Clinical trialPhase 2Completed
Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine Alone or Followed by CRS-207 in Adults With Metastatic Pancreatic Adenocarcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 21 September 2011
- Expected end
- 10 February 2017
- Enrollment
- 93 participants
- Sites
- 10
- Primary outcomes
- Overall Survival (OS) in Subjects Receiving Test Treatments (FAS)
- Sponsor
- Industry
- Results posted
- 2018-05-08
- Last update
- 8 May 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 GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) in Subjects Receiving Test Treatments (FAS) [Subjects were followed from the date of randomization to the date of death or discontinuation, whichever came first, assessed up to 60 months.]. Median, months (95% Confidence Interval). Cy/GVAX + CRS-207 (n=61): 6.28 (4.47 to 9.40); Cy/GVAX (n=29): 4.07 (3.32 to 5.42).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
To Assess Safety of the Cyclophosphamide, GVAX Pancreas Vaccine, and CRS-207 Treatment Regimen [Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.]. Count Of Participants, Participants. Serious AEs: Cy/GVAX + CRS-207 (n=64): 29; Cy/GVAX (n=29): 10. Total AEs: Cy/GVAX + CRS-207 (n=64): 64; Cy/GVAX (n=29): 29.