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Cancer Vaccine

Immunotherapy Combination for Prostate Cancer

Phase 1 & 2

Recruiting

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

Castrate testosterone level less than 50ng/dl or 1.7nmol /L (Participants with a malignancy other than prostate cancer are excluded from this criterion)

Participants must have histologically or cytologically confirmed any solid tumor (Cohort 1) or castration-resistant prostate cancer (CRPC, Cohorts 2A, 2D and 2R)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is for people with castration-resistant prostate cancer (CRPC) or another metastatic cancer. The objective is to test if the combination of the drugs BN-brachyury, M7824, N-803, and Epacadostat is safe and shrinks tumors.

Who is the study for?

Adults with castration-resistant prostate cancer or other metastatic solid tumors, who have not had certain treatments recently and agree to use contraception. They must have adequate organ function and no severe allergies to study drugs, no recent major surgery, and cannot be immunocompromised.Check my eligibility

What is being tested?

The trial tests a combination of immunotherapy drugs (BN-brachyury vaccine, M7824, N-803, Epacadostat) for safety and tumor shrinkage in patients with CRPC or other cancers. Treatments are given in cycles involving IVs, injections, and oral pills.See study design

What are the potential side effects?

Potential side effects may include skin changes at injection sites, immune system reactions affecting various organs due to the nature of immunotherapies involved. Specific side effect profiles will be monitored throughout the treatment cycles.

Eligibility Criteria

Inclusion Criteria

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

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My testosterone levels are below 50ng/dl, and I do not have prostate cancer.

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I have a confirmed solid tumor or castration-resistant prostate cancer.

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My advanced cancer has no cure with standard treatments or those have failed.

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My scans show my cancer has spread or gotten worse with low testosterone levels.

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I agree to continue hormone therapy for my condition as required.

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I have received specific treatments before.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

To determine if there is clinical benefit to any of a set of 3 possible treatments for patients with mCRPC

Secondary outcome measures

Evaluate PFS in CRPC patients treated with BN-Brachyury + M7824

Evaluate PFS in CRPC patients treated with BN-Brachyury + M7824 + N-803

Evaluate PFS in CRPC patients treated with BN-Brachyury + M7824 + N-803 + Epacadostat

+1 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: Arm 2.3BExperimental Treatment5 Interventions

M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIB

Group II: Arm 2.3AExperimental Treatment5 Interventions

M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA

Group III: Arm 2.2BExperimental Treatment4 Interventions

M7824 + BN-Brachyury + N-803 during phase IIB

Group IV: Arm 2.2AExperimental Treatment4 Interventions

M7824 + BN-Brachyury + N-803 during phase IIA

Group V: Arm 2.1BExperimental Treatment3 Interventions

M7824 + BN-Brachyury during phase IIB

Group VI: Arm 2.1AExperimental Treatment3 Interventions

M7824 + BN-Brachyury during phase IIA

Group VII: Arm 1.1Experimental Treatment2 Interventions

M7824 + N-803

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epacadostat

2018

Completed Phase 3

~1080

M7824

2020

Completed Phase 2

~350

N-803

2021

Completed Phase 2

~30

MVA-BN-Brachyury

2020

Completed Phase 1

~20

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,554 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,060 Patients Enrolled for Prostate Cancer

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

19 Previous Clinical Trials

35,733 Total Patients Enrolled

6 Trials studying Prostate Cancer

25,213 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Clinical Trial 2023: BN-Brachyury Vaccine Highlights & Side Effects. Trial Name: NCT03493945 — 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 particular investigation a pioneer in its field?

"The scientific community has researched N-803 since 2014, when ImmunityBio Inc. sponsored its initial trial of 596 patients. After the successful completion of Phase 1 & 2 trials, 32 live studies for the drug have been launched in 412 cities across 27 nations."

Answered by AI

What is the upper limit of participants in this medical research?

"True, the information provided on clinicaltrials.gov reveals that recruitment for this trial is active as of November 1st 2022. This medical research was initially posted on May 1st 2018 and requires 113 individuals to be recruited from one single location."

Answered by AI

Has recruitment for this trial opened up to the public yet?

"Per the clinicaltrials.gov portal, the study is actively searching for participants who meet its criteria; it was initially posted on May 1st 2018 and recently modified on November 1st 2022."

Answered by AI

What objectives is this research trying to fulfill?

"This two year study seeks to evaluate the therapeutic efficacy of a triad of treatments for patients with metastatic Castrate-Resistant Prostate cancer (mCRPC). Researchers will be assessing Progression Free Survival in those that receive BN-Brachyury + M7824 + N-803 + Epacadostat, BN-Brachyury + M7824, and M7824 + N-803 interventions. Additionally, this experiment will be measuring safety profiles related to all three therapies."

Answered by AI

Are there any previous studies that have explored the effects of N-803?

"Presently, 32 trials are analysing the efficacy of N-803. Of those active studies, five have progressed to Phase 3. Ann Arbor, Michigan is homebase for most research into this medication; however 876 other sites are also conducting tests in relation to N-803."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Differential Combination Immunotherapy Requirements for Inflamed (warm) Tumors Versus T Cell Excluded (cool) Tumors: Engage, Expand, Enable, and Evolve

Fabian, Kellsye P, Michelle R Padget, Rika Fujii, Jeffrey Schlom, and James W Hodge. 2021. “Differential Combination Immunotherapy Requirements for Inflamed (warm) Tumors Versus T Cell Excluded (cool) Tumors: Engage, Expand, Enable, and Evolve”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2020-001691.

Journal for ImmunoTherapy of CancerJournal

Quick Efficacy Seeking Trial (quest1): A Novel Combination Immunotherapy Study Designed for Rapid Clinical Signal Assessment Metastatic Castration-resistant Prostate Cancer

Redman, Jason M., Seth M. Steinberg, and James L. Gulley. 2018. “Quick Efficacy Seeking Trial (quest1): A Novel Combination Immunotherapy Study Designed for Rapid Clinical Signal Assessment Metastatic Castration-resistant Prostate Cancer”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1186/s40425-018-0409-8.

Journal for ImmunoTherapy of CancerJournal

Quick Efficacy Seeking Trial (quest1): A Novel Combination Immunotherapy Study Designed for Rapid Clinical Signal Assessment Metastatic Castration-resistant Prostate Cancer

clinicaltrials.govStudy

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)