GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
NCT ID: NCT02243371
Last Updated: 2021-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2015-01-02
2017-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: CY/ GVAX/ CRS-207/ nivolumab
CRS-207
1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
nivolumab
3 mg/kg administered IV on Day 1 of Cycles 1-6
GVAX
5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY
200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
Arm B: CY/ GVAX/ CRS-207
CRS-207
1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
GVAX
5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY
200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
Interventions
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CRS-207
1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
CRS-207
1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
nivolumab
3 mg/kg administered IV on Day 1 of Cycles 1-6
GVAX
5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
CY
200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Stand Up To Cancer
OTHER
Aduro Biotech, Inc.
INDUSTRY
American Association for Cancer Research
OTHER
Lustgarten Foundation
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Dung Le, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Providence Portland Medical Center
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Hopkins AC, Yarchoan M, Durham JN, Yusko EC, Rytlewski JA, Robins HS, Laheru DA, Le DT, Lutz ER, Jaffee EM. T cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. JCI Insight. 2018 Jul 12;3(13):e122092. doi: 10.1172/jci.insight.122092.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ADU-CL-06
Identifier Type: -
Identifier Source: secondary_id
IRB00043936
Identifier Type: OTHER
Identifier Source: secondary_id
J14113
Identifier Type: -
Identifier Source: org_study_id
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