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

NCT05445882 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-04-02

No results posted yet for this 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.

Conditions

  • Castration Resistant Prostate Cancer

Interventions

DRUG

Bintrafusp alfa

Bintrafusp alfa (1,200 mg) will be given via IV infusion every 2 weeks for up to 3 years.

DRUG

N-803

N-803 (15 mcg/kg) subcutaneous injection will be given every 2 weeks for up to 3 years.

BIOLOGICAL

BN-Brachyury

BN-Brachyury collectively refers to the priming doses (MVA-BN-Brachyury) and the boost doses (FPV-Brachyury). MVA-BN-Brachyury subcutaneous injection will be given as 2 priming doses 2 weeks apart. FPV-Brachyury subcutaneous injection will follow MVA-BN-Brachyury injection 2 weeks later every month for 6 months total, then every 3 months until reaching 2 years. After 2 years FPV-Brachyury may be continued at 6-month dosing intervals for up to 3 years.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • James L Gulley, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-04-01
Completion
2024-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445882 on ClinicalTrials.gov