CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
CRS-207 +4 morebiological
Likely dose
nivolumab 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02243371
NCT02243371Phase 2Completed
CompareCT.gov

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 Hopkins·interventional·Posted Sep 17, 2014·Updated Apr 6, 2021

In Brief

A Phase 2 clinical trial evaluating CRS-207, nivolumab, and 2 other interventions for Previously Treated Metastatic Adenocarcinoma of the Pancreas. Completed, enrolled 93 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreviously Treated Metastatic Adenocarcinoma of the Pancreas
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Stand Up To Cancer, Aduro Biotech, Inc., American Association for Cancer Research, Lustgarten Foundation

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 17, 2014
Enrollment StartJan 2, 2015
Primary CompletionJul 21, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.8 years ago

Interventions

CRS-207biological

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

CRS-207biological

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

nivolumabdrug

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

GVAXbiological

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

CYdrug

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