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

Conditions

• Previously Treated Metastatic Adenocarcinoma of the Pancreas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CRS-207 — BIOLOGICAL
  1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
• CRS-207 — BIOLOGICAL
  1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
• nivolumab — DRUG
  3 mg/kg administered IV on Day 1 of Cycles 1-6
• GVAX — BIOLOGICAL
  5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
• CY — DRUG
  200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Study Details

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).

Key Dates

Start date

Jan 2, 2015

Status verified

Feb 2020

Primary completion

Jul 21, 2017

Completion

Jul 21, 2017

Study Design

Enrollment

93 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: CY/ GVAX/ CRS-207/ nivolumab
• Experimental: Arm B: CY/ GVAX/ CRS-207

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 2 years and 7 months ]

Locations (5)

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