← Back to Search

Cytokine

N-803 + Immunotherapy for Prostate Cancer

Phase 2

Waitlist Available

Led By James L Gulley, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants willing to continue androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone analog/antagonist or bilateral orchiectomy

Progressive disease at study entry defined as radiographic progression or PSA progression in the setting of castrate levels of testosterone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing whether an immunotherapy drug, N-803, can help treat castration-resistant prostate cancer. The drug is given alone or in combination with other drugs.

Who is the study for?

This trial is for men 18 or older with castration-resistant prostate cancer (CRPC) that has spread, and who have previously undergone testosterone-lowering therapy. They must have a low testosterone level and show signs of disease progression. Participants need to be able to sign consent, continue hormone therapy, and use contraception during the study.Check my eligibility

What is being tested?

The trial tests N-803 immunotherapy alone or combined with BN-Brachyury vaccine or Bintrafusp alfa in treating CRPC. Patients will receive treatments via injections under the skin or through an IV every two weeks while continuing hormone therapy, with follow-ups including imaging scans every 12 weeks.See study design

What are the potential side effects?

Potential side effects may include typical immune-related reactions due to immunotherapy such as inflammation in various organs, infusion reactions at the injection site, fatigue, possible blood disorders, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am willing to continue hormone therapy for my cancer.

Select...

My cancer has worsened, shown by tests or rising PSA levels with low testosterone.

Select...

I have been treated with testosterone lowering therapy for prostate cancer.

Select...

I am 18 years old or older.

Select...

I agree to use effective birth control.

Select...

My hepatitis C is treated and currently undetectable.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Clinical Efficacy of N-803 alone or in combination with brachyury vaccine or bintrafusp alfa

Secondary outcome measures

Duration of response

Radiographic response

Safety profile of N-803 alone or in combination with brachyury vaccine or bintrafusp alfa

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3Experimental Treatment2 Interventions

N-803 + bintrafusp alfa (+ BN-Brachyury if progression beyond 12 weeks)

Group II: Arm 2Experimental Treatment1 Intervention

N-803 (+ BN-Brachyury + bintrafusp alfa if progression beyond 12 weeks)

Group III: Arm 1Experimental Treatment2 Interventions

N-803 + BN-Brachyury (+ bintrafusp alfa if progression beyond 12 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bintrafusp alfa

2020

Completed Phase 2

~1110

N-803

2021

Completed Phase 2

~30

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

James L Gulley, M.D.Principal InvestigatorNational Cancer Institute (NCI)

19 Previous Clinical Trials

35,846 Total Patients Enrolled

7 Trials studying Prostate Cancer

25,326 Patients Enrolled for Prostate Cancer

Media Library

N-803 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT05445882 — Phase 2

Prostate Cancer Research Study Groups: Arm 1, Arm 2, Arm 3

Prostate Cancer Clinical Trial 2023: N-803 Highlights & Side Effects. Trial Name: NCT05445882 — Phase 2

N-803 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445882 — Phase 2

Frequently Asked Questions

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

How efficacious is BN-Brachyury for human utilization?

"Our team at Power assigned BN-Brachyury a score of 2, considering there is evidence of safety but not efficacy from this Phase 2 clinical trial."

Answered by AI

Are recruiting efforts underway for this clinical trial?

"Unfortunately, the clinicaltrials.gov site attests that this trial is no longer accepting new patients after its initial posting on December 4th 2022 and last update in late November of the same year. Nonetheless, there are still 1255 other medical trials actively enrolling subjects at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer

2024. "N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445882.