Kenansville

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are evaluating the use of osimertinib alone versus a combination of osimertinib and bevacizumab for treating advanced non-small cell lung cancer (NSCLC) that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial focuses on whether adding bevacizumab, which blocks blood vessel growth to tumors, can better control cancer and improve survival compared to osimertinib alone, a drug that blocks EGFR involved in cancer cell growth. Patients are randomly assigned to receive either osimertinib by mouth once daily or osimertinib with bevacizumab given intravenously every 21 days. Treatment continues unless the cancer progresses or side effects become unacceptable. The study includes imaging tests like CT, MRI, echocardiography, and MUGA scans to monitor disease and heart function, along with blood and urine sample collection. Participants are followed for up to 10 years after treatment ends, with check-ups every 3 months to measure progression-free survival, overall survival, response rates, and side effects. Researchers also analyze blood samples to study how the cancer develops resistance to treatment. This thorough monitoring helps understand long-term effects and how well the treatments control the cancer.

Researchers are evaluating whether starting treatment early with venetoclax and obinutuzumab improves overall survival compared to delayed treatment in patients newly diagnosed with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase III trial focuses on patients who have asymptomatic disease but high-risk factors such as a high CLL-International Prognostic Index score or complex cytogenetics. Venetoclax is a drug that blocks a protein needed for cancer cell survival, while obinutuzumab is an immunotherapy that may help the immune system attack cancer cells and prevent tumor growth. Participants are randomly assigned to one of two groups: early treatment or delayed treatment. Both groups receive obinutuzumab intravenously on specific days in cycles and venetoclax orally daily during treatment cycles, with each cycle lasting 28 days for up to 12 cycles unless the disease progresses or unacceptable side effects occur. The early treatment group starts therapy as soon as they meet eligibility, while the delayed group begins once standard criteria for active treatment are met. Throughout the study, participants undergo procedures including CT scans, blood sample collection, and bone marrow aspiration and biopsy. During the study, participants are monitored closely through various tests and questionnaires to assess overall survival, quality of life using the FACT-Leukemia scale, response to treatment, and disease progression. The trial also studies measurable residual disease and various biomarkers to understand treatment impact. After treatment, participants are followed for up to 10 years to observe long-term outcomes and safety.

Researchers are evaluating a combination therapy for adults with newly diagnosed multiple myeloma, a type of plasma cell cancer. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination without bortezomib. The study aims to determine if adding bortezomib improves overall survival, especially in patients with minimal residual disease (MRD), while also assessing side effects, progression-free survival, and patient-reported outcomes related to quality of life and neuropathy. Treatment begins with a standard induction phase where all patients receive daratumumab subcutaneously, lenalidomide orally, and dexamethasone orally over nine 28-day cycles. After induction, patients are randomized to receive consolidation therapy either with the four-drug combination including bortezomib or the three-drug combination without bortezomib for nine additional 28-day cycles. Following consolidation, maintenance therapy with daratumumab and lenalidomide is given in repeated 28-day cycles until disease progression or unacceptable side effects occur. The study also incorporates imaging and biomarker assessments to evaluate treatment response and risk. Participants undergo regular evaluations including blood tests, bone marrow biopsies, and imaging scans to monitor disease status and treatment effects. Patient-reported questionnaires assess quality of life and symptoms such as neuropathy. After treatment, follow-up visits occur every three months for up to two years, then every six months for three years, and annually thereafter for up to 15 years. The primary outcome measured is overall survival from the time of randomization to the date of death or last known alive status.

Researchers are evaluating treatments for men with prostate cancer that has returned after surgery, shown by rising PSA levels. The trial tests two main questions: whether adding enhanced systemic therapy (apalutamide combined with abiraterone and prednisone) to the standard care of prostate radiation and short-term hormone therapy helps patients without cancer spread beyond the pelvis, and whether adding targeted radiation to this enhanced therapy benefits patients whose cancer has spread outside the pelvis as seen on PET imaging. This phase III study aims to see if using PET scans to guide more personalized treatment improves outcomes compared to standard care alone. Participants are divided into four groups based on PET scan results. Those without cancer outside the pelvis receive either standard radiation plus hormone therapy or the same treatment with added apalutamide. Those with cancer spread beyond the pelvis receive similar treatments but may also get targeted radiation to the metastatic sites. Treatments include various forms of radiation therapy and hormone therapies given by injection or orally. The study includes baseline PET scans, possible repeat PET scans during follow-up, and treatment lasting about six months. During the study, participants have regular assessments, including PET/CT or PET/MR imaging, blood tests, and quality-of-life questionnaires over two years and longer for some measures. Researchers track progression-free survival for up to 10 years, quality of life up to 24 months, and other outcomes like overall survival, side effects, and cognitive function. Follow-up visits occur every 3 months for two years, then less frequently up to 10 years to monitor health and treatment effects.