Arm 1 for Prostate Cancer

Phase-Based Progress Estimates
National Institutes of Health Clinical Center, Bethesda, MD
Prostate Cancer+1 More
Bintrafusp alfa - Drug
What conditions do you have?

Study Summary

Background: Prostate cancer does not trigger a strong immune response in the body. Hormone therapy, to reduce levels of testosterone in the body, can be helpful to treat some prostate cancers. However, castration-resistant prostate cancer (CRPC) keeps growing even when the testosterone is reduced to a very low level. Men with metastatic CRPC survive an average of only 3 years. More effective treatments are needed. Objective: To test whether an immunotherapy drug (N-803), alone or in combination with other drugs, can help treat CRPC. Eligibility: Males aged 18 or older with CRPC. Prior treatment with testosterone-lowering therapy is required. Design: Participants will be screened. They will have blood and urine tests. They will have a CT scan of the chest, abdomen, and pelvis. They will continue to receive hormone therapy for prostate cancer. Participants will come to the NIH clinic once a week for the first 4 weeks. Then they will come once every 2 weeks. Visits will last up to 8 hours. The study will continue up to 3 years. All participants will receive N-803 once every 2 weeks. The drug is injected just under the skin with a small needle. Some participants will receive N-803 plus another drug (brachyury vaccine). This drug is also injected under the skin with a small needle. Some participants will receive N-803 plus a different drug (bintrafusp alfa) once every 2 weeks. This drug is given through a tube attached to a needle placed in a vein in the arm. Some participants may receive all 3 drugs. Participants will have imaging scans every 12 weeks.

Eligible Conditions

  • Prostate Cancer
  • Castration Resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 3 years

12 weeks
Clinical Efficacy of N-803 alone or in combination with brachyury vaccine or bintrafusp alfa
3 years
Duration of response
Radiographic response
Safety profile of N-803 alone or in combination with brachyury vaccine or bintrafusp alfa

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Arm 1
1 of 3
Arm 2
1 of 3
Arm 3
1 of 3
Experimental Treatment

28 Total Participants · 3 Treatment Groups

Primary Treatment: Arm 1 · No Placebo Group · Phase 2

Arm 1Experimental Group · 2 Interventions: N-803, BN-Brachyury · Intervention Types: Drug, Biological
Arm 2
Experimental Group · 1 Intervention: N-803 · Intervention Types: Drug
Arm 3Experimental Group · 2 Interventions: Bintrafusp alfa, N-803 · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp alfa
Completed Phase 2

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
35 TrialsResearching Prostate Cancer
270 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of castration-resistant prostate cancer (CRPC) with histologic confirmation of diagnosis at any time point prior to initiation of study therapy
You have a castrate testosterone level.\n
You have radiographic progression of prostate cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.