Fort Smith

Hidradenitis Suppurativa HS is a skin condition that causes painful bumps, abscesses, scars, and tunnels in areas where the skin rubs together. This condition may start when hair follicles become damaged, triggering the immune system and allowing bacteria to worsen the symptoms. Researchers are evaluating the safety, effectiveness, and tolerance of a drug called zasocitinib in adults with moderate to severe HS compared with a placebo in this Phase 2 clinical trial. Participants will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks in a double-blind period. After this, all participants will receive zasocitinib for an additional 36 weeks in an open-label period. The placebo capsules look like zasocitinib but contain no medicine. Treatment dosing involves a specific dose of zasocitinib labeled as Dose A. During the study, participants will visit the clinic 12 times for assessments. Researchers will monitor the percentage of participants achieving a 75% reduction in HS symptoms at week 16 as the primary outcome. They will also track safety through adverse events and other measures throughout the 56 weeks of treatment. Participants will undergo evaluations including clinical exams, questionnaires, and safety tests to understand treatment effects and tolerability.

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

Pancreatic cancer is often diagnosed late, when it has spread to other parts of the body, making treatment challenging. This study focuses on adults with metastatic pancreatic cancer who have a specific KRAS G12D gene mutation. Researchers aim to evaluate whether adding setidegrasib to standard chemotherapy improves survival compared to chemotherapy with placebo. The study also explores how setidegrasib affects disease progression, symptoms, how the body processes the drug, and its safety. Participants receive either setidegrasib or placebo once weekly, combined with one of two chemotherapy regimens mFOLFIRINOX or NALIRIFOX. Chemotherapy is given in 28-day cycles through intravenous infusions. The choice of chemotherapy is determined by the doctor, with NALIRIFOX given only after confirming the safety of setidegrasib combined with it in another study. Treatment continues until cancer worsens, side effects become intolerable, other treatments are started, or the participant or doctor decides to stop. During the study, participants are regularly monitored with safety checks, health assessments, and laboratory tests. Researchers measure overall survival up to 3.5 years, along with progression-free survival, pain improvement, quality of life, response to treatment, and side effects. Pharmacokinetics of setidegrasib are studied up to 9 months. The study involves ongoing evaluation of participants wellbeing and medical status throughout the treatment period.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

This trial evaluates treatment approaches for patients with locally advanced nasal and paranasal sinus squamous cell carcinoma that can be removed by surgery. It compares chemotherapy given before surgery and radiation therapy to surgery and radiation therapy alone. The study aims to assess organ preservation rates, overall survival, and progression-free survival, along with the accuracy of imaging predictions and the effects of tobacco use on treatment outcomes and patient symptoms. Participants are randomly assigned to one of two treatment groups. One group undergoes standard surgery followed by image-guided intensity-modulated radiation therapy IMRT and may receive cisplatin or carboplatin chemotherapy during radiation if certain risk factors are present. The other group receives up to three courses of chemotherapy with docetaxel and cisplatin or carboplatin before surgery, followed by the same radiation and chemotherapy approach. Chemotherapy is administered intravenously, and radiation is given daily for 30 treatments over several weeks. During the study, participants have imaging scans such as MRI and PETCT before and after chemotherapy to evaluate tumor status and organ preservation. After treatment, patients are monitored with follow-up visits every three months for up to two years, then every six months up to five years. The research team collects laboratory tests, questionnaires, and clinical assessments to measure survival outcomes, organ preservation, treatment side effects, and patient-reported symptoms throughout the study period.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.