Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer

ConditionNon-muscle Invasive Bladder Cancer (NMIBC)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

N-803 and BCG
Drug
Combination therapy N-803 plus BCG
N-803 and Gemcitabine
Drug
Combination therapy N-803 plus Gemcitabine

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: N-803 and BCGExperimental treatment 1 intervention

Group B: N-803 and GemcitabineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Efficacy of Arms A and B at Month 3 and Month 6

Evaluate efficacy of experimental therapies with a) intravesical N-803 plus BCG or b) intravesical N-803 plus gemcitabine by CR rate at month 3 or month 6 (for re-inducted participants) in participants with intermediate-risk NMIBC.

Time frame

At Month 3 and Month 6

Secondary outcomes

Efficacy of Arms A and B at by CR rate at each response assessment

Evaluate efficacy of experimental therapy by CR rate at each response assessment.

Time frame

At Month 3 through Month 36

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmunityBio, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: