This trial is active, not recruiting.

Condition 2nd-line, 3rd-line and greater metastatic pancreatic cancer
Treatments gvax pancreas vaccine, crs-207, gemcitabine, capecitabine, 5-fu, irinotecan or erlotinib, cyclophosphamide
Phase phase 2
Target EGFR
Sponsor Aduro BioTech, Inc.
Start date January 2014
End date December 2016
Trial size 240 participants
Trial identifier NCT02004262, ADU-CL-04


Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
cyclophosphamide (200 mg/m^2) D0 of Weeks 1, 4 GVAX Pancreas Vaccine (5 × 10e8 cells) D 1 of Weeks 1, 4 CRS-207 (1 × 10e9 CFU) Weeks 7, 10, 13, 16
gvax pancreas vaccine
cyclophosphamide Cytoxan
CRS-207 Weeks 1, 4, 7, 10, 13, 16
(Active Comparator)
chemotherapy: gemcitabine, capecitabine, 5-FU, irinotecan or erlotinib in accordance with defined treatment schedule
gemcitabine, capecitabine, 5-fu, irinotecan or erlotinib

Primary Outcomes

Overall survival in subjects receiving test treatments
time frame: Subjects followed on study for 2 years from last subject enrolled; expected duration of follow-up = 3 years

Secondary Outcomes

Adverse events in each treatment arm treatment regimen
time frame: Subjects followed on study for 2 years from last subject enrolled; expected duration of follow-up = 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required, mixed histology is not allowed; subjects must have metastatic disease - 2nd line, 3rd line or greater - At least 18 years of age - ECOG of 0 or 1 - Anticipated life expectancy >12 weeks - For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.) - Have adequate organ function as defined by specified laboratory values Exclusion Criteria: - Allergy to both penicillin & sulfa or suspected hypersensitivity to GM-CSF, dimethyl sulfoxide, fetal bovine serum, trypsin, yeast, glycerol or other component of the therapy options - Known history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment - Have any evidence of hepatic cirrhosis or clinical or radiographic ascites - Have prosthetic heart valves, major implant or device placed in the last 12 months or history of infection with implant/device that cannot be easily removed - Rapidly progressing disease - Clinically significant and/or malignant pleural effusion - Received prior GVAX pancreas vaccine or CRS-207 - Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia - Infection with HIV or hepatitis B or C at screening - Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis - Be pregnant or breastfeeding - Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen - Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

Additional Information

Official title A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS 207 Compared to Chemotherapy or to CRS-207 Alone in Adults With Previously-Treated Metastatic Pancreatic Adenocarcinoma
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Aduro BioTech, Inc..
Location data was received from the National Cancer Institute and was last updated in January 2016.