Trial Outcomes & Findings for GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab (NCT NCT02243371)
NCT ID: NCT02243371
Last Updated: 2021-04-06
Results Overview
OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
2 years and 7 months
Results posted on
2021-04-06
Participant Flow
Participant milestones
| Measure |
CY/ GVAX/ CRS-207/ Nivolumab
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
CY/ GVAX/ CRS-207
CRS-207: 1 × 10\^9 CFU administered IV Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
42
|
|
Overall Study
COMPLETED
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
37
|
32
|
Reasons for withdrawal
| Measure |
CY/ GVAX/ CRS-207/ Nivolumab
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
CY/ GVAX/ CRS-207
CRS-207: 1 × 10\^9 CFU administered IV Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Overall Study
Progressive Disease (clinic & radio)
|
35
|
24
|
|
Overall Study
Death (unrelated)
|
2
|
4
|
|
Overall Study
Adverse Event (unrelated)
|
0
|
1
|
|
Overall Study
Lack of Clinical Benefit
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
Baseline characteristics by cohort
| Measure |
CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 9.28 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years and 7 monthsOS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).
Outcome measures
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Overall Survival (OS)
|
5.88 months
Interval 4.73 to 8.64
|
6.11 months
Interval 3.52 to 7.0
|
SECONDARY outcome
Timeframe: 2 years and 7 monthsWhen calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
Outcome measures
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
|
18 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 years and 7 monthsPFS is defined as the number of months from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Outcome measures
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients
|
2.23 months
Interval 2.14 to 2.33
|
2.17 months
Interval 2.0 to 2.3
|
SECONDARY outcome
Timeframe: 2 years and 7 monthsirPFS is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using irRC RECIST 1.1 criteria) or death due to any cause. Per irRC criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in tumor burden compared with baseline, Progressive Disease (PD) is \>20% increase in tumor burden compared with nadir, Stable Disease (SD) is \<30% decrease in tumor burden compared with baseline or \<20% increase in tumor burden compared to nadir.
Outcome measures
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients
|
2.27 months
Interval 2.17 to 2.33
|
2.23 months
Interval 2.1 to 2.4
|
SECONDARY outcome
Timeframe: 2 years and 7 monthsTime to progression (TTP) is defined as the time from randomization to the date of documented disease progression as defined by RECIST 1.1 criteria. Individuals are censored at the date of the last radiological assessment that occurs prior to any of the following: death, switch to another anti-cancer therapy, or end of follow-up. Individuals without follow-up or baseline measurements are censored at 1 day. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Outcome measures
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients
|
2.20 months
Interval 2.1 to 2.33
|
2.20 months
Interval 2.0 to 2.3
|
SECONDARY outcome
Timeframe: 2 years and 7 monthsPer RECIST 1.1 criteria, PR is defined as =\>30% decrease in sum of diameters of target lesions and CR is the disappearance of all target lesions.
Outcome measures
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 120 daysNumber of participants with stable or responding (\<50% increase of serum CA19-9 concentration) at 120 days.
Outcome measures
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 Participants
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration
|
18 Participants
|
7 Participants
|
Adverse Events
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
Serious events: 5 serious events
Other events: 46 other events
Deaths: 45 deaths
Arm B: CY/ GVAX/ CRS-207
Serious events: 1 serious events
Other events: 40 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 participants at risk
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 participants at risk
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Number of events 1 • 2 years and 7 months
|
0.00%
0/42 • 2 years and 7 months
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.0%
1/51 • Number of events 1 • 2 years and 7 months
|
0.00%
0/42 • 2 years and 7 months
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.0%
1/51 • Number of events 1 • 2 years and 7 months
|
0.00%
0/42 • 2 years and 7 months
|
|
Cardiac disorders
MYOCARDITIS
|
2.0%
1/51 • Number of events 1 • 2 years and 7 months
|
0.00%
0/42 • 2 years and 7 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.0%
1/51 • Number of events 1 • 2 years and 7 months
|
0.00%
0/42 • 2 years and 7 months
|
|
Infections and infestations
LISTERIA SEPSIS
|
0.00%
0/51 • 2 years and 7 months
|
2.4%
1/42 • Number of events 1 • 2 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
2.0%
1/51 • Number of events 1 • 2 years and 7 months
|
0.00%
0/42 • 2 years and 7 months
|
Other adverse events
| Measure |
Arm A: CY/ GVAX/ CRS-207/ Nivolumab
n=51 participants at risk
CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
Arm B: CY/ GVAX/ CRS-207
n=42 participants at risk
CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
|
|---|---|---|
|
General disorders
VACCINATION SITE ERYTHEMA
|
90.2%
46/51 • 2 years and 7 months
|
95.2%
40/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE INDURATION
|
80.4%
41/51 • 2 years and 7 months
|
73.8%
31/42 • 2 years and 7 months
|
|
General disorders
CHILLS
|
82.4%
42/51 • 2 years and 7 months
|
69.0%
29/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE PRURITUS
|
70.6%
36/51 • 2 years and 7 months
|
71.4%
30/42 • 2 years and 7 months
|
|
General disorders
PYREXIA
|
74.5%
38/51 • 2 years and 7 months
|
64.3%
27/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE PAIN
|
66.7%
34/51 • 2 years and 7 months
|
69.0%
29/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE DISCOMFORT
|
43.1%
22/51 • 2 years and 7 months
|
50.0%
21/42 • 2 years and 7 months
|
|
General disorders
FATIGUE
|
45.1%
23/51 • 2 years and 7 months
|
28.6%
12/42 • 2 years and 7 months
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
25.5%
13/51 • 2 years and 7 months
|
19.0%
8/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE OEDEMA
|
17.6%
9/51 • 2 years and 7 months
|
19.0%
8/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE SWELLING
|
5.9%
3/51 • 2 years and 7 months
|
11.9%
5/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE VESICLES
|
9.8%
5/51 • 2 years and 7 months
|
7.1%
3/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE REACTION
|
9.8%
5/51 • 2 years and 7 months
|
4.8%
2/42 • 2 years and 7 months
|
|
General disorders
VACCINATION SITE BRUISING
|
7.8%
4/51 • 2 years and 7 months
|
4.8%
2/42 • 2 years and 7 months
|
|
General disorders
PAIN
|
3.9%
2/51 • 2 years and 7 months
|
7.1%
3/42 • 2 years and 7 months
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
17/51 • 2 years and 7 months
|
45.2%
19/42 • 2 years and 7 months
|
|
Gastrointestinal disorders
VOMITING
|
7.8%
4/51 • 2 years and 7 months
|
11.9%
5/42 • 2 years and 7 months
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
13.7%
7/51 • 2 years and 7 months
|
14.3%
6/42 • 2 years and 7 months
|
|
Cardiac disorders
TACHYCARDIA
|
9.8%
5/51 • 2 years and 7 months
|
4.8%
2/42 • 2 years and 7 months
|
|
Nervous system disorders
HEADACHE
|
19.6%
10/51 • 2 years and 7 months
|
14.3%
6/42 • 2 years and 7 months
|
|
Nervous system disorders
DIZZINESS
|
7.8%
4/51 • 2 years and 7 months
|
7.1%
3/42 • 2 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
13.7%
7/51 • 2 years and 7 months
|
9.5%
4/42 • 2 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
13.7%
7/51 • 2 years and 7 months
|
4.8%
2/42 • 2 years and 7 months
|
|
Vascular disorders
HYPERTENSION
|
11.8%
6/51 • 2 years and 7 months
|
9.5%
4/42 • 2 years and 7 months
|
|
Vascular disorders
HYPOTENSION
|
11.8%
6/51 • 2 years and 7 months
|
2.4%
1/42 • 2 years and 7 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
11.8%
6/51 • 2 years and 7 months
|
0.00%
0/42 • 2 years and 7 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
7.8%
4/51 • 2 years and 7 months
|
2.4%
1/42 • 2 years and 7 months
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
7.8%
4/51 • 2 years and 7 months
|
2.4%
1/42 • 2 years and 7 months
|
Additional Information
Dung Le, MD
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 443-287-0002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place