← Back to Search

Other

Nivolumab + BMS-986253 for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Mark N. Stein, MD

Research Sponsored by Mark Stein

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years

Awards & highlights

Study Summary

This trial is testing whether adding immunotherapy to hormone therapy can help prevent prostate cancer from coming back.

Who is the study for?

Men over 18 with hormone-sensitive prostate cancer who've had primary therapy like surgery or radiation. They must have rising PSA levels, good physical health (ECOG 0-1 or Karnofsky ≥70%), and normal organ function. Participants need to agree to use contraception for about 7 months post-treatment and be willing to undergo biopsies if in the biopsy subgroup.Check my eligibility

What is being tested?

The MAGIC-8 trial is testing how well Nivolumab alone or combined with BMS-986253 works alongside Degarelix, a testosterone-suppressing drug, in reducing the chance of prostate cancer returning. The study measures PSA recurrence rates at 10 months and checks safety/tolerability.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, fatigue, skin issues, hormonal changes due to testosterone suppression by Degarelix, infusion reactions from Nivolumab or BMS-986253, and potential impacts on blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

Select...

My prostate cancer was confirmed by a biopsy or surgery.

Select...

I am 18 years old or older.

Select...

My PSA levels are increasing after my initial prostate cancer treatment.

Select...

My testosterone level was checked and is above 150 ng/dL within the last 28 days.

Select...

I am fully active or able to carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two 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

Incidence of adverse events that are serious in nature and related to the investigational product.

Rate of PSA recurrence

Secondary outcome measures

Percentage change in PSA

Relapse-free survival (RFS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Nivolumab plus BMS-986253Experimental Treatment3 Interventions

Men with hormone-sensitive prostate cancer will receive Nivolumab plus BMS-986253 every 4 weeks for 8 weeks (2 doses), followed by Nivolumab + BMS-986253 + Degarelix every 4 weeks for 16 weeks (4 doses).

Group II: Arm A: Nivolumab aloneExperimental Treatment2 Interventions

Men with hormone-sensitive prostate cancer will receive Nivolumab alone every 4 weeks for 8 weeks (2 doses), followed by Nivolumab + Degarelix every 4 weeks for 16 weeks (4 doses).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Degarelix

2002

Completed Phase 3

~3600

Nivolumab

2014

Completed Phase 3

~4750

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mark SteinLead Sponsor

3 Previous Clinical Trials

89 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,454 Total Patients Enrolled

41 Trials studying Prostate Cancer

5,387 Patients Enrolled for Prostate Cancer

Matthew DallosLead Sponsor

3 Previous Clinical Trials

83 Total Patients Enrolled

1 Trials studying Prostate Cancer

26 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

What is the current scope of participants in this clinical trial?

"This clinical trial is now closed. It was initially posted on October 11th 2018 and last updated May 6th 2022. If you would like to investigate other studies, 1325 trials related to prostate cancer are currently recruiting, while 746 are actively enrolling patients for BMS-986253."

Answered by AI

Have any other controlled experiments been conducted using BMS-986253?

"BMS-986253 was tested for the first time in 2012 at Memorial Sloan Kettering Cancer Center. Subsequently, 313 trials have been completed and there are presently 746 active clinical studies with numerous locations situated around Philadelphia, Pennsylvania."

Answered by AI

Is the research team currently seeking participants for the experiment?

"Unfortunately, this particular experiment is not currently enrolling candidates. The study was initially published on October 11th 2018 and its most recent update occurred on May 6th 2022. Nevertheless, there are numerous other clinical trials that require participants at present - 2,071 to be precise."

Answered by AI

What ailment does BMS-986253 typically aid in remedying?

"BMS-986253 is a medication that can be used to treat malignant neoplasms, as well as certain cases of melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."

Answered by AI

Who are the eligible participants for this clinical trial?

"This clinical trial is recruiting 60 individuals aged 18-99 that have been previously treated for prostate cancer. Additional eligibility criteria includes: ECOG performance status/Karnofsky score of 0-1 or ≥ 70%, testosterone levels > 150 ng/dL, WBCs > 3000 cells/mm3, histopathological adenocarcinoma diagnosis from biopsy or radical prostatectomy specimen, two consecutive rising PSA values above the nadir plus 2.0 ng/mL (or RP with two consecutive rising values above 0.2ng/ml and last value ≥ 2ng), PSADT ≤ 12 months calculated"

Answered by AI

Are applicants aged 25 and above eligible for participation in this clinical experiment?

"This clinical research is open to participants between 18 and 99 years old. For those below the age of consent, there are 130 trials available while 2048 studies can be found for individuals over 65."

Answered by AI

Is this research pioneering or has it been conducted before?

"Currently, there are 746 ongoing clinical trials associated with BMS-986253 that span 49 countries and 2371 cities. This pharmaceutical first appeared in a Ferring Pharmaceuticals sponsored trial back in 2012 which involved 41 participants and concluded its N/A drug approval stage. Since then, 313 additional studies have been conducted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)

Mark Stein 2018. "Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03689699.

All > Acth