GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:7/25/2018
Start Date:December 2014
End Date:January 2019

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A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

The primary objective of this study is to compare the overall survival (OS) of subjects with
previously treated metastatic pancreatic cancer treated with cyclophosphamide
(CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects
treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).


Inclusion Criteria:

- Age ≥18 years.

- Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients
with mixed histology will be excluded.

- Have metastatic disease.

- Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer.

- Patients with the presence of at least one measurable lesion.

- Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on
treatment if the lesion can be biopsied with acceptable clinical risk (as judged by
the investigator).

- ECOG performance status 0 or 1.

- Life expectancy of greater than 3 months.

- Patients must have adequate organ and marrow function defined by study-specified
laboratory tests.

- Must use acceptable form of birth control while on study.

- Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

- known history or evidence of brain metastases.

- Had surgery within the last 28 days

- Have received any non-oncology vaccine therapy used for prevention of infectious
diseases including seasonal vaccinations within 28 days of study treatment.

- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, GVAX or CRS-207

- Systemic steroids within the last 14 days

- Use more than 3 g/day of acetaminophen.

- Patients on immunosuppressive agents.

- Patients receiving growth factors within the last 14 days

- Known allergy to both penicillin and sulfa.

- Severe hypersensitivity reaction to any monoclonal antibody.

- Have artificial joints or implants that cannot be easily removed

- Have any evidence of hepatic cirrhosis or clinical or radiographic ascites.

- Have significant and/or malignant pleural effusion

- Infection with HIV or hepatitis B or C at screening

- Significant heart disease

- 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

- Unable to avoid intimate 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.

- Are pregnant or breastfeeding.

- Have rapidly progressing disease
We found this trial at
5
sites
Baltimore, Maryland 21231
410-955-6190
Principal Investigator: Dung Le, MD
Phone: 410-502-2800
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Robert Vonderheide, MD
Phone: 215-898-0077
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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San Francisco, California 94143
Principal Investigator: Andrew Ko, MD
Phone: 415-353-7683
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San Francisco, CA
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: George Fisher, MD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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