Lawrence

Researchers are evaluating the effects of nipocalimab on children and adolescents aged 2 to less than 18 years with generalized myasthenia gravis (gMG), a condition causing muscle weakness. The study aims to understand how nipocalimab impacts total serum immunoglobulin G (IgG) levels, its safety, tolerability, and how the drug behaves in the body (pharmacokinetics) in participants who have not responded well enough to their current standard treatments. This research includes participants globally aged 2 to under 18 years, with a focus in the United States on ages 8 to under 18 years. Nipocalimab will be given as an intravenous (IV) infusion to participants. The study is open-label and uncontrolled, meaning all participants receive the drug and know they are receiving it. The study will monitor participants for up to three years to assess the drug’s pharmacokinetics, pharmacodynamics, safety, and activity. During this time, researchers will carefully observe changes in IgG levels, measure the concentration of nipocalimab in the blood over time, and track any adverse events or safety concerns. Participants will be closely followed with blood tests to measure IgG levels and drug concentrations, physical examinations, vital sign checks, and laboratory tests over the three-year period. Researchers will record any infectious or serious adverse events and monitor for any abnormalities in laboratory tests or physical exams. The study’s long duration allows a thorough evaluation of how the drug works and its safety profile in children and adolescents living with generalized myasthenia gravis.

This research is focused on females undergoing breast reconstruction surgery, specifically those having a two-stage procedure using a pre-pectoral technique. The study evaluates the use of an acellular dermal matrix device called Cortiva Tissue Matrix, which is a non-crosslinked dermis, in this type of breast reconstruction. The goal is to understand outcomes related to the reconstruction process in this patient group. Participants will receive breast reconstruction using the pre-pectoral technique in two stages. The study involves the use of the Cortiva Tissue Matrix device during this procedure. This approach is applied following nipple or skin sparing mastectomy. The study is conducted across multiple centers and includes two groups, though it is non-randomized. During the 12-month study period, participants will be monitored for major adverse events and their health-related quality of life. Researchers will collect data on participant safety and wellbeing, including any complications that occur. Study requirements include follow-up visits and compliance with the study protocol to ensure accurate evaluation of outcomes over the year following reconstruction.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab in patients with advanced or locally unresectable stomach or esophageal adenocarcinoma. This phase II/III trial aims to determine if adding nivolumab improves progression-free survival and overall survival compared to paclitaxel and ramucirumab alone. The study also assesses response rates, disease control, safety, tolerability, and quality of life in participants with PD-L1 CPS 21 1 advanced gastric or esophageal cancer. Participants are randomly assigned to one of two treatment groups. The first group receives nivolumab IV on day 1 of each 28-day cycle, ramucirumab IV on days 1 and 15, and paclitaxel IV on days 1, 8, and 15. The second group receives ramucirumab IV on days 1 and 15 and paclitaxel IV on days 1, 8, and 15 of each cycle. Treatment continues every 28 days until disease progression or unacceptable side effects occur. Optional blood samples may be collected during the study. Imaging with CT and MRI is performed throughout. Participants undergo scans and assessments at baseline and during treatment to monitor cancer progression and treatment effects. They also complete questionnaires on quality of life and symptoms. After treatment ends, participants are followed up at 30, 60, and 90 days and then every 6 months for up to 3 years. Researchers measure progression-free survival and overall survival as primary outcomes, along with other safety and patient-reported measures.

Researchers are evaluating the effects of adding cemiplimab, an immunotherapy drug that blocks the PD-1 pathway to help the immune system attack tumor cells, to the usual treatment of docetaxel and ramucirumab in patients with stage IV or recurrent non-small cell lung cancer. This phase II/III Expanded Lung-MAP trial compares cemiplimab combined with docetaxel and ramucirumab versus docetaxel and ramucirumab alone, aiming to improve treatment outcomes in patients who previously received platinum chemotherapy and immunotherapy but developed resistance or disease progression. Participants are randomly assigned to one of two treatment arms. In Arm I, patients receive dexamethasone orally twice daily on days 0-2, ramucirumab and docetaxel intravenously on day 1 of each 21-day cycle. In Arm II, patients receive the same treatments plus cemiplimab intravenously on day 1 of each cycle. Treatment cycles continue every 21 days until disease progression or unacceptable side effects occur. Throughout the study, patients undergo regular blood sample collection and imaging scans such as CT or MRI to monitor disease status. During the study, participants are closely monitored with scans, blood tests, and physical exams to assess overall survival and other outcomes like progression-free survival, response rates, and treatment safety. Researchers also collect blood samples for future molecular studies. After completing treatment, patients are followed up every 3 to 6 months for up to 3 years to track long-term survival and health status. The study measures overall survival from randomization to death from any cause, assessed up to 3 years.

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Eating disorders, especially binge-spectrum disorders like bulimia nervosa and binge-eating disorder, are a growing concern among university students, with prevalence increasing significantly since the COVID-19 pandemic. This research evaluates the effectiveness of a mobile health guided self-help Cognitive Behavioral Therapy program called Building Healthy Eating and Self-Esteem Together for University Students (BEST-U) compared to present-centered therapy (PCT). The study aims to understand how BEST-U reduces binge eating by targeting dietary restraint, weight and shape concerns, and negative emotions, while also exploring factors that influence treatment response and barriers to implementation on college campuses. Participants are randomly assigned to either the BEST-U program or PCT, each involving similar doses of therapy. BEST-U uses smartphone app modules based on behavior therapy combined with 20-30 minute coaching sessions, offering a comprehensive, accessible intervention that has been tested across diverse groups. PCT focuses on managing current life stressors through therapeutic support and improving interpersonal connections. The study tests these approaches over a 12-week intervention period. During the study, participants will complete assessments including the Eating Pathology Symptoms Inventory at baseline, weekly during the intervention, and at 3- and 6-month follow-ups. Daily behavior surveys are also collected throughout the 12-week intervention. Researchers will monitor binge eating symptoms, target mechanisms like dietary restraint, and other eating disorder symptoms to evaluate treatment effects and safety. The total participation includes intervention and follow-up assessments to understand long-term outcomes and treatment engagement.

Researchers are evaluating how well chemotherapy given before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus squamous cell carcinoma that can be removed by surgery. This phase II randomized trial focuses on patients with locally advanced resectable tumors classified as T3 or T4a stages, aiming to preserve important structures like the skull base and orbit, and to improve overall survival. The study also examines additional outcomes such as progression-free survival, the accuracy of imaging predictions, and the effects of tobacco use on treatment and symptoms. Participants are randomly assigned to one of two groups. One group undergoes standard surgery followed by image-guided intensity-modulated radiation therapy (IMRT) daily for 30 treatments starting 4-6 weeks after surgery, with additional chemotherapy (cisplatin or carboplatin) if certain high-risk features are present. The other group receives up to three cycles of chemotherapy including docetaxel and cisplatin (or carboplatin if cisplatin is not suitable), followed by surgery within six weeks. After surgery, they receive the same radiation therapy and additional chemotherapy as needed. The study includes correlative biomarker and questionnaire analyses. Throughout the study, participants have evaluations including magnetic resonance imaging (MRI) and positron emission tomography/computed tomography (PET/CT) scans before registration and during treatment. After completing therapy, patients are followed every three months for up to two years, then every six months up to five years to monitor structure preservation and survival outcomes. Researchers also assess treatment side effects, physical and psychological symptoms, and tobacco use behaviors during this time.

Researchers are evaluating the effect of adding chemotherapy to immunotherapy (pembrolizumab) compared to using immunotherapy alone in treating older adults aged 70 and above with advanced non-small cell lung cancer (stage IIIB-IV). This phase III trial aims to determine if combining chemotherapy with pembrolizumab improves overall survival and other outcomes like progression-free survival, response rates, toxicity, and quality of life in this vulnerable patient group. Participants are randomly assigned to one of two treatment groups. In the immunotherapy-alone group, patients receive pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years if there is no disease progression or unacceptable side effects. In the combination group, patients receive pembrolizumab plus a chemotherapy regimen chosen by their doctor, including drugs such as pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel, given intravenously on specific schedules for four cycles, followed by the same pembrolizumab maintenance. Imaging scans like MRI, CT, and PET are performed at baseline and throughout the study. During the study, participants undergo various assessments including imaging scans, laboratory tests, and questionnaires to evaluate treatment effects, side effects, and quality of life. Researchers monitor overall survival for up to five years from randomization, with follow-up visits every three months for the first two years and every six months thereafter until five years. Additional exploratory analyses include safety, tolerability, and correlations with gut microbiome and geriatric assessments to better understand treatment outcomes in this population.