Trial · NCT02004262
Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
NCT02004262, Phase 2, Completed, Aduro Biotech, Inc.; results first posted 2018-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting. Trials, record NCT02004262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02004262
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
- NCT number
- NCT02004262
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 303 participants, actual
- Lead sponsor
- Aduro Biotech, Inc.
- Conditions
- 2nd-line, 3rd-line and Greater Metastatic Pancreatic Cancer
- Interventions
- GVAX Pancreas Vaccine, CRS-207, Chemotherapy, cyclophosphamide
- First posted
- 2013-12-09
- Last updated
- 2018-06-04
- Results first posted
- 2018-05-03
- Limitations and caveats
- A high number of patients in the chemotherapy arm withdrew from the study before receiving treatment. This high dropout rate may have an impact on interpretation of the study results.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | OS was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs), with censoring at the date when 138 deaths were reached in the Primary Cohort in the FAS. Subjects without documentation of death at the time of final analysis were censored as of the date the subject was last known to be alive on/prior to the primary analysis data cut. |
| Primary | 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. | For all treated subjects, OS was calculated using KM methods with 95% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis data cut. |
| Primary | 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. | For all treated subjects, OS was calculated using KM methods with 70% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis cut. 70% CIs were selected to provide an 80% probability to rule out differences in median survival less than -2.4 months between the 2nd-line Cohort: Chemotherapy arm and the 2nd-line Cohort: Cy/GVAX + CRS-207 and 2nd-line Cohort: CRS-207 arms, based upon the assumptions made in the statistical analysis plan (SAP). |
| Secondary | 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. | Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Analysis based on subjects in the Primary Cohort in the intent-to-treat (ITT) set. The ITT set is the analysis population that included all randomized study subjects. | months | MEDIAN |
| PRIMARY | 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. | Analysis based on subjects in the Primary Cohort in the FAS. | months | MEDIAN |
| PRIMARY | 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. | Analysis based on subjects in the 2nd-line Cohort in the FAS. | months | MEDIAN |
| SECONDARY | 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. | Analysis conducted for the FAS of each study arm. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set) | Primary Cohort: Cy/GVAX + CRS-207 | 3.8 | 95% Confidence Interval 2.9 to 5.3 | months | |
| Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set) | Primary Cohort: CRS-207 | 5.4 | 95% Confidence Interval 4.2 to 6.9 | months | |
| Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set) | Primary Cohort: Chemotherapy | 4.6 | 95% Confidence Interval 4.2 to 5.8 | months | |
| Primary Cohort: OS (All Data, FAS) | Primary Cohort: Cy/GVAX + CRS-207 | 4.2 | 95% Confidence Interval 3.0 to 5.4 | months | |
| Primary Cohort: OS (All Data, FAS) | Primary Cohort: CRS-207 | 5.2 | 95% Confidence Interval 4.2 to 6.3 | months | |
| Primary Cohort: OS (All Data, FAS) | Primary Cohort: Chemotherapy | 4.7 | 95% Confidence Interval 3.8 to 6.0 | months | |
| 2nd-line Cohort: OS (All Data, FAS) | 2nd-line Cohort: Cy/GVAX + CRS-207 | 4.6 | 70% Confidence Interval 3.9 to 6.0 | months | |
| 2nd-line Cohort: OS (All Data, FAS) | 2nd-line Cohort: CRS-207 | 4.0 | 70% Confidence Interval 3.4 to 6.7 | months | |
| 2nd-line Cohort: OS (All Data, FAS) | 2nd-line Cohort: Chemotherapy | 6.9 | 70% Confidence Interval 4.2 to 12.3 | months | |
| Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen | Pooled Cohort: Cy/GVAX + CRS-207 | Serious AEs | 44 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Primary Cohort: Cy/GVAX + CRS-207 | 73 | |
| Overall Study | STARTED | Primary Cohort: CRS-207 | 68 | |
| Overall Study | STARTED | Primary Cohort: Chemotherapy | 72 | |
| Overall Study | STARTED | 2nd-line Cohort: Cy/GVAX + CRS-207 | 29 | |
| Overall Study | STARTED | 2nd-line Cohort: CRS-207 | 31 | |
| Overall Study | STARTED | 2nd-line Cohort: Chemotherapy | 30 | |
| Overall Study | Treated | Primary Cohort: Cy/GVAX + CRS-207 | 68 | |
| Overall Study | Treated | Primary Cohort: CRS-207 | 58 | |
| Overall Study | Treated | Primary Cohort: Chemotherapy | 43 | |
| Overall Study | Treated | 2nd-line Cohort: Cy/GVAX + CRS-207 | 26 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events468
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chills | General disorders | Pooled Cohort: Cy/GVAX + CRS-207 | 59 | 94 | |
| other | Chills | General disorders | Pooled Cohort: CRS-207 | 81 | 87 | |
| other | Chills | General disorders | Pooled Cohort: Chemotherapy | 5 | 54 | |
| other | Pyrexia | General disorders | Pooled Cohort: Cy/GVAX + CRS-207 | 51 | 94 | |
| other | Pyrexia | General disorders | Pooled Cohort: CRS-207 | 58 | 87 | |
| other | Pyrexia | General disorders | Pooled Cohort: Chemotherapy | 9 | 54 | |
| other | Fatigue | General disorders | Pooled Cohort: Cy/GVAX + CRS-207 | 50 | 94 | |
| other | Fatigue | General disorders | Pooled Cohort: CRS-207 | 38 | 87 | |
| other | Fatigue | General disorders | Pooled Cohort: Chemotherapy | 26 | 54 | |
| other | Vaccination site erythema | General disorders | Pooled Cohort: Cy/GVAX + CRS-207 | 77 | 94 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pooled Cohort: Cy/GVAX + CRS-207 | 88 | 94 |
| Total, all-cause mortality | Pooled Cohort: CRS-207 | 82 | 87 |
| Total, all-cause mortality | Pooled Cohort: Chemotherapy | 51 | 54 |
| Total, other adverse events | Pooled Cohort: Cy/GVAX + CRS-207 | 94 | 94 |
| Total, other adverse events | Pooled Cohort: CRS-207 | 87 | 87 |
| Total, other adverse events | Pooled Cohort: Chemotherapy | 51 | 54 |
| Total, serious adverse events | Pooled Cohort: Cy/GVAX + CRS-207 | 44 | 94 |
| Total, serious adverse events | Pooled Cohort: CRS-207 | 32 | 87 |
| Total, serious adverse events | Pooled Cohort: Chemotherapy | 15 | 54 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02004262
GET https://conductscience.org/api/trials/v1/NCT02004262/flow?page=2