CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Ipilimumab +2 moredrug
Likely dose
Ipilimumab 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/NCT01896869
NCT01896869Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination With Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jul 11, 2013·Updated May 19, 2020

In Brief

A Phase 2 clinical trial evaluating Ipilimumab, Vaccine, and 1 other intervention for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 83 participants across 3 sites.

Detailed Summary

This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX. Funding Source - FDA Office of Orphan Product Development (OOPD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartNov 1, 2013
Primary CompletionMay 3, 2019
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 13.0 years ago

Interventions

Ipilimumabdrug

3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccinebiological

5x10\^8 cells administered in 6 intradermal injections

FOLFIRINOXdrug

Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.