Number of Participants With Prostate-specific Antigen (PSA) Recurrence
| Group | Value (Participants) |
|---|---|
| Arm A: Nivolumab Alone | 8 |
| Arm B: Nivolumab Plus BMS-986253 | 6 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
NCT0368969911 Oct 2018 to 2 May 2024
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Arm A: Nivolumab alone
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).
Experimental
Arm B: Nivolumab plus BMS-986253
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).
Outcomes the sponsor listed as primary.
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.
Percentage Change in PSA
Time frame · Baseline, 8 weeks
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
Relapse-free Survival (RFS)
Time frame · Up to two years
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Arm A: Nivolumab Alone | 8 |
| Arm B: Nivolumab Plus BMS-986253 | 6 |
| Group | Value (Participants) |
|---|---|
| Arm A: Nivolumab Alone | 4 |
| Arm B: Nivolumab Plus BMS-986253 | 3 |
| Group | Value (percent decline from baseline) |
|---|---|
| Arm A: Nivolumab Alone | 95.5 |
| Arm B: Nivolumab Plus BMS-986253 | 97.3 |
| Group | Value (months) |
|---|---|
| Arm A: Nivolumab Alone | 12.5 |
| Arm B: Nivolumab Plus BMS-986253 | 12.0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Arm A: Nivolumab AloneMen 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). | 0 / 30 | 4 / 30 | 29 / 30 |
| Arm B: Nivolumab Plus 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). | 0 / 29 | 3 / 29 | 29 / 29 |
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