Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

NCT06998940

Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

Led by SWOG Cancer Research Network · Updated on 2026-03-27

Participants Needed

274

Research Sites

243 weeks

Total Duration

AI-Summary

What this Trial Is About

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil \[5-FU\] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

CONDITIONS

Official Title

Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have a confirmed diagnosis of pancreatic ductal adenocarcinoma
Participants must have documented KRAS wild type and BRAF V600E wild type status by tumor tissue-based NGS assay
Participants must have unresectable and/or metastatic disease documented by CT or MRI imaging within specified timeframes
Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, HER2 and MET amplifications, or RET, NTRK1, and ALK gene fusions
Participants must not have known brain metastases or cranial epidural disease unless treated and stable for at least 28 days
Participants must have received only one prior line of systemic chemotherapy for locally advanced or metastatic disease with progression, refractory, or intolerance
Participants must not have prior treatment with anti-EGFR antibodies or EGFR tyrosine kinase inhibitors
Participants must not have received pancreatic anticancer therapy within 14 days prior to randomization
Participants must not have contraindications to receiving the planned chemotherapy doses
Participants must be 18 years or older at randomization
Participants must have Zubrod performance status of 0-2
Participants must have complete medical history and physical exam within 28 days prior to randomization
Participants must have adequate blood counts and liver and kidney function within 28 days prior to randomization
Participants with HIV must be on effective therapy with undetectable viral load within 6 months
Participants with chronic hepatitis B must have undetectable viral load on suppressive therapy within 6 months if indicated
Participants with hepatitis C must have been treated and cured or have undetectable viral load within 6 months if indicated
Participants must not have prior or concurrent malignancy interfering with safety or efficacy assessment
Participants must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential
Participants must be offered participation in specimen banking and quality-of-life studies
Participants must provide informed consent according to guidelines

You will not qualify if you...

Participants with brain metastases or cranial epidural disease that are untreated or unstable
Participants with prior treatment using anti-EGFR antibodies or EGFR tyrosine kinase inhibitors
Participants who received any pancreatic anticancer therapy within 14 days before randomization
Participants with known contraindications to planned chemotherapy doses
Participants who are pregnant or nursing
Participants with prior or concurrent malignancies that may interfere with study assessments

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Trial Site Locations

Total: 274 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Alaska Breast Care and Surgery LLC