Trial Outcomes & Findings for Neoadjuvant PROSTVAC-VF With or Without Ipilimumab for Prostate Cancer (NCT NCT02506114)
NCT ID: NCT02506114
Last Updated: 2021-11-24
Results Overview
The proportion of participants who demonstrated a positive response following neoadjuvant therapy as measured by change from baseline in CD3+ T cell infiltration within prostate tumor tissue by immunohistochemistry (IHC) assessment following treatment will be reported. The change in the number of CD3+ T cell infiltration within prostate tissue between the biopsy and radical prostatectomy (RP) specimen will be quantified using immunohistochemistry (IHC),with a positive result if there is \>=2 fold increase in the number of CD3+T cell infiltration.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2021-11-24
Participant Flow
Participant milestones
| Measure |
Arm A: PROSTVAC-V/F
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Montherapy
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant PROSTVAC-VF With or Without Ipilimumab for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A: PROSTVAC-V/F
n=5 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Monotherapy
n=4 Participants
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
n=6 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Customized
50-59 years old
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Customized
60-69 years old
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Customized
70-79 years old
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Total Gleason Score
Gleason Score = 6
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Total Gleason Score
Gleason Score = 7
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Total Gleason Score
Gleason Score = 8
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Total Gleason Score
Gleason Score = 9
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Few participants had evaluable labs for this outcome.
The proportion of participants who demonstrated a positive response following neoadjuvant therapy as measured by change from baseline in CD3+ T cell infiltration within prostate tumor tissue by immunohistochemistry (IHC) assessment following treatment will be reported. The change in the number of CD3+ T cell infiltration within prostate tissue between the biopsy and radical prostatectomy (RP) specimen will be quantified using immunohistochemistry (IHC),with a positive result if there is \>=2 fold increase in the number of CD3+T cell infiltration.
Outcome measures
| Measure |
Arm A: PROSTVAC-V/F
n=2 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Monotherapy
n=3 Participants
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
n=3 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
|---|---|---|---|
|
Proportion of Participants With Positive CD3+ T Cell Immune Response
|
0 proportion of participants
|
0.33 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Few participants had evaluable labs for this outcome.
The proportion of participants who demonstrated any change in the number of infiltrating T cells/μm2 of CD3 within the prostatic tumor tissue from the diagnostic core biopsy specimens to the post treatment prostatectomy tissue specimens will be assessed, based upon IHC analysis following neoadjuvant PROSTVAC, ipilimumab, or the combination of the two treatments.
Outcome measures
| Measure |
Arm A: PROSTVAC-V/F
n=2 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Monotherapy
n=3 Participants
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
n=3 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
|---|---|---|---|
|
Proportion of Participants With Any Positive Change in Immunologic Infiltration (CD3)
|
0 proportion of participants
|
0.667 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe proportion of participants who demonstrated any change in the number of circulating effector T cells/μm2 within the prostatic tumor tissue from the diagnostic core biopsy specimens to the post treatment prostatectomy tissue specimens will be assessed, based upon IHC analysis following neoadjuvant PROSTVAC, ipilimumab, or the combination by flow cytometry assessment of peripheral blood mononuclear cells
Outcome measures
| Measure |
Arm A: PROSTVAC-V/F
n=5 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Monotherapy
n=4 Participants
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
n=6 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
|---|---|---|---|
|
Proportion of Participants With Any Positive Change in Circulating Effector T Cells
|
0.8 proportion of participants
|
1.0 proportion of participants
|
0.8333 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe proportion of participants who demonstrated a change in the number of Regulatory T Cells/μm2 within the prostatic tumor tissue from the diagnostic core biopsy specimens to the post treatment prostatectomy tissue specimens will be assessed, based upon IHC analysis following neoadjuvant PROSTVAC, ipilimumab, or the combination by flow cytometry assessment of peripheral blood mononuclear cells
Outcome measures
| Measure |
Arm A: PROSTVAC-V/F
n=5 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Monotherapy
n=4 Participants
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
n=6 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
|---|---|---|---|
|
Proportion of Participants With a Positive Change in Regulatory T Cells
|
0.4 proportion of participants
|
1.0 proportion of participants
|
1.0 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsSafety analyses will be performed for all participants having received at least one dose of study drug. The investigator will use the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.03 for reporting the number of participants with treatment-related, non-hematologic, adverse events and modified criteria for hematologic adverse events defined as having an attribute of possible, probable, or definite by toxicity and treatment group.
Outcome measures
| Measure |
Arm A: PROSTVAC-V/F
n=5 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Monotherapy
n=4 Participants
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
n=6 Participants
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events
Fatigue
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Related Adverse Events
Fever
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Related Adverse Events
Injection site reaction
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Related Adverse Events
Lipase increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Related Adverse Events
Pruritus
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Related Adverse Events
Dizziness
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Related Adverse Events
Skin and subcutaneous tissue disorders - Other
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Arm A: PROSTVAC-V/F
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm B: Ipilimumab Monotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm C: Combined PROSTVAC-V/F + Ipilimumab
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: PROSTVAC-V/F
n=5 participants at risk
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
|
Arm B: Ipilimumab Monotherapy
n=4 participants at risk
Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
|
Arm C: Combined PROSTVAC-V/F + Ipilimumab
n=6 participants at risk
PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
|
|---|---|---|---|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 3 • Up to 2 years
|
50.0%
2/4 • Number of events 2 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
General disorders
Injection site reaction
|
60.0%
3/5 • Number of events 6 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
50.0%
3/6 • Number of events 5 • Up to 2 years
|
|
General disorders
Fever
|
60.0%
3/5 • Number of events 3 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
General disorders
Flu like symptoms
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
General disorders
General disorders and administration site conditions - Other
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
40.0%
2/5 • Number of events 2 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/5 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Up to 2 years
|
25.0%
1/4 • Number of events 2 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/5 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Investigations
Lipase increased
|
40.0%
2/5 • Number of events 3 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Investigations
Serum amylase increased
|
40.0%
2/5 • Number of events 2 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Investigations
Weight gain
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/5 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
40.0%
2/5 • Number of events 2 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to 2 years
|
25.0%
1/4 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 3 • Up to 2 years
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
0.00%
0/6 • 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