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Cancer Vaccine

BCG + N-803 for Bladder Cancer

Phase 1 & 2

Recruiting

Research Sponsored by ImmunityBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

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.

Who is the study for?

This trial is for adults with high-grade non-muscle invasive bladder cancer who haven't had BCG treatment before. They should be in good enough health to undergo the therapy, with specific blood counts and organ functions within set limits. Women of childbearing age must use birth control, as must men, to prevent pregnancy during the study.Check my eligibility

What is being tested?

The study compares two treatments: one group receives a combination of an immune response booster called N-803 plus BCG (a type of immunotherapy), while another group gets only BCG. It's designed to see if adding N-803 improves outcomes for patients who are new to this kind of treatment.See study design

What are the potential side effects?

Potential side effects may include irritation or discomfort in the bladder area due to intravesical administration, flu-like symptoms from immune system activation by BCG or N-803, and typical risks associated with immunotherapies such as allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My bladder cancer is confirmed to be high-grade and not muscle-invasive.

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I had a biopsy and a cystoscopy showing no removable cancer within the last 3 and 6 weeks, respectively.

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I can care for myself and am up and about more than 50% of my waking hours.

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I am eligible for bladder treatment with BCG.

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My bladder cancer is confirmed and either in early stage or high-grade but not invasive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Response (CR) Rate

Disease Free Survival (DFS)

Secondary outcome measures

Disease specific survival

Overall survival

Progression-free survival (PFS)

+3 more

Other outcome measures

Immunogenicity: serum level of anti-N-803 in patient samples

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: N-803+BCGExperimental Treatment1 Intervention

(Phase Ib and IIb) for BCG-naive patients

Group II: BCG aloneActive Control1 Intervention

(Phase IIb) for BCG-naive patients

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor

63 Previous Clinical Trials

4,540 Total Patients Enrolled

Chad Garner, PhDStudy DirectorImmunityBio, Inc.

3 Previous Clinical Trials

1,686 Total Patients Enrolled

Bobby Reddy, MDStudy DirectorImmunityBio, Inc.

4 Previous Clinical Trials

36 Total Patients Enrolled

Media Library

ALT-803 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02138734 — Phase 1 & 2

Bladder Cancer Research Study Groups: BCG alone, N-803+BCG

Bladder Cancer Clinical Trial 2023: ALT-803 Highlights & Side Effects. Trial Name: NCT02138734 — Phase 1 & 2

ALT-803 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02138734 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Does this trial currently have vacancies?

"Affirmative. Clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

2014. "A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02138734.

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