North Platte

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT andor MRI scans, and optical coherence tomography OCT. Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

Researchers are conducting a combined phase 2b and phase 3 study to evaluate the drug CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing dialysis. The study focuses on participants with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. The trial aims to find the best dose of CSL300 and then assess its effects on cardiovascular outcomes and safety compared to a placebo. The study is divided into two parts Part 1 phase 2b is a dose-finding phase where different doses of CSL300 are given intravenously to participants to determine the optimal dose versus placebo. Part 2 phase 3 evaluates the efficacy and safety of the selected CSL300 dose compared to placebo over approximately five years. All treatments are administered by intravenous infusion. Participants will be involved in regular assessments including blood tests to measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events tracking, and monitoring for adverse events. The phase 2b portion includes up to 24 weeks of follow-up for dose evaluation, while the phase 3 portion monitors cardiovascular outcomes like heart attacks or cardiovascular death over about five years. Safety and drug levels in the blood will also be closely observed throughout the study.

Researchers are evaluating copper Cu 64 PSMA IT injection as a PETCT imaging tracer in men newly diagnosed with unfavorable intermediate high-risk, high-risk, or very high-risk prostate cancer. This Phase 3, open-label study aims to assess the diagnostic accuracy of this imaging method in staging prostate cancer before surgery. The study involves patients who are planning to undergo radical prostatectomy with pelvic lymph node dissection. Participants will receive an intravenous dose of approximately 8 mCi of copper Cu 64 PSMA IT. PETCT scans will be performed between 1 to 4 hours after the injection. The images will be independently reviewed by three experts who will identify and score lesions positive for prostate cancer in the pelvic lymph nodes, prostate, extra pelvic lymph nodes, bones, and soft tissues. The imaging results will be compared to findings from histopathology and conventional imaging to determine sensitivity and specificity. During the study, patients will undergo PETCT imaging and their scans will be carefully analyzed to evaluate the detection of cancer lesions. Researchers will monitor safety by tracking any adverse events up to 72 hours after the injection. The primary measures include sensitivity and specificity of the imaging at 4 hours post-injection. Additional assessments include agreement among image readers and predictive values. The study is expected to last until September 2026.

Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.

Researchers are creating and maintaining the Integrated Cancer Repository for Cancer Research iCaRe2, a multi-institutional resource gathering detailed, ongoing data and biospecimens from adult cancer patients, people at high risk, and healthy controls. This platform covers a wide geographic area, including many small and rural hospitals, to support comprehensive studies on cancer risks, development, progression, and to aid in designing new prevention, screening, early detection, and personalized treatment strategies. The iCaRe2 collects multi-dimensional cancer-related data and biospecimens such as tumor specimens, DNA, serum, urine, and plasma from various cancer registries covering numerous cancer types, including pancreatic, breast, thyroid, lung, gastrointestinal, genitourinary, central nervous system, blood cancers, skin cancers, and more. It uses a flexible confederation model allowing multiple centers to participate based on their expertise and resources. The platform is web-based, HIPAA compliant, and supports secure data collection, validation, standard vocabularies, and reporting. Participants provide informed consent and may include those diagnosed with cancer, at risk for cancer, or healthy controls. Data collection includes longitudinal monitoring and banking of biological materials for future study. Researchers measure the development and implementation of this web-based cancer registry and the procurement of biological materials over many years. Participants involvement includes data sharing and biospecimen donation, supporting studies in cancer biology, genetics, epidemiology, early detection, and patient care, with ongoing follow-up up to many years.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in treating patients who have stage III-IVA squamous cell carcinoma of the head and neck and have undergone surgery. This phase II trial aims to understand how well these treatments work, focusing on disease-free survival and the role of p53 gene mutations in predicting patient outcomes. The study also examines treatment side effects and explores genetic changes that could guide new therapies. Participants are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy IMRT once daily, five days a week for six weeks. The other group receives the same radiation schedule combined with weekly intravenous cisplatin over 1-2 hours for six weeks. After treatment, patients will be followed up every six months for three years and then annually for seven more years to monitor their health status and disease progression. Throughout the study, participants undergo various assessments including surgical tissue analysis for p53 mutations, imaging tests to check for disease spread, and regular evaluations of treatment side effects. Researchers measure disease-free survival, tracking the time until cancer recurrence, new tumors in the head and neck region, or death for up to ten years. Safety is monitored closely during treatment, with adverse events recorded up to six weeks after therapy. The total participation duration can extend up to ten years due to long-term follow-up.

This research aims to evaluate the safety and effectiveness of plozasiran in adults with severe hypertriglyceridemia SHTG who have a history of at least two acute pancreatitis AP episodes, with one episode occurring within the last year before screening. The study is a phase 3, double-blind, placebo-controlled trial designed to better understand how plozasiran may help reduce the risk of AP events in this high-risk group. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months. During the double-blind treatment period, participants will continue a low-fat diet and maintain their standard lipid and triglyceride-lowering medications. If a participant experiences a confirmed AP event or completes the double-blind period, they will enter a 12-month open-label extension where all receive plozasiran injections every three months. Throughout the study, participants will undergo regular assessments including monitoring for acute pancreatitis events, changes in fasting triglyceride levels, and patient-reported health and productivity measures. Safety will be closely tracked through adverse event reporting and cardiovascular event monitoring. The primary outcome is the time to first confirmed AP event during the double-blind phase, with the entire study lasting up to approximately 62 months including follow-up.