Prostate CancerPhase 1/2NCT03689699
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
A Phase 1/2 study testing Nivolumab, Degarelix and BMS-986253 in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Mark Stein at 4 sites in United States.
Trial summary
MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA). Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of the Prostate
- What is being tested?
- Nivolumab, Degarelix and BMS-986253
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Oct 2018to 2 May 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen.
- Age ≥18 years
- Previously undergone primary therapy for prostate cancer. Salvage XRT or cryotherapy following primary therapy ≥ 6 months prior to randomization is allowed.
- A rising PSA defined as the following:
- If the subject's primary therapy was RP (radical prostatectomy) (with or without adjuvant or salvage XRT), rising PSA is defined as 2 consecutive rising values above 0.2 ng/mL, each taken ≥ 3 weeks apart, and the last value ≥ 2.0 ng/mL
- If the subject received other primary therapies (e.g. XRT, cryosurgery, brachytherapy), rising PSA is defined per the Phoenix definition, i.e., 2 consecutive rising values above the PSA nadir plus 2.0 ng/mL.
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- For the biopsy sub-groups, patients must be willing to undergo pre and on- treatment biopsies.
- PSADT ≤ 12 months. PSADT(prostate-specific antigen doubling time) will be determined from all non-zero PSA values collected preferably, however not limited to, from the 12 months prior to randomization. To calculate PSADT, there must be at least THREE PSA values, with at least 4 weeks between each measurement. The PSADT will be computed from the formula: PSADT = (loge2)/k, with k being the estimated slope of the logarithm of PSA over time. The following web site may also be used: http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)
- Testosterone ≥ 150 ng/dL ≤ 28 days of prior to registration
- Adequate bone marrow, hepatic, and renal function:
- White Blood Cell (WBC)>3,000 cells/mm3
- Absolute neutrophil count (ANC)>1,500 cells/mm3
- Hemoglobin >9.0 g/dL
- Platelet count >100,000 cells/mm3
- Serum creatinine <1.5 × upper limit of normal (ULN)
- Serum total bilirubin <1.5 × ULN
- ALT (alanine aminotransferase) <3 × ULN
- AST(aspartate aminotransferase) <3 × ULN
- Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
- Willingness to use barrier contraception during treatment plus 5 half-lives of nivolumab (~125 days) plus 90 days (duration of sperm turnover) for a total of 215 days post-treatment completion (azoospermic men are not exempt from contraceptive requirements)
Who cannot join
- Received any experimental immunotherapy on an experimental clinical trial ≤ 1 year prior to randomization
- PSA > 50 at time of enrollment
- High volume disease defined as >5 bone metastases or lymph nodes >3cm in size.
- Histologic predominance of other types of prostate cancers such as sarcomatous, lymphoma, small cell, and neuroendocrine tumors (note: a maximum of 5 subjects with ductal prostate cancer will be allowed to enroll to each arm of study treatment across all sites).
- Received salvage XRT ≤ 6 months prior to randomization
- Received ADT ≤ 6 months prior to randomization
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- Received any form of chemotherapy ≤ 90 days prior to randomization
- Received granulocyte colony-stimulating factor or GM-CSF ≤ 90 days prior to randomization
- Any major surgery requiring general anesthesia ≤ 28 days prior to randomization.
- Any other concurrent or prior treatment for prostate cancer ≤ 28 days prior to randomization.
- An active infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5 o F or 38.1 o C) within 1 week prior to randomization
- Prior systemic, ongoing immunosuppressive therapy ≤ 14 days prior to study treatment administration (except for adrenal replacement steroid doses ≤ 10mgdaily prednisone equivalent in the absence of active autoimmune disease or a short course of steroids (<5 days) up to 7 days prior to initiating study treatment).
- Prior participation in an anti-IL8 clinical study
- A candidate is scheduled or likely to be scheduled for salvage external beam XRT or surgery for prostate cancer during the study period
- Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors such as Dutasteride or Finasteride (prior use of these agents is allowed if ≥3 months prior to randomization).
- History of known or suspected autoimmune disease with the following exceptions:
- Asthma and/or allergic rhinitis (seasonal allergies)
- Vitiligo
- Resolved childhood atopic dermatitis
- Psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- Residual hypothyroidism due to an autoimmune condition only requiring hormone replacement
- Euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin (Ig) prior to the first dose of study treatment).
- Type 1 diabetes mellitus
- History of malignancy within the last 2 years (except non-melanoma skin cancers and superficial bladder cancer) and for which no additional therapy is required or anticipated to be required during the study period.
- Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
- Known prior or current history of HIV and/or hepatitis B/C
- Prior organ allograft
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Weill Cornell Medical Center
New York, New York, 10021
Columbia University Irving Medical Center
New York, New York, 10032
Sidney Kimmel Cancer Center- Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Randomized Phase 1b/2 Study of Nivolumab or Nivolumab Plus BMS-986253 in Combination With Intermittent Androgen Deprivation Therapy in Men With Hormone-Sensitive Prostate Cancer
MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA). The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back.
The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy; and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer. The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone.
Read the detailed description
Prostate cancer is common and remains a major cause of death in men. Following local therapy with surgery or radiation, a significant number of men recur either with a rising PSA only (biochemical recurrence (BCR)) or clear metastatic disease on imaging. Although androgen deprivation therapy (ADT) is a frequently used and effective treatment for prostate cancer, it is associated with significant side effects including fatigue, hot flashes, decreased libido and bone loss. Therefore, new approaches to decrease the time on ADT are crucial to improving quality of life for men with prostate cancer.
Once initiated, ADT can be given either continuously or intermittently. However, even with an intermittent approach the ADT-free interval typically decreases with each cycle and most men eventually develop castration resistance. Therefore new treatment strategies are needed to improve disease control while minimizing ADT exposure for men with early prostate cancer.
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Being tested
- Nivolumab, Degarelix, BMS-986253
- Keywords
- Immunotherapy, Nivolumab, BMS-986253, Degarelix, HuMax IL-8
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo®
A dose of 480mg every 4 weeks as a 30 minute IV infusion for 6 doses has been selected for this study. 6 total doses.
DegarelixDrug
Also called Firmagon®
Standard treatment at a dose of 240mg subcutaneously (SQ) as a loading dose followed by 80mg SQ every 4 weeks for 4 doses.
BMS-986253Drug
Also called HuMax IL-8
BMS-986253 (also referred to as anti-IL8 mAb or HuMax IL8) is a fully human-sequence IgG1κ monoclonal antibody (mAb) directed against human interleukin-8 (IL-8). Subjects will be treated with an intravenous (IV) flat dose of 2400mg every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Nivolumab alone | Experimental | 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). Receives: Drug: Nivolumab; Drug: Degarelix |
| Arm B: Nivolumab plus BMS-986253 | Experimental | 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). Receives: Drug: Nivolumab; Drug: Degarelix; Drug: BMS-986253 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prostate-specific Antigen (PSA) Recurrence
Defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy.
Measured: Up to 10 months after completion of therapy, an average of 15 months
Incidence of Adverse Events That Are Serious in Nature and Related to the Investigational Product.
All participants receiving at least one dose of the study drug will be evaluated for safety and toxicity. Adverse events will be classified and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 10 months after completion of therapy, an average of 15 months
Secondary outcomes (2)
Percentage Change in PSA
Determine the % change in PSA in response to immunotherapy by comparing the PSA prior to and following 8 weeks of immunotherapy and before initiation of ADT
Measured: Baseline, 8 weeks
Relapse-free Survival (RFS)
Relapse-free survival (RFS) is the length of time after primary cancer treatment ends that a patient survives without any signs or symptoms of that cancer. "Relapse" is defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start11 Oct 2018
- Primary completion22 Sep 2023
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include a total of approximately 30 patients per arm to achieve at least 23 evaluable patients per arm.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Stein
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Mark Stein, Columbia University
- Investigators
- Mark N. Stein, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689699
- Sponsor's protocol ID
- AAAR7949
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2018
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 1b/2 Study of Nivolumab or Nivolumab Plus BMS-986253 in Combination With Intermittent Androgen Deprivation Therapy in Men With Hormone-Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT03689699
- Acronym / sponsor ID
- AAAR7949
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Keywords
- Immunotherapy, Nivolumab, BMS-986253, Degarelix, HuMax IL-8
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mark SteinUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA). The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back.
The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy; and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer. The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone.
Detailed description
Prostate cancer is common and remains a major cause of death in men. Following local therapy with surgery or radiation, a significant number of men recur either with a rising PSA only (biochemical recurrence (BCR)) or clear metastatic disease on imaging. Although androgen deprivation therapy (ADT) is a frequently used and effective treatment for prostate cancer, it is associated with significant side effects including fatigue, hot flashes, decreased libido and bone loss. Therefore, new approaches to decrease the time on ADT are crucial to improving quality of life for men with prostate cancer.
Once initiated, ADT can be given either continuously or intermittently. However, even with an intermittent approach the ADT-free interval typically decreases with each cycle and most men eventually develop castration resistance. Therefore new treatment strategies are needed to improve disease control while minimizing ADT exposure for men with early prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include a total of approximately 30 patients per arm to achieve at least 23 evaluable patients per arm.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Nivolumab alone | Experimental | Drug: Nivolumab, Drug: DegarelixMen 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). |
| Arm B: Nivolumab plus BMS-986253 | Experimental | Drug: Nivolumab, Drug: Degarelix, Drug: BMS-986253Men 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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen.
- Age ≥18 years
- Previously undergone primary therapy for prostate cancer. Salvage XRT or cryotherapy following primary therapy ≥ 6 months prior to randomization is allowed.
- A rising PSA defined as the following:
- For the biopsy sub-groups, patients must be willing to undergo pre and on- treatment biopsies.
Key exclusion criteria (27 listed)
- Received any experimental immunotherapy on an experimental clinical trial ≤ 1 year prior to randomization
- PSA > 50 at time of enrollment
- High volume disease defined as >5 bone metastases or lymph nodes >3cm in size.
- Histologic predominance of other types of prostate cancers such as sarcomatous, lymphoma, small cell, and neuroendocrine tumors (note: a maximum of 5 subjects with ductal prostate cancer will be allowed to enroll to each arm of study treatment across all sites).
- Received salvage XRT ≤ 6 months prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo®A dose of 480mg every 4 weeks as a 30 minute IV infusion for 6 doses has been selected for this study. 6 total doses. | Drug | Arm A: Nivolumab alone, Arm B: Nivolumab plus BMS-986253 |
| DegarelixAlso: Firmagon®Standard treatment at a dose of 240mg subcutaneously (SQ) as a loading dose followed by 80mg SQ every 4 weeks for 4 doses. | Drug | Arm A: Nivolumab alone, Arm B: Nivolumab plus BMS-986253 |
| BMS-986253Also: HuMax IL-8BMS-986253 (also referred to as anti-IL8 mAb or HuMax IL8) is a fully human-sequence IgG1κ monoclonal antibody (mAb) directed against human interleukin-8 (IL-8). Subjects will be treated with an intravenous (IV) flat dose of 2400mg every 2 weeks. | Drug | Arm B: Nivolumab plus BMS-986253 |
Primary outcome
Number of Participants With Prostate-specific Antigen (PSA) Recurrence
Time frame: Up to 10 months after completion of therapy, an average of 15 months
Defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy.
Incidence of Adverse Events That Are Serious in Nature and Related to the Investigational Product.
Time frame: Up to 10 months after completion of therapy, an average of 15 months
All participants receiving at least one dose of the study drug will be evaluated for safety and toxicity. Adverse events will be classified and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
2 secondary outcomes
Percentage Change in PSA
Time frame: Baseline, 8 weeks
Relapse-free Survival (RFS)
Time frame: Up to two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark N. Stein, MD principal investigator
Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivolumab, Degarelix and BMS-986253 in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Mark Stein at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Prostate-specific Antigen (PSA) Recurrence (time frame: Up to 10 months after completion of therapy, an average of 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.