Clinical trialPhase 2Completed
GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
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
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 2 January 2015
- Expected end
- 21 July 2017
- Enrollment
- 93 participants
- Sites
- 5
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Other
- Results posted
- 2019-10-08
- Last update
- 6 April 2021
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Brief summary public domain (ClinicalTrials.gov)
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).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [2 years and 7 months]. Median, months (95% Confidence Interval). Arm A: CY/ GVAX/ CRS-207/ Nivolumab (n=51): 5.88 (4.73 to 8.64); Arm B: CY/ GVAX/ CRS-207 (n=42): 6.11 (3.52 to 7.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity [2 years and 7 months]. Count Of Participants, Participants. Arm A: CY/ GVAX/ CRS-207/ Nivolumab (n=51): 18; Arm B: CY/ GVAX/ CRS-207 (n=42): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients [2 years and 7 months]. Median, months (95% Confidence Interval). Arm A: CY/ GVAX/ CRS-207/ Nivolumab (n=51): 2.23 (2.14 to 2.33); Arm B: CY/ GVAX/ CRS-207 (n=42): 2.17 (2.00 to 2.30).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients [2 years and 7 months]. Mean, months (95% Confidence Interval). Arm A: CY/ GVAX/ CRS-207/ Nivolumab (n=51): 2.27 (2.17 to 2.33); Arm B: CY/ GVAX/ CRS-207 (n=42): 2.23 (2.10 to 2.40).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients [2 years and 7 months]. Median, months (95% Confidence Interval). Arm A: CY/ GVAX/ CRS-207/ Nivolumab (n=51): 2.20 (2.10 to 2.33); Arm B: CY/ GVAX/ CRS-207 (n=42): 2.20 (2.00 to 2.30).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients [2 years and 7 months]. Count Of Participants, Participants. Arm A: CY/ GVAX/ CRS-207/ Nivolumab (n=51): 1; Arm B: CY/ GVAX/ CRS-207 (n=42): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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 [120 days]. Count Of Participants, Participants. Arm A: CY/ GVAX/ CRS-207/ Nivolumab (n=51): 18; Arm B: CY/ GVAX/ CRS-207 (n=42): 7.
Papers 2
- Registry-listed results paperEvaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Pat… DOI 10.1158/1078-0432.ccr-19-3978↗
- Builds on itT cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. DOI 10.1172/jci.insight.122092↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.