Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

Completed · Phase 2

Conditions studied: 2nd-line, 3rd-line and Greater Metastatic Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT02004262

Run by

Aduro Biotech, Inc.

People needed

303

Starts

2014-02-05

Expected to finish

2016-08-23

Last updated by the study team

2018-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status 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

You may not qualify if…

• Allergy to both penicillin \& sulfa or suspected hypersensitivity to granulocyte-macrophage colony stimulating factor (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 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
• 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

Where it is running

• Scottsdale Healthcare Research Institute — Scottsdale, Arizona, United States
• University California San Diego Moores Cancer Center — La Jolla, California, United States
• University of California Mt Zion Comprehensive Cancer Center — San Francisco, California, United States
• University of California Los Angeles — Santa Monica, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• University of Miami/Sylvester Cancer Center — Miami, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center Morris Cancer Center — Durham, North Carolina, United States
• Providence Cancer Center — Portland, Oregon, United States
• University of Pittsburgh Medical Center Cancer Pavillion — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States
• Princess Margaret Hospital Princess Margaret Cancer Center — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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