Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03161379
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Cyclophosphamide Drug: Nivolumab Drug: GVAX Pancreas Vaccine Radiation: Stereotactic Body Radiation (SBRT) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CY, Nivolumab, GVAX, and SBRT
CY, Nivolumab, GVAX, and SBRT
Drug: Cyclophosphamide
Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
Other Name: CY

Drug: Nivolumab
Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
Other Name: OPDIVO

Drug: GVAX Pancreas Vaccine
Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.
Other Name: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine

Radiation: Stereotactic Body Radiation (SBRT)
SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).




Primary Outcome Measures :
  1. Pathologic complete response (pCR) rate at surgical resection. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Number of subjects who receive an R0 surgical resection. [ Time Frame: 4 years ]
  2. Objective response rate (ORR) [ Time Frame: 4 years ]
  3. Overall survival (OS) [ Time Frame: 4 years ]
  4. Distant metastasis free survival (DMFS) [ Time Frame: 4 years ]
  5. Number of drug related adverse events [ Time Frame: 4 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histologically proven pancreatic cancer that is borderline resectable
  • No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
  • Age >18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
  • Woman of child bearing potential must have a negative pregnancy test.
  • Must use an acceptable form of birth control while on study.
  • Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Had major surgery within the last 28 days
  • Had an investigational drug or device within the past 28 days
  • Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc)
  • Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
  • Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
  • Other cancer diagnosis requiring treatment within two years
  • History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study.
  • Patients receiving growth factors within the last 14 days.
  • Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
  • Pregnant or breastfeeding.
  • Have known history of infection with HIV, hepatitis B, or hepatitis C.
  • Unwilling or unable to follow the study schedule for any reason.
  • Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft)
  • Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells >30%

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): NCT03161379


Contacts
Layout table for location contacts
Contact: Anna Ferguson, RN 4106147186 afergus1@jhmi.edu
Contact: Arsen Osipov, MD aosipov1@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Anna Ferguson, RN    410-614-7186    afergus1@jhmi.edu   
Contact: Mark Yarchoan, MD    410-614-1058    mark.yarchoan@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Colin D Weekes, MD    617-724-7000    cdweekes@mgh.harvard.edu   
Principal Investigator: Colin D Weekes, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Mark Yarchoan, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator: Arsen Osipov, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03161379     History of Changes
Other Study ID Numbers: J1756
IRB00130075 ( Other Identifier: JHM IRB )
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Pancreatic Vaccine
borderline resectable
Neoadjuvant therapy
immunotherapy
Cytoxan
Cyclophosphamide
SBRT
GVAX
Nivolumab
Radioimmunotherapy
Vaccine
Antibody
Anti-PD-1
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Cyclophosphamide
Nivolumab
Pancrelipase
Pancreatin
Vaccines
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