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Pancreatic Cancer Clinical Trials 2021

Testing Treatments For Advanced Pancreatic Cancer

Together Facing Pancreatic Cancer 2021

New treatments for metastatic pancreatic cancer that are being investigated in clinical trials are

  • RAS-directed therapies
  • the RAS genes make proteins that take part in signaling pathways that control cell growth. Altered forms of these genes are found in more than 90% of pancreatic cancers. Developing drugs that target mutant forms of RAS has proved challenging. However such drugs are now becoming available, such as a drug that targets a form of RAS that has a mutation called G12C. Although few pancreatic cancer patients have this mutation, scientists hope to develop drugs that target RAS alterations more common in pancreatic cancers.
  • researchers have found that drugs blocking the activity of proteins that mediate the effects of RAS, force cancer cells to rely on a way of creating energy called autophagy. A study in mice found that a combination of two drugs shrank pancreatic tumors. One drug targets a protein that RAS works through, and the other drug blocks autophagy. Whether such combinations will be effective in pancreatic patients is still being studied.
  • pembrolizumab. A rare group of people with pancreatic cancer have mutations in their tumor that cause high microsatellite instability . Pembrolizumab is an immune checkpoint inhibitor approved for patients with pancreatic cancer that has high MSI. Immune checkpoint inhibitors work by helping the patient’s own immune system fight their tumor. Patients should ask to have their tumors tested for high MSI.
  • Modern Clinical Trial Designs For Patients With Pancreatic Cancer

    The momentum in pancreatic cancer clinical trial advances has energized the field and resulted in a number of innovative and exciting clinical trial designs focused on accelerating progress. These trials represent a multi-institutional collaborative effort among many investigators who have gathered forces to tackle the daunting problem of pancreatic adenocarcinoma. These efforts are summarized below and indicated by their focus on precision medicine, immunotherapy, or general platform trials.

    1. Precision medicine

    Precision medicine in pancreatic cancer has been advanced by organizations/projects with large tissue collections, such as the International Cancer Genome Consortium and the Cancer Genome Atlas, as well as real-world efforts, such as the Pancreatic Cancer Action Networks Know Your Tumor® program. To link high-quality DNA and RNA sequencing with patient outcomes, the prospective Comprehensive Molecular Characterization of Advanced Pancreatic Ductal Adenocarcinoma for Better Treatment Selection trial was initiated in 2015 at several institutions in Canada, including Princess Margaret Cancer Center, Kingston Health Sciences Centre, Universite de Montreal, and McGill University. This observational study concluded that prospective genomic profiling of advanced pancreatic adenocarcinoma is feasible and provides a platform to better understand chemotherapy response among patients with different genomic/transcriptomic subtypes.

    2. Immunotherapy platforms

    Hyperpolarized 13c Pyruvate Mri For Treatment Response Assessment In Patients With Locally Advanced Or Metastatic Pancreatic Cancer

    Sorry, in progress, not accepting new patients

    This phase II trial investigates whether magnetic resonance imaging using hyperpolarized carbon-13 pyruvate can be useful for evaluating early treatment response in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes or spread to other places in the body . Hyperpolarized 13C pyruvate is different from standard clinical MRI contrast in that it provides information on how a tumor processes nutrients. MRI is used to see tumor uptake and breakdown of hyperpolarized carbon-13 pyruvate molecules, which can tell how the tumor processes nutrients. Hyperpolarized 13C pyruvate MRI may help in understanding how the tumor responds to the treatments patients may be receiving.

    San Francisco, California

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    Colony Stimulating Factor 1 Receptor

    The colony stimulating factor 1 receptor is a cell surface tyrosine kinase receptor expressed by macrophages as well as dendritic cells, neutrophils, and myeloid-derived suppressor cells . Diverse studies have linked CSF1R with cancer metastasis, invasiveness, and disease progression . CSF1R signalling enhances the recruitment, differentiation, and maintenance of immunosuppressive macrophages into the tumours . PDAC tumours express high levels of colony stimulating factors compared to normal tissues and it has been linked to poor prognosis . In a randomised phase 1a/b trial, patients showed tolerable response to the combination of cabiralizumab + nivolumab . It also showed strong clinical benefit in pre-treated PDAC patients with gemcitabine or 5-FU . In a randomised phase II clinical trial including patients with advanced pancreatic cancer , patients receive cabiralizumab plus nivolumab or a combination of cabiralizumab, nivolumab, gemcitabine, and nab-paclitaxel. The overall aim is to examine the efficacy of immunotherapy alone versus immunotherapy plus systemic chemotherapy in the treatment of advanced pancreatic cancer.

    What Is An Mrna Vaccine

    Pancreatic cancer: PD

    Messenger RNA is genetic material that provides the instructions or code contained in the DNA strands for making proteins. An mRNA-based vaccine teaches cells how to make a specific protein that triggers an immune response in the body. Recently, mRNA vaccines have been shown to prevent infectious diseases such as COVID-19 these vaccines also have the potential to be used in cancer treatment. The mRNA vaccine tested in this clinical study, called mRNA-5671 or V941, instructs the immune system to recognize the mutated KRAS proteins and attack the cancer cells.

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    Surgical Resection For Ipmns And Other Cystic Lesions

    Surgical resection is indicated in patients with any of the following: Solid pancreatic lesion 5 mm of indeterminate pathology or if additional evaluation does not yield a definitive preoperative diagnosis Any positive fine-needle aspiration result, except for a pancreatic neuroendocrine tumor Main-duct IPMNs with any one of the following: Main pancreatic duct dilation of 10 mm Main pancreatic duct stricture or Mural nodules Branch duct IPMNs with any one of the following: Rapid growth Mural nodules or an enhancing solid component Abrupt main pancreatic duct caliber change with distal atrophy Main pancreatic duct dilation of 10 mm Positive cytology or Associated symptoms of pancreatitis, jaundice, or pancreatic-type pain or Asymptomatic main pancreatic duct stricture with an associated suspicious mass.

    For patients who do not meet these criteria for surgery, repeat imaging in three months if worrisome features are present. Worrisome features include the following: Solid lesion with main pancreatic duct size of 5 mm to 9 mm in diameter Main pancreatic duct stricture and/or dilation 6 mm of unknown etiology without an associated mass and Solid lesion < 5 mm of uncertain significance.

    Individuals without worrisome features of malignancy should undergo repeat imaging in 12 mo.

    Screening/surveillance should be continued until the patient is no longer a surgical candidate.

    Clinical Trial Sets Out To Improve Prognosis For Pancreatic Cancer Patients

    It is estimated that more than 60,000 Americans will be diagnosed with pancreatic cancer in 2021. That is more than 160 people every day and a 5% increase over last years estimate.

    Pancreatic cancer is the third-leading cause of cancer-related deaths in the U.S., and despite significant advances in radiographic and endoscopic staging, improved surgical treatments and chemotherapy, the overall five-year survival rate is less than 10%.

    Compared to other cancers, pancreatic cancer can be more difficult to diagnose. This disease currently does not have effective screening tests, begins to metastasize early, and shows vague early symptoms.

    Dr. Ramsay Camp, chief of surgical oncology in the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, working alongside Dr. Ben Musher, medical director of medical oncology at the Dan L Duncan Comprehensive Cancer Center, have initiated a clinical trial with the potential to improve the prognosis for patients with pancreatic adenocarcinoma.

    Currently, only 5% of pancreatic cancer patients nationwide are enrolled in clinical trials. Camp and his team are hoping to change that by using a unique combination of immune checkpoint therapy and chemotherapy.

    Additional Resources

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    Joining A Clinical Trial

    Throughout the course of your care, your doctor may suggest a clinical trial that they feel is a good option for you. To join a clinical trial, you must meet pre-specified criteria of the study. Patients in a clinical trial are often alike with regards to their cancer stage and overall general health. This is to because doctors and scientists want to know that any progress a patient is making is because of the treatment and not because of differences between patients. Even if you meet the criteria for the study it will be your choice if you want to join or not. Your doctor, or a qualified member of their research team, will review a document with you called an informed consent. The informed consent form will provide details about the study and contact information if you have more questions.

    Pilot Study Of Pancreatic Cancer Screening

    Treatment Approaches for Pancreatic Cancer

    open to eligible people ages 18 years and up

    This study investigates how often abnormal findings from routine magnetic resonance imaging occur in people with genetic mutations in BReast CAncer gene. , ataxia telangiectasia mutated gene , or PALB2 screened for pancreatic cancer. This study may lead to a greater understanding of cancer and potentially, improvements in cancer screening and treatment.

    San Francisco, California

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    Pancreatic Cancer Accounts For 58% Share Of Global Oncology Clinical Trial Activity In 2021

    ByCarmen

    Pancreatic Cancer accounted for a 5.8% share of the global clinical trials within the Oncology therapy area in 2021, registering an increase of 0.3% when compared with the last ten-year average of 5.5% share, according to GlobalData.

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    Non-industry sponsored trials outnumber industry sponsored trials for Pancreatic Cancer

    Industry sponsored trials held a 48.7% share of all the clinical trials for Pancreatic Cancer indication in 2021, registering an increase of 10.3% when compared with the ten-year average of 38.4%. Non-industry sponsored trials accounted for a 51.3% share in 2021, marking a decrease of 10.3% over the ten-year average of 61.6%.

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    Top regions of industry sponsored Pancreatic Cancer trials

    Top regions of non-industry sponsored Pancreatic Cancer trials

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    Clinical Trials For Pancreatic Cancer

    You may be offered the opportunity to take part in a clinical trial at some point during your treatment with us. Clinical trials are research studies that evaluate the safety and effectiveness of new treatment approaches for diseases. In some cases, a study may give you access to new therapies that are not yet widely available.

    Sometimes we use clinical trials to compare diagnostic tests, prevention strategies, or other aspects of care.

    We only conduct trials that we believe may improve some aspect of treatment and outcomes. You should always discuss the pros and cons of participating in a clinical trial with your doctor.

    We are using next generation sequencing methods to determine the unique features of each patients cancer. This type of information helps us better understand genetic features of pancreatic cancers that come back after treatment, for example, and the value of liquid biopsies in determining the effectiveness of certain treatments.

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    A Phase 1 Study Of Pegilodecakin In Participants With Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

    San Francisco, California

    Targeting The Tumour Microenvironment

    New Clinical Trial Studies Pancreatic Cancer Tumour Traits To Uncover ...

    A hallmark of pancreatic cancer is the presence of a dense desmoplastic stroma, also known as the tumour microenvironment , which can comprise up to 90% of the tumour volume. This stroma is composed of heterogeneous populations of cells, including cancer cells but also stromal components which are tightly embedded in a fibrotic extracellular matrix . This abundant ECM mediates elevations in interstitial fluid pressure and solid stress, thereby resulting in blood vessel constriction and vasculature collapse, reducing micro-vessel density and increasing intra-tumour hypoxia . Several studies have confirmed the key role of the TME in PDAC disease progression, metastasis niche formation and therapeutic resistance by favouring immune evasion or acting as a mechanical barrier for drug delivery . In the last years, it has also been shown the presence of cancer-associated fibroblast phenotypic and functional heterogeneity , making the development of therapies targeting the crosstalk between cancer cells and stromal components challenging . Thus, stromal-targeting therapy in PDAC is an emerging research field aiming at achieving the optimal balance between stromal depletion and TME reprogramming. In this section, we have summarised the main clinical trials currently evaluating this strategy.

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    Transforming Growth Factor Receptor

    The transforming growth factor beta is a cytokine of the transforming growth factor family composed of TGF- and TGF-. TGF- signalling deregulation is involved in tumorigenic processes and in the pathophysiology of pancreatic cancer . At early stages of pancreatic cancer development, TGF- acts as a tumour suppressor but at later stages of the disease, it promotes genomic instability, immune evasion and metastasis. A phase Ib dose-escalation and cohort expansion study of safety and activity of the TGF- inhibitor galunisertib plus the PD-L1 antibody durvaluab, in metastatic pancreatic cancer, reported no dose limiting toxicity and a median PFS of 1.9 months . A multi-centre, open label phase Ib/II study is investigating the safety, tolerability and efficacy of TEW-7197 when combined with FOLFOX chemotherapy, in patients with metastatic pancreatic cancer after failure on gemcitabine and nab-paclitaxel therapy. Some additional receptors currently being targeted for pancreatic cancer therapy are shown in Table 3.

    Phase Ii Trial Of Azd6738 Alone And In Combination With Olaparib

    open to eligible people ages 18 years and up

    This phase II trial studies how well ATR kinase inhibitor AZD6738 works alone or in combination with olaparib in treating participants with renal cell carcinoma, urothelial carcinoma, all pancreatic cancers, endometrial cancer, and other solid tumors excluding clear cell ovarian cancer that have spread to nearby tissue or lymph nodes or other parts of the body. ATR kinase inhibitor AZD6738 and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if giving ATR kinase inhibitor AZD6738 with or without olaparib may work better in treating participants with solid tumors.

    San Francisco, California

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    M6620 And Irinotecan Hydrochloride In Treating Patients With Solid Tumors That Are Metastatic Or Cannot Be Removed By Surgery

    Sorry, not currently recruiting here

    This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery . M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    San Francisco, California

    A Study Of The Drug Onc

    New pancreatic cancer treatment to begin trial | 7NEWS

    open to eligible people ages 18 years and up

    This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

    Davis, California

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    What Is A Clinical Trial

    Clinical trials are medical research studies where an intervention or treatment is offered to people to test how well it works compared to the current standard. Trials are carried out because the benefit of a treatment or intervention is currently unknown. It may be better, the same, or sometimes not as good as standard treatments.

    Clinical trials are the end of a long research process. Before a drug is ever tested on humans it will have been developed and tested in a laboratory. The trial will only take place if it is believed that there is likely to be some benefit for patients. Trials may show whether new approaches to prevention, screening, diagnosis or treatment work better or worse than those currently used, and whether they are safe or practical to use with patients.Depending on how far through the testing process a drug is depends on the kind of trial you may be asked to take part in. Clinical trials usually have up to three phases, and information gathered in each phase helps researchers decide whether the study can move on to the next phase and the best way to do so. In phase one and two clinical trials, the intervention is received by everybody taking part . The third phase can involve comparing to existing treatment, a placebo or no treatment.

    More Efficient Clinical Trials In Pancreatic Cancer: Develop Better Treatment Options Faster

    Allison Rosenzweig Cassadie Moravek Lynn M. Matrisian

    Scientific and Medical Affairs, Pancreatic Cancer Action Network, Manhattan Beach, CA 90266, USA.

    Correspondence to: Dr. Lynn Matrisian, Scientific and Medical Affairs, Pancreatic Cancer Action Network 1500 Rosecrans Ave. Suite 200, Manhattan Beach, CA 90266, USA. E-mail: lmatrisian@pancan.org

    Received:First Decision:Revised:Accepted:Academic Editors:Copy Editor: Production Editor:

    © The Author 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License , which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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    Earlier Detection Remains The Holy Grail

    A big factor in pancreatic cancer treatment is that the disease is often diagnosed once it has spread beyond the reach of surgery. Earlier detection would make more patients eligible for surgical intervention, which remains the only potentially curative treatment. Gloria M. Petersen, Ph.D., of the Mayo Clinic opened a session dedicated to earlier detection of pancreatic cancer by reviewing the current state of research and open challenges. Petersen, a professor of epidemiology, noted there remains a need for better biomarkers to detect pancreatic cancer earlier. Yet investigators are faced with challenges in developing and validating these biomarkers which, in some cases, is due to the lack of high-risk cohorts for easier clinical validation. Part of the issue is that only up to about 10 percent of pancreatic cancer patients carry germline mutations , and many germline carriers have no family history of pancreatic cancer.

    Scientists are looking at other potential markers such as recent onset diabetes, which is emerging as an interesting at-risk group. According to current research, about 20-25 percent of pancreatic cancer patients received a diagnosis of diabetes three to 36 months prior to their diagnosis of pancreatic cancer. The National Cancer Institute is developing a large, new-onset diabetes cohort for study and is also developing a registry of pancreatic cancer case-control samples through the Pancreatic Cancer Detection Consortium .

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