Locally Advanced Pancreatic AdenocarcinomaPhase 3NCT06998940
Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations
A Phase 3 study testing Biospecimen Collection, Computed Tomography and Fluorouracil in people with Locally Advanced Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, run by SWOG Cancer Research Network at 274 sites in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Fluorouracil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 274 sitesUnited States
- Study dates
- 13 May 2026to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas
- 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
- 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
- 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)
- 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
- 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
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- 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).
- NOTE: Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment
- 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.
- 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
- 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.
- Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1/2 or PALB2 mutations does not count as a line of therapy.
- Participants must not have prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)
- Participants must not have prior treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib)
- Participants must not have received any pancreatic anticancer therapy (e.g., standard of care or investigational chemotherapy, molecularly targeted therapy, or radiation) within 14 days prior to randomization
- Participants must not have a known contraindication to receiving chosen chemotherapy backbone at the planned doses in accordance with the local approved label
- Participant must be ≥ 18 years old at the time of randomization
- Participants must have Zubrod performance status of 0-2
- Participants must have a complete medical history and physical exam within 28 days prior to 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)
- Absolute neutrophil count ≥ 1.0 x 10^3/uL (within 28 days prior to 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)
- Note: Use of growth factor support (e.g., Granulocyte Colony-Stimulating Factor [G-CSF] or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
- Hemoglobin ≥ 8 g/dL (within 28 days prior to 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)
- Note: Use of growth factor support (e.g., G-CSF or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
- Platelets ≥ 75 x 10^3/uL (within 28 days prior to 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)
- Note: Use of growth factor support (e.g., G-CSF or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (within 28 days prior to 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)
- Aspartate aminotransferase (AST) ≤ 10 x upper limits of normal (ULN) (within 28 days prior to 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)
- Participants must have a creatinine ≤ the IULN OR measured OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration (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)
- Participants with known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
- Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
- Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
- Participants must be offered the opportunity to participate in specimen banking
- Participants who can complete patient reported outcomes (FACT-G and PRO-CTCAE) questionnaires in English or Spanish must be offered the opportunity to participate in the quality-of-life studies
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Who cannot join
None listed.
Trial locations and contacts
274 sites in 1 country. Contact the study team or a site near you to ask about taking part.
274 sites in 1 country
United States274 sites, 272 recruiting
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Olumide B. Gbolahan
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Olumide B. Gbolahan
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Olumide B. Gbolahan
- Recruiting
Sutter Auburn Faith Hospital
Auburn, California, 95602
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Site Public Contact, 410-601-9083
Pallavi P. Kumar
- Recruiting
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Our Lady of The Lake
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659
Marshall P. Stagg
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425
Site Public Contact, 218-828-2880
Bret E. Friday
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223, achapman1@peacehealth.org
Charles W. Drescher
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Charles W. Drescher
- Recruiting
Mills-Peninsula Medical Center
Burlingame, California, 94010
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Eden Hospital Medical Center
Castro Valley, California, 94546
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Site Public Contact, protocols@swog.org
John M. Schallenkamp
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Olugbenga Olowokure (Gbenga)
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Charles W. Drescher
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota, 56442
Site Public Contact, 218-692-1010
Bret E. Friday
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Sutter Davis Hospital
Davis, California, 95616
Site Public Contact, NCIclinicaltrials@sutterhealth.org
Uma Suryadevara
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Emory Decatur Hospital
Decatur, Georgia, 30033
Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org
Olumide B. Gbolahan
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy Medical Center
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Site Public Contact, 410-443-1360, frank.crum@christianacare.org
Gregory A. Masters
- Recruiting
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Site Public Contact, 218-365-7900
Bret E. Friday
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Charles W. Drescher
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Raymond C. Wadlow
- Recruiting
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Raymond C. Wadlow
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
Site Public Contact, 479-872-8100, research@hogonc.com
Joseph T. Beck
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Essentia Health - Fosston
Fosston, Minnesota, 56542
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Hi-Line Sletten Cancer Center
Havre, Montana, 59501
Site Public Contact, protocols@swog.org
John M. Schallenkamp
- Recruiting
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Tamarack Health Hayward Medical Center
Hayward, Wisconsin, 54843
Site Public Contact, 218-568-4416
Bret E. Friday
- Recruiting
Benefis Helena Specialty Center
Helena, Montana, 59601
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
Site Public Contact, 503-215-1979, canrsrchstudies@provdience.org
Charles W. Drescher
- Recruiting
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Site Public Contact, 218-283-9431
Bret E. Friday
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Recruiting
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
Site Public Contact, 404-778-5714, m.lisa.hwang@emory.edu
Olumide B. Gbolahan
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Aleksandar Jankov
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
David E. Marinier
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
The Watson Clinic
Lakeland, Florida, 33805
Site Public Contact, 863-680-7780
Shalini Mulaparthi
- Recruiting
Saint Anthony Hospital
Lakewood, Colorado, 80228
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Beebe Medical Center
Lewes, Delaware, 19958
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Saint Joseph Hospital
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph London
London, Kentucky, 40741
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Longmont United Hospital
Longmont, Colorado, 80501
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Mercy Cancer Center
Merced, California, 95340
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Site Public Contact, 406-327-3118, amy.hanneman@providence.org
Charles W. Drescher
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Memorial Medical Center
Modesto, California, 95355
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota, 55767
Site Public Contact, 218-485-4481
Bret E. Friday
- Recruiting
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274
Site Public Contact, 360-814-2182, rcccclinicalresearch@skagitvalleyhospital.org
Charles W. Drescher
- Recruiting
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Providence Queen of The Valley
Napa, California, 94558
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen Y. Butler
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Site Public Contact, 616-391-1230, connie.szczepanek@crcwm.org
Kathleen Y. Butler
- Recruiting
Sutter Cancer Research Consortium
Novato, California, 94945
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Creighton University Medical Center
Omaha, Nebraska, 68131
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Essentia Health - Saint Joseph's Pequot Lakes Clinic
Pequot Lakes, Minnesota, 56472
Site Public Contact, 218-568-4416
Bret E. Friday
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Valley Radiation Oncology
Peru, Illinois, 61354
Site Public Contact, 815-664-4141
Bryan A. Faller
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Essentia Health - Saint Joseph's Pine River Clinic
Pine River, Minnesota, 56474
Site Public Contact, 218-587-4416
Bret E. Friday
- Recruiting
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Site Public Contact, 910-715-3500, jcwilliams@firsthealth.org
Charles S. Kuzma
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Northwest Hospital Center
Randallstown, Maryland, 21133
Site Public Contact, 410-601-4673, cancerinstitute@lifebridgehealth.org
Pallavi P. Kumar
- Recruiting
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Site Public Contact, 605-755-2370, research@monument.health
Abdel-Ghani Azzouqa
- Recruiting
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Site Public Contact, 541-706-2909
Charles W. Drescher
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California, 95765
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758
Site Public Contact, 479-872-8130, research@hogonc.com
Joseph T. Beck
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Sutter Roseville Medical Center
Roseville, California, 95661
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Sutter Medical Center Sacramento
Sacramento, California, 95816
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mills Health Center
San Mateo, California, 94401
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Ridley-Tree Cancer Center
Santa Barbara, California, 93105
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, 95065
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Santa Cruz Radiation Oncology Medical Group
Santa Cruz, California, 95065
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403
Site Public Contact, 415-209-2683, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Rachael A. Safyan
- Recruiting
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Rachael A. Safyan
- Recruiting
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Site Public Contact, 360-788-8239, achapman1@peacehealth.org
Charles W. Drescher
- Recruiting
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Saint Michael Cancer Center
Silverdale, Washington, 98383
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Site Public Contact, 509-228-1680, research@ccnw.net
Charles W. Drescher
- Recruiting
Cancer Care Northwest-Valley
Spokane, Washington, 99216
Site Public Contact, 509-228-1680, research@ccnw.net
Charles W. Drescher
- Recruiting
Cancer Care Northwest-North Spokane
Spokane, Washington, 99218
Site Public Contact, 509-228-1680, research@ccnw.net
Charles W. Drescher
- Recruiting
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
Site Public Contact, 479-872-8130, research@hogonc.com
Joseph T. Beck
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904
Site Public Contact, 203-323-8944
Salvatore A. Del Prete
- Recruiting
Essentia Health - Saint Joseph's Staples Clinic
Staples, Minnesota, 56479
Site Public Contact, 218-894-7870
Bret E. Friday
- Recruiting
Saint Joseph's Medical Center
Stockton, California, 95204
Site Public Contact, 209-461-5257
Shahzad Siddique
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Site Public Contact, 701-364-6272
Bret E. Friday
- Recruiting
Munson Medical Center
Traverse City, Michigan, 49684
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Upper Valley Medical Center
Troy, Ohio, 45373
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Site Public Contact, 360-514-3940, kmakin-bond@peacehealth.org
Charles W. Drescher
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
Site Public Contact, 509-897-5993, Cheryl.Dodd@providence.org
Charles W. Drescher
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Site Public Contact, 513-584-7698, cancer@uchealth.com
Olugbenga Olowokure (Gbenga)
- Recruiting
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Saint Anthony North Hospital
Westminster, Colorado, 80023
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland, 21157
Site Public Contact, 410-871-6400
Pallavi P. Kumar
- Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Woodland Memorial Hospital
Woodland, California, 95695
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
University of Michigan Health - West
Wyoming, Michigan, 49519
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
About this study
Official title: Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare overall survival (OS) between participants with locally advanced or metastatic KRAS wild type (WT) pancreatic ductal adenocarcinoma (PDA) randomized to panitumumab plus second-line cytotoxic chemotherapy (5FU- or gemcitabine-based) versus chemotherapy alone.
SECONDARY OBJECTIVES:
- To compare progression-free survival (PFS) between treatment arms. II. To compare the overall response rate (ORR) (ORR, including confirmed and unconfirmed, complete and partial response according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) between treatment arms in participants with measurable disease.
III. To compare disease control rate (DCR) (DCR, defined as ORR + stable disease rate [SD]) between treatment arms in participants with measurable disease.
IV. To evaluate the frequency and severity of toxicity within each treatment arm.
- To compare duration of response (DoR) between treatment arms in participants with measurable disease.
ADDITIONAL OBJECTIVES:
- To compare OS and PFS between treatment arms in the subgroup of participants with MAPK negative cancers, that is, cancers without any known mitogen-activated protein kinase (MAPK) pathway molecular alterations (type 1 or 2 BRAF mutations; BRAF, NRG1, ROS1, FGFR1-3 and RAF1 fusions; EGFR, KRAS, and FGFR1-3 amplification).
II. To compare ORR in participants with MAPK negative cancers between treatment arms in participants with measurable disease.
PATIENT-REPORTED OUTCOMES COMMON TERMINOLOGY CRITIERIA FOR ADVERSE EVENTS (CTCAE) OBJECTIVES:
- To compare health-related quality of life (QOL) by treatment arm at 8 weeks after randomization, measured by the Functional Assessment of Cancer Therapy - General (FACT-G) total score.
II. To compare the impact of treatment toxicity by treatment arm at 8 weeks after randomization, measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Item GP5.
III. To compare changes from baseline in QOL and impact of treatment toxicity between treatment arms using FACT-G total score and FACIT Item GP5 to 24 weeks after randomization.
IV. To assess patient-reported symptoms by treatment arm using selected patient reported outcome (PRO)-CTCAE items including gastrointestinal, dermatologic, and constitutional symptoms of pain and fatigue.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive panitumumab intravenously (IV) over 30-90 minutes on days 1 and 15. Patients also receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.
ARM B: Patients receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up for up to 3 years post randomization.
- Conditions
- Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
- Being tested
- Biospecimen Collection, Computed Tomography, Fluorouracil, Gemcitabine, Irinotecan
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given IV
IrinotecanDrug
Given IV
Irinotecan SucrosofateDrug
Also called inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation, Irinotecan Liposome, Irinotecan Sucrosofate Liposome, Irinotecan Sucrosofate-containing Pegylated Liposomal Formulation
Given IV
LeucovorinDrug
Also called Folinic acid
Given IV
Nab-paclitaxelDrug
Also called ABI 007, ABI-007, ABI007, Abraxane
Given IV
PanitumumabBiological
Also called ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3
Given IV
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (panitumumab and standard chemotherapy) | Experimental | Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Patients also receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Irinotecan Sucrosofate; Drug: Leucovorin; Drug: Nab-paclitaxel; Biological: Panitumumab; Other: Questionnaire Administration |
| Arm B (standard chemotherapy) | Active comparator | Patients receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Irinotecan Sucrosofate; Drug: Leucovorin; Drug: Nab-paclitaxel; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Analysis of OS will be conducted in all eligible participants according to the intent-to-treat principle using a 1-sided stratified log rank test.
Measured: From date of randomization to date of death due to any cause, assessed up to 3 years
Secondary outcomes (8)
Objective response rate (ORR)
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be compared across treatment arms via Fisher's exact test.
Measured: Up to 3 years after randomization
Disease control rate
Will be compared across treatment arms via Fisher's exact test.
Measured: Up to 3 years after randomization
Duration of response (DoR)
The distributions of DoR will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Measured: Up to 3 years after randomization
Progression free survival (PFS)
The distributions of PFS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Measured: From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
Incidence of adverse events
Measured: Up to 30 days after last study treatment
OS in participants with MAPK negative cancers
The distributions of OS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Measured: From date of randomization to date of death due to any cause, assessed up to 3 years
PFS in participants with MAPK negative cancers
The distributions of PFS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Measured: From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
ORR in participants with MAPK negative cancers
Will be compared across treatment arms via Fisher's exact test.
Measured: Up to 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start13 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rachael A Safyan, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998940
- Sponsor's protocol ID
- S2433
- Other IDs
- NCI-2025-03014, S2433, S2433, U10CA180888
- Status last verified
- May 2026
- First submitted
- 21 May 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06998940
- Acronym / sponsor ID
- S2433
- Conditions
- Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To compare overall survival (OS) between participants with locally advanced or metastatic KRAS wild type (WT) pancreatic ductal adenocarcinoma (PDA) randomized to panitumumab plus second-line cytotoxic chemotherapy (5FU- or gemcitabine-based) versus chemotherapy alone.
SECONDARY OBJECTIVES:
- To compare progression-free survival (PFS) between treatment arms. II. To compare the overall response rate (ORR) (ORR, including confirmed and unconfirmed, complete and partial response according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) between treatment arms in participants with measurable disease.
III. To compare disease control rate (DCR) (DCR, defined as ORR + stable disease rate [SD]) between treatment arms in participants with measurable disease.
IV. To evaluate the frequency and severity of toxicity within each treatment arm.
- To compare duration of response (DoR) between treatment arms in participants with measurable disease.
ADDITIONAL OBJECTIVES:
- To compare OS and PFS between treatment arms in the subgroup of participants with MAPK negative cancers, that is, cancers without any known mitogen-activated protein kinase (MAPK) pathway molecular alterations (type 1 or 2 BRAF mutations; BRAF, NRG1, ROS1, FGFR1-3 and RAF1 fusions; EGFR, KRAS, and FGFR1-3 amplification).
II. To compare ORR in participants with MAPK negative cancers between treatment arms in participants with measurable disease.
PATIENT-REPORTED OUTCOMES COMMON TERMINOLOGY CRITIERIA FOR ADVERSE EVENTS (CTCAE) OBJECTIVES:
- To compare health-related quality of life (QOL) by treatment arm at 8 weeks after randomization, measured by the Functional Assessment of Cancer Therapy - General (FACT-G) total score.
II. To compare the impact of treatment toxicity by treatment arm at 8 weeks after randomization, measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Item GP5.
III. To compare changes from baseline in QOL and impact of treatment toxicity between treatment arms using FACT-G total score and FACIT Item GP5 to 24 weeks after randomization.
IV. To assess patient-reported symptoms by treatment arm using selected patient reported outcome (PRO)-CTCAE items including gastrointestinal, dermatologic, and constitutional symptoms of pain and fatigue.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive panitumumab intravenously (IV) over 30-90 minutes on days 1 and 15. Patients also receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.
ARM B: Patients receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up for up to 3 years post randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (panitumumab and standard chemotherapy) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Irinotecan, Drug: Irinotecan Sucrosofate, Drug: Leucovorin, Drug: Nab-paclitaxel, Biological: Panitumumab, Other: Questionnaire AdministrationPatients receive panitumumab IV over 30-90 minutes on days 1 and 15. Patients also receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study. |
| Arm B (standard chemotherapy) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Irinotecan, Drug: Irinotecan Sucrosofate, Drug: Leucovorin, Drug: Nab-paclitaxel, Other: Questionnaire AdministrationPatients receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas
- 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
- 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)
- 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
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| FluorouracilAlso: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedioneGiven IV | Drug | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| GemcitabineAlso: dFdC, dFdCyd, DifluorodeoxycytidineGiven IV | Drug | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| IrinotecanGiven IV | Drug | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| Irinotecan SucrosofateAlso: inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation, Irinotecan Liposome, Irinotecan Sucrosofate Liposome, Irinotecan Sucrosofate-containing Pegylated Liposomal FormulationGiven IV | Drug | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| LeucovorinAlso: Folinic acidGiven IV | Drug | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| Nab-paclitaxelAlso: ABI 007, ABI-007, ABI007, AbraxaneGiven IV | Drug | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
| PanitumumabAlso: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3Given IV | Biological | Arm A (panitumumab and standard chemotherapy) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (panitumumab and standard chemotherapy), Arm B (standard chemotherapy) |
Primary outcome
Overall survival (OS)
Time frame: From date of randomization to date of death due to any cause, assessed up to 3 years
Analysis of OS will be conducted in all eligible participants according to the intent-to-treat principle using a 1-sided stratified log rank test.
8 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 3 years after randomization
Disease control rate
Time frame: Up to 3 years after randomization
Duration of response (DoR)
Time frame: Up to 3 years after randomization
Progression free survival (PFS)
Time frame: From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
Incidence of adverse events
Time frame: Up to 30 days after last study treatment
OS in participants with MAPK negative cancers
Time frame: From date of randomization to date of death due to any cause, assessed up to 3 years
PFS in participants with MAPK negative cancers
Time frame: From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
ORR in participants with MAPK negative cancers
Time frame: Up to 3 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anchorage Associates in Radiation Medicine
Anchorage, United States
Alaska Breast Care and Surgery LLC
Anchorage, United States
Alaska Oncology and Hematology LLC
Anchorage, United States
Rachael A Safyan principal investigator
SWOG Cancer Research Network
274 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biospecimen Collection, Computed Tomography and Fluorouracil in people with Locally Advanced Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, run by SWOG Cancer Research Network at 274 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 274 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From date of randomization to date of death due to any cause, assessed up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.