Trial Outcomes & Findings for Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) (NCT NCT03689699)
NCT ID: NCT03689699
Last Updated: 2025-04-29
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Up to 10 months after completion of therapy
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
Baseline characteristics by cohort
| Measure |
Arm A: Nivolumab Alone
n=30 Participants
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).
|
Arm B: Nivolumab Plus BMS-986253
n=29 Participants
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).
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
n=5 Participants
|
68.0 years
n=7 Participants
|
68.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 10 months after completion of therapyDefined 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.
Outcome measures
| Measure |
Arm A: Nivolumab Alone
n=30 Participants
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).
|
Arm B: Nivolumab Plus BMS-986253
n=29 Participants
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).
|
|---|---|---|
|
Number of Participants With Prostate-specific Antigen (PSA) Recurrence
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 100 days after completion of therapyAll 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.
Outcome measures
| Measure |
Arm A: Nivolumab Alone
n=30 Participants
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).
|
Arm B: Nivolumab Plus BMS-986253
n=29 Participants
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).
|
|---|---|---|
|
Incidence of Adverse Events That Are Serious in Nature and Related to the Investigational Product.
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksDetermine 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to two yearsRelapse defined as a PSA \>0.2ng/ml for radical prostatectomy patients or PSA \>2.0ng/ml for patients who received primary radiation therapy.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Nivolumab Alone
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Arm B: Nivolumab Plus BMS-986253
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Nivolumab Alone
n=30 participants at risk
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).
|
Arm B: Nivolumab Plus BMS-986253
n=29 participants at risk
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).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
3.3%
1/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • up to 100 days after completion of therapy
|
3.4%
1/29 • up to 100 days after completion of therapy
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
|
Renal and urinary disorders
Adrenal insufficiency
|
3.3%
1/30 • up to 100 days after completion of therapy
|
6.9%
2/29 • up to 100 days after completion of therapy
|
|
Immune system disorders
Autoimmune diabetes
|
3.3%
1/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
|
Endocrine disorders
Pancreatitis
|
3.3%
1/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
Other adverse events
| Measure |
Arm A: Nivolumab Alone
n=30 participants at risk
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).
|
Arm B: Nivolumab Plus BMS-986253
n=29 participants at risk
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).
|
|---|---|---|
|
General disorders
Hot flashes
|
46.7%
14/30 • up to 100 days after completion of therapy
|
62.1%
18/29 • up to 100 days after completion of therapy
|
|
General disorders
Fatigue
|
53.3%
16/30 • up to 100 days after completion of therapy
|
48.3%
14/29 • up to 100 days after completion of therapy
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
13.3%
4/30 • up to 100 days after completion of therapy
|
34.5%
10/29 • up to 100 days after completion of therapy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
20.0%
6/30 • up to 100 days after completion of therapy
|
20.7%
6/29 • up to 100 days after completion of therapy
|
|
General disorders
Headache
|
3.3%
1/30 • up to 100 days after completion of therapy
|
13.8%
4/29 • up to 100 days after completion of therapy
|
|
General disorders
Flu-like symptoms
|
6.7%
2/30 • up to 100 days after completion of therapy
|
13.8%
4/29 • up to 100 days after completion of therapy
|
|
General disorders
Memory impairment
|
0.00%
0/30 • up to 100 days after completion of therapy
|
10.3%
3/29 • up to 100 days after completion of therapy
|
|
General disorders
Insomnia
|
3.3%
1/30 • up to 100 days after completion of therapy
|
6.9%
2/29 • up to 100 days after completion of therapy
|
|
General disorders
Anorexia
|
3.3%
1/30 • up to 100 days after completion of therapy
|
6.9%
2/29 • up to 100 days after completion of therapy
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/30 • up to 100 days after completion of therapy
|
6.9%
2/29 • up to 100 days after completion of therapy
|
|
General disorders
Dizziness
|
0.00%
0/30 • up to 100 days after completion of therapy
|
6.9%
2/29 • up to 100 days after completion of therapy
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
2/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
12/30 • up to 100 days after completion of therapy
|
37.9%
11/29 • up to 100 days after completion of therapy
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
6/30 • up to 100 days after completion of therapy
|
13.8%
4/29 • up to 100 days after completion of therapy
|
|
Endocrine disorders
Thyroid disorder
|
23.3%
7/30 • up to 100 days after completion of therapy
|
17.2%
5/29 • up to 100 days after completion of therapy
|
|
Hepatobiliary disorders
Hepatotoxicity
|
6.7%
2/30 • up to 100 days after completion of therapy
|
34.5%
10/29 • up to 100 days after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • up to 100 days after completion of therapy
|
20.7%
6/29 • up to 100 days after completion of therapy
|
|
Renal and urinary disorders
Adrenal insufficiency
|
0.00%
0/30 • up to 100 days after completion of therapy
|
6.9%
2/29 • up to 100 days after completion of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
2/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
|
Hepatobiliary disorders
Pancreatitis
|
3.3%
1/30 • up to 100 days after completion of therapy
|
13.8%
4/29 • up to 100 days after completion of therapy
|
|
General disorders
Oral mucositis
|
13.3%
4/30 • up to 100 days after completion of therapy
|
0.00%
0/29 • up to 100 days after completion of therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place