Trial Outcomes & Findings for FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer (NCT NCT01896869)
NCT ID: NCT01896869
Last Updated: 2020-05-19
Results Overview
Overall Survival is the time between the date of randomization on study and death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
4 years
Results posted on
2020-05-19
Participant Flow
Participant milestones
| Measure |
Ipilimumab + Vaccine
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
40
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Ipilimumab + Vaccine
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Individuals who did not express CA19-9 were considered non-secretors and were excluded from analysis.
Baseline characteristics by cohort
| Measure |
Ipilimumab + Vaccine
n=41 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=42 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=41 Participants
|
26 Participants
n=42 Participants
|
56 Participants
n=83 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=41 Participants
|
16 Participants
n=42 Participants
|
27 Participants
n=83 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=41 Participants
|
16 Participants
n=42 Participants
|
33 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=41 Participants
|
26 Participants
n=42 Participants
|
50 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=41 Participants
|
39 Participants
n=42 Participants
|
80 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=41 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=83 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=41 Participants
|
36 Participants
n=42 Participants
|
72 Participants
n=83 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
CA19-9 Secretors
|
32 Participants
n=41 Participants
|
31 Participants
n=42 Participants
|
63 Participants
n=83 Participants
|
|
CA19-9 at baseline
|
185.0 IU/mL
n=32 Participants • Individuals who did not express CA19-9 were considered non-secretors and were excluded from analysis.
|
85.0 IU/mL
n=31 Participants • Individuals who did not express CA19-9 were considered non-secretors and were excluded from analysis.
|
117.1 IU/mL
n=63 Participants • Individuals who did not express CA19-9 were considered non-secretors and were excluded from analysis.
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: 1 Arm A (Ipilimumab + Vaccine) patient was lost to follow-up prior to treatment and was excluded from analysis.
Overall Survival is the time between the date of randomization on study and death.
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=40 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=42 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
9.38 Months
Interval 5.0 to 12.2
|
14.7 Months
Interval 11.6 to 20.0
|
SECONDARY outcome
Timeframe: From the first dose of study drug through 70 days after last dose, up to 13 monthsPopulation: AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity. Dose of Ipilimumab was reduced from 10 mg/kg to 3 mg/kg due to toxicity concerns. Toxicity rates are compared between these dosing subgroups.
Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section).
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=14 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=25 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
Any study drug-related AE
|
13 Participants
|
25 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
adrenal insufficiency
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
alopecia
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
ALT increased
|
0 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
arthralgia
|
0 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
AST increased
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
chills
|
2 Participants
|
5 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
colitis
|
1 Participants
|
4 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
cough
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
diarrhea
|
1 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
dry mouth
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
dry skin
|
1 Participants
|
0 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
edema face
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
fatigue
|
1 Participants
|
7 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
fever
|
3 Participants
|
11 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
flu-like symptoms
|
1 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
flushing
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
hepatitis
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
hyperhidrosis
|
0 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
hypophysitis
|
1 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
hypotension
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
hypothyroidism
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
lymph node pain
|
0 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
lymph node swelling
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
malaise
|
1 Participants
|
0 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
myalgia
|
2 Participants
|
0 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
nausea
|
1 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
pneumonitis
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
pruritus
|
2 Participants
|
7 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
rash
|
8 Participants
|
18 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
swelling, chest wall mass
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
thyroiditis
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
urticaria
|
2 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vomiting
|
1 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
weight loss
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site blisters
|
1 Participants
|
4 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site bruising
|
1 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site erythema
|
11 Participants
|
20 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site flares
|
0 Participants
|
2 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site induration
|
12 Participants
|
25 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site oozing
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site pruritus
|
11 Participants
|
22 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site scabbing
|
0 Participants
|
1 Participants
|
|
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
vaccine site tenderness
|
3 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: 1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis.
Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=40 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=42 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.40 Months
Interval 1.87 to 2.53
|
5.55 Months
Interval 3.32 to 8.51
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: 1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis.
Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=40 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=42 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Immune-related Progression Free Survival (irPFS)
|
2.50 Months
Interval 2.14 to 2.92
|
5.55 Months
Interval 3.38 to 8.51
|
SECONDARY outcome
Timeframe: Assessed until disease progression, up to 2 yearsPopulation: 6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease)
Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST).
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=35 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=29 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Objective Response Rate
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed until disease progression, up to 2 yearsPopulation: 6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease)
Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are evaluated using immune-related response criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=35 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=29 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Immune-related Objective Response Rate
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: Only 1 patient on Arm A (Ipilimumab + Vaccine) and 3 patients on Arm B (FOLFIRINOX) achieved a response by RECIST and were included in this analysis. 2 additional patients (1 Arm A and 1 Arm B) achieved a response by irRC, but these patients were both taken off study the same day as their partial response, for disease progression by RECIST.
Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=1 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=3 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Duration of Response
|
2.5 months
Interval 2.5 to 2.5
|
8.49 months
Interval 2.73 to 17.45
|
SECONDARY outcome
Timeframe: Baseline, Week 7, and Week 10 visitsPopulation: Only patients who were considered CA19-9 secretors (expressed CA19-9 either on study or prior to study) were included in the analysis. 32 in Arm A (Ipilimumab+Vaccine) and 31 in Arm B (FOLFIRINOX). Only subjects evaluable for this outcome at the specified time points had CA19-9 drawn and could be included in the analysis.
Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL.
Outcome measures
| Measure |
Ipilimumab + Vaccine
n=32 Participants
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
FOLFIRINOX
n=31 Participants
Administered every 14 days (one cycle)
FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
|
|---|---|---|
|
Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
Week 7
|
189.2 IU/mL
Interval 61.2 to 7123.7
|
77.9 IU/mL
Interval 23.4 to 430.0
|
|
Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
Week 10
|
237.1 IU/mL
Interval 64.4 to 4690.1
|
66.8 IU/mL
Interval 24.0 to 443.5
|
|
Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
Baseline
|
185.0 IU/mL
Interval 46.0 to 1091.5
|
85.0 IU/mL
Interval 41.6 to 178.7
|
Adverse Events
Ipilimumab + Vaccine
Serious events: 20 serious events
Other events: 39 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Ipilimumab + Vaccine
n=39 participants at risk
Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Renal and urinary disorders
acute kidney injury
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Endocrine disorders
adrenal insufficiency
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
alkaline phosphatase increased
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Infections and infestations
bacteremia
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
blood bilirubin increased
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Infections and infestations
catheter related infection
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
chest wall pain
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
colitis
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death, disease progression
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Psychiatric disorders
delerium
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
diarrhea
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Endocrine disorders
hypophysitis
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
INR increased
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Infections and infestations
lung infection
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
malabsorption
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
nausea
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
neutropenia
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
obstruction gastric
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Infections and infestations
sepsis
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
platelet count decreased
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Vascular disorders
thromboembolic event - pulmonary embolism
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
vomiting
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
weight loss
|
2.6%
1/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
Other adverse events
| Measure |
Ipilimumab + Vaccine
n=39 participants at risk
Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.
Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Vaccine: 5x10\^8 cells administered in 6 intradermal injections
|
|---|---|
|
Gastrointestinal disorders
abdominal distention
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
abdominal pain
|
33.3%
13/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
alkaline phosphatase increased
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
alanine aminotransferase (ALT) increased
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
anemia
|
10.3%
4/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
anorexia
|
23.1%
9/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Psychiatric disorders
anxiety
|
17.9%
7/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
15.4%
6/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
ascites
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
aspartate aminotransferase (AST) increased
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
10.3%
4/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
17.9%
7/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
bloating
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
blood bilirubin increased
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Injury, poisoning and procedural complications
bruising
|
10.3%
4/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
chills
|
30.8%
12/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
cold intolerance
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
colitis
|
10.3%
4/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
constipation
|
35.9%
14/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
15.4%
6/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Psychiatric disorders
depression
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
diarrhea
|
30.8%
12/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Renal and urinary disorders
difficulty urinating
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Nervous system disorders
dizziness
|
10.3%
4/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
dry mouth
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
dyspepsia
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
edema limbs
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Injury, poisoning and procedural complications
fall
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
fatigue
|
43.6%
17/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
fever
|
51.3%
20/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
flatulence
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
flu-like symptoms
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
gait disturbance
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Nervous system disorders
headache
|
15.4%
6/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Vascular disorders
hot flashes
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Endocrine disorders
hypophysitis
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Vascular disorders
hypotension
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Psychiatric disorders
insomnia
|
30.8%
12/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Blood and lymphatic system disorders
lymph node pain
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
lymphocyte count decreased
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
muscle cramp
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
nausea
|
30.8%
12/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
non-cardiac pain
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
oral pain
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Injury, poisoning and procedural complications
pain, site of procedure/conmed
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Nervous system disorders
peripheral sensory neuropathy
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
23.1%
9/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
rash
|
71.8%
28/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Reproductive system and breast disorders
rhinitis
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Cardiac disorders
sinus tachycardia
|
10.3%
4/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
platelet count decreased
|
10.3%
4/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Vascular disorders
thromboembolic event
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Infections and infestations
upper respiratory infection
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Renal and urinary disorders
urinary frequency
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Infections and infestations
urinary tract infection
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Gastrointestinal disorders
vomiting
|
28.2%
11/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
Investigations
weight loss
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
vaccine site blisters
|
12.8%
5/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
vaccine site bruising
|
7.7%
3/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
vaccine site erythema
|
79.5%
31/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
vaccine site flares
|
5.1%
2/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
vaccine site induration
|
94.9%
37/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
vaccine site pruritus
|
84.6%
33/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
|
General disorders
vaccine site tenderness
|
41.0%
16/39 • Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
|
Additional Information
Dr. Dung Le
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 443-287-0002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigators (PIs) from participating sites must provide the Johns Hopkins PI with a copy of any proposed publication for review and comment at least 30 days prior to submission.
- Publication restrictions are in place
Restriction type: OTHER