Trial Outcomes & Findings for GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (NCT NCT03161379)
NCT ID: NCT03161379
Last Updated: 2025-02-03
Results Overview
Mean CD8+ T cell density \[log(cells per mm\^2)\], found in resected surgical tissue by Immunohistochemistry (IHC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
evaluated at time of surgery, approximately 2 months from first dose of study drug
Results posted on
2025-02-03
Participant Flow
Participants with borderline resectable pancreatic cancer were enrolled on the study prior to starting standard of care chemotherapy. After completing chemotherapy, participants were re-screened to determine if they were eligible to continue on the study and receive study drug.
Participant milestones
| Measure |
CY, Nivolumab, GVAX, and SBRT
Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected.
Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle.
Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle.
GVAX Pancreas Vaccine: 5x10\^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle.
Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
CY, Nivolumab, GVAX, and SBRT
Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected.
Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle.
Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle.
GVAX Pancreas Vaccine: 5x10\^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle.
Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
disease progression during chemotherapy
|
5
|
|
Overall Study
no longer surgical candidate after chemotherapy
|
2
|
|
Overall Study
not eligible to start study drug after chemotherapy
|
2
|
Baseline Characteristics
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
CY, Nivolumab, GVAX, and SBRT
n=31 Participants
Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected.
Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle.
Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle.
GVAX Pancreas Vaccine: 5x10\^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle.
Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 0
|
16 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 1
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: evaluated at time of surgery, approximately 2 months from first dose of study drugPopulation: Only participants who received study drug, completed surgical resection, and had sufficient tissue to perform IHC analysis. Of the 18 participants treated on study, 13 had sufficient tissue to perform CD8 analysis.
Mean CD8+ T cell density \[log(cells per mm\^2)\], found in resected surgical tissue by Immunohistochemistry (IHC).
Outcome measures
| Measure |
CY, Nivolumab, GVAX, and SBRT
n=13 Participants
Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected.
Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle.
Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle.
GVAX Pancreas Vaccine: 5x10\^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle.
Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days
|
|---|---|
|
CD8+ T Cell Density in Tumor Tissue
|
5.4 log (cells per mm^2)
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Assessed at time of surgical resection, approximately 2 months after first dose of study drugPopulation: Only participants who received study drug and completed surgical resection are included. Of the 18 participants treated on study, 14 completed surgical resection.
Number of patients with a pathologic complete response (pCR) rate at surgical resection. A pCR is defined as no viable residual tumor remaining at the time of evaluation.
Outcome measures
| Measure |
CY, Nivolumab, GVAX, and SBRT
n=14 Participants
Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected.
Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle.
Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle.
GVAX Pancreas Vaccine: 5x10\^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle.
Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days
|
|---|---|
|
Pathologic Complete Response (pCR) Rate at Surgical Resection
|
1 Participants
|
Adverse Events
CY, Nivolumab, GVAX, and SBRT
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CY, Nivolumab, GVAX, and SBRT
n=18 participants at risk
Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected.
Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle.
Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle.
GVAX Pancreas Vaccine: 5x10\^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle.
Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days
|
|---|---|
|
Hepatobiliary disorders
bile duct stenosis
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Infections and infestations
sepsis
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Infections and infestations
skin infection
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
weight loss
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
Other adverse events
| Measure |
CY, Nivolumab, GVAX, and SBRT
n=18 participants at risk
Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected.
Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle.
Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle.
GVAX Pancreas Vaccine: 5x10\^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle.
Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Endocrine disorders
hyperthyroidism
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Endocrine disorders
hypothyroidism
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Eye disorders
blurred vision
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Eye disorders
dry eye
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
abdominal pain
|
27.8%
5/18 • Number of events 6 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
bloating
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
constipation
|
11.1%
2/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
diarrhea
|
16.7%
3/18 • Number of events 5 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
dyspepsia
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
flatulence
|
11.1%
2/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
blood in stool
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
nausea
|
22.2%
4/18 • Number of events 7 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
upper gastrointestinal hemorrage
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Gastrointestinal disorders
vomiting
|
22.2%
4/18 • Number of events 6 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
chills
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
edema limbs
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
fatigue
|
16.7%
3/18 • Number of events 4 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
flu-like symptoms
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
11.1%
2/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
pain at site of biopsy
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
alanine aminotransferase increased
|
11.1%
2/18 • Number of events 4 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
alkaline phosphatase increased
|
5.6%
1/18 • Number of events 3 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
aspartate aminotransferase increased
|
11.1%
2/18 • Number of events 4 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
creatinine increased
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
hypokalemia
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
neutrophil count decreased
|
5.6%
1/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
platelet count decreased
|
11.1%
2/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
weight loss
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Investigations
white blood cell decreased
|
5.6%
1/18 • Number of events 3 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
anorexia
|
16.7%
3/18 • Number of events 5 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
dehydration
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
11.1%
2/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
joint stiffness
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
16.7%
3/18 • Number of events 3 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Nervous system disorders
dizziness
|
11.1%
2/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Nervous system disorders
headache
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Nervous system disorders
peripheral sensory neuropathy
|
11.1%
2/18 • Number of events 2 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Psychiatric disorders
confusion
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Reproductive system and breast disorders
breast pain
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
voice alteration
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
rash maculopapular
|
22.2%
4/18 • Number of events 4 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Vascular disorders
hot flashes
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Vascular disorders
hypertension
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
Vascular disorders
hypotension
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
vaccine site discoloration
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
erythema at vaccine site
|
77.8%
14/18 • Number of events 21 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
induration at vaccine site
|
38.9%
7/18 • Number of events 7 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
peeling skin at vaccine site
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
pruritus at vaccine site
|
66.7%
12/18 • Number of events 17 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
swelling at vaccine sites
|
27.8%
5/18 • Number of events 11 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
|
General disorders
tenderness at vaccine site
|
5.6%
1/18 • Number of events 1 • Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
|
Additional Information
Daniel Laheru, MD
Sidney Kimmel Cancer Center at Johns Hopkins
Phone: 410-955-8974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place