Trial Outcomes & Findings for Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer (NCT NCT01804465)
NCT ID: NCT01804465
Last Updated: 2021-08-18
Results Overview
Immune response will be tested using the single sample binomial exact test when induction therapy is completed. The Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibody responses to PAP and/or PA2024 will be assessed by ELISA assay at baseline and week 20 after start of sipT treatment (day 113 of study treatment). A positive response is defined as a titer \> 1:400. The positive immune percentage for both IgG and IgM antibodies to PAP and to PA2024 will be used to summarize the results for each study arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 20 weeks
Results posted on
2021-08-18
Participant Flow
Participant milestones
| Measure |
Immediate IpilimumabTreatment
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of Sipuleucel-T (SipT).
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-59 years old
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Customized
60-69 years old
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Customized
70-79 years old
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
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
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 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
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 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
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
26 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 20 weeksPopulation: Only a small portion of the collected samples contained enough aliquots or tissue available for this particular analysis
Immune response will be tested using the single sample binomial exact test when induction therapy is completed. The Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibody responses to PAP and/or PA2024 will be assessed by ELISA assay at baseline and week 20 after start of sipT treatment (day 113 of study treatment). A positive response is defined as a titer \> 1:400. The positive immune percentage for both IgG and IgM antibodies to PAP and to PA2024 will be used to summarize the results for each study arm.
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=7 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=8 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Percentage of Participants With an Immune Response to Prostatic Acid Phosphatase (PAP) and/or PA2024
|
71.4 percentage of participants
|
87.5 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 20 weeksImmune Response Adverse Events (IRAEs) will be reported for each study arm by tabulating the frequency of the maximum grade occurring for each patient for each type of iRAE using NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0. IRAEs will be reported as a proportion of the participants in the treatment arm with the associated highest grade IRAE occurrences during protocol therapy.
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 2 Adrenal Insufficiency
|
0.042 proportion of participants
|
0.038 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 3 Adrenal insufficiency
|
0 proportion of participants
|
0.038 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 3 Diarrhea
|
0.042 proportion of participants
|
0.115 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 4 Diarrhea
|
0 proportion of participants
|
0.038 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 2 Hyperthyroidism
|
0 proportion of participants
|
0.038 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 1 Hypothyroidism
|
0 proportion of participants
|
0.038 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 2 Hypothyroidism
|
0.042 proportion of participants
|
0 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 3 Lipase increased
|
0.083 proportion of participants
|
0.038 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 2 Rash
|
0.083 proportion of participants
|
0.038 proportion of participants
|
|
Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Grade 3 Rash
|
0.042 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 3 weeksDescriptive statistics will be calculated to characterize the proportion of patients achieving a PSA decline of at least \>30% after 1 cycle of treatment and presented along with the 95% confidence intervals for each study arm.
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Proportion of Patients Achieving a Prostate-specific Antigen (PSA) Decline of at Least 30% Below Baseline
|
0.125 proportion
Interval 0.026 to 0.324
|
0.115 proportion
Interval 0.025 to 0.302
|
SECONDARY outcome
Timeframe: Up to 3 weeksDescriptive statistics will be calculated to characterize the proportion of patients achieving a PSA decline of at least \>50% and presented along with the 95% confidence intervals for each study arm.
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Proportion of Patients Achieving a PSA Decline of at Least 50% Below Baseline
|
0.083 proportion
Interval 0.01 to 0.27
|
0.115 proportion
Interval 0.025 to 0.302
|
SECONDARY outcome
Timeframe: Up to 2 yearsProportion of patients achieving an objective response as defined by Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) as complete response (irCR), partial response (irPR) will be reported along with 95% confidence intervals
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Proportion of Patients Achieving an Objective Response
|
0 proportion
No participants achieved an objective response so a confidence interval could not be calculated
|
0 proportion
No participants achieved an objective response so a confidence interval could not be calculated
|
SECONDARY outcome
Timeframe: Up to 2 yearsProportion of patients achieving an objective response as defined by irRECIST as irCR +irPR and stratified by history of prior RP will be reported along with 95% confidence intervals.
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Proportion of Patients Achieving an Objective Response Stratified by Prior Radical Prostatectomy (RP)
|
0 proportion
No participants achieved an objective response so a confidence interval could not be calculated
|
0 proportion
No participants achieved an objective response so a confidence interval could not be calculated
|
SECONDARY outcome
Timeframe: Up to 2 yearsProportion of patients achieving an objective response as defined by irRECIST as irCR + irPR stratified by prior RT will be reported along with 95% confidence intervals
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Proportion of Patients Achieving an Objective Response Stratified by Radiation Therapy (RT)
|
0 proportion
No participants achieved an objective response so a confidence interval could not be calculated
|
0 proportion
No participants achieved an objective response so a confidence interval could not be calculated
|
SECONDARY outcome
Timeframe: Up to 6 monthsFor each treatment arm, for patients with objective disease, using immune-related response criteria (irRC) criteria, the proportion of patients achieving a complete or partial response will be determined and reported with 95% confidence intervals
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Radiographic Clinical Response Rate
|
0.833 proportion
Interval 0.626 to 0.953
|
0.769 proportion
Interval 0.564 to 0.91
|
SECONDARY outcome
Timeframe: Up to 12 weeksTime to PSA progression is defined as the start of protocol therapy to progression status at the end of 4 cycles of treatment as determined by the irRECIST.
Outcome measures
| Measure |
Immediate IpilimumabTreatment
n=24 Participants
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 Participants
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Median Time to PSA Progression
|
49 days
Interval -103.0 to 1092.0
|
47.5 days
Interval -54.0 to 414.0
|
Adverse Events
Immediate IpilimumabTreatment
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Delayed IpilimumabTreatment
Serious events: 11 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Immediate IpilimumabTreatment
n=24 participants at risk
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 participants at risk
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/24 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Retinal detachment
|
0.00%
0/24 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/24 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/24 • Up to 2 years
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/24 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/24 • Up to 2 years
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/24 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Vascular Disorders - Other
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
0.00%
0/26 • Up to 2 years
|
|
General disorders
Chills
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
0.00%
0/26 • Up to 2 years
|
|
General disorders
Fever
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
0.00%
0/26 • Up to 2 years
|
Other adverse events
| Measure |
Immediate IpilimumabTreatment
n=24 participants at risk
Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
Delayed IpilimumabTreatment
n=26 participants at risk
Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.
SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
4/24 • Number of events 14 • Up to 2 years
|
42.3%
11/26 • Number of events 19 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 4 • Up to 2 years
|
30.8%
8/26 • Number of events 13 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
2/24 • Number of events 2 • Up to 2 years
|
23.1%
6/26 • Number of events 9 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
4/24 • Number of events 4 • Up to 2 years
|
19.2%
5/26 • Number of events 6 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
|
General disorders
Fatigue
|
33.3%
8/24 • Number of events 8 • Up to 2 years
|
42.3%
11/26 • Number of events 20 • Up to 2 years
|
|
General disorders
Pain
|
33.3%
8/24 • Number of events 13 • Up to 2 years
|
23.1%
6/26 • Number of events 14 • Up to 2 years
|
|
General disorders
Fever
|
20.8%
5/24 • Number of events 5 • Up to 2 years
|
3.8%
1/26 • Number of events 2 • Up to 2 years
|
|
General disorders
Chills
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
4/24 • Number of events 4 • Up to 2 years
|
38.5%
10/26 • Number of events 13 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
20.8%
5/24 • Number of events 5 • Up to 2 years
|
19.2%
5/26 • Number of events 9 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
4/24 • Number of events 6 • Up to 2 years
|
15.4%
4/26 • Number of events 9 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/24 • Up to 2 years
|
11.5%
3/26 • Number of events 4 • Up to 2 years
|
|
Investigations
Lipase increased
|
20.8%
5/24 • Number of events 5 • Up to 2 years
|
15.4%
4/26 • Number of events 7 • Up to 2 years
|
|
Investigations
Investigations - Other
|
8.3%
2/24 • Number of events 2 • Up to 2 years
|
19.2%
5/26 • Number of events 8 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24 • Number of events 3 • Up to 2 years
|
11.5%
3/26 • Number of events 7 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
8.3%
2/24 • Number of events 4 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Investigations
Serum amylase increased
|
12.5%
3/24 • Number of events 3 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Investigations
Weight loss
|
8.3%
2/24 • Number of events 2 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
7.7%
2/26 • Number of events 5 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
2/24 • Number of events 2 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Investigations
Creatinine increased
|
8.3%
2/24 • Number of events 2 • Up to 2 years
|
0.00%
0/26 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
8.3%
2/24 • Number of events 2 • Up to 2 years
|
0.00%
0/26 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
3/24 • Number of events 5 • Up to 2 years
|
23.1%
6/26 • Number of events 9 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
3/24 • Number of events 3 • Up to 2 years
|
15.4%
4/26 • Number of events 6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
2/24 • Number of events 3 • Up to 2 years
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
4/24 • Number of events 6 • Up to 2 years
|
23.1%
6/26 • Number of events 6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urine discoloration
|
16.7%
4/24 • Number of events 4 • Up to 2 years
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
16.7%
4/24 • Number of events 5 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
3/24 • Number of events 3 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Up to 2 years
|
11.5%
3/26 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
8.3%
2/24 • Number of events 3 • Up to 2 years
|
0.00%
0/26 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
3/24 • Number of events 3 • Up to 2 years
|
15.4%
4/26 • Number of events 8 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
2/24 • Number of events 2 • Up to 2 years
|
3.8%
1/26 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Vascular disorders
Hot flashes
|
12.5%
3/24 • Number of events 3 • Up to 2 years
|
15.4%
4/26 • Number of events 6 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
11.5%
3/26 • Number of events 5 • Up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/24 • Up to 2 years
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
2/24 • Number of events 6 • Up to 2 years
|
19.2%
5/26 • Number of events 7 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
12.5%
3/24 • Number of events 3 • Up to 2 years
|
15.4%
4/26 • Number of events 5 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
3/24 • Number of events 3 • Up to 2 years
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
4.2%
1/24 • Number of events 1 • Up to 2 years
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
0.00%
0/24 • Up to 2 years
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
Additional Information
Dr. Lawrence Fong, MD
University of California, San Francisco
Phone: (415) 514-3160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place