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Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Rochester, MN
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts will undergo endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This is a pilot study to assess safety and efficacy.
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A Study to Compare Colon Lavage Fluids for Pancreatic Cancer Marker Validation
Jacksonville, FL
The purpose of this study is to compare the proteomic markers from gastrointestinal lavage fluid collected from patients with a pancreatic mass to a control group of otherwise healthy subjects.
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Evaluation of PCLs Using Three EUS-FNA Needles
Scottsdale/Phoenix, AZ; Jacksonville, FL
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
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Optical and Biochemical Biomarkers in Early Pancreatic Cancer
Jacksonville, FL
The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.
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Evaluating Markers which Might be a Predictor of Pancreatic Cancer or Precancer by Analyzing the Secretions (fluid) from a Pancreatic cyst
Rochester, MN
The purpose of this study is to evaluate molecular markers which might be a predictor of pancreatic cancer or precancer by analyzing the secretions (fluid) from a pancreatic cyst, pancreas fluid and tissue from a resected pancreatic cyst.
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Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer
Scottsdale/Phoenix, AZ
This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatment until disease progression or unacceptable toxicity.
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Phase 2 Nab®-Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects with Locally Advanced Pancreatic Cancer (LAPC)
Scottsdale/Phoenix, AZ
This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.
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A Biobank for Pancreatic Diseases
Rochester, MN
To develop a resource (bank) of biospecimens and data collected from individuals with pancreatic diseases to facilitate discovery and development of novel biomarkers of risk and early detection, severity prediction, etiology and response to therapy.
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A Study of Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
Rochester, MN
The purpose of this study is to evaluate the effects of treating pancreas cysts that connect with the main pancreas duct with injected ethanol using endoscopic retrograde cholangiopancreatography (ERCP) and/or endoscopic ultrasound. Past studies have excluded these cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol.
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A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
Scottsdale/Phoenix, AZ
A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.
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BPM31510 Administered Intravenously With or Without Gemcitabine in Advanced Pancreatic Cancer Patients
Scottsdale/Phoenix, AZ
This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and effectiveness of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as a monotherapy or in combination with gemcitabine in advanced pancreatic cancer patients as 2nd / 3rd line therapy. The study will enroll up to 50 patients in the US and Europe.
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Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients with Resected Pancreatic Cancer (the "Apact" Study)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in subjects with surgically removed pancreatic cancer who then take nab-paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.
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A Study Combining Tofacitinib with Gemcitabine for the Treatment of Pancreas Cancer in Patients who are Losing Weight
Rochester, MN
The purpose of this study is to test the safety, tolerability and possible benefit of a drug called tofacitinib in patients with metastatic pancreas cancer when given combined with a standard chemotherapy drug called gemcitabine.
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A Study to Increase Understanding About Pancreatic Cancer Genetics and Response to Drug Therapy
Rochester, MN
The purpose of this study is to learn more about pancreatic cancer genetics in association with response to drug therapy. Pancreatic cancer has identifiable genetic (DNA) changes, yet for many it is not known whether these affect response to cancer drugs.
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Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients with Pancreatic Cancer That Has Been Removed by Surgery
Jacksonville, FL; Rochester, MN
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor ...
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A Study to Evaluate Binimetinib in Combination with Encorafenib in Patients with Pancreatic Malignancies and a Somatic BRAFV600E Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.
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A Study of Leukemia Inhibitory Factor Biomarker Monitoring Progression and Treatment Response of Locally-advanced Unresectable and Metastatic Pancreatic Cancer Therapies
Jacksonville, FL
The purpose of this study is to determine if LIF (Leukemia Inhibitory Factor) level is positively correlated with disease progression and CA19-9 level in Pancreatic Ductal Adenocarcinoma (PDAC) patients and is a reliable biomarker of response.
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High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery
Rochester, MN; La Crosse, WI
This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...
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Pharmacokinetic and Safety Study of Nab ®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects with Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubenemia
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and pharmacokinetic profile of nab® -paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who have cholestatic hyperbilirubenemia secondary to bile duct obstruction.
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A Study of LY2090314 and Chemotherapy in Participants with Metastatic Pancreatic Cancer
Jacksonville, FL; Rochester, MN
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.
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A Randomized Study of Olaparib or Placebo in Patients With Surgically Removed Pancreatic Cancer Who Have a BRCA1, BRCA2 or PALB2 Mutation, The APOLLO Trial
Rochester, MN
The purpose of this study is to evaluate how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.
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A Study to Analyze the Safety and Effectiveness of the NanoKnife® System in Unresectable Stage 3 Pancreatic Adenocarcinom Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System for the ablation of unresectable Stage 3 pancreatic adenocarcinoma (Stage 3 pancreatic cancer).
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Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates
Scottsdale/Phoenix, AZ
The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).
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A Study to Test Adding Pembrolizumab to Olaparib Alone as Therapy for Patients with Pancreatic Cancer That Has Spread with Inherited BRCA Mutations
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary purpose of this study is to evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
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Validation of Potential Biomarkers for Pancreas Cancer in Human Saliva
Jacksonville, FL
The goal of this study is to determine if the biomarkers found to be upregulated in tissue samples are specific to PDAC and can be detected in saliva. Saliva will be collected form PDAC and control subjects for comparison. Additionally, to determine if the biomarkers are specific to PDAC or other KRAS driven cancers, saliva will be collected from patients with breast and lung cancer. The saliva collected from these subjects will be studied for the presence of specific protein biomarkers and used in experiments such as western blots and ELISAs.
Pancreatic ductal adenocarcinoma (PDAC) is one ...
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Safety and Efficacy Study of PRI-724 Plus Gemcitabine in Subjects With Advanced or Metastatic Pancreatic Adenocarcinoma
Rochester, MN
Laboratory studies suggest that the study drug may stop cancer cells from growing by affecting an interaction between proteins in the cells referred to as cAMP-response element-binding protein and ß-catenin.
The purpose of this research study is to determine the highest safe dose of study drug that may be used when it is given together with a chemotherapy drug to patients with cancer of the pancreas.
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Evaluating FDG PET-MRI-based Biomarkers in Borderline Resectable Pancreatic Cancer
Rochester, MN
Aims, purpose, or objectives:
- Evaluation of quantitative biomarkers derived from simultaneous time-of-flight FDG PET-MRI/MRCP for assessment of response to neoadjuvant therapy in borderline resectable PDAC.
- Evaluate the comparative performance of blood and FDG PET-MRI/MRCP based biomarkers for assessment of response to neoadjuvant therapy in borderline resectable PDAC.
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Institutional Analysis of Non-metastatic Pancreatic Adenocarcinoma Outcomes from 2011-2016
No Locations
The purpose of this study is to evaluate survival of patients with resectable, borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC) separately and as a group.
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Long Term Outcomes in Pancreas Cancer Patients
Rochester, MN
The purpose of this study is to access long-term quality of life, complications, and implications of treatments on patients who are long-term survivors of pancreas cancer and were treated at Mayo Clinic.
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Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202)
Scottsdale/Phoenix, AZ
This study will assess the efficacy and safety of BL-8040 as a single agent and in combination with pembrolizumab (Keytruda®) in subjects with metastatic pancreatic adenocarcinoma.
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A Study to Create a Registry for Patients at High-Risk for Pancreatic Cancer
Rochester, MN
This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC). and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.
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A Study of Pancreatic Cancer Risk
Rochester, MN
The primary purpose of this study is to develop a cohort (biobank of biospecimens and data) of individuals aged 50 and older without pancreatic cancer who are members of kindreds containing three blood relatives with pancreatic cancer, OR who carry a mutation in a known predisposition gene for pancreatic cancer.
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Optimizing Pancreatic Cancer Management Using Next Generation Imaging and Liquid Biopsy
Rochester, MN
The purpose of this study is to examine the relationship of ctDNA status and FDG PET/MRI findings with other clinicopathologic variables and standard staging examinations. We will develop a multivariable model combining ctDNA and FDG PET/MRI biomarkers to predict treatment response and survival. In addition, we will define the quantitative thresholds for early chemotherapy switch in patients who do not respond to first-line chemotherapy.
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A Study to Evaluate the Diagnostic Potential of a Lateral Flow Assay to Detect QSOX1 Peptide in Patients With or At Risk for Pancreatic Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the lateral flow assay (LFA) to be used in conjunction with imaging and existing biomarkers in diagnosed or at-risk-for pancreatic cancer patients.
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Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
Rochester, MN
The purpose of this study is to develop a blood test to distinguish various causes of diabetes by evaluating patients who have developed diabetes within the last 3 years, but we will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison.
Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels. This is a frequent problem that is most commonly due to type 2 diabetes. However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as ...
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Preclinical investigation of immunotherapeutic efficacy and safety of a novel oncolytic vesicular stomatitis virus expressing extracellular matrix-destructing enzymes in combination with immune checkpoint inhibitors in pancreatic adenocarcinoma
Jacksonville, FL
The purpose of this study is to bioengineer a novel vesicular stomatitis virus (VSV) to express extracellular matrix (ECM) destructing enzymes to overcome desmoplastic pancreatic adenocarcinoma (PDAC) tumor microenvironment and assess the oncolytic virus (OVs’) therapeutic safety and efficacy as monotherapy and in combination with immune checkpoint inhibitors (ICIs) in preclinical settings. This effectiveness will be investigated in vitro, ex vivo and in vivo.
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Collecting Medical Information and Tissue Samples from Patients with Pancreatic Cancer or Other Pancreatic Disorders
Rochester, MN
The purpose of this study is to develop a panel of primary care controls to be used to compare the pancreatic disease patients who are recruited into the ongoing IRB protocol 354-06.
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Exploring Duodenal Biopsies as a Biomarker of Pancreatic Cancer
Rochester, MN
To determine whether the microbiome, metagenome and metabolome of the tissue of the second portion of duodenum of patients with pancreatic cancer are different from that of patients with benign conditions not affecting the pancreas.
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Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Tumor Treating Fields (TTFields), in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic denocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients. DISEASE STATE - Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed. - Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or MRI (with contrast) required (endoscopic ultrasound is not required). - No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 (unless nodes are biopsied and ...
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A Study to Analyze Onvansertib Treatment in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
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A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to observe adverse events and effectiveness of hypofractionated concurrent chemoradiotherapy for the treatment of pancreatic cancer.
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A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer
No Locations
This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
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A Study to Analyze Pancreatic Juice Genetic Alterations for Early Testing and Diagnosis of Pancreatic Cancer
Jacksonville, FL
The purpose of this study is to develop and test a method for early detection of pancreatic cancer by analyzing genetic changes from pancreatic juice.
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A Study to Evaluate the NanoKnife SYstem for Stage 3 Pancreatic Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC).
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A Study to Detect Pancreatic Cancer Using Circulating Tumor Markers
Rochester, MN
The primary purpose of this study is to select and validate candidate methylated DNA markers (MDMs) (individually and in combined panels) for the detection of pancreative ductal adenocarcinoma (PDAC). The potential complementary value of mutant KRAS and CA19-9 will also be evaluated.
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Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Rochester, MN
The purpose of this study is to to determine the effect to overall survival (OS) by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic.
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A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that ...
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A Study of the Safety and Effectiveness of TH-302 Combined with Gemcitabine and Compared with Gemcitabine Alone for Previously Untreated Patients with Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if TH-302 combined with Gemcitabine versus Gemcitabine alone is as safe and effective in the treatment of patients who have first-line metastatic pancreatic adenocarcinoma.
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Collection of Tissue, Blood Samples, and Cystic Fluid in Patients with Benign, Premalignant and/or Malignant Pancreatic Disease
No Locations
The goal of this study is to establish and maintain a biospecimen bank containing samples of neoplasms, cysts, normal tissue, blood and/or any other tissue or cystic fluid from patients undergoing a diagnostic or therapeutic procedure for pancreatic disease.
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A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to observe adverse events and effectiveness of hypofractionated concurrent chemoradiotherapy for the treatment of pancreatic cancer.
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A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer
No Locations
This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
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A Study to Analyze Pancreatic Juice Genetic Alterations for Early Testing and Diagnosis of Pancreatic Cancer
Jacksonville, FL
The purpose of this study is to develop and test a method for early detection of pancreatic cancer by analyzing genetic changes from pancreatic juice.
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A Study to Evaluate the NanoKnife SYstem for Stage 3 Pancreatic Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC).
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A Study to Detect Pancreatic Cancer Using Circulating Tumor Markers
Rochester, MN
The primary purpose of this study is to select and validate candidate methylated DNA markers (MDMs) (individually and in combined panels) for the detection of pancreative ductal adenocarcinoma (PDAC). The potential complementary value of mutant KRAS and CA19-9 will also be evaluated.
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Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Rochester, MN
The purpose of this study is to to determine the effect to overall survival (OS) by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic.
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A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that ...
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Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Rochester, MN
This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. Investigators hypothesize that providing dignity therapy to this population will be feasible.
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A Study to Establish a Platform for Managing Pancreatic Adenocarcinoma Using Patient-derived Tumoroids
Jacksonville, FL
The purposes of this study are to determine the optimal patient-derived tumoroid (PDT) model, to determine the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach, to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish PDT as a platform for a personalized approach to guide multimodality treatment.
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PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Jacksonville, FL
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
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68GaFAPI-46 PET/CT for Pancreatic Ductal Adenocarcinoma
Rochester, MN
The purpose of this study is to examine the utility of 68GaFAPI-46 PET/CT imaging in adult patients with biopsy-proven Pancreatic Ductal Adenocarcinoma (PDA) who have no prior treatment for their PDA and who are expected to undergo surgical resection following NAT.
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Gemcitabine Hydrochloride in Treating Patients with Locally Advanced Pancreatic Cancer
No Locations
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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International Multicenter Registry of Cancer of the Pancreas Screening
Jacksonville, FL
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To determine whether a surveillance program consisting of in a cohort of high-risk individuals results in an excess number of detected and surgically resected high-grade premalignant lesions and early stage pancreatic cancers compared to the natural disease development and manifestation.
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To determine whether above mentioned strategy results in an improved survival
compared to high-risk individuals not under surveillance and compared to the survival
statistics of sporadic pancreatic cancer.
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To determine patient and lesion characteristics by which precursor lesions can be stratified according ...
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A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
Rochester, MN
The primary objectives for this study are to compare each investigational arm versus standard of care (SOC) for superiority in overall survival in 1st and/or 2nd line metastatic pancreatic cancer patients, and to determine which, if any, patients benefit from each investigational arm.
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A Study of ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness, safety, biological activity, and drug/body interactions of ACP-196 alone and combined with Pembrolizumab for the treatment of patients who have advanced or metastatic pancreatic cancer.
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A Study of BBI608 Combined with Standard Chemotherapies in Adult Patients who have Pancreatic Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, and best study dose of BBI608 when administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or with MM-398, 5-FU and leucovorin in patients who have pancreatic adenocarcinoma that has spread.
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A Study Assessing DNA Markers for the Detection of Pancreatic Cancer and Precancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess DNA markers in pancreatic juice and stool for the detection of pancreatic cancer and precancer.
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Study of SBP-101 in Pancreatic Cancer
Scottsdale/Phoenix, AZ
This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.
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Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) in Patients with Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL
The purpose of this study is to assess the safety of a specific treatment regimen (protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN)) combined with a device called Tumor Treatment Fields (TTF) in preventing tumor growth in paitents with recurrent recurrent and/or metastatic pancreatic cancer (met-PC).
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A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ
This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.
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Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer
Scottsdale/Phoenix, AZ
This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.
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A Study Evaluating Effectiveness and Safety of FFX Versus Combination of CPI-613 with mFFX in Patients with Metastatic Adenocarcinoma of the Pancreas
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of Folfirinox (FFX) versus CPI-613 + Modified Folfirinox (mFFX) in patients with metastatic adenocarcinoma of the pancreas.
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Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
Rochester, MN
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.
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Phase II Study of EUS-guided Verteporfin PDT in Solid Pancreatic Tumors
Rochester, MN
The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a photodynamic therapy (PDT) to evaluate response of tumor.
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A Study to Investigate Blood-derived Circulating Tumor DNA, Circulating Tumor RNA, and Circulating Tumor miRNA in Pancreatic Cancer Patients
Jacksonville, FL
The purpose of this study is to establish a cohort of 200 patients receiving definitive radiotherapy at Mayo Clinic Florida for locally advanced pancreatic cancer (T3-4NxM0; TxN+M0), and establish a biobank of 10 ml of plasma (frozen at –80o C) for each patient at baseline (prior to starting radiation treatment), week 2 of radiation treatment and 4-8 weeks following radiation treatment.
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Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
Rochester, MN
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma
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Oligomets pancreas SBRT
Jacksonville, FL
The primary endpoint for this study will compare PFS between SBRT + standard chemotherapy vs. standard chemotherapy alone in patients with oligometastatic pancreatic cancer. PFS is defined as the time from randomization to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria and will be documented at each enrolling site with no central review planned.
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A Study to Evaluate the Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate whether pembrolizumab (MK-3475 ) can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer. Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.
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A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Rochester, MN
The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.
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A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
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A Study of Disulfiram and Chemotherapy in Pancreas Cancer Patients
Rochester, MN
This partially randomized phase I trial studies the side effects and best dose of disulfiram when given together with gemcitabine hydrochloride in treating patients with a solid tumor that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (metastatic) and to compare whether disulfiram and gemcitabine hydrochloride may reduce tumor induced muscle loss. Weight loss occurs in pancreatic cancer patients and is common in a multitude of other cancers. Patients with metastatic cancer and weight loss sometimes are not able to receive treatment due to physical weakness or debility. Disulfiram is ...
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A Study to Evaluate if New Tests (“biomarkers”) of Blood, Stool, Pancreas Cyst Fluid, or Pancreas Juice can be Used to Diagnose Malignant or Pre-malignant Changes in People with Pancreas Cysts
Rochester, MN
The goal of this protocol is to collect biospecimens in order to prospectively evaluate diagnostic and prognostic performance of MDMs for detection of advanced neoplasia in pancreatic cysts.
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Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
Rochester, MN
The purpose of this study is to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection.
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A Study to Evaluate Hyperthermic Intraperitoneal Chemotherapy to Treat Patients with Pancreatic Cancer and Peritoneal Metastasis
Rochester, MN
The primary purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.
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A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ Capsules in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors
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Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)
Rochester, MN
The purpose of the study is to evaluate the effectiveness, safety and patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
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A Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.
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Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, 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. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
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Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery
Rochester, MN; Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body, does not respond to treatment, or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth
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Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers
Rochester, MN
A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.
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Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose ...
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Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in ...
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Identifying Gene Modifiers of Melanoma and Pancreatic Cancer Susceptibility
Rochester, MN
The purpose of this study is to understand the interplay of factors increasing susceptibility and expression of pancreatic cancer and melanoma to develop new diagnostic and chemopreventive regimens.
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A Study of GDC-0449 and Erlotinib Hydrochloride, with or without Gemcitabine Hydrochloride for Treating Patients with Metastatic Pancreatic Cancer or Solid Tumors that cannot be Removed by Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449, and either with or without gemcitabine hydrochloride, for the treatment of patients who have metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with ...
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Rochester, MN
We wish to examine pancreatic adenocarcinoma cell lines to determine what genes are being expressed in the cells that might cause muscle wasting in patients. We will also perform chemical analyses of plasma obtained from these patients to identify substances that might be causing muscle wasting. Finally, we will examine proteins that are secreted by such cells to identify mediator is of cachexia or muscle wasting.
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Project Survival-Prospective Biomarker Discovery
Scottsdale/Phoenix, AZ
This sample-collection study is open to participants in several categories: healthy volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed with pancreatitis or any stage of pancreatic cancer. All participants will submit urine, saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit tissue samples if biopsy/ies or surgery is part of the care being provided by their doctor. In partnership with Berg Health, LLC, biomarkers will be investigated for potential use in early detection of pancreatic cancer, to determine prognosis of patients, and to find the most appropriate treatments for patients.
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Examination of the Pancreas in New-onset Diabetes
Rochester, MN
The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer
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A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
Eau Claire, WI; Rochester, MN; Mankato, MN; La Crosse, WI
The purpose of this study is to prospectively assemble a cohort of subjects >50 and ≤85 years of age with New-onset Diabetes (NOD):
- Estimate the probability of pancreatic ductal adenocarcinoma (PDAC) in the NOD Cohort;
- Establish a biobank of clinically annotated biospecimens including a reference set of biospecimens from pre-symptomatic PDAC and control new-onset type 2 diabetes mellitus (DM) subjects;
- Facilitate validation of emerging tests for identifying NOD subjects at high risk for having PDAC using the reference set; and
- Provide a platform for development of an interventional protocol for early detection of sporadic PDAC ...
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Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Jacksonville, FL
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
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A Study of Pancreatic Polypeptide Response in Patients with Diabetes Mellitus with and without Pancreatic Cancer
Rochester, MN
The purpose of this study is to determine if a blood test called "pancreatic polypeptide" can help distinguish between patients with diabetes mellitus with and without pancreatic cancer.
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A Study of Pancreatic Polypeptide Response in Patients with Diabetes Mellitus with and without Pancreatic Cancer
Rochester, MN
The purpose of this study is to determine if a blood test called "pancreatic polypeptide" can help distinguish between patients with diabetes mellitus with and without pancreatic cancer.
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Evaluation of a Mixed Meal Test for Diagnosis and Characterization of Type 3c diabeTes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis
Rochester, MN
Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels. This is a frequent problem that is most commonly due to type 2 diabetes. However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas.
The goal of this study is to develop a test to distinguish these ...
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A Trial to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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Cisplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients With Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery
Rochester, MN
This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current ...
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Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers (specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme).
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A Study to Evaluate Triapine Combined with Lutetium Lu 177 Dotatate for Gastroenteropancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.
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Two Cancers, One Gene. Why Some People in Families Develop Melanoma or Pancreas Cancer, While Still Others Never Develop Cancer (TCOG)
Rochester, MN
The overall purpose of this study is to understand the factors that increase susceptibility and expression of pancreatic cancer and melanoma in high risk families. Individuals who are affected with pancreas cancer and melanoma, as well as those without either cancer who have been identified as 1st or 2nd degree relatives of family members with pancreas cancer and melanoma, will be asked to participate. The participant will be asked to complete a survey about their health and family history of cancer and to give a blood sample for specific gene testing and storage for future research studies.
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Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
Rochester, MN
This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life ...
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A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of ZB131 in patients with solid tumors where prevalence of CSP expression is high.
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A Study of Intravital Microscopy (IVM) in Human Solid Tumors
Jacksonville, FL
The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.
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Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of AG-270 and characterize its dose-limiting toxicities (DLTs) when given daily by mouth to subjects with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).
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A Study of Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.
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MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment
Scottsdale/Phoenix, AZ
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
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A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of Part A of this study is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.
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A Study of AbGn-107 in Patients With Gastric, Colorectal, or Pancreatic Cancer
Scottsdale/Phoenix, AZ
This study is to define the safety profile and to determine the maximum tolerated dose (MTD) and preliminary efficacy of AbGn-107 administered every 28 days (4 weeks) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal or pancreatic adenocarcinoma.
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Aggressive Malignancy PDX (Avatar) and Cryopreservation Program
Rochester, MN
The purpose of this study is to assess the ability to successfully create numerous validated patient-derived xenograft (PDX) models from patient tumor specimens obtained at surgery/biopsy via the new Pathology/TRAG cryopreservation protocol, and to generate a large catalog and repertoire of previously unavailable histologically validated PDX.
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Early pancreatic cancer detection
Jacksonville, FL
The primary purpose of this study is to standardize the collection of demographic, clinical, and imaging data, and biosamples for a large high-risk familial Pancreatic Ductal Adenocarinoma (PDAC) cohort at consortium clinical cancer centers, worldwide.
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A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of these phase I/II trial studies is to analyze the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium, and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body. Drugs used in chemotherapy, such as liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib, 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.
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A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This is an open label, multi-center, Phase Ib dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX or FOLFIRI with and without bevacizumab, or regorafenib.
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A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors.
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Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).
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A Study of Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Scottsdale/Phoenix, AZ
The primary purpose of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
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Establishment of a Biorepository of Baseline and Follow-up Saliva Samples Collected from Newly Diagnosed, Treatment-naïve Cancer Patients
Jacksonville, FL
The ultimate goal of this biobank will be to provide the resource to initiate an exploration of human saliva as a potential liquid biopsy for cancer detection and surveillance.
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A Study to Evaluate Precision Pharmacogenomics in Cancer Patients
Scottsdale/Phoenix, AZ
THe purpose of this study is to examine the current and (potential) future therapeutic relevance of pharmacogenomics (PGx) testing for a cohort of cancer patients in order to improve quality of life (QOL) in patients receiving clinical care at Mayo Clinic.
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A2B101-101: Obtaining Solid Tumor Tissue from Subjects Having Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing
Rochester, MN; Jacksonville, FL
The primary objectives for this study are:
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
- Percentage of screened subjects experiencing loss ...
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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A Study to Evaluate the Effectiveness and Safety of Rivaroxaban as Prophylaxis Treatment for Venous Thromboembolism (VTE) in Ambulatory Cancer Patients
Rochester, MN
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult patients with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
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A Study of CART-TnMUC1 in Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.
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A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic solid tumors. Phase 1 is an assessment to evaluate the safety and tolerability of epacadostat when given in combination with pembrolizumab and chemotherapy. Once the recommended doses have been confirmed, subjects with advanced or metastatic CRC, PDAC, NSCLC (squamous or nonsquamous), UC, SCCHN or any advanced or metastatic solid tumor who progressed on previous therapy with a PD-1 or PD-L1 inhibitor will be enrolled in Phase 2.
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A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic ...
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JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.
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hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.
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Mayo Clinic Cancer Genomics Service Line Biorepository
Eau Claire, WI; Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of the study is to create a database of clinical information and a repository of biological specimens for genetic, molecular and microbiological research to better understand hereditary cancer and help develop new therapies and preventive strategies.
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A Study of Mogamulizumab Combined with Nivolumab in Patients who have Locally Advanced or Metastatic Solid Tumors
Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of combined treatment with mogamulizumab and nivolumab, and also determine the maximum tolerated dose and the recommended fixed dose for the treatment of patients who have locally advanced or metastatic solid tumors.
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cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
Rochester, MN
The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.
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A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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Study of E7386 in Participants With Selected Advanced Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
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Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.
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Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
The purpose of this study is to collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.
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A Study to Evaluate Exercise for Cancer Patients at Risk of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.
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The Circulating Cell-free Genome Atlas Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.