Trial · NCT02261714
Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer
NCT02261714, Phase 1, Phase 2, Completed, Targovax ASA; results first posted 2020-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer. Trials, record NCT02261714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02261714
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer
- NCT number
- NCT02261714
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Targovax ASA
- Conditions
- Pancreatic Cancer, Resected
- Interventions
- TG01, TG01
- First posted
- 2014-10-10
- Last updated
- 2020-05-14
- Results first posted
- 2020-05-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients' Safety During Study | 2 years | Assess the safety (number and nature of Adverse events and laboratory data occurring during study (before, during and after chemotherapy is given) in subjects treated with the Pancreatic Cancer ASCI |
| Primary | Patients' Immune Response | During the 2 years of treatment | Assess the Immune response (DTH responses and Proliferative T-cell responses) up to 2 years of treatment |
| Secondary | Clinical Efficacy | DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years. | Efficacy exploring disease free survival and overall survival. |
| Other | Relationship Between (KRAS) Status and Clinical Efficacy | 2 years | Relationship between KRAS status and recurrence |
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 | Patients' Safety During Study | 2 years | Events related to TG01 and /or GM-CSF | NUMBER | |
| PRIMARY | Patients' Immune Response | During the 2 years of treatment | percentage of patients | NUMBER | |
| SECONDARY | Clinical Efficacy | DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years. | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Relationship Between (KRAS) Status and Clinical Efficacy | 2 years | As the majority of the patients (26 of 32) patients had a KRAS mutation detected, it was not possible to accurately assess relationship between KRAS status and survival outcomes. |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients' Safety During Study | TG01/GM-CSF and Gemcitabine | AEs related to TG01 and/or GM-CSF | 90 | Events related to TG01 and /or GM-CSF | |
| Patients' Safety During Study | TG01/GM-CSF and Gemcitabine | SAEs related to TG01 and/or GM-CSF | 2 | Events related to TG01 and /or GM-CSF | |
| Patients' Immune Response | TG01/GM-CSF and Gemcitabine | 94 | percentage of patients | ||
| Clinical Efficacy | TG01/GM-CSF and Gemcitabine | Overall survival | 33.3 | Full Range 24.0 to 40.0 | Months |
| Clinical Efficacy | TG01/GM-CSF and Gemcitabine | Disease free survival | 16.1 | Full Range 11.1 to 19.6 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TG01/GM-CSF and Gemcitabine | 32 | |
| Overall Study | COMPLETED | TG01/GM-CSF and Gemcitabine | 4 | |
| Overall Study | NOT COMPLETED | TG01/GM-CSF and Gemcitabine | 28 |
Source ClinicalTrials.gov
Adverse events3
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 | Nausea | Gastrointestinal disorders | TG01/GM-CSF and Gemcitabine | 16 | 32 | 43 |
| serious | Pyrexia | General disorders | TG01/GM-CSF and Gemcitabine | 1 | 32 | 2 |
| serious | Anaphylactic reaction | Immune system disorders | TG01/GM-CSF and Gemcitabine | 2 | 32 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TG01/GM-CSF and Gemcitabine | 18 | 32 |
| Total, other adverse events | TG01/GM-CSF and Gemcitabine | 16 | 32 |
| Total, serious adverse events | TG01/GM-CSF and Gemcitabine | 3 | 32 |
Source ClinicalTrials.gov
Papers3
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/NCT02261714
GET https://conductscience.org/api/trials/v1/NCT02261714/registered