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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

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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

This is a Phase 2, randomized, multicenter, open-label study of cyclophosphamide and GVAX
pancreas vaccine followed by CRS-207 in adults with metastatic pancreatic adenocarcinoma who
have received or refused at least one prior chemotherapy treatment.

Eligible subjects will be randomized in a 2:1 ratio to receive either two doses of
cyclophosphamide and GVAX pancreas vaccine and up to 4 doses of CRS-207 at 1 × 10e9 CFU
(Treatment Arm A) or up to six doses of cyclophosphamide and GVAX pancreas vaccine
(Treatment Arm B). Study assessments include blood draws for safety and immune response
monitoring and CT scans for tumor response evaluations.

After completion of treatment, subjects will continue to be followed by phone and optional
clinic visits for the duration of the study. At the investigator's discretion, subjects may
receive additional cycles of the assigned treatment regimen if they are clinically stable
and meet dosing eligibility. At the conclusion of the study, all remaining subjects will be
offered enrollment in a long-term follow-up study.

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

- Be at least 18 years of age

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Have an anticipated life expectancy of greater than 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

- Have a 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

- An artificial (prosthetic) joint or other artificial implant or device that cannot be
easily removed (with some exceptions for dental and breast implants and biliary
stents and mediports)

- Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring
within 28 days prior to receiving study drug, or planned surgery requiring general

- 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 a woman who is 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare overall survival in subjects receiving test treatments

Outcome Description:

Patients will be followed at regular intervals to assess survival

Outcome Time Frame:

Up to five years

Safety Issue:


Principal Investigator

Dung T Le, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

October 2014

Related Keywords:

  • Pancreatic Cancer
  • Cancer
  • Cancer vaccine
  • Listeria monocytogenes
  • Listeria-based vaccines
  • GVAX
  • Cyclophosphamide
  • Cytoxan
  • T regulatory cells
  • Heterologous Prime-Boost
  • Immunotherapy
  • Mesothelin
  • Pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



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Virginia Mason Medical CenterSeattle, Washington  98111
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
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National Cancer InstituteBethesda, Maryland  20892-1922
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins HospitalBaltimore, Maryland  21231
NYU Langone Medical CenterNew York, New York  10016
Herbert Irving Comprehensive Cancer Center of Columbia UniversityNew York, New York  10032