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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Aduro BioTech, Inc.
Sponsor:
Information provided by (Responsible Party):
Aduro BioTech, Inc.
ClinicalTrials.gov Identifier:
NCT02004262
First received: October 23, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
2nd-line, 3rd-line and Greater Metastatic Pancreatic Cancer
Biological: GVAX Pancreas Vaccine
Biological: CRS-207
Drug: gemcitabine, capecitabine, 5-FU, irinotecan or erlotinib
Drug: cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Aduro BioTech, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: January 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

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

Biological: GVAX Pancreas Vaccine Biological: CRS-207 Drug: cyclophosphamide
Other Name: Cytoxan
Experimental: B
CRS-207 Weeks 1, 4, 7, 10, 13, 16
Biological: CRS-207
Active Comparator: C
chemotherapy: gemcitabine, capecitabine, 5-FU, irinotecan or erlotinib in accordance with defined treatment schedule
Drug: gemcitabine, capecitabine, 5-FU, irinotecan or erlotinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004262

  Show 22 Study Locations
Sponsors and Collaborators
Aduro BioTech, Inc.
  More Information

Additional Information:
Publications:

Responsible Party: Aduro BioTech, Inc.
ClinicalTrials.gov Identifier: NCT02004262     History of Changes
Other Study ID Numbers: ADU-CL-04
Study First Received: October 23, 2013
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aduro BioTech, Inc.:
cancer
cancer vaccine
Listeria monocytogenes
Listeria-based vaccine
GVAX
cyclophosphamide
Cytoxan
immunotherapy
mesothelin

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Erlotinib
Irinotecan
Cyclophosphamide
Pancreatin
Pancrelipase
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on September 18, 2014