NCT02243371

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 2, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 8, 2019

Completed
Last Updated

April 6, 2021

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

September 15, 2014

Results QC Date

August 6, 2019

Last Update Submit

March 17, 2021

Conditions

Previously Treated Metastatic Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    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).

    2 years and 7 months

Secondary Outcomes (6)

  • 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

  • Immune-related Progression-free Survival (irPFS) by IRRC 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

  • +1 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL
Biological: CRS-207Drug: nivolumabBiological: GVAXDrug: CY

Arm B: CY/ GVAX/ CRS-207

EXPERIMENTAL
Biological: CRS-207Biological: GVAXDrug: CY

Interventions

CRS-207BIOLOGICAL

1 Ă— 10\^9 CFU administered IV on Day 2 of Cycles 3-6

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

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

Also known as: BMS-936558; anti-PD-1 mAb
Arm A: CY/ GVAX/ CRS-207/ nivolumab
GVAXBIOLOGICAL

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

Also known as: GVAX pancreas vaccine, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo
Arm A: CY/ GVAX/ CRS-207/ nivolumabArm B: CY/ GVAX/ CRS-207
CYDRUG

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

Also known as: Cytoxan, Cyclophosphamide
Arm A: CY/ GVAX/ CRS-207/ nivolumabArm B: CY/ GVAX/ CRS-207

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Hopkins AC, Yarchoan M, Durham JN, Yusko EC, Rytlewski JA, Robins HS, Laheru DA, Le DT, Lutz ER, Jaffee EM. T cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. JCI Insight. 2018 Jul 12;3(13):e122092. doi: 10.1172/jci.insight.122092.

    PMID: 29997287DERIVED

MeSH Terms

Interventions

NivolumabCyclophosphamide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Dung Le, MD
Organization
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
dle@jhmi.edu
443-287-0002

Study Officials

  • Dung Le, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

January 2, 2015

Primary Completion

July 21, 2017

Study Completion

July 21, 2017

Last Updated

April 6, 2021

Results First Posted

October 8, 2019

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)