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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06115499
Other study ID # A022106
Secondary ID NCI-2023-06547
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 6, 2023
Est. completion date December 9, 2029

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact Jamie Crawley, MA
Phone 773-702-9934
Email jcrawley@bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.


Description:

PRIMARY OBJECTIVES: I. To evaluate and compare overall response rate (ORR) in patients with BRCA1/2 or PALB2 mutant pancreas cancer whose disease has progressed on front-line fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX) treated with nab-paclitaxel, gemcitabine, and cisplatin (NABPLAGEM) = nab-paclitaxel, gemcitabine, and cisplatin (arm 1) versus nab-paclitaxel and gemcitabine (arm 2). (Phase II) II. To evaluate and compare overall survival (OS) time in patients with BRCA1/2 or PALB2 mutant whose disease has progressed on front-line FOLFIRINOX treated with 1) NABPLAGEM = nab-paclitaxel, gemcitabine, and cisplatin (arm 1) versus nab-paclitaxel and gemcitabine (arm 2). (Phase III) SECONDARY OBJECTIVES: I. To evaluate and compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria between 2 treatment arms. II. To evaluate and compare duration of response (DoR) between 2 treatment arms. III. To evaluate and compare CA19-9 response (defined as patients with a baseline CA19-9 >= 2x upper limit of normal (ULN) who demonstrate a minimum 25% decrease in CA19-9 at any time point) between 2 treatment arms. IV. To evaluate and compare toxicity profile as assessed by treating clinicians between 2 treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nab-paclitaxel intravenously (IV) over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study. ARM II: Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study. After completion of study treatment, patients are followed up within 30 days and then every 3 months for 2 years or until death, whichever comes first.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 9, 2029
Est. primary completion date January 15, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable - BRCA1/2 or PALB2 mutation (somatic or germline) identified on any Clinical Laboratory Improvement Amendments (CLIA)-certified gene panel. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org. (Submission of mutation report will be required) - Measurable disease - Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment - Clinical or radiographic progression on first-line FOLFIRINOX (or nanoliposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin [NALIRIFOX]) for metastatic disease - Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to leucovorin calcium, fluorouracil, and oxaliplatin [FOLFOX], leucovorin calcium, fluorouracil, and irinotecan [FOLFIRI], fluorouracil [5-FU] [including capecitabine]) will be eligible - Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible - Patients who develop metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX in either the locally advanced or adjuvant/neoadjuvant settings will be eligible - Patients may not have received prior cisplatin for their pancreatic cancer in any setting * Note: Patients may have previously received gemcitabine +/- nab-paclitaxel for resectable (neoadjuvant/adjuvant) or locally advanced disease if (1) treatment was completed > 1 year ago and (2) in the opinion of the treating provider, re-treatment with gemcitabine/nab-paclitaxel is appropriate - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky performance status >= 60) - Absolute neutrophil count >= 1,500/mm^3 - Platelet count >= 100,000/mm^3 - Hemoglobin >= 8.0 g/dL - Creatinine =< 1.8 x institutional upper limit of normal (ULN) or calculated creatinine clearance (Calc. CrCl) > 40 mL/min - Total bilirubin =< 2.0 x institutional ULN * Any elevated bilirubin should be asymptomatic at enrollment (except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN) - Aspartate transaminase (AST)/alanine transaminase (ALT) =< 3 x institutional ULN * AST/ALT of =< 5 x ULN if liver metastases are present - Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required - Patients with > grade 2 peripheral sensory neuropathy are not eligible - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 8-weeks. * Patients with known, new or progressive brain metastases (active brain metastases) or leptomeningeal disease are ineligible - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load anytime within 6 months prior to registration are eligible for this trial - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Concomitant chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study - Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment Exclusion Criteria: - N/A

Study Design


Intervention

Drug:
Nab paclitaxel
Given IV
Gemcitabine
Given IV
Cisplatin
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo MRI
Computed Tomography
Undergo CT
Biospecimen Collection
Undergo blood sample collection

Locations

Country Name City State
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Hickman Cancer Center Adrian Michigan
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Flaget Memorial Hospital Bardstown Kentucky
United States Bronson Battle Creek Battle Creek Michigan
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Billings Clinic Cancer Center Billings Montana
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States McFarland Clinic - Boone Boone Iowa
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Mercy Cancer Center - Carmichael Carmichael California
United States Mercy San Juan Medical Center Carmichael California
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Heartland Oncology and Hematology LLP Council Bluffs Iowa
United States Methodist Jennie Edmundson Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Carle at The Riverfront Danville Illinois
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Mercy Cancer Center - Elk Grove Elk Grove California
United States Walter Knox Memorial Hospital Emmett Idaho
United States Providence Regional Cancer Partnership Everett Washington
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Glens Falls Hospital Glens Falls New York
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States McFarland Clinic - Jefferson Jefferson Iowa
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States CHI Health Good Samaritan Kearney Nebraska
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Saint Anthony Hospital Lakewood Colorado
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Saint Joseph London London Kentucky
United States Longmont United Hospital Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Mercy Cancer Center Merced California
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Monticello Cancer Center Monticello Minnesota
United States Saint Joseph Mount Sterling Mount Sterling Kentucky
United States Skagit Regional Health Cancer Care Center Mount Vernon Washington
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Providence Queen of The Valley Napa California
United States Dartmouth Cancer Center - Nashua Nashua New Hampshire
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Providence Newberg Medical Center Newberg Oregon
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Oncology Associates PC Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Midlands Community Hospital Papillion Nebraska
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Fairview Northland Medical Center Princeton Minnesota
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Saint Charles Health System-Redmond Redmond Oregon
United States Corewell Health Reed City Hospital Reed City Michigan
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mercy Cancer Center - Rocklin Rocklin California
United States Mercy Cancer Center - Sacramento Sacramento California
United States Dartmouth Cancer Center - North Saint Johnsbury Vermont
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States UCSF Medical Center-Mission Bay San Francisco California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Providence Medical Foundation - Santa Rosa Santa Rosa California
United States Providence Santa Rosa Memorial Hospital Santa Rosa California
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Welch Cancer Center Sheridan Wyoming
United States Saint Michael Cancer Center Silverdale Washington
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Munson Medical Center Traverse City Michigan
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Carle Cancer Center Urbana Illinois
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Rice Memorial Hospital Willmar Minnesota
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Woodland Memorial Hospital Woodland California
United States Fairview Lakes Medical Center Wyoming Minnesota
United States University of Michigan Health - West Wyoming Michigan
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate (ORR) (Phase II) Will be assessed by the proportion of patients who achieve complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) during the protocol treatment. Fisher's exact test will be conducted based on the first 32 patients in each arm who meet PP population criteria. Up to 12 months
Primary Overall Survival (OS) (Phase III) Will be conducted on modified intention-to-treat population. Stratified Cox model will be constructed to compare OS in the experimental arm to OS in the control arm. From the date of randomization to the date of death due to all causes, assessed up to 5 years
Secondary Progression-free survival Will be assessed per RECIST 1.1. Will be estimated, in each arm, using the method of Kaplan-Meier and compared by stratified Cox regression model. From the date of randomization to the date of first documented disease progression or death due to all causes, whichever occurs first, assessed up to 5 years
Secondary Incidence of adverse events The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient. Up to 30 days after the last dose of study treatment
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