Trial Outcomes & Findings for Neoadjuvant Ipilimumab in Prostate Cancer (NCT NCT01194271)
NCT ID: NCT01194271
Last Updated: 2024-06-06
Results Overview
Immunological response assays were measured at several time points starting at baseline until the eighth week after starting the medicine for each participant. The immunological responses measured were Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Inducible T-cell Costimulatory (ICOS) markers. T-cells with the CD4 marker help coordinate the immune system response to an invader. Killer T-cells have the CD8 marker and are responsible for killing the invader. ICOS is a molecule which stimulates the activity of the immune response of the killer T-Cells and memory T cells. Participants with at least a 2 fold increase in the presence of CD4, CD8, or ICOS markers from the participant's baseline measure were considered a responder for that marker.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2024-06-06
Participant Flow
Recruitment period: September 1, 2010 to June 5, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Neoadjuvant Ipilimumab
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Neoadjuvant Ipilimumab
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Ineligible, Screen Failure
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Neoadjuvant Ipilimumab in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Ipilimumab
n=17 Participants
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
|
|---|---|
|
Age, Continuous
|
57.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
|
PSA (Average) Tumor Clinical Stage
T1
|
5 Participants
n=5 Participants
|
|
PSA (Average) Tumor Clinical Stage
T2
|
4 Participants
n=5 Participants
|
|
PSA (Average) Tumor Clinical Stage
T3
|
8 Participants
n=5 Participants
|
|
Gleason Score
7
|
1 Participants
n=5 Participants
|
|
Gleason Score
8
|
5 Participants
n=5 Participants
|
|
Gleason Score
9
|
10 Participants
n=5 Participants
|
|
Gleason Score
10
|
1 Participants
n=5 Participants
|
|
Lupron Ipilimumab Dose
One dose
|
1 Participants
n=5 Participants
|
|
Lupron Ipilimumab Dose
Two doses
|
16 Participants
n=5 Participants
|
|
Surgery
Yes
|
16 Participants
n=5 Participants
|
|
Surgery
No
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: One participant was not evaluable for outcome due to early death. Of evaluable 16 participants, the number of participants (N) analyzed reflected in CD4, CD8 and ICOS that are associated with immune response.
Immunological response assays were measured at several time points starting at baseline until the eighth week after starting the medicine for each participant. The immunological responses measured were Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Inducible T-cell Costimulatory (ICOS) markers. T-cells with the CD4 marker help coordinate the immune system response to an invader. Killer T-cells have the CD8 marker and are responsible for killing the invader. ICOS is a molecule which stimulates the activity of the immune response of the killer T-Cells and memory T cells. Participants with at least a 2 fold increase in the presence of CD4, CD8, or ICOS markers from the participant's baseline measure were considered a responder for that marker.
Outcome measures
| Measure |
Neoadjuvant Ipilimumab
n=16 Participants
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
|
|---|---|
|
Immunologic Response: Number of Participants With Immune Response
CD4
|
12 Participants
|
|
Immunologic Response: Number of Participants With Immune Response
CD8
|
7 Participants
|
|
Immunologic Response: Number of Participants With Immune Response
ICOS
|
9 Participants
|
Adverse Events
Neoadjuvant Ipilimumab
Serious events: 2 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Neoadjuvant Ipilimumab
n=17 participants at risk
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pulmonary embolism
|
5.9%
1/17 • Number of events 1 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Cardiac disorders
Cardiac arrest
|
5.9%
1/17 • Number of events 1 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
Other adverse events
| Measure |
Neoadjuvant Ipilimumab
n=17 participants at risk
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
5.9%
1/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome (ARDS)
|
5.9%
1/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Rash
|
52.9%
9/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
General disorders
Fatigue
|
47.1%
8/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Investigations
Transaminitis
|
41.2%
7/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Gastrointestinal disorders
Colitis/Diarrhea
|
52.9%
9/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
General disorders
Headache
|
35.3%
6/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Gastrointestinal disorders
Pancreatitis
|
29.4%
5/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Investigations
Hypophysitis
|
29.4%
5/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
General disorders
Fever
|
5.9%
1/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Nervous system disorders
Synocope
|
5.9%
1/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
1/17 • Adverse event collection from baseline until 30 days after the last dose of drug, approximately 14 weeks post surgery.
Two participants of nineteen registered on the study were excluded prior to any treatment assignment due to screen failure and withdrawal, therefore are not included in adverse event reporting.
|
Additional Information
Padmanee Sharma, Professor, Genitourinary Medical Oncology
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place