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Trial record 2 of 2 for:    ipilimumab sipuleucel | Prostate Cancer

Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01804465
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : January 25, 2021
Last Update Posted : February 15, 2021
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Dendreon
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: SipT Treatment
Drug: Ipilimumab
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immediate IpilimumabTreatment Delayed IpilimumabTreatment
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 24 26
Completed 24 26
Not Completed 0 0
Arm/Group Title Immediate IpilimumabTreatment Delayed IpilimumabTreatment Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
50-59 years old
3
  12.5%
2
   7.7%
5
  10.0%
60-69 years old
13
  54.2%
15
  57.7%
28
  56.0%
70-79 years old
8
  33.3%
9
  34.6%
17
  34.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
24
 100.0%
26
 100.0%
50
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Hispanic or Latino
2
   8.3%
2
   7.7%
4
   8.0%
Not Hispanic or Latino
17
  70.8%
19
  73.1%
36
  72.0%
Unknown or Not Reported
5
  20.8%
5
  19.2%
10
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   8.3%
1
   3.8%
3
   6.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   8.3%
1
   3.8%
3
   6.0%
White
17
  70.8%
21
  80.8%
38
  76.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  12.5%
3
  11.5%
6
  12.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 26 participants 50 participants
24 26 50
1.Primary Outcome
Title Percentage of Participants With an Immune Response to Prostatic Acid Phosphatase (PAP) and/or PA2024
Hide Description 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.
Time Frame Up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only a small portion of the collected samples contained enough aliquots or tissue available for this particular analysis
Arm/Group Title Immediate IpilimumabTreatment Delayed IpilimumabTreatment
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 7 8
Measure Type: Number
Unit of Measure: percentage of participants
71.4 87.5
2.Primary Outcome
Title Proportion of Participants With Highest Grade, Treatment-related, Immune Response Adverse Events (IRAEs)
Hide Description Immune 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.
Time Frame Up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate IpilimumabTreatment Delayed IpilimumabTreatment
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 24 26
Measure Type: Number
Unit of Measure: proportion of participants
Grade 2 Adrenal Insufficiency 0.042 0.038
Grade 3 Adrenal insufficiency 0 0.038
Grade 3 Diarrhea 0.042 0.115
Grade 4 Diarrhea 0 0.038
Grade 2 Hyperthyroidism 0 0.038
Grade 1 Hypothyroidism 0 0.038
Grade 2 Hypothyroidism 0.042 0
Grade 3 Lipase increased 0.083 0.038
Grade 2 Rash 0.083 0.038
Grade 3 Rash 0.042 0
3.Secondary Outcome
Title Prostate Specific Antigen (PSA) Response Rate
Hide Description Descriptive statistics will be calculated to characterize the proportion of patients achieving a PSA decline of at least >30% and >50% and presented along with the 95% confidence intervals for each study arm. The proportion of patients achieving an objective response will also be determined. Descriptive statistics will be presented for each study arm to summarize response according to important disease features such as lactate dehydrogenase (LDH) (abnormal vs. normal) and prior treatment (radiation therapy, radical prostatectomy (RP), systemic steroid usage > 3 months).
Time Frame Up to 3 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to PSA Progression
Hide Description Descriptive statistics will be used to summarize time to PSA progression. The Kaplan-Meier product limit will be used to estimate the probability of time to PSA progression with durations measured from the start of protocol therapy. For each study arm the median time to progression with 95% confidence intervals will be presented to summarize clinical efficacy.
Time Frame Up to 2 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Radiographic Clinical Response Rate
Hide Description For 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
Time Frame Up to 6 months
Outcome Measure Data Not Reported
Time Frame Up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate IpilimumabTreatment Delayed IpilimumabTreatment
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Immediate IpilimumabTreatment Delayed IpilimumabTreatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      1/26 (3.85%)    
Hide Serious Adverse Events
Immediate IpilimumabTreatment Delayed IpilimumabTreatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      11/26 (42.31%)    
Endocrine disorders     
Endocrine disorders - Other  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Eye disorders     
Retinal detachment  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Eye disorders - Other  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders     
Colitis  1  0/24 (0.00%)  0 3/26 (11.54%)  3
Colonic perforation  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Diarrhea  1  0/24 (0.00%)  0 3/26 (11.54%)  3
General disorders     
Chills  1  1/24 (4.17%)  1 0/26 (0.00%)  0
Fever  1  1/24 (4.17%)  1 0/26 (0.00%)  0
Vascular disorders     
Hematoma  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Vascular Disorders - Other  1  1/24 (4.17%)  1 0/26 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate IpilimumabTreatment Delayed IpilimumabTreatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/24 (87.50%)      26/26 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  2/24 (8.33%)  6 5/26 (19.23%)  7
Endocrine disorders     
Adrenal insufficiency  1  1/24 (4.17%)  1 3/26 (11.54%)  5
Hyperthyroidism  1  0/24 (0.00%)  0 3/26 (11.54%)  3
Hypothyroidism  1  1/24 (4.17%)  1 2/26 (7.69%)  3
Eye disorders     
Blurred vision  1  1/24 (4.17%)  1 3/26 (11.54%)  3
Gastrointestinal disorders     
Diarrhea  1  4/24 (16.67%)  14 11/26 (42.31%)  19
Nausea  1  3/24 (12.50%)  4 8/26 (30.77%)  13
Abdominal pain  1  2/24 (8.33%)  2 6/26 (23.08%)  9
Constipation  1  4/24 (16.67%)  4 5/26 (19.23%)  6
Gastrointestinal disorders - Other  1  1/24 (4.17%)  1 2/26 (7.69%)  2
Vomiting  1  0/24 (0.00%)  0 2/26 (7.69%)  3
General disorders     
Fatigue  1  8/24 (33.33%)  8 11/26 (42.31%)  20
Pain  1  8/24 (33.33%)  13 6/26 (23.08%)  14
Fever  1  5/24 (20.83%)  5 1/26 (3.85%)  2
Chills  1  0/24 (0.00%)  0 2/26 (7.69%)  4
Hepatobiliary disorders     
Hepatobiliary disorders - Other  1  0/24 (0.00%)  0 2/26 (7.69%)  3
Infections and infestations     
Upper respiratory infection  1  3/24 (12.50%)  3 1/26 (3.85%)  1
Investigations     
Lipase increased  1  5/24 (20.83%)  5 4/26 (15.38%)  7
Investigations - Other  1  2/24 (8.33%)  2 5/26 (19.23%)  8
Aspartate aminotransferase increased  1  1/24 (4.17%)  3 3/26 (11.54%)  7
Lymphocyte count decreased  1  2/24 (8.33%)  4 2/26 (7.69%)  2
Serum amylase increased  1  3/24 (12.50%)  3 1/26 (3.85%)  1
Weight loss  1  2/24 (8.33%)  2 2/26 (7.69%)  2
Alanine aminotransferase increased  1  1/24 (4.17%)  1 2/26 (7.69%)  5
Alkaline phosphatase increased  1  2/24 (8.33%)  2 2/26 (7.69%)  2
Creatinine increased  1  2/24 (8.33%)  2 0/26 (0.00%)  0
Neutrophil count decreased  1  2/24 (8.33%)  2 0/26 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycemia  1  3/24 (12.50%)  5 6/26 (23.08%)  9
Anorexia  1  3/24 (12.50%)  3 4/26 (15.38%)  6
Hyponatremia  1  2/24 (8.33%)  3 2/26 (7.69%)  3
Hypoalbuminemia  1  0/24 (0.00%)  0 2/26 (7.69%)  2
Hypokalemia  1  0/24 (0.00%)  0 2/26 (7.69%)  3
Musculoskeletal and connective tissue disorders     
Back pain  1  4/24 (16.67%)  6 6/26 (23.08%)  6
Arthralgia  1  0/24 (0.00%)  0 2/26 (7.69%)  2
Chest wall pain  1  0/24 (0.00%)  0 2/26 (7.69%)  3
Pain in extremity  1  0/24 (0.00%)  0 2/26 (7.69%)  2
Nervous system disorders     
Dizziness  1  0/24 (0.00%)  0 3/26 (11.54%)  4
Headache  1  1/24 (4.17%)  1 2/26 (7.69%)  2
Paresthesia  1  2/24 (8.33%)  3 0/26 (0.00%)  0
Psychiatric disorders     
Insomnia  1  3/24 (12.50%)  3 4/26 (15.38%)  5
Renal and urinary disorders     
Urine discoloration  1  4/24 (16.67%)  4 3/26 (11.54%)  3
Hematuria  1  4/24 (16.67%)  5 1/26 (3.85%)  1
Proteinuria  1  3/24 (12.50%)  3 2/26 (7.69%)  2
Renal and urinary disorders - Other  1  1/24 (4.17%)  1 2/26 (7.69%)  2
Urinary frequency  1  0/24 (0.00%)  0 2/26 (7.69%)  3
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/24 (12.50%)  3 4/26 (15.38%)  8
Dyspnea  1  2/24 (8.33%)  2 1/26 (3.85%)  2
Respiratory, thoracic and mediastinal disorders - Other  1  0/24 (0.00%)  0 2/26 (7.69%)  2
Skin and subcutaneous tissue disorders     
Pruritus  1  4/24 (16.67%)  4 10/26 (38.46%)  13
Skin and subcutaneous tissue disorders - Other  1  5/24 (20.83%)  5 5/26 (19.23%)  9
Rash maculo-papular  1  4/24 (16.67%)  6 4/26 (15.38%)  9
Dry skin  1  0/24 (0.00%)  0 3/26 (11.54%)  4
Vascular disorders     
Hot flashes  1  3/24 (12.50%)  3 4/26 (15.38%)  6
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lawrence Fong, MD
Organization: University of California, San Francisco
Phone: (415) 514-3160
EMail: Lawrence.Fong@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01804465    
Other Study ID Numbers: 12557
NCI-2014-00318 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Submitted: February 27, 2013
First Posted: March 5, 2013
Results First Submitted: January 4, 2021
Results First Posted: January 25, 2021
Last Update Posted: February 15, 2021