A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High-Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Phase: PHASE3
Conditions: Superficial Bladder Cancer
Sponsor: Ferring Pharmaceuticals

 
 
 
Cover page for Protocol 
 
Sponsor name 
Ferring Pharmaceuticals A/S 
NCT Number 
NCT02773849 
Sponsor trial ID:  
rAd-IFN-CS-003 
Official title of study 
A Phase III, Open Label Study to Evaluate the 
Safety and Efficacy of INSTILADRIN® (rAd-
IFN)/Syn3) Administered Intravesically to Patients 
With High Grade, BCG Unresponsive Non-Muscle 
Invasive Bladder Cancer (NMIBC) 
Document Date 
01 February 2022 
 

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INSTILADRIN@ ltna-mNlsynt ;
(Generic name rAd-IFN: nadofaragene firadenovec)
Protocol rAd-IFN-CS-003 version 8.0
PROTOCOL APPROVAL PAGE
A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN@
(rAd-IFN/Syn3) Administered Intravesically to Patients with High-Grade, BCG
Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC).
Senior Vice President
Global Research &
Development
Ferring Pharmaceuticals A/S
f*"
l"o"'
2022
Associate Vice President
Global Regulatory Affairs
Ferring Pharmaceuticals A/S
u&2L,2022
Vice president
Global Biometrics
Ferring Pharmaceuticals A/S
Feb2t.2022
Date
Medical Ofhcer
Vice President, TA Urology
Ferrine Pharmaceuticals A/S
lrebzz,
l*
2022
Page 3 of75
CONFIDENTIAL
Dated 01 February 2022

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INSTILADRIN@ 1.na-IrNlsyn: ;
(Generic name rAd-IFN: nadofaragene firadenovec)
2. PHASE III PROTOCOL SYNOPSIS
Protocol rAd-IFN-CS-003 version 8.0
TITLE OF STUDY:
A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADruN@1r,a,d-lFN/Syn3)
Administered Intravesically to Patients with High-Grade, BCG Unresponsive, Non-Muscle Invasive
Bladder Cancer (NMIBC).
PRINCIPAL INVESTIGATOR:
SPONSOR:
Ferring Pharmaceuticals A/S
Amager Strandvej 405
DK-2770 Kastrup
Denmark
CLINICAL PHASE: III
BACKGROUND & RATIONALE:
INSTILADRIN@ (herein INSTILADRIN, rAd-IFN/Syn3) is a gene-based therapy designed to improve
delivery of, and hence prolong the exposure of non-muscle invasive bladder cancer (NMIBC) cells to
interferon-alfa2b (IFNalfa2b). Intravesical administration of INSTILADRIN delivers the gene encoding
IFNalfa2b to the cells on the luminal surface of the bladder safely and effrciently. Within hours of
administration of a single dose of INSTILADRIN, the anti-tumor IFNalfa2b protein can subsequently be
detected in the urine.
Extensive nonclinical safety and efficacy studies were conducted to support clinical investigation of
INSTILADRIN. A Phase I study with INSTILADRIN in 17 patients who had failed prior Bacillus
Calmette-Guerin (BCG) therapy has been completed at the University of Texas MD Anderson Cancer
Center and the University of Iowa. The treatment was well tolerated and seven of the 17 patients achieved
a complete response (CR) at 3 months. Five of the seven patients who achieved CR received a second
intravesical dose of INSTILADRIN.
A Phase II multi-center, randomized, parallel arm, open label study to investigate the safety and efficacy
of INSTILADRIN administered intravesically to patients with high-grade BCG refractory or relapsed
NMIBC has been completed. The primary objective of the study was to evaluate the incidence of high-
grade-recurrence-free survival at 12 months. Secondary objectives included but were not limited to the
evaluation of the incidence of high-grade-recrrlrence-free survival at 3, 6 and 9 months, to the
determinafion of the time to progression to muscle invasive disease, and safety of INSTILADRIN.
This study enrolled 40 patients (two treatment groups of up to 20 patients each). Patients were randomized
to receive a75 nlL intravesical administration of INSTILADRIN at a dose of either I x l0rt vp/ml or
3 x 1011 vp/ml on day I of the study.
Three, 6 and 9 months after the start of treatrnent all patients were evaluated for recrurence of high-grade
disease. Cytology, cystoscopy and, if clinically indicated, biopsies were performed to obtain accwate
staging. If no evidence of recurrence of high-grade disease was detected, a further dose of INSTILADRIN
was administered. The final efficacy evaluation was performed at 12 months. Patients could receive up
to four intravesical administrations of INSTILADRIN over the 12 month period of the study. Patients
who had recurrence of high-erade disease were withdrawn from treatment. Overall, 14 subjects (35.0%;
Page 6 of75
CONFIDENTIAL
Dated 0l Februuy2022

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INSTILADRIN@ lrnO-rrNlSyn:;
(Generic name rAd-IFN: nadofaragene firadenovec)
5. NIVESTIGATORS AND ADMINISTRATryE STRUCTURE
Protocol rAd-IFN-CS-003 version 8.0
Coordinating Investigator
Dr. Stephen Boorjian MD
FKD Study Operational Head
Statistician
Contract Research Organization:
Clinical Laboratories:
Clinical Investigational Product Distribution:
Ferring Pharmaceuticals A/S
Medical Monitor
Page20 of75
CONFIDENTIAL
Dated 0l February 2022

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Related (Suspected
Adverse Reaction)
INSTILADRIN@ (rAd-IFN/Syn3)
(Generic name rAd-IFN: nadofaragene firadenovec)
Protocol rAd-IFN-CS-003 version 8.0
Not related
(Not Suspected)
A suspected adverse reaction means any AE for which there is a
reasonable possibility that the drug caused the AE. Reasonable
possibility means there is evidence to suggest a causal relationship
between the drug and the AE such as a plausible temporal
relationship between the onset of the AE and administration of the
drug; and/or the AE follows a known pattem of response to the drug;
and/or the AE abates or resolves upon discontinuation of the drug or
dose reduction and, if applicable, reappears upon re-challenge.
Further examples of type of evidence that would suggest a causal
relationship between the drug and the AE:
o A single occurrence of an event that is uncommon and known
to be strongly associated with drug exposure (e.g., angioedema,
hepatic injury, Stevens-Johnson Syndrome)
r 
One or more occrurences of an event that is not commonly
associated with drug exposure, but is otherwise uncommon in the
population exposed to the drug (e.g., acute myocardial infarction
in a young woman)
o An aggregate analysis of specific events observed in a clinical
trial 
(such as known consequences ofthe underlying disease or
condition under investigation or other events that commonly
occur in the study population independent of drug therapy) that
indicates those events occur more frequently in the drug treafrnent
group that in a concurrent orhistorical control group
Adverse events that do not match the above
15.2.3, Presnancv and Abortion
Report any pregnancy that occurs in a patient or patient's parher from the time of consent to
60 days after the last dose of study drug. Record any occurrence ofpregnancy on the Pregnancy
Report Form and submit to the 
 Clinical Safety within 24 hours of learning of the event.
Outcomes of the pregnancy, such as birth of the baby or spontaneous abortion etc will be collected.
Abortion and the reason for it, whether therapeutic, elective or spontaneous, will be reported as an
SAE.
A patient must immediately inform the Investigator if the patient or patient's partner becomes
pregnant from the time of consent to 60 days after the last dose of study drug. Any female patients
receiving INSTILADRIN who becomes pregnant should be withdrawn from the study. The
lnvestigator should counsel the patient, discussing any risks ofcontinuing the pregnancy and any
possible effects on the fetus.
Page 6l of75
CONFIDENTIAL
Dated 0l February 2022

INSTILADRINo (rAdJFN/Syn3)
(Generic name rAd-IFN: nadofaragene firadenovec)
Protocol rAd-IFN-CS-003 version 8.0
15.3. Reportins and Evaluation of Serious Adverse Events
15.3.1. Renortins Requirements for Serious Adverse Events
All SAEs regardless of causality will be reported by the Investigator to 
 Clinical Safety
for all patients during treatment as per the schedule. Patients withdrawn from treatment for any
reason and experiencing SAEs that are considered related to study drug or study procedures must
also be reported and will be entered into the safety database for up to 5 years (month 60) from first
dose. These events will be entered and followed in the clinical database until either resolution or
the study database is finally closed.
All SAEs (initial and follow-up information) will be reported via the eCRF AE page within
24 hours of the discovery of the event. The 
 Clinical Safety may request follow-up and
other additional information from the Investigator (e.9., hospital admission or discharge summary,
laboratory results). If the eCRF is not assessable for SAE reporting, the 
 SAE hotline
must be contacted and the SAE completed using the paper form and submitted using the details
below
 Clinical Safetv
 SAE informatron:
Telephone: 
Facsimile :
E-mail :
All deaths should be reported with the primary cause of death as the AE and SAE term, as death
is the outcome of the event, not the event itself. If an autopsy was performed, the primary cause
of death on the autopsy report should be the term reported. Autopsy and postmortem reports must
be forwarded to 
 Clinical Safety, as outlined above.
If INSTILADRIN is discontinued, temporarily suspended or dose reduced because of an SAE, this
information must be included in the SAE report.
Suspected Unexpected Serious Adverse Reactions (SUSARs) are SAEs that qualify for mandatory
expedited reporting to regulatory authorities where the SAE is suspected to be caused by the study
drug or study regimen and is considered unexpected (i.e., not defined as expected in the cunent
Investigator's Brochure, or clinical study protocol). In this case, 
 Clinical Safety will
forward a formal notification describing the SAE to all Investigators. Each Investigator must then
notifr his or her Institutional Review Board (IRB) or Independent Ethics Committee (IEC) of the
SAE as required by local regulatory authorities and in accordance with IRB or IEC policy.
15.4. Stopnine Criteria
The Stopping Criteria for the study will be based on the occurrence of clinically significant and
causally related serious adverse reactions higher than Grade 3 (as defined by the CTCAE criteria)
Page 62 of75
CONFIDENTIAL
Dated 0l February 2022

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