2 a cystoscopy may be 
performed at Week  if clinically indicated. 
This change was to clarify this 
procedure in Cohort 2. 
8.9.7 Disease-related Events 
and Disease-related Outcomes 
Not Qualifying as Adverse 
Events or Serious Adverse 
Events
Added text and instruction related to disease-
related events and outcomes that do not qualify 
as AEs or SAEs. 
This change was made to 
provide clarity and align with 
the current Sponsor template. 
8.12 Biomarkers
Applied CCI considerations to details of IHC 
analysis of immune markers.
To ensure compliance with 
CCI guidelines.
9.3 Participants for Analysis 
Sets
9.4.5 Safety Analyses
Added definition of the “Enrolled” patient 
population. 
Updated description of planned statistical 
analyses related to Clinical Laboratory Tests, 
Electrocardiogram, Vital Signs and Physical 
Examinations. 
Relocated information related to IDMC 
throughout the section. 
This change was made to align 
with the SAP. 
9.4.4 Exploratory Endpoints
Added statistical description and definition of 
Overall Survival.  
Consistency.
C
C

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Status: Approved,  Date: 20 April 2023
Section Number
and Name
Description of Change
Brief Rationale
9.4.6 Other Analyses
Clarified descriptives statistics for PK:
Added gemcitabine and dFdU urine amount.
Clarified that all PK results will be listed by 
study arm while summary statistics will be 
provided for serial urine PK only. 
Summary statistics do not need
to be performed for sparse PK 
sampling.
10.2 Appendix 2: Clinical 
Laboratory Tests
Added Nitrite as standard test for routine 
urinalysis. Added Ketones and C-Peptides as 
clinically indicated (unscheduled visit only). 
This change was made to 
enhance patient safety and 
clarified required tests. 
10.7 Appendix 7: PRO 
Questionnaires (PGIS)
Updated PGIS to bladder cancer specific 
questionnaire. 
This change was made to 
correct an error. 
10.9.2 Hepatic Adverse 
Events
Added information and instruction regarding 
participants with predominant cholestatic 
pattern of liver injury. 
This change was made to 
provide guidance on 
management of participants 
with predominant cholestatic 
pattern of liver injury.
10.9.12 Injection Site 
Reaction
Deleted section 10.9.2 Injection Site Reaction.
This section is not applicable 
to this study due to the IV 
administration of the 
cetrelimab. 
10.13 Appendix 13: Cytokine 
Release Syndrome – Severity 
Grading and Management
10.14 Appendix 14: Hepatitis 
B Virus Screening
Added appendices to provide guidance on 
management of cytokine release syndrome and 
screening for hepatitis B. 
This change was made to 
enhance patient safety and 
align with the latest Sponsor 
template. 
10.16 Appendix 16: 
Anticipated Events
Added an Anticipated Events Appendix (US 
only) to provide a list of anticipated events that 
commonly occurs in the study population 
independent of exposure to the drug under 
investigation.
To ensure compliance with US 
clinical trial legislation.
10.17 Appendix 17: Protocol 
Amendment History
Text revised to note that the Protocol 
Amendment Summary of Changes Table for 
this amendment is located directly before the 
Table of Contents (TOC).
Change for Protocol 
Amendment 1.
Throughout the protocol
Protocol template-driven updates were made 
where applicable.
Minor clarifications including grammatical, 
formatting, or spelling changes were made, 
and links and cross-references 
corrected/updated. Abbreviations were added 
to tables and noted where applicable within 
the document.
To align with updates to the 
oncology protocol template.
Minor errors were noted.

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11.
REFERENCES
American Cancer Society. Survival Rates for Bladder Cancer. 
https://www.cancer.org/content/cancer/en/cancer/bladder-cancer/detection-diagnosis-staging/survival-rates.html. 
Accessed 9 February 2020.
American Joint Committee on Cancer (AJCC) Cancer Staging Manual. Eighth Edition. New York: Springer; 2017.
American Red Cross (ARC). Guidelines on Assessing Donor Suitability for Blood Donation. 
http://www.redcrossblood.org/learn-about-blood/blood-facts-and-statistics. Accessed 10 December 2020.
Bellmunt J, Powles T, Vogelzang NJ. A review on the evolution of PD-1/PD-L1 immunotherapy for bladder cancer: 
The future is now. Cancer Treat Rev. 2017;54:58-67.
Brant A, Kates M, Chappidi MR, et al. Pathologic response in patients receiving neoadjuvant chemotherapy for 
muscle-invasive bladder cancer: Is therapeutic effect owing to chemotherapy or TURBT? Urol Oncol. 
2017;35(1):34.e17-34.e25.
Calabro F, Sternberg CN. High-risk metastatic urothelial cancer: chances for cure? Curr Opin Urol. 
2002;12(5):441-448.
Cancer Trends Progress Report. Financial Burden of Cancer Care. 
http://progressreport.cancer.gov/after/economic_burden. Accessed 20 March 2019.
Cattel L, Airoldi M, Delprino L, et al. Pharmacokinetic evaluation of gemcitabine and 29,29-diﬂuorodeoxycytidine-
59-triphosphate after prolonged infusion in patients affected by different solid tumors. Ann Oncol. 2006;17 
(Supplement 5): v142–v147.
Cockroft D, Gault MK. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
Daneshmand S, Pohar KS, Steinberg GD, et al. Effect of GemRIS (gemcitabine-releasing intravesical system, 
TAR-200) on antitumor activity in muscle-invasive bladder cancer (MIBC). J Clin Oncol. 2017;35(15 
suppl):e16000.
Duchesne GM, Bolger JJ, Griffiths GO, et al. A randomized trial of hypofractionated schedules of palliative 
radiotherapy in the management of bladder carcinoma: results of medical research council trial BA09. Int J Radiat 
Oncol Biol Phys. 2000;47(2):379-388.
Eriksson E, Wenthe J, Irenaeus S, Ullenhag G. Gemcitabine reduces MDSCs, tregs and TGFß-1 while restoring the 
teff/treg ratio in patients with pancreatic cancer. J Transl Med. 2016;14(1):282.
GEMZAR(Gemcitabine) [Package Insert]. Indianapolis, IN: Lilly USA, LLC; 2019.
GEMZAR (Gemcitabine) [Summary of Product Characteristics]. The Netherlands: Sun Pharmaceuticals Limited; 
2019.
Gray PJ, Fedewa SA, Shipley WU, et al. Use of potentially curative therapies for muscle-invasive bladder cancer in 
the United States: results from the National Cancer Data Base. Eur Urol. 2013;63(5):823-829.
Grossman HB, Natale RB, Tangen CM, et. al. Neoadjuvant Chemotherapy plus Cystectomy Compared with 
Cystectomy Alone for Locally Advanced Bladder Cancer. N Engl J Med. 2003;349:859-866.
Guerrero-Ramos F, Cadavid SP, Sánchez AT, et al. Survival analysis of patients with muscle invasive bladder 
cancer not suitable for treatment with a curative intent [abstract MP54-16]. J Urol. 2017;4S:e728.
Haseebuddin M, Parker D, Piotrowski Z, et al. Medical comorbidities, not neoadjuvant chemotherapy, affects 
decline in renal function following radical cystectomy and eligibility for platinum based adjuvant chemotherapy. J 
Urol. 2015;139(4S):e852-e853.
Ipilimumab [Package Insert]. Princeton, NJ: Bristol-Myers Squibb; October 2015.
Jeon HG, Yoon CY, Yu JH, et al. Induction of caspase mediated apoptosis and down-regulation of nuclear factor-κB 
and Akt signaling are involved in the synergistic antitumor effect of gemcitabine and the histone deacetylase 
inhibitor trichostatin A in human bladder cancer cells. J Urol. 2011;186(5):2084-2093.
Kemp TJ, Ludwig AT, Earel JK, et al. Neutrophil stimulation with Mycobacterium bovis bacillus Calmette-Guérin 
(BCG) results in the release of functional soluble TRAIL/Apo-2L. Blood. 2005;106(10):3474-3482.

JNJ-17000139 (TAR-200) / JNJ-63723283 (Cetrelimab)
Clinical Protocol 17000139BLC2002 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
175
Status: Approved,  Date: 20 April 2023
Kurtzhalts K, Gee ME, Feuz L, Krajewski KC. Evidence of a clinically significant interaction between warfarin and 
intravesical gemcitabine. Am J Health Syst Pharm. 2016;73(19):1508-1511.
Liu WM, Fowler DW, Smith P, Dalgleish AG. Pre-treatment with chemotherapy can enhance the antigenicity and 
immunogenicity of tumours by promoting adaptive immune responses. Br J Cancer. 2010;102(1):115-123.
Massacesi C, Burattini L, Marcucci F, Bonsignori M. Short communication: the efficacy of fixed dose rate infusion 
of gemcitabine combined with IFN-alpha2a in patients with advanced refractory renal cell carcinoma. J Interferon 
Cytokine Res. 2005;25(3):165-168.
Messing E, Tangen CM, Lerner SP, et al. Effect of intravesical instillation of gemcitabine vs saline immediately 
following resection of suspected low-grade non-muscle-invasive bladder cancer on tumor recurrence. JAMA. 
2018;319(18):1880-1888.
Milowsky MI, Rumble RB, Booth CM, et al. Guideline on muscle-invasive and metastatic bladder cancer (European 
Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline 
Endorsement. J Clin Oncol. 2016;34(16):1945-1952.
National Cancer Institute. Surveillance, Epidemiology, and End Results Program Turning Cancer Data Into 
Discovery. Cancer of the Urinary Bladder. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed May 27, 2019.
Necchi A, Anichini A, Raggi D, et al. Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in 
Patients With Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01): An Open-Label, Single-Arm, Phase II 
Study. J Clin Oncol. 2018;36:3353-3360.
Nivolumab [Summary of Product Characteristics]. Uxbridge, United Kingdom: Bristol-Myers Squibb Pharma EEIG; 
2020.
Nivolumab [Package Insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2021.
Nowak AK, Robinson BW, Lake RA. Gemcitabine exerts a selective effect on the humoral immune response: 
implications for combination chemo-immunotherapy. Cancer Res. 2002;62(8):2353-2358.
Nowak AK, Lake RA, Marzo AL, et al. Induction of tumor cell apoptosis in vivo increases tumor antigen cross-
presentation, cross-priming rather than cross-tolerizing host tumor-specific CD8 T cells. J Immunol. 
2003;170(10):4905-4913.
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology 
Group. Am J Clin Oncol. 1982;596:649-655.
Pembrolizumab Summary of Product Characteristics. Hertfordshire, United Kingdom: Merck Sharp & Dohme 
Limited; 2021.
Pembrolizumab [Package Insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & 
Co., Inc.;2020.
Powles T, Kockx M, Rodriguez-Vida A, et al. Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab 
in operable urothelial carcinoma in the ABACUS trial. Nat Med. 2019;(11):1706-1714.
Scarpato KR, Morgans AK, Moses KA. Optimal management of muscle-invasive bladder cancer – A review. Res 
Rep Urol. 2015;7:143-151.
Shelley MD, Jones G, Cleves A, Wilt TJ, Mason MD, Kynaston HG. Intravesical gemcitabine therapy for 
non-muscle invasive bladder cancer (NMIBC): a systematic review. BJU Init. 2012;109(4):496-505.
Shevchenko I, Karakhanova S, Soltek S, et al. Low-dose gemcitabine depletes regulatory T cells and improves 
survival in the orthotopic Panc02 model of pancreatic cancer. Int J Cancer. 2013;133(1):98-107.
Skinner E, Goldman B, Sakr WA, et al. SWOG S0353: phase II trial of intravesical gemcitabine in patients with 
nonmuscle invasive bladder cancer and recurrence after 2 prior courses of intravesical bacillus Calmette-Guérin. J 
Urol. 2013;190:1200-1204.
Sonpavde G, Goldman BH, Speights VO, et al. Quality of pathologic response and surgery correlate with survival for 
patients with completely resected bladder cancer after neoadjuvant chemotherapy. Cancer. 2009;115(18):4104-4109.
Stenehjem DD, Tran D, Nkrumah MA, Gupta S. PD1/PDL1 inhibitors for the treatment of advanced urothelial 
bladder cancer. Onco Targets Ther. 2018 Sep 19;11:5973-5989.

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Westergren DO, Gardmark T, Lindhagen L, Chau A, Malmstrom PU. A nationwide, population based analysis of 
patients with organ confined, muscle invasive bladder cancer not receiving curative intent therapy in Sweden from 
1997 to 2014. J Urol. 2019;202(5):905-912.
World Cancer Research Fund. Worldwide cancer data. https://www.wcrf.org/dietandcancer/cancer-
trends/worldwide-cancer-data. Accessed 9 February 2020.
World Health Organization (WHO). Guidelines on Assessing Donor Suitability for Blood Donation. 
https://www.who.int/bloodsafety/publications/guide_selection_assessing_suitability.pdf. Accessed 10 December 2020.