Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Gastrointestinal Agents

Nivolumab

Vaccines

Cyclophosphamide

Pancrelipase

Pancreatin

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

3 mg/kg administered IV on Day 1 of Cycles 1-6

nivolumab

5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2

GVAX

200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Dung Le, MD

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).

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

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

OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.

PFS is defined as the number of months from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

irPFS is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using irRC RECIST 1.1 criteria) or death due to any cause. Per irRC criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in tumor burden compared with baseline, Progressive Disease (PD) is \>20% increase in tumor burden compared with nadir, Stable Disease (SD) is \<30% decrease in tumor burden compared with baseline or \<20% increase in tumor burden compared to nadir.

Time to progression (TTP) is defined as the time from randomization to the date of documented disease progression as defined by RECIST 1.1 criteria. Individuals are censored at the date of the last radiological assessment that occurs prior to any of the following: death, switch to another anti-cancer therapy, or end of follow-up. Individuals without follow-up or baseline measurements are censored at 1 day. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Per RECIST 1.1 criteria, PR is defined as =\>30% decrease in sum of diameters of target lesions and CR is the disappearance of all target lesions.

Number of participants with stable or responding (\<50% increase of serum CA19-9 concentration) at 120 days.

Bristol-Myers Squibb

Stand Up To Cancer

Aduro Biotech, Inc.

American Association for Cancer Research

Lustgarten Foundation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6

GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2

nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6

CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Arm A: CY/ GVAX/ CRS-207/ Nivolumab

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

Arm B: CY/ GVAX/ CRS-207

CY/ GVAX/ CRS-207/ Nivolumab

CRS-207: 1 × 10\^9 CFU administered IV 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

CY/ GVAX/ CRS-207

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Overall Survival (OS)

Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity

Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients

Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients

Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients

Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients

Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration

Spots Global Cancer Trial Database for GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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