Trial Outcomes & Findings for Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC (NCT NCT02463799)
NCT ID: NCT02463799
Last Updated: 2021-07-08
Results Overview
Peripheral PA2024-specific T-cell proliferation responses using a 3H-thymidine incorporation assay at 6 weeks after the first dose of sipuleucel-T, measured by SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-07-08
Participant Flow
One screen failure and one withdrew consent prior to randomization, two participants withdrew prior to receiving treatment
Participant milestones
| Measure |
Sipuleucel-T and Radium 223 Combination
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC
Baseline characteristics by cohort
| Measure |
Sipuleucel-T and Radium 223 Combination
n=16 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=16 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Continuous
|
71.6 years
n=99 Participants
|
70.3 years
n=107 Participants
|
71 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPeripheral PA2024-specific T-cell proliferation responses using a 3H-thymidine incorporation assay at 6 weeks after the first dose of sipuleucel-T, measured by SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ).
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=16 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=16 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation
|
7.0 fold change
Interval 4.12 to 20.2
|
22.4 fold change
Interval 17.2 to 31.4
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm
Mean peripheral PA2024 specific T-cell proliferation using a 3H-thymidine incorporation assay reported as SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ) at baseline and 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=13 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=10 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 10
|
27.8 Stimulation Index
Interval 8.6 to 34.2
|
42.0 Stimulation Index
Interval 26.3 to 56.0
|
|
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 14
|
23.0 Stimulation Index
Interval 7.0 to 21.8
|
42.2 Stimulation Index
Interval 32.1 to 56.1
|
|
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 26
|
27.2 Stimulation Index
Interval 12.2 to 26.4
|
25.6 Stimulation Index
Interval 15.4 to 36.6
|
|
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 39
|
20.7 Stimulation Index
Interval 5.4 to 22.3
|
25.3 Stimulation Index
Interval 25.3 to 25.3
|
|
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 52
|
16.5 Stimulation Index
Interval 4.4 to 23.3
|
11.8 Stimulation Index
Interval 11.8 to 11.8
|
|
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Baseline
|
1.7 Stimulation Index
Interval 1.0 to 2.2
|
1.4 Stimulation Index
Interval 1.2 to 1.5
|
|
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 6
|
25.7 Stimulation Index
Interval 4.4 to 37.0
|
49.8 Stimulation Index
Interval 30.5 to 44.5
|
SECONDARY outcome
Timeframe: Up to 2 yearsNumber of weeks from baseline until radiographic or clinical progression, whichever comes first. Radiographic progression is assessed by RECIST (Response Evaluation Criteria in Solid Tumors) and PCWG2 criteria (Prostate Cancer Working Group 2). Per RECIST, progression is defined as ≥ 20% and ≥ 5 mm from nadir of the sum of the diameters of target lesions. Per PCWG2 criteria, radiographic progression is defined as ≥ 20% sum of the longest diameter of target lesions, or ≥ 2 new lesions on bone scan from baseline. Clinical progression is defined as new spinal cord or nerve root compression, new pathologic fracture or use of opioid analgesics for cancer-related pain.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=16 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=16 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Time to Radiographic or Clinical Progression
|
38.7 WEEKS
Interval 18.9 to
Upper bound of median not reached, therefore cannot be calculated
|
11.9 WEEKS
Interval 8.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsNumber of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=15 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
PSA50 Response (at Least a 50% Decline in PSA)
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm
Mean peripheral PAP specific T-cell proliferation using a 3H-thymidine incorporation assay reported as SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ) at baseline and 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=13 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=10 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Baseline
|
1.1 Stimulation Index
Interval 0.7 to 1.0
|
1.2 Stimulation Index
Interval 1.0 to 1.4
|
|
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 6
|
1.6 Stimulation Index
Interval 0.9 to 1.4
|
12.5 Stimulation Index
Interval 1.3 to 4.6
|
|
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 10
|
3.1 Stimulation Index
Interval 0.8 to 3.8
|
5.7 Stimulation Index
Interval 1.2 to 4.2
|
|
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 14
|
2.3 Stimulation Index
Interval 0.7 to 2.3
|
6.1 Stimulation Index
Interval 1.0 to 7.9
|
|
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 26
|
3.9 Stimulation Index
Interval 0.7 to 3.8
|
1.5 Stimulation Index
Interval 1.0 to 1.7
|
|
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 39
|
4.1 Stimulation Index
Interval 1.3 to 3.5
|
1.8 Stimulation Index
Interval 1.8 to 1.8
|
|
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time
Week 52
|
2.2 Stimulation Index
Interval 0.5 to 3.1
|
1.9 Stimulation Index
Interval 1.9 to 1.9
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm
Mean peripheral PA2024 specific T-cell activation to sipuleucel-T using interferon gamma (IFNγ) enzyme-linked immunosorbent spot (ELISPOT), as measured by cells per 300,000 PBMCs at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=13 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=10 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Peripheral PA2024 Specific T-cell Activation
Baseline
|
3.6 cells per 300,000 PBMCs
Interval 1.0 to 1.8
|
6.0 cells per 300,000 PBMCs
Interval 1.0 to 4.8
|
|
Peripheral PA2024 Specific T-cell Activation
Week 6
|
66.5 cells per 300,000 PBMCs
Interval 17.5 to 127.7
|
194.3 cells per 300,000 PBMCs
Interval 34.2 to 349.8
|
|
Peripheral PA2024 Specific T-cell Activation
Week 10
|
72.9 cells per 300,000 PBMCs
Interval 8.0 to 133.7
|
116.4 cells per 300,000 PBMCs
Interval 14.3 to 232.8
|
|
Peripheral PA2024 Specific T-cell Activation
Week 14
|
73.6 cells per 300,000 PBMCs
Interval 17.3 to 115.3
|
137.8 cells per 300,000 PBMCs
Interval 41.7 to 164.0
|
|
Peripheral PA2024 Specific T-cell Activation
Week 26
|
87.7 cells per 300,000 PBMCs
Interval 12.7 to 137.0
|
169.9 cells per 300,000 PBMCs
Interval 112.7 to 247.8
|
|
Peripheral PA2024 Specific T-cell Activation
Week 39
|
27.3 cells per 300,000 PBMCs
Interval 6.4 to 43.8
|
19.0 cells per 300,000 PBMCs
Interval 19.0 to 19.0
|
|
Peripheral PA2024 Specific T-cell Activation
Week 52
|
22.4 cells per 300,000 PBMCs
Interval 12.0 to 33.2
|
26.0 cells per 300,000 PBMCs
Interval 26.0 to 26.0
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm
Mean peripheral PAP specific T-cell activation to sipuleucel-T using interferon gamma (IFNγ) enzyme-linked immunosorbent spot (ELISPOT) measured as cells per 300,000 PBMCs at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=13 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=10 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Peripheral PAP Specific T-cell Activation
Baseline
|
0.9 cells per 300,000 PBMCs
Interval 0.0 to 1.8
|
4.8 cells per 300,000 PBMCs
Interval 0.0 to 1.7
|
|
Peripheral PAP Specific T-cell Activation
Week 6
|
7.8 cells per 300,000 PBMCs
Interval 0.0 to 2.8
|
10.9 cells per 300,000 PBMCs
Interval 0.0 to 18.7
|
|
Peripheral PAP Specific T-cell Activation
Week 10
|
14.1 cells per 300,000 PBMCs
Interval 0.0 to 3.7
|
19.4 cells per 300,000 PBMCs
Interval 0.0 to 6.5
|
|
Peripheral PAP Specific T-cell Activation
Week 14
|
12.2 cells per 300,000 PBMCs
Interval 0.2 to 5.3
|
9.0 cells per 300,000 PBMCs
Interval 0.0 to 5.0
|
|
Peripheral PAP Specific T-cell Activation
Week 26
|
10.4 cells per 300,000 PBMCs
Interval 0.7 to 2.3
|
1.0 cells per 300,000 PBMCs
Interval 0.0 to 1.5
|
|
Peripheral PAP Specific T-cell Activation
Week 39
|
5.0 cells per 300,000 PBMCs
Interval 0.3 to 2.8
|
1.3 cells per 300,000 PBMCs
Interval 1.3 to 1.3
|
|
Peripheral PAP Specific T-cell Activation
Week 52
|
3.0 cells per 300,000 PBMCs
Interval 0.8 to 4.5
|
0.0 cells per 300,000 PBMCs
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm
Mean titer of PA2024 specific antibody (IgM) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=14 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
PA2024 Specific Antibody (IgM) Response
Baseline
|
1567.9 titer
Interval 200.0 to 1600.0
|
2253.6 titer
Interval 350.0 to 3200.0
|
|
PA2024 Specific Antibody (IgM) Response
Week 6
|
108941.7 titer
Interval 19400.0 to 204800.0
|
164114.3 titer
Interval 102400.0 to 204800.0
|
|
PA2024 Specific Antibody (IgM) Response
Week 10
|
165434.6 titer
Interval 25600.0 to 204800.0
|
214690.9 titer
Interval 128000.0 to 307200.0
|
|
PA2024 Specific Antibody (IgM) Response
Week 14
|
101422.7 titer
Interval 7200.0 to 153600.0
|
185600.0 titer
Interval 102400.0 to 204800.0
|
|
PA2024 Specific Antibody (IgM) Response
Week 26
|
56586.4 titer
Interval 16000.0 to 76800.0
|
28800.0 titer
Interval 17600.0 to 40000.0
|
|
PA2024 Specific Antibody (IgM) Response
Week 39
|
37338.9 titer
Interval 3200.0 to 51200.0
|
204800.0 titer
Interval 204800.0 to 204800.0
|
|
PA2024 Specific Antibody (IgM) Response
Week 52
|
28400.0 titer
Interval 2800.0 to 30400.0
|
—
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm
Mean titer of PA2024 specific antibody (IgG) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=14 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
PA2024 Specific Antibody (IgG) Response
Baseline
|
382.1 titer
Interval 50.0 to 350.0
|
771.4 titer
Interval 62.5 to 800.0
|
|
PA2024 Specific Antibody (IgG) Response
Week 6
|
1476.9 titer
Interval 200.0 to 1600.0
|
7878.6 titer
Interval 1000.0 to 5600.0
|
|
PA2024 Specific Antibody (IgG) Response
Week 10
|
3442.9 titer
Interval 400.0 to 6400.0
|
23272.7 titer
Interval 1600.0 to 6400.0
|
|
PA2024 Specific Antibody (IgG) Response
Week 14
|
4191.7 titer
Interval 350.0 to 4000.0
|
15733.3 titer
Interval 800.0 to 3200.0
|
|
PA2024 Specific Antibody (IgG) Response
Week 26
|
3568.2 titer
Interval 1000.0 to 6400.0
|
7200.0 titer
Interval 4400.0 to 10000.0
|
|
PA2024 Specific Antibody (IgG) Response
Week 39
|
2738.9 titer
Interval 400.0 to 1600.0
|
25600.0 titer
Interval 25600.0 to 25600.0
|
|
PA2024 Specific Antibody (IgG) Response
Week 52
|
3812.5 titer
Interval 612.5 to 4400.0
|
—
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm
Mean titer of PAP specific antibody (IgG) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=14 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
PAP Specific Antibody (IgG) Response Over Time
Week 26
|
5354.5 titer
Interval 400.0 to 4800.0
|
51400.0 titer
Interval 25900.0 to 76900.0
|
|
PAP Specific Antibody (IgG) Response Over Time
Week 39
|
3916.7 titer
Interval 400.0 to 6400.0
|
204800.0 titer
Interval 204800.0 to 204800.0
|
|
PAP Specific Antibody (IgG) Response Over Time
Week 52
|
5100 titer
Interval 700.0 to 8000.0
|
—
|
|
PAP Specific Antibody (IgG) Response Over Time
Week 14
|
6554.2 titer
Interval 625.0 to 6400.0
|
6450.0 titer
Interval 2450.0 to 12800.0
|
|
PAP Specific Antibody (IgG) Response Over Time
Baseline
|
796.4 titer
Interval 50.0 to 800.0
|
1475.0 titer
Interval 125.0 to 800.0
|
|
PAP Specific Antibody (IgG) Response Over Time
Week 6
|
3765.4 titer
Interval 400.0 to 1600.0
|
10546.4 titer
Interval 800.0 to 5600.0
|
|
PAP Specific Antibody (IgG) Response Over Time
Week 10
|
15125.0 titer
Interval 800.0 to 11200.0
|
44563.6 titer
Interval 4800.0 to 25600.0
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm
Mean titer of PAP specific antibody (IgM) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=14 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
PAP Specific Antibody (IgM) Response
Baseline
|
4714.3 titer
Interval 250.0 to 1600.0
|
6253.8 titer
Interval 400.0 to 3200.0
|
|
PAP Specific Antibody (IgM) Response
Week 6
|
99209.1 titer
Interval 19200.0 to 51200.0
|
112114.3 titer
Interval 16000.0 to 204800.0
|
|
PAP Specific Antibody (IgM) Response
Week 10
|
183184.6 titer
Interval 25600.0 to 409600.0
|
210909.1 titer
Interval 76800.0 to 409600.0
|
|
PAP Specific Antibody (IgM) Response
Week 14
|
73250.0 titer
Interval 5200.0 to 64000.0
|
238400.0 titer
Interval 166400.0 to 409600.0
|
|
PAP Specific Antibody (IgM) Response
Week 26
|
72363.6 titer
Interval 12800.0 to 38400.0
|
205600.0 titer
Interval 103600.0 to 307600.0
|
|
PAP Specific Antibody (IgM) Response
Week 39
|
36425.0 titer
Interval 5600.0 to 25600.0
|
409600.0 titer
Interval 409600.0 to 409600.0
|
|
PAP Specific Antibody (IgM) Response
Week 52
|
33200.0 titer
Interval 2800.0 to 44800.0
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm
Mean number of CD54 + cells
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=14 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Sipuleucel-T Product Immune Parameters as Assessed by Number of CD54+ Cells
|
2730.3 cells x 10 ^ 6
Interval 1704.8 to 3474.5
|
2059.1 cells x 10 ^ 6
Interval 1598.2 to 2512.5
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm
Mean CD54+ Upregulation of Sipuleucel-T
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=14 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Sipuleucel-T Product Immune Parameters as Assessed by CD54+ Upregulation
|
29.8 cells x 10^6
Interval 26.4 to 35.1
|
31.3 cells x 10^6
Interval 25.1 to 35.1
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm
Mean number of Total Nucleated Cells
Outcome measures
| Measure |
Sipuleucel-T and Radium 223 Combination
n=14 Participants
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=14 Participants
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Sipuleucel-T Product Immune Parameters as Assessed by Total Nucleated Cell Count
|
11580.5 cells 10^6
Interval 7445.2 to 13961.0
|
12740.5 cells 10^6
Interval 9127.8 to 14740.2
|
Adverse Events
Sipuleucel-T and Radium 223 Combination
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Sipuleucel-T Alone
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sipuleucel-T and Radium 223 Combination
n=16 participants at risk
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=16 participants at risk
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/16 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
Other adverse events
| Measure |
Sipuleucel-T and Radium 223 Combination
n=16 participants at risk
Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
Sipuleucel-T Alone
n=16 participants at risk
Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10
Sipuleucel-T: 3 infusions of sipuleucel-T alone
|
|---|---|---|
|
General disorders
Pain
|
75.0%
12/16 • Number of events 12 • 1 year
|
75.0%
12/16 • Number of events 12 • 1 year
|
|
General disorders
Chills
|
12.5%
2/16 • Number of events 2 • 1 year
|
37.5%
6/16 • Number of events 6 • 1 year
|
|
General disorders
Fatigue
|
31.2%
5/16 • Number of events 5 • 1 year
|
18.8%
3/16 • Number of events 3 • 1 year
|
|
General disorders
Flu Like Symptoms
|
25.0%
4/16 • Number of events 4 • 1 year
|
18.8%
3/16 • Number of events 3 • 1 year
|
|
General disorders
Fever
|
12.5%
2/16 • Number of events 2 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • 1 year
|
18.8%
3/16 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Investigations
White Blood Cell Decreased
|
12.5%
2/16 • Number of events 2 • 1 year
|
0.00%
0/16 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
6/16 • Number of events 6 • 1 year
|
37.5%
6/16 • Number of events 6 • 1 year
|
|
Investigations
Platelet Count Decreased
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Number of events 6 • 1 year
|
25.0%
4/16 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
8/16 • Number of events 8 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Number of events 2 • 1 year
|
31.2%
5/16 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
2/16 • Number of events 2 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypertension
|
18.8%
3/16 • Number of events 3 • 1 year
|
0.00%
0/16 • 1 year
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Edema Limbs
|
6.2%
1/16 • Number of events 1 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 2 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/16 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/16 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place