Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

NCT04926467 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 020-476
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• To determine the percentage of patients that have a normalization of CA19-9 after pre-op treatment with the combination of nab-paclitaxel (abraxane), gemcitabine, cisplatin and anakinra.

  24 months

Secondary Outcomes (7)

• To determine the effect of anakinra in combination with perioperative chemotherapy on overall survival (OS) of PDAC patients. A benchmark of 24 months OS will be used to determine how many patients meet or exceed this goal.

  24 months

• To determine the effect of anakinra in combination with perioperative chemotherapy on the median disease free survival (DFS). A benchmark of 12 months DFS will be used to determine how many patients meet or exceed this goal.

  12 months

• To determine the effect of anakinra in combination with perioperative chemotherapy on response rate

  24 months

• To determine the R0 resection rates (complete tumor removal with negative resection margins) obtained with anakinra + pre-operative chemotherapy.

  24 months

• To describe the effect of anakinra in combination with perioperative chemotherapy on the prevalence and severity of pain by monitoring patients' pain level using memorial pain assessment card (MPAC).

  24 months

Study Arms (1)

Anakinra plus Chemotherapy

EXPERIMENTAL

Patients will receive Anakinra during both pre-operative chemotherapy with Nab-paclitaxel, gemcitabine and cisplatin, followed by surgery and post-operative chemotherapy with 5-fluorouracil, oxaliplatin, and irinotecan.

Drug: Anakinra

Interventions

Anakinra DRUG

Anakinra (100 mg) twice a day (BID), daily, will be self-administered subcutaneously starting on D1 of chemotherapy. Anakinra will be held 2 days prior to surgery. A dosing diary will be given to the patient for anakinra documentation.

Also known as: Kineret

Anakinra plus Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
• Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
• American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
• Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 1
• Serum albumin ≥2.0 g/dL.
• Adequate hematologic function as defined by:
• Absolute neutrophil count (ANC) ≥1500/mm3;
• Platelets ≥70,000 x 10\^3/µl;
• Hemoglobin ≥9 g/dL (in the absence of red blood transfusion).
• Adequate liver function, as defined by:
• Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
• ALT (SGPT) and AST (SGOT) ≤2.5 x upper limit of normal (ULN).
• Adequate renal function, as defined by serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
• Women of child bearing potential and men must agree to use contraception throughout the study and for one month after the last anakinra administration.

You may not qualify if:

• \<18 years of age
• History of organ transplant.
• Patients with islet cell neoplasms
• Patients with stage IV pancreatic carcinoma
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Known active infection with hepatitis B or hepatitis C
• Presence of clinically significant cirrhosis as determined by the investigator
• Known HIV positive status.
• Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
• Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study
• Prior chemotherapy or radiation for pancreatic cancer
• History of allergy or hypersensitivity to the study drugs
• Patient is enrolled in any outside therapeutic clinical protocol or investigational trial with an investigational drug within 5 half-lives prior to Study ID assignment
• Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor
• Other malignancy within five years(except cutaneous, non-melanoma malignancies or cervical carcinoma in site), unless the probability of recurrence of the prior malignancy is \<5% as determined by the Principal Investigator based on available information.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center, Charles A Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• A. Scott Paulson, MD

  Charles A. Sammons Cancer Center/Texas Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Page Blas, MA

CONTACT

(214) 818-7879; page.blas@bswhealth.org

Joyce Ghormley

CONTACT

(214) 818-8961; Joyce.Ghormley@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 15, 2021
• Study Start: July 23, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)