BCG+N-803 for Bladder Cancer

Hoag Cancer Center, Irvine, CA
Bladder CancerBCG+N-803 - Biological
All Sexes

Study Summary

This trial is testing a new drug to treat bladder cancer. The new drug is being tested against the standard treatment to see if it is more effective.

Eligible Conditions
  • Non-muscle Invasive Bladder Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 48 months

12 months
Complete Response (CR) Rate
24 months
Disease Free Survival (DFS)
Disease specific survival
Immunogenicity: serum level of anti-N-803 in patient samples
Overall survival
Progression-free survival (PFS)
Time to cystectomy
Time to disease worsening
48 months
Safety Profile: Number and severity of treatment related AEs

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

BCG alone
1 of 2
1 of 2

Active Control

Experimental Treatment

596 Total Participants · 2 Treatment Groups

Primary Treatment: BCG+N-803 · No Placebo Group · Phase 1 & 2

Experimental Group · 1 Intervention: BCG+N-803 · Intervention Types: Biological
BCG alone
ActiveComparator Group · 1 Intervention: BCG · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
54 Previous Clinical Trials
4,373 Total Patients Enrolled
Chad Garner, PhDStudy DirectorImmunityBio, Inc.
3 Previous Clinical Trials
1,686 Total Patients Enrolled
Bobby Reddy, MDStudy DirectorImmunityBio, Inc.
1 Previous Clinical Trials
3 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can't participate if you're currently receiving intravesical BCG therapy.

Frequently Asked Questions

Is this a pioneering endeavor in the field of medical research?

"ImmunityBio, Inc. first trialled BCG+N-803 in 2014 and has since conducted a total of 30 investigations across 332 cities and 1 nation. At present, 20 trials are still ongoing from the initial 596 participants enrolled at Phase 1 & 2 stage." - Anonymous Online Contributor

Unverified Answer

Does this trial currently have vacancies?

"Affirmative. records show that this research endeavour, which began on July 21st 2014, is still actively searching for participants. A total of 596 volunteers are needed across 10 different clinical sites." - Anonymous Online Contributor

Unverified Answer

What is the current size of cohort enrolled in this investigation?

"This medical study necessitates the enrolment of 596 patients that are eligible under it criteria. Potential participants may register in locations such as UCLA Department of Urology in Los Angeles, New Hampshire and Dartmouth-Hitchcock Medical Center in Lebanon, North Carolina." - Anonymous Online Contributor

Unverified Answer

What is the geographic scope of this experiment's supervision?

"10 clinical centres are offering this trial, including UCLA Department of Urology in Los Angeles, Dartmouth-Hitchcock Medical Center in Lebanon and Associated Urologists of North Carolina in Raleigh. Additional locations exist too." - Anonymous Online Contributor

Unverified Answer

Are there any supplementary investigations that have employed BCG+N-803?

"Arkansas Urology initiated the investigation of BCG+N-803 in 2014. Since then, 30 studies have been concluded and there are 20 ongoing trials occurring primarily in Los Angeles and New Hampshire." - Anonymous Online Contributor

Unverified Answer

What is the aim of this investigation?

"The primary endpoint of this projected 12-month study will be to evaluate Disease Free Survival (DFS). Secondary outcomes include Time to Disease Worsening, Time to Cystectomy, and Overall Survival." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.