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Monoclonal Antibodies

Immunotherapy + Hormone Therapy for Prostate Cancer (Neo-Red-P Trial)

Phase < 1
Waitlist Available
Led By Karie D. Runcie, MD
Research Sponsored by Matthew Dallos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights

Neo-Red-P Trial Summary

This trial is testing whether adding immunotherapy to degarelix, which suppresses testosterone, can decrease the chance cancer will come back after surgery, compared to degarelix alone.

Who is the study for?
Men over 18 with high-risk localized prostate cancer (clinical stage T1c-T3b, N0, M0) who have not had prior treatments for their cancer and are scheduled for radical prostatectomy at Columbia University Irving Medical Center. They must have adequate organ function and agree to use barrier contraception post-treatment. Exclusions include significant heart disease, other cancers within the last 2 years, autoimmune diseases, uncontrolled infections or cardiovascular issues.Check my eligibility
What is being tested?
The trial is testing if adding BMS-986218 (an immunotherapy drug) to degarelix (a testosterone-suppressing medication) before surgery can lower the risk of cancer returning compared to using degarelix alone in men with high-risk localized prostate cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to BMS-986218 such as inflammation in various organs, infusion reactions similar to allergic responses during treatment administration, fatigue, hormonal changes from degarelix leading to hot flashes or decreased libido.

Neo-Red-P Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly active and can care for myself.
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I am 18 years old or older.
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I am scheduled for a major prostate surgery at Columbia University Irving Medical Center.
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My prostate cancer is confirmed and has not spread to lymph nodes or other organs.
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My initial prostate biopsy shows at least 2 positive cores with a Gleason score of 7 or higher.
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My liver, kidneys, and bone marrow are working well.
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I agree to use barrier contraception during and up to 165 days after my treatment.

Neo-Red-P Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of patients with an adverse event will be reported with an exact binomial 95% confidence interval
Secondary outcome measures
Mean Treg cell staining percentage in harvested prostate tissues will be reported and compared post-treatment between the treatment groups using paired sample test.
PSA response rates- a 50% change in pre-treatment and post-treatment PSA.
Pathological complete responses (pCR)- an absence of tumor identification on standard histological analysis of the resected prostate specimens.
+2 more

Neo-Red-P Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Safety lead-inExperimental Treatment1 Intervention
The first 4 subjects enrolled will be given degarelix plus BMS-986218.
Group II: Arm BExperimental Treatment1 Intervention
BMS-986218 20mg IV every 2 weeks x 2 doses starting 3 weeks prior to radical prostatectomy plus degarelix 240mg SQ x1 dose 2 weeks prior to radical prostatectomy.
Group III: Arm AActive Control1 Intervention
Degarelix 240mg subcutaneous (SQ) x1 dose 2 weeks prior to radical prostatectomy

Find a Location

Who is running the clinical trial?

Matthew DallosLead Sponsor
3 Previous Clinical Trials
117 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Columbia UniversityLead Sponsor
1,423 Previous Clinical Trials
2,473,016 Total Patients Enrolled
13 Trials studying Prostate Cancer
36,485 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,290 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,421 Patients Enrolled for Prostate Cancer

Media Library

BMS-986218 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04301414 — Phase < 1
Prostate Cancer Research Study Groups: Safety lead-in, Arm A, Arm B
Prostate Cancer Clinical Trial 2023: BMS-986218 Highlights & Side Effects. Trial Name: NCT04301414 — Phase < 1
BMS-986218 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04301414 — Phase < 1

Frequently Asked Questions

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

What prior experiments have there been concerning the use of BMS-986218 and Degarelix?

"Currently, there are 31 active trials assessing the efficacy and safety of BMS-986218 and Degarelix with 8 being at Phase 3. Although many clinical studies for these drugs are located in Los Angeles, California; other sites across the country - totalling 1481 locations - have ongoing activities related to them."

Answered by AI

What is the scope of participants in this clinical experiment?

"Affirmative. The clinicaltrials.gov website attests that this medical investigation is currently enrolling volunteers, having been uploaded on February 25th 2020 and updated as recently as October 27th 2021. This study requires 24 participants from a single location to complete the trial."

Answered by AI

Is this the inaugural study of its type?

"Since its initial clinical trial, sponsored by Ferring Pharmaceuticals in 2012 and involving 41 patients, BMS-986218 and Degarelix has seen tremendous research. Subsequently receiving N/A drug approval, the medication is now being examined through 31 distinct trials conducted across 14 nations in 563 cities."

Answered by AI

Are there still positions available to join this clinical experiment?

"Clinicaltrials.gov indicates that registration for this medical trial, which was first launched on February 25th 2020, is still open and recruiting patients. The latest report of the study's progress was posted on October 27 2021."

Answered by AI
~1 spots leftby Jun 2024