Completed

NCT Number: NCT02243371

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

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).

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Key information

Conditions

Previously Treated Metastatic Adenocarcinoma of the Pancreas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Francisco, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRS-207

Biological

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

Nivolumab

Drug

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

Other names: BMS-936558; anti-PD-1 mAb

GVAX

Biological

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

Other names: GVAX pancreas vaccine, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo

CY

Drug

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

Other names: Cytoxan, Cyclophosphamide

Primary outcomes

Overall Survival (OS)

Time frame: 2 years and 7 months

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).

Secondary outcomes

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

Time frame: 2 years and 7 months

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients

Time frame: 2 years and 7 months

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

Time frame: 2 years and 7 months

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) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients

Time frame: 2 years and 7 months

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

Time frame: 2 years and 7 months

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.
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

Time frame: 120 days

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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

Aduro Biotech, Inc.
American Association for Cancer Research
Bristol-Myers Squibb
Lustgarten Foundation
Stand Up To Cancer

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Sep 17, 2014
Registry last updated: Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.