Clinical Trials/NCT02243371

NCT02243371

Completed

Phase 2

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins5 sites in 1 country93 target enrollmentJanuary 2, 2015

ConditionsPreviously Treated Metastatic Adenocarcinoma of the Pancreas

InterventionsCY CRS-207 nivolumab GVAX

Drugsnivolumab CY

Overview

Phase: Phase 2
Intervention: CY
Conditions: Previously Treated Metastatic Adenocarcinoma of the Pancreas
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 93
Locations: 5
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2, 2015

End Date

July 21, 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility 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
•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.

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.

Arms & Interventions

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

Intervention: CY

Arm B: CY/ GVAX/ CRS-207

Intervention: CRS-207

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

Intervention: CRS-207

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

Intervention: nivolumab

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

Intervention: GVAX

Arm B: CY/ GVAX/ CRS-207

Intervention: GVAX

Arm B: CY/ GVAX/ CRS-207

Intervention: CY

Outcomes

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

Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity(2 years and 7 months)
Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
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(120 days)