Metastatic Pancreatic Cancer, Nonresectable Pancreatic Cancer
Conditions
Keywords
cancer vaccine, pancreatic cancer, metastatic pancreatic cancer, unresectable pancreatic cancer, immunotherapy
Brief summary
To evaluate the safety and effectiveness of CG8020 and CG2505.
Detailed description
To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas
Interventions
BIOLOGICALCG 8020 and CG 2505
Sponsors
Cell Genesys
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma * Chemotherapy naïve or chemotherapy experienced pancreatic cancer
Exclusion criteria
* Prior cancer vaccines or gene therapy * History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis) * History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
| Efficacy measured by clinical benefit response | — |
| Progression-free survivial | — |
| Overall survival | — |
Countries
United States
Outcome results
None listed