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Trial Title:
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
NCT ID:
NCT06545955
Condition:
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Conditions: Official terms:
Urinary Bladder Neoplasms
Carcinoma in Situ
Non-Muscle Invasive Bladder Neoplasms
Gemcitabine
Pembrolizumab
Docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nadofaragene Firadenovec
Description:
vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses
by interferon (IFN) alfa-2b (IFN-α2b) amplification. It is a non-replicating recombinant
adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.
Arm group label:
Nadofaragene firadenovec
Arm group label:
Nadofaragene firadenovec + gemcitabine & docetaxel
Arm group label:
Nadofaragene firadenovec + pembrolizumab
Other name:
ADSTILADRIN
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.
Arm group label:
Nadofaragene firadenovec + gemcitabine & docetaxel
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.
Arm group label:
Nadofaragene firadenovec + gemcitabine & docetaxel
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab is an FDA approved immune checkpoint inhibitor which restores the
anti-tumour immune response by blocking the programmed cell death protein 1 (PD-1).
Pembrolizumab is administered via intravenous (IV) infusion.
Arm group label:
Nadofaragene firadenovec + pembrolizumab
Summary:
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene
firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a
complete response (CR) at 3 months. In this trial, the safety and efficacy of
intravesical instillation of nadofaragene firadenovec alone or in combination with
chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (±
high-grade Ta/T1).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease.
- Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last
12 months. BCG-unresponsive refers to subjects with high-grade non-muscle invasive
bladder cancer (NMIBC) who are unlikely to benefit from and who will not be
receiving further intravesical BCG. The term "BCG-Unresponsive" includes subjects
who did not respond to BCG treatment and have a persistent high-grade recurrence
within 12 months after BCG was initiated, and those who despite an initial complete
response to BCG, relapse with CIS within 12 months of their last intravesical
treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their
last intravesical treatment with BCG. The following criteria define the subjects who
may be included in the trial:
- Have received at least 2 courses of BCG within a 12 month period - defined as
at least 5 of 6 induction BCG instillations and at least 2 of 3 instillations
of maintenance BCG, or at least 2 of 6 instillations of a second induction
course, where maintenance BCG is not given.
o Exception: those who have T1 high-grade disease at 1st evaluation after
induction BCG alone (at least 5 of 6 doses) may qualify in the absence of
disease progression
- At the time of tumour recurrence, subjects with CIS alone or high-grade Ta/T1
with CIS should be within 12 months of last exposure to BCG
- No maximum limit to the amount of BCG administered
- All visible papillary tumours must be resected and those with persistent T1
disease on transurethral resection of bladder tumour (TURBT) should undergo an
additional re-TURBT within 14 to 70 days prior to beginning trial treatment.
Obvious areas of CIS should also be fulgurated
Exclusion Criteria:
- Current or previous evidence of muscle-invasive (muscularis propria) or metastatic
disease presented at the screening visit. Examples of increased risk of
muscle-invasive disease include but are not limited to:
- Presence of lymphovascular invasion and / or micropapillary, sarcomatoid,
plasmacytoid and / or neuroendocrine disease as shown in the histology of the
biopsy sample
- Subjects with CIS+T1 disease accompanied by the presence of hydronephrosis
secondary to the primary tumour
- Current systemic therapy for bladder cancer other than investigational medicinal
products used in randomisation arm
- Current or prior investigational treatment for BCG-unresponsive NMIBC or any other
investigational drug (drug used in a clinical trial, i.e drug used in a Ferring
sponsored non interventional study does not apply) within 1 month prior to screening
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ferring Investigational Site
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Global Clinical Compliance
Phone:
888-337-7464
Email:
Disclosure@ferring.com
Start date:
October 1, 2024
Completion date:
July 30, 2028
Lead sponsor:
Agency:
Ferring Pharmaceuticals
Agency class:
Industry
Source:
Ferring Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06545955
