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

• Status: Completed
• Trial end date: 2017-07-21
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Aduro BioTech; Aduro Biotech, Inc.; American Association for Cancer Research; Bristol-Myers Squibb; Lustgarten Foundation; Stand Up To Cancer
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Nivolumab; Pancreatin; Pancrelipase; Vaccines

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