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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 belowSelect...
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.
Neo-Red-P Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
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 moreNeo-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
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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
1,438 Previous Clinical Trials
2,448,769 Total Patients Enrolled
13 Trials studying Prostate Cancer
22,566 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,806 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,542 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly active and can care for myself.I am 18 years old or older.I do not have any serious heart conditions.My prostate cancer is not the usual type.I have taken steroids for less than 5 days within the last week.You have had a severe allergic reaction to a specific type of medication called a monoclonal antibody.I have not had a heart attack or stroke in the last 6 months.I am scheduled for a major prostate surgery at Columbia University Irving Medical Center.I have a serious heart condition, such as heart failure or cardiomyopathy.My cancer has spread to lymph nodes or other parts of my body.My prostate cancer is confirmed and has not spread to lymph nodes or other organs.My initial prostate biopsy shows at least 2 positive cores with a Gleason score of 7 or higher.I haven't had cancer in the past 2 years, except for skin or superficial bladder cancer.My thyroid condition is stable now.You had eczema as a child, but it's no longer a problem for you.I have vitiligo.I need daily oxygen therapy due to heart disease.I have not had an infection in the last week.My liver, kidneys, and bone marrow are working well.I have not received a live vaccine in the last 30 days.I agree to use barrier contraception during and up to 165 days after my treatment.I haven't taken high doses of steroids or immunosuppressants in the last 14 days.I am not currently on hormonal therapy or taking medication to reduce prostate gland size.I have received treatments like radiation, hormone therapy, or chemotherapy for prostate cancer.I have a history of serious heart rhythm problems.I have a history of HIV.My psoriasis hasn't needed systemic treatment in the last 2 years.I have received immunotherapy or vaccine therapy for prostate cancer.I have had myocarditis in the past.I have not had unstable chest pain in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Safety lead-in
- Group 2: Arm A
- Group 3: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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