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Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Phase 2 trial testing GVAX pancreas vaccine in Pancreatic Cancer in 56 participants. Completed in 10 December 2022.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 11 September 2006 |
| Primary completion | 11 October 2021 |
| Estimated completion | 10 December 2022 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
When calculating the incidences of adverse events, each adverse event (as defined by NCI CTCAE v3) will be counted only once for a given subject.
| Group | Value | 95% CI |
|---|---|---|
| Previously Vaccinated With GVAX Pancreas Vaccine | 1 | |
| GVAX Pancreas Vaccine Naive | 5 |
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
| Group | Value | 95% CI |
|---|---|---|
| Previously Vaccinated With GVAX Pancreas Vaccine | 80.5 | 22.5 – 187.8 |
| GVAX Pancreas Vaccine Naive | 30.7 | 19.3 – 40.7 |
DFS is defined as the time from the first dose until evidence of disease recurrence or progression confirmed by first scan. DFS will be censored at the date of the last scan for subjects without documentation of disease recurrence or progression at the time of analysis. Estimation based on the Kaplan-Meier curve.
| Group | Value | 95% CI |
|---|---|---|
| Previously Vaccinated With GVAX Pancreas Vaccine | 109.5 | 5.59 – NA |
| GVAX Pancreas Vaccine Naive | 13.7 | 5.55 – 25.1 |
Time frame: 16 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Previously Vaccinated With… | GVAX Pancreas Vaccine Naive |
|---|---|---|---|
| Presyncope | Nervous system disorders | — | — |
| Reaction | System | Previously Vaccinated With… | GVAX Pancreas Vaccine Naive |
|---|---|---|---|
| Erythema (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
| Induration (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
| Pruritus (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
| Warmth (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
| Tenderness (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
| Flu-Like symptoms | General disorders | — | — |
| Eosinophil count elevated | Investigations | — | — |
| Vaccine Flares (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Blisters | Skin and subcutaneous tissue disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Chills | General disorders | — | — |
| Fever | General disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Malaise | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Skin hyperpigmentation (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
| Lymphadenopathy | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| White blood cell count elevated | Investigations | — | — |
| Weakness | Musculoskeletal and connective tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Bruising (vaccination site) | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Presyncope.
Data from ClinicalTrials.gov NCT00389610 adverse events section.
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00389610.
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