Trial Outcomes & Findings for Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer (NCT NCT01420965)
NCT ID: NCT01420965
Last Updated: 2019-07-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
2 years
Results posted on
2019-07-10
Participant Flow
Participant milestones
| Measure |
Arm A
Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)
Sipuleucel-T (Provenge): Vaccine
|
Arm B
Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
|
Arm C
Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV \[first cycle only\] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
Cyclophosphamide: Low dose- Immune Enhancer
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
|
Overall Study
COMPLETED
|
1
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A
Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)
Sipuleucel-T (Provenge): Vaccine
|
Arm B
Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
|
Arm C
Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV \[first cycle only\] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
Cyclophosphamide: Low dose- Immune Enhancer
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=2 Participants
Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)
Sipuleucel-T (Provenge): Vaccine
|
Arm B
n=2 Participants
Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
|
Arm C
n=3 Participants
Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV \[first cycle only\] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
Cyclophosphamide: Low dose- Immune Enhancer
|
Total
n=7 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
7 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Study discontinued due to drug supply issues; no analysis performed or meaningful data derived.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study discontinued due to drug supply issues; no analysis performed or meaningful data derived.
Outcome measures
Outcome data not reported
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=2 participants at risk
Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)
Sipuleucel-T (Provenge): Vaccine
|
Arm B
n=2 participants at risk
Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
|
Arm C
n=3 participants at risk
Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV \[first cycle only\] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
CT-011 (Anti-PD1 Antibody): Immune Enhancer
Sipuleucel-T (Provenge): Vaccine
Cyclophosphamide: Low dose- Immune Enhancer
|
|---|---|---|---|
|
Immune system disorders
Negative infusion reaction
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER