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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 51 participants | 42 participants | 93 participants | |
Female |
14 27.5%
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18 42.9%
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32 34.4%
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Male |
37 72.5%
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24 57.1%
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61 65.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 51 participants | 42 participants | 93 participants | |
Hispanic or Latino |
2 3.9%
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0 0.0%
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2 2.2%
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Not Hispanic or Latino |
46 90.2%
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38 90.5%
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84 90.3%
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Unknown or Not Reported |
3 5.9%
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4 9.5%
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7 7.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 51 participants | 42 participants | 93 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
5 9.8%
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5 11.9%
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10 10.8%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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4 9.5%
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4 4.3%
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White |
44 86.3%
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33 78.6%
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77 82.8%
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More than one race |
2 3.9%
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0 0.0%
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2 2.2%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Name/Title: | Dung Le, MD |
Organization: | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Phone: | 443-287-0002 |
EMail: | dle@jhmi.edu |
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 |