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GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

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ClinicalTrials.gov Identifier: NCT02243371
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : October 8, 2019
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
Bristol-Myers Squibb
Stand Up To Cancer
Aduro Biotech, Inc.
American Association for Cancer Research
Lustgarten Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Previously Treated Metastatic Adenocarcinoma of the Pancreas
Interventions Biological: CRS-207
Drug: nivolumab
Biological: GVAX
Drug: CY
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CY/ GVAX/ CRS-207/ Nivolumab CY/ GVAX/ CRS-207
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 51 42
Completed 14 10
Not Completed 37 32
Reason Not Completed
Progressive Disease (clinic & radio)             35             24
Death (unrelated)             2             4
Adverse Event (unrelated)             0             1
Lack of Clinical Benefit             0             1
Withdrawal by Subject             0             2
Arm/Group Title CY/ GVAX/ CRS-207/ Nivolumab CY/ GVAX/ CRS-207 Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 51 42 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 42 participants 93 participants
63.6  (8.08) 63.2  (9.28) 63.4  (8.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 42 participants 93 participants
Female
14
  27.5%
18
  42.9%
32
  34.4%
Male
37
  72.5%
24
  57.1%
61
  65.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 42 participants 93 participants
Hispanic or Latino
2
   3.9%
0
   0.0%
2
   2.2%
Not Hispanic or Latino
46
  90.2%
38
  90.5%
84
  90.3%
Unknown or Not Reported
3
   5.9%
4
   9.5%
7
   7.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 42 participants 93 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   9.8%
5
  11.9%
10
  10.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
   9.5%
4
   4.3%
White
44
  86.3%
33
  78.6%
77
  82.8%
More than one race
2
   3.9%
0
   0.0%
2
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description 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).
Time Frame 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 51 42
Median (95% Confidence Interval)
Unit of Measure: months
5.88
(4.73 to 8.64)
6.11
(3.52 to 7.00)
2.Secondary Outcome
Title Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
Hide Description When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
Time Frame 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 51 42
Measure Type: Count of Participants
Unit of Measure: Participants
18
  35.3%
5
  11.9%
3.Secondary Outcome
Title Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients
Hide Description PFS 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.
Time Frame 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 51 42
Median (95% Confidence Interval)
Unit of Measure: months
2.23
(2.14 to 2.33)
2.17
(2.00 to 2.30)
4.Secondary Outcome
Title Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients
Hide Description irPFS 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.
Time Frame 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 51 42
Mean (95% Confidence Interval)
Unit of Measure: months
2.27
(2.17 to 2.33)
2.23
(2.10 to 2.40)
5.Secondary Outcome
Title Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients
Hide Description Time 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.
Time Frame 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 51 42
Median (95% Confidence Interval)
Unit of Measure: months
2.20
(2.10 to 2.33)
2.20
(2.00 to 2.30)
6.Secondary Outcome
Title Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients
Hide Description Per 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.
Time Frame 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 51 42
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
1
   2.4%
7.Secondary Outcome
Title 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
Hide Description Number of participants with stable or responding (<50% increase of serum CA19-9 concentration) at 120 days.
Time Frame 120 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 51 42
Measure Type: Count of Participants
Unit of Measure: Participants
18
  35.3%
7
  16.7%
Time Frame 2 years and 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Affected / at Risk (%) Affected / at Risk (%)
Total   45/51 (88.24%)      36/42 (85.71%)    
Hide Serious Adverse Events
Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/51 (9.80%)      1/42 (2.38%)    
Blood and lymphatic system disorders     
THROMBOCYTOPENIA   1/51 (1.96%)  1 0/42 (0.00%)  0
Cardiac disorders     
MYOCARDITIS   1/51 (1.96%)  1 0/42 (0.00%)  0
Gastrointestinal disorders     
DIARRHOEA   1/51 (1.96%)  1 0/42 (0.00%)  0
Infections and infestations     
LISTERIA SEPSIS   0/51 (0.00%)  0 1/42 (2.38%)  1
Metabolism and nutrition disorders     
Dehydration   1/51 (1.96%)  1 0/42 (0.00%)  0
HYPERGLYCAEMIA   1/51 (1.96%)  1 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
PNEUMONITIS   1/51 (1.96%)  1 0/42 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: CY/ GVAX/ CRS-207/ Nivolumab Arm B: CY/ GVAX/ CRS-207
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/51 (90.20%)      40/42 (95.24%)    
Blood and lymphatic system disorders     
LYMPHOPENIA   4/51 (7.84%)  1/42 (2.38%) 
Cardiac disorders     
SINUS TACHYCARDIA   7/51 (13.73%)  6/42 (14.29%) 
TACHYCARDIA   5/51 (9.80%)  2/42 (4.76%) 
Gastrointestinal disorders     
NAUSEA   17/51 (33.33%)  19/42 (45.24%) 
VOMITING   4/51 (7.84%)  5/42 (11.90%) 
General disorders     
VACCINATION SITE ERYTHEMA   46/51 (90.20%)  40/42 (95.24%) 
VACCINATION SITE INDURATION   41/51 (80.39%)  31/42 (73.81%) 
CHILLS   42/51 (82.35%)  29/42 (69.05%) 
VACCINATION SITE PRURITUS   36/51 (70.59%)  30/42 (71.43%) 
PYREXIA   38/51 (74.51%)  27/42 (64.29%) 
VACCINATION SITE PAIN   34/51 (66.67%)  29/42 (69.05%) 
VACCINATION SITE DISCOMFORT   22/51 (43.14%)  21/42 (50.00%) 
FATIGUE   23/51 (45.10%)  12/42 (28.57%) 
INFLUENZA LIKE ILLNESS   13/51 (25.49%)  8/42 (19.05%) 
VACCINATION SITE OEDEMA   9/51 (17.65%)  8/42 (19.05%) 
VACCINATION SITE SWELLING   3/51 (5.88%)  5/42 (11.90%) 
VACCINATION SITE VESICLES   5/51 (9.80%)  3/42 (7.14%) 
VACCINATION SITE REACTION   5/51 (9.80%)  2/42 (4.76%) 
VACCINATION SITE BRUISING   4/51 (7.84%)  2/42 (4.76%) 
PAIN   2/51 (3.92%)  3/42 (7.14%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED   6/51 (11.76%)  0/42 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED   4/51 (7.84%)  1/42 (2.38%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA   7/51 (13.73%)  4/42 (9.52%) 
MYALGIA   7/51 (13.73%)  2/42 (4.76%) 
Nervous system disorders     
HEADACHE   10/51 (19.61%)  6/42 (14.29%) 
DIZZINESS   4/51 (7.84%)  3/42 (7.14%) 
Vascular disorders     
HYPERTENSION   6/51 (11.76%)  4/42 (9.52%) 
HYPOTENSION   6/51 (11.76%)  1/42 (2.38%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dung Le, MD
Organization: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 443-287-0002
EMail: dle@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02243371    
Other Study ID Numbers: J14113
ADU-CL-06
IRB00043936 ( Other Identifier: JHMIRB )
First Submitted: September 15, 2014
First Posted: September 17, 2014
Results First Submitted: August 6, 2019
Results First Posted: October 8, 2019
Last Update Posted: April 6, 2021