A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy

February 16, 2026 updated by: Baylor Research Institute

A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients

The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the study drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Kineret (anakinra) is a FDA-approved drug indicated for rheumatoid arthritis. Anakinra is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Anakinra blocks the biologic activity of IL -1 by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic effects including inflammatory and immunological responses.

This is a pilot, prospective, non-randomized, consecutive enrollment study that will enroll up to 12 subjects who meet the study defined inclusion and exclusion criteria.

Subjects will undergo standard of care chemotherapy treatment/regimens (i.e., modified FOLFIRINOX). Subjects will be dispensed a 2 weeks supply of anakinra the day they begin chemotherapy. They will be instructed to begin self-administering the anakinra (study drug) injections the day after their first dose of chemotherapy.

They will have a blood sample collected at baseline and 6 months follow up. If they have surgery for their disease, they may have a tissue sample collected for later analysis.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • Male or non-pregnant and non-lactating female
  • Confirmed metastatic/inoperable metastatic pancreas cancer and/or Histologically/cytologically confirmed metastatic adenocarcinoma of pancreas
  • Patients' blood counts and blood chemistry levels at baseline must be not clinically significant (NCS) as determined by the enrolling investigator.
  • Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 2 (refer to Appendix 5):
  • Signed study consent form

Exclusion Criteria:

  • <18 years of age
  • Pregnant or lactating female
  • Patient has islet cell neoplasms
  • Active secondary malignancies (2nd cancer not treated/present)
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Known infection with hepatitis B, hepatitis C, or cirrhosis
  • Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
  • History of allergy or hypersensitivity to the study drugs
  • Patient is enrolled in any concurrent-outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
  • Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled CHF, or prior MI last 6-months
  • Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
  • Peripheral sensory neuropathy ≥ to grade 2 at baseline
  • Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
  • Study consent form not signed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anakinra with Modified Folfirinox

8-weeks of anakinra and modified FOLFIRINOX regimen (refer to Appendix 9 for regimen) as follows

Kineret (anakinra) Dosage Route Administration 100 mg SC Every Other Day

Modified FOLFIRINOX Drug Dose Administration Oxaliplatin 85 mg/m2 2-4 hours Irinotecan 180 mg/m2 90 minutes fluorouracil 2400 mg/m2 48 hours
Drug: anakinra
Dosage Route Administration 100 mg SC Every Other Day
Other Names:
  • Kineret
Drug: Oxaliplatin
Oxaliplatin 85 mg/m2 2-4 hours
Drug: Irinotecan
Irinotecan 180 mg/m2 90 minutes
Other Names:
  • Camptosar
Drug: fluorouracil
fluorouracil 2400 mg/m2 48 hours
Other Names:
  • 5 FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants with SAEs and AEs.
Time Frame: 6 months
Test the safety of Anakinra in combination with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) as evidenced by the Number of Participants with serious adverse events (SAEs) and adverse events (AEs).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 6 months
Overall Survival (OS) rate as defined by the percentage of people who are alive for a certain period of time after diagnosis
6 months
Adverse events associated with injection site reactions and the incidence of infections
Time Frame: 6 Months
Adverse events associated with injection site reactions and the incidence of infections
6 Months
Data Collection: tumor measurements by CT scans
Time Frame: 6 months
Data Collection: tumor measurements by CT scans
6 months
Gather preliminary information on the immune modulation and clinical activity of this therapy
Time Frame: 6 month
  • Blood transcriptional profiling
  • Composition of white blood cells
  • Assessment of PDAC antigen--specific T cell repertoire in the blood
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Carlos Becerra, MD, Baylor Sammons Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimated)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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