Clinical Trials

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.

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.

The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.

We will study the effects of photodynamic priming for pancreatic adenocarcinoma treatment. Prior to study treatment, the patient will undergo photodynamic therapy using endoscopic ultrasound or CT-guided fine needle aspirate to directly target the tumor. After recovery from the procedure, the patient will start pembrolizumab. These steps are hoped to enhance the effect of standard chemotherapy given to eradicate the tumor.

The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.

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.

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).

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

 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.

A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.

The objective of this study is to measure real-world recall and precision of Natural Language Processing (NLP) algorithms in identifying the presence of known risk factors for Pancreatic (PDAC) in a defined primary care population using unstructured clinical notes.

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

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.

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 ...

The purpose of this study is to assess DNA markers in pancreatic juice and stool for the detection of pancreatic cancer and precancer.

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a photodynamic therapy (PDT) to evaluate response of tumor.

The purpose of this study is to develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at high-risk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts. Additionally to follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes and to make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.

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.

This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

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.

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. 

• 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.

• 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.

• To determine patient and lesion characteristics by which precursor lesions can be stratified according ...

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.

Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

The purpose of this study is to establish a prospective, longitudinal registry of patients with pancreatic cancer receiving clinician-directed therapy in routine practice, including FDA-approved agents used off-label or even investigational agents under a single-patient IND, in order to characterize real-world treatment patterns, effectiveness, and safety and to evaluate how clinical and tumor features, including molecular characteristics, relate to outcomes.

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 ...

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 ...

This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo [¹⁸F]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such [¹⁸F]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. ...

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).

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.

The purpose of this study is to establish a prospective, longitudinal registry of patients with pancreatic cancer receiving clinician-directed therapy in routine practice, including FDA-approved agents used off-label or even investigational agents under a single-patient IND, in order to characterize real-world treatment patterns, effectiveness, and safety and to evaluate how clinical and tumor features, including molecular characteristics, relate to outcomes.

The purpose of this study is to identify and describe disease‑related voice changes.

The purpose of this study is to learn more about the function of CCK receptor in human ACC cells and test the effect of high concentration CCK on ACC cells.  

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.

This biorepository is meant to collect longitudinal peripheral blood research samples for the purposes of biomarker studies. Such studies are meant for the purposes of measuring minimal residual disease in the perioperative setting, assess dynamics of treatment response, and to determine predictive value of risk stratification.

The specific aims of this study are as follows:

Aim # 1:  To determine the prevalence of pancreas solid tumor intratumoral microbiota, their composition and diversity in specimens prospectively acquired via endoscopic ultrasound (EUS).

Aim # 2:  To investigate both the oral and duodenal microbiome of such patients to evaluate for similarities and differences.

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.   

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.

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.

Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.

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.

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.

The purpose of this study is perform HOUSES index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria.  A subset of 40 patients, who did not have appropriate NCCN intervention (the opportunity to have a genetic consultation to consider genetic testing) will prospectively be offered this opportunity. This subset of patients will also be surveyed on their family hisotry and knowledge and experiences of genetic consults/testing to better understand their decision-making when offered genetic counseling and testing.

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.

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.

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.

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 ...

To evaluate the feasibility and potential clinical utility of serial AI-augmented computed tomography (CT) imaging and longitudinal blood biobanking in individuals with glycemically-defined new-onset diabetes (gNOD) and elevated pancreatic cancer risk (ENDPAC score ≥3), with the aim of determining whether this approach enables earlier detection of pancreatic ductal adenocarcinoma (PDA) relative to symptom-driven diagnosis

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.

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. 

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.

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 ...

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.

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.

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.

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.

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

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.

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.

The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">

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 ...

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

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).

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.

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.

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.

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 ...

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 ...

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

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.

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.