This trial is active, not recruiting.

Condition pancreatic cancer
Treatments gvax pancreas, crs-207, cyclophosphamide
Phase phase 2
Sponsor Aduro Biotech, Inc.
Collaborator Johns Hopkins University
Start date September 2011
End date November 2016
Trial size 93 participants
Trial identifier NCT01417000, ADU-CL-01, NCT01468870


Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.

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 x 10e8 cells) D1 of Weeks 1, 4; CRS-207 (1 x 10e9 CFU) Weeks 7, 10, 13, 16
gvax pancreas
cyclophosphamide Cytoxan
cyclophosphamide (200 mg/m^2) D0 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 x 10e8 cells) D1 of Weeks 1, 4, 7, 10, 13, 16
gvax pancreas
cyclophosphamide Cytoxan

Primary Outcomes

Overall survival in subjects receiving test treatments
time frame: Up to five years

Secondary Outcomes

To assess safety of the cyclophosphamide, GVAX Pancreas vaccine, and CRS-207 treatment regimen
time frame: About 2 years
To assess the immune response
time frame: About three 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. (Subjects with mixed histology will be included if the predominant component is adenocarcinoma. Subjects must have metastatic disease.) - Have received or refused at least one chemotherapy regimen - At least 18 years of age - ECOG of 0 or 1 - Anticipated life expectancy of >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.) - Be willing and able to give written informed consent, and be able to comply with all study procedures - Have adequate organ function as defined by specified laboratory values Exclusion Criteria: - Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions - Known history or evidence of brain metastases - Have any evidence of hepatic cirrhosis or clinical or radiographic ascites - Have clinically significant and/or malignant pleural effusion - Known or suspected hypersensitivity to any component of GVAX Pancreas vaccine or CRS-207, or known allergy to both penicillin and sulfa - Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration - Used any systemic steroids within 28 days of study treatment - Use more than 3 g/d of acetaminophen - Prosthetic joint or other artificial implant or device that cannot be easily removed (there are some exceptions) - 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 - Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment - 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 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine Alone or Followed by CRS-207 in Adults With Metastatic Pancreatic Adenocarcinoma
Principal investigator Dung T Le, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Aduro Biotech, Inc..
Location data was received from the National Cancer Institute and was last updated in July 2016.