GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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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Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
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Tracking Information | ||||
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First Submitted Date ICMJE | September 15, 2014 | |||
First Posted Date ICMJE | September 17, 2014 | |||
Results First Submitted Date ICMJE | August 6, 2019 | |||
Results First Posted Date ICMJE | October 8, 2019 | |||
Last Update Posted Date | April 6, 2021 | |||
Actual Study Start Date ICMJE | January 2, 2015 | |||
Actual Primary Completion Date | July 21, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Survival (OS) [ Time Frame: 2 years and 7 months ] 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).
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Original Primary Outcome Measures ICMJE |
Overall survival (OS) in metastatic pancreatic cancer patients treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) versus patients treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B) [ Time Frame: 4 years ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab | |||
Official Title ICMJE | A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma | |||
Brief Summary | The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Previously Treated Metastatic Adenocarcinoma of the Pancreas | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Hopkins AC, Yarchoan M, Durham JN, Yusko EC, Rytlewski JA, Robins HS, Laheru DA, Le DT, Lutz ER, Jaffee EM. T cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. JCI Insight. 2018 Jul 12;3(13):e122092. doi: 10.1172/jci.insight.122092. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
93 | |||
Original Estimated Enrollment ICMJE |
94 | |||
Actual Study Completion Date ICMJE | July 21, 2017 | |||
Actual Primary Completion Date | July 21, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02243371 | |||
Other Study ID Numbers ICMJE | J14113 ADU-CL-06 IRB00043936 ( Other Identifier: JHMIRB ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Verification Date | February 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |