Trial Outcomes & Findings for Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (NCT NCT01727154)

Last Updated: 2019-08-19

Results Overview

The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).

Recruitment status

TERMINATED

Target enrollment

139 participants

Primary outcome timeframe

Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.

Results posted on

2019-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Sipuleucel-T Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Study STARTED	139
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	59

Reasons for withdrawal

Reasons for withdrawal
Measure	Sipuleucel-T Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Study Death	17
Overall Study Withdrawal by Subject	14
Overall Study Subject Withdrew Consent	18
Overall Study Study Terminated	6
Overall Study No Discontinuation Documentation	4

Baseline Characteristics

Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sipuleucel-T n=139 Participants Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	106 Participants n=5 Participants
Age, Continuous	71.8 Years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants
Race (NIH/OMB) White	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	139 Participants n=5 Participants
Height	177.6 Centemeters STANDARD_DEVIATION 6.8 • n=5 Participants
Weight	91.1 Kg STANDARD_DEVIATION 19.2 • n=5 Participants
Body Mass Index (BMI)	28.8 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=0	89 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=1	34 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=2	4 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=3	3 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Missing	9 Participants n=5 Participants
Gleason Sum Reported Gleson Sum<= 6	14 Participants n=5 Participants
Gleason Sum Reported Gleson Sum=7	37 Participants n=5 Participants
Gleason Sum Reported Gleson Sum>= 8	63 Participants n=5 Participants
Gleason Sum Reported Missing	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.

Population: This study was terminated early due to administrative reasons. A min of 200 patients were needed to obtain reliable data but only 139 were enrolled, 123 treated only 118 had analyzable immune response samples. Therefore this was a descriptive analysis of only 118pts with an immune response after dosing with Provenge. No comparative group available.

Outcome measures

Outcome measures
Measure	Sipuleucel-T n=118 Participants Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). Subjects who had an immune response	110 Participants
The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). Subjects who did not have an immune response	8 Participants

Adverse Events

Sipuleucel-T

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shabnam Vaziri

Dendreon

Phone: 206.455.2323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Publication restrictions are in place

Restriction type: OTHER