FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01896869|
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : May 6, 2020
Last Update Posted : May 19, 2020
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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)
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma||Drug: Ipilimumab Biological: Vaccine Drug: FOLFIRINOX||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 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 in the Treatment of Metastatic Pancreatic Cancer|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 3, 2019|
|Actual Study Completion Date :||May 3, 2019|
Experimental: Ipilimumab + Vaccine (Arm A)
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)
5x10^8 cells administered in 6 intradermal injections
Experimental: FOLFIRINOX (Arm B)
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 (OS) [ Time Frame: 4 years ]Overall Survival is the time between the date of randomization on study and death.
- Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine [ Time Frame: From the first dose of study drug through 70 days after last dose, up to 13 months ]Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section).
- Progression Free Survival (PFS) [ Time Frame: Up to 4 years ]Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.
- Immune-related Progression Free Survival (irPFS) [ Time Frame: Up to 4 years ]
Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.
Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
- Objective Response Rate [ Time Frame: Assessed until disease progression, up to 2 years ]Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST).
- Immune-related Objective Response Rate [ Time Frame: Assessed until disease progression, up to 2 years ]
Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are evaluated using immune-related response criteria (irRC).
irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
- Duration of Response [ Time Frame: Up to 22 months ]Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.
- Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels [ Time Frame: Baseline, Week 7, and Week 10 visits ]Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria (abbreviated):
- Documented adenocarcinoma of the pancreas
- Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 3 months
- Adequate organ and marrow function defined by study-specified laboratory tests.
- Must use acceptable form of birth control while on study
- Oxygen saturation on room air >92%
Exclusion Criteria (abbreviated):
- Surgery within 4 weeks of dosing investigational agent (some exceptions for minor procedures)
- Off FOLFIRINOX treatment for more than 70 days prior to treatment on study
- Prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX or adjuvant therapy).
- History of prior treatment with ipilimumab, anti-PD1 antibody, CD137 agonist, or anti-CD40 antibody
- Received any non-oncology live vaccine therapy up to one month prior to or after any dose of ipilimumab/vaccine
- Receiving any other investigational agents
- Any of the following concomitant therapy: IL-2, interferon, immunosuppressive agents, or chronic use of systemic corticosteroids
- History of symptomatic autoimmune disease or immune impairment. Thyroid disease is allowed.
- Known brain metastasis
- Radiographic ascites that is apparent on physical exam or requiring intervention in the 2 months prior to enrollment
- Uncontrolled intercurrent illness
- Known or suspected hypersensitivity to GM-CSF
- Chronic HIV, Hepatitis B or Hepatitis C
- Pregnant or breastfeeding women
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|
Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
NA_00086350 ( Other Identifier: JHMIRB )
FD-R-004819-01 ( Other Grant/Funding Number: FDA OOPD )
|First Posted:||July 11, 2013 Key Record Dates|
|Results First Posted:||May 6, 2020|
|Last Update Posted:||May 19, 2020|
|Last Verified:||April 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action