Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunityBio, Inc.
About this trial
This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Low-grade (LG) Ta papillary disease as determined by Investigator.
History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the participant is being screened. Any presence of variant histology, or LVI should be deemed high-risk.
Negative voiding cytology for HG disease within 12 weeks prior to screening.
Disqualifiers
Received BCG treatment for urothelial carcinoma.
History of HG bladder cancer (papillary or CIS) in the past 2 years.
Clinically significant urethral stricture that would preclude passage of a urethral catheter.
Life expectancy < 2 years.
Trial design
Treatments tested in this trial
- N-803 and BCG
- N-803 and Gemcitabine
Treatment groups
20 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov