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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

Must not have

Known prior or current history of HIV and/or hepatitis B/C

Prior organ allograft

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My prostate cancer was confirmed by a biopsy or surgery.

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I am 18 years old or older.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of HIV or hepatitis B/C.

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I have received an organ transplant from another person.

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I have more than 5 bone metastases or lymph nodes larger than 3cm.

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My prostate cancer is not the most common type.

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I had a major surgery under general anesthesia recently.

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I have not taken antibiotics for an infection in the last week.

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I am not currently on any immunosuppressive treatments.

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I am scheduled or likely to be scheduled for prostate cancer treatment with radiation or surgery during the study.

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I am currently on specific hormonal therapy.

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I do not have any uncontrolled serious health conditions.

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I have not had any cancer except for certain types in the last 2 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Rate of PSA recurrence

Secondary study objectives

Percentage change in PSA

Relapse-free survival (RFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

BMS-986253

2020

Completed Phase 2

~50

Degarelix

2002

Completed Phase 3

~3730