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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02243371
Recruitment Status : Active, not recruiting
First Posted : September 17, 2014
Last Update Posted : July 23, 2018
Sponsor:
Collaborators:
Bristol-Myers Squibb
Stand Up To Cancer
Aduro Biotech, Inc.
American Association for Cancer Research
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Previously Treated Metastatic Adenocarcinoma of the Pancreas Biological: CRS-207 Biological: GVAX Drug: nivolumab Drug: CY Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CY/ GVAX/ CRS-207/ nivolumab Biological: CRS-207
1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6 (Arm A) or Day 1 of Cycles 3-6 (Arm B)

Biological: GVAX
5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 (Arm A and B)
Other Name: GVAX pancreas vaccine, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo

Drug: nivolumab
3 mg/kg administered IV on Day 1 of Cycles 1-6 (Arm A only)
Other Name: BMS-936558; anti-PD-1 mAb

Drug: CY
200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 (Arm A and B)
Other Name: Cytoxan, Cyclophosphamide

Experimental: CY/ GVAX/ CRS-207 Biological: CRS-207
1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6 (Arm A) or Day 1 of Cycles 3-6 (Arm B)

Biological: GVAX
5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 (Arm A and B)
Other Name: GVAX pancreas vaccine, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo

Drug: CY
200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 (Arm A and B)
Other Name: Cytoxan, Cyclophosphamide




Primary Outcome Measures :
  1. Overall survival (OS) in metastatic pancreatic cancer patients treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) versus patients treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Number of patients experiencing treatment-related toxicities [ Time Frame: 4 years ]
  2. Progression-free survival (PFS) by RECIST 1.1 in metastatic pancreatic cancer patients treated with CY/GVAX/CRS-207/nivolumab (Arm A) versus patients treated with CY/GVAX/CRS-207 (Arm B) [ Time Frame: 4 years ]
  3. Immune-related progression-free survival (irPFS) by IRRC in metastatic pancreatic cancer patients treated with CY/GVAX/CRS-207/nivolumab (Arm A) versus patients treated with CY/GVAX/CRS-207 (Arm B) [ Time Frame: 4 years ]
  4. Time to progression (TTP) by RECIST 1.1 and IRRC in metastatic pancreatic cancer patients treated with CY/GVAX/CRS-207/nivolumab (Arm A) versus patients treated with CY/GVAX/CRS-207 (Arm B) [ Time Frame: 4 years ]
  5. Response rate measured by RECIST 1.1 in metastatic pancreatic cancer patients treated with CY/GVAX/CRS-207/nivolumab (Arm A) versus patients treated with CY/GVAX/CRS-207 (Arm B) [ Time Frame: 4 years ]
  6. Tumor marker kinetics (CA 19-9) in metastatic pancreatic cancer patients treated with CY/GVAX/CRS-207/nivolumab (Arm A) versus patients treated with CY/GVAX/CRS-207 (Arm B) [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243371


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford University
Stanford, California, United States, 94305
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Stand Up To Cancer
Aduro Biotech, Inc.
American Association for Cancer Research
Investigators
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Principal Investigator: Dung Le, MD Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02243371     History of Changes
Other Study ID Numbers: J14113
ADU-CL-06
IRB00043936 ( Other Identifier: JHMIRB )
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Cyclophosphamide
Nivolumab
Pancrelipase
Pancreatin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Gastrointestinal Agents