FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT01896869
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
  • Vaccine — BIOLOGICAL
    5x10\^8 cells administered in 6 intradermal injections
  • FOLFIRINOX — DRUG
    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.

Study Details

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)

Key Dates

First listed
Jul 11, 2013
Start date
Nov 30, 2013
Status verified
Apr 2020
Primary completion
May 3, 2019
Completion
May 3, 2019

Study Design

Enrollment
83 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + Vaccine (Arm A)
    Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
  • Experimental: FOLFIRINOX (Arm B)
    Administered every 14 days (one cycle)

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 4 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94143-
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21205-
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in San Francisco, CA

By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDWashington University School of Medicine· St Louis, MO

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