Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (NCT06998940)

🧪 Interventions in This Study

• Fluorouracil (DRUG)
• Gemcitabine (DRUG)
• Irinotecan (DRUG)
• Irinotecan Sucrosofate (DRUG)
• Leucovorin (DRUG)
• Nab-paclitaxel (DRUG)
• Panitumumab (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas
2. Participants must have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification status
3. NOTE: Blood-based next generation sequencing (NGS) assays, such as circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsies, will not be accepted for meeting eligibility criteria
4. Participants must have documented unresectable and/or metastatic disease on CT or magnetic resonance imaging (MRI) imaging completed prior to randomization. Imaging must have been completed within 28 days prior to randomization for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
5. Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK by tumor tissue-based NGS analysis
6. NOTE: Participants who are not tested for these mutations are eligible if they have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status
7. Participants must not have known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 28 days before randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day).
8. NOTE: Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment
9. Participants must have received only one line of prior systemic cytotoxic chemotherapy for locally advanced or metastatic PDA, and have radiographically progressed, refractory, or intolerant to this therapy.
10. Prior neoadjuvant or adjuvant therapy with 5-FU or gemcitabine-based chemotherapy counts as a line of therapy if the participant's disease progressed to locally advanced or metastatic disease within 6 months of completing treatment
11. Participants with cancers harboring molecular alterations including microsatellite instability (MSI-high), elevated tumor mutational burden (TMB) (TMB ≥ 10 mut/Mb), and FGFR1-3, NRG1, and ROS fusions are allowed to have received an additional line of targeted therapy applicable to the respective molecular alterations at the treating investigators discretion.
12. Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1/2 or PALB2 mutations does not count as a line of therapy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (274 Sites)

Showing the first 25 of 274 sites.

• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
• Highlands Oncology Group - Rogers — Rogers, Arkansas
• Highlands Oncology Group — Springdale, Arkansas
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
• Sutter Auburn Faith Hospital — Auburn, California
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Mills-Peninsula Medical Center — Burlingame, California
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
• Mercy Cancer Center - Carmichael — Carmichael, California
• Mercy San Juan Medical Center — Carmichael, California
• Eden Hospital Medical Center — Castro Valley, California
• Sutter Davis Hospital — Davis, California
• Mercy Cancer Center - Elk Grove — Elk Grove, California
• Palo Alto Medical Foundation-Fremont — Fremont, California
• Mercy Cancer Center — Merced, California

📞 Contact the Study Coordinator

Phone: (907) 212-6871

Email: AKPAMC.OncologyResearchSupport@providence.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Locally Advanced Pancreatic Adenocarcinoma

• PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy — Los Angeles, California
• A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer. — Duarte, California
• Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer — Scottsdale, Arizona
• Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma — Houston, Texas
• Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer — Duarte, California

Explore by condition: All Locally Advanced Pancreatic Adenocarcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.