Pancreatic Cancer Research

Clinical trialPhase 2Completed

Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS 207 Compared to Chemotherapy or to CRS-207 Alone in Adults With Previously-Treated Metastatic Pancreatic Adenocarcinoma

NCT02004262↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Outcome unknown
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
5 February 2014
Expected end
23 August 2016
Enrollment
303 participants
Sites
21
Primary outcomes
Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set); Primary Cohort: OS (All Data, FAS); 2nd-line Cohort: OS (All Data, FAS)
Sponsor
Industry
Results posted
2018-05-03
Last update
4 June 2018

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Brief summary public domain (ClinicalTrials.gov)

Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set) [Subjects were followed from date of randomization to the date of death by any cause, whichever came first, assessed up to 32 months. Analysis conducted when 138 deaths reached in the Primary Cohort in the FAS.]. Median, months (95% Confidence Interval). Primary Cohort: Cy/GVAX + CRS-207 (n=73): 3.8 (2.9 to 5.3); Primary Cohort: CRS-207 (n=68): 5.4 (4.2 to 6.9); Primary Cohort: Chemotherapy (n=72): 4.6 (4.2 to 5.8).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Primary Cohort: OS (All Data, FAS) [Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.]. Median, months (95% Confidence Interval). Primary Cohort: Cy/GVAX + CRS-207 (n=68): 4.2 (3.0 to 5.4); Primary Cohort: CRS-207 (n=58): 5.2 (4.2 to 6.3); Primary Cohort: Chemotherapy (n=43): 4.7 (3.8 to 6.0).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

2nd-line Cohort: OS (All Data, FAS) [Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.]. Median, months (70% Confidence Interval). 2nd-line Cohort: Cy/GVAX + CRS-207 (n=26): 4.6 (3.9 to 6.0); 2nd-line Cohort: CRS-207 (n=29): 4.0 (3.4 to 6.7); 2nd-line Cohort: Chemotherapy (n=11): 6.9 (4.2 to 12.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen [From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.]. Count Of Participants, Participants. Serious AEs: Pooled Cohort: Cy/GVAX + CRS-207 (n=94): 44; Pooled Cohort: CRS-207 (n=87): 32; Pooled Cohort: Chemotherapy (n=54): 15. Total AEs: Pooled Cohort: Cy/GVAX + CRS-207 (n=94): 94; Pooled Cohort: CRS-207 (n=87): 87; Pooled Cohort: Chemotherapy (n=54): 52.

Papers 3