A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab With Allogenic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01896869|
Recruitment Status : Suspended (On hold during during interim analysis)
First Posted : July 11, 2013
Last Update Posted : March 14, 2018
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 OOPD
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma||Drug: Ipilimumab Biological: Vaccine Drug: FOLFIRINOX||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination With Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine (GVAX) in the Treatment of Metastatic Pancreatic Cancer|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Ipilimumab + Vaccine
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Other Names:Biological: Vaccine
5x10^8 cells administered in 6 intradermal injections
Administered every 14 days (one cycle)
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.
- Overall Survival [ Time Frame: 4 years ]Comparison of overall survival between patients on Arm A (Vaccine + IPI) and Arm B (FOLFIRINOX)
- Number of adverse events as a measure of toxicity [ Time Frame: 4 years ]
- Progression Free Survival (PFS) [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to 4 years ]Average time from start of treatment to progression or death, whichever comes first.
- immune-related Progression Free Survival (irPFS) [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to 4 years ]Average time from start of treatment to progression or death, whichever comes first. New lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
- Objective Response Rate [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to four years ]Evaluation of percentage of patients from each group Achieving a Complete Response (CR) or Partial Response (PR) by RECIST and immune-related response criteria (irRC).
- Duration of Response [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to four years ]Average length of time between achieving a complete response (CR) or partial response (PR)and documentation of recurrent or progressive disease.
- Tumor Marker (CA19-9) Kinetics [ Time Frame: Assessed every 3-4 weeks for up to four years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896869
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94143|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21205|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Dung Le, M.D.||The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|