Lawrence

Researchers are studying the effects of nipocalimab, a drug given by IV infusion, on children and adolescents aged 2 to less than 18 years who have generalized myasthenia gravis gMG and have not responded sufficiently to standard treatments. The study aims to assess the safety, tolerability, and how nipocalimab behaves in the body, including its impact on total serum immunoglobulin G IgG levels. The study is open-label and uncontrolled, focusing on pediatric patients with this condition globally, and specifically for ages 8 to less than 18 years at US sites. Participants are divided into two groups based on age children aged 2 to less than 12 years and adolescents aged 12 to less than 18 years. They will receive nipocalimab once every two weeks for 24 weeks. After completing the 24-week treatment, participants have the option to join a long-term extension LTE to continue receiving the drug. The study tracks various outcomes including IgG levels, safety events, and drug pharmacokinetics over a period of up to three years. During the study, participants will undergo regular blood tests and clinical evaluations to monitor IgG levels, adverse events, and other health markers. Researchers will also assess changes in muscle strength, quality of life, fatigue, and overall disease severity using various scores and questionnaires. Safety will be closely monitored through laboratory tests, vital signs, physical exams, and recording of any adverse events. The study duration includes up to three years of follow-up to evaluate long-term effects and immune responses to the medication.

Researchers are evaluating breast reconstruction techniques in females undergoing a two-stage procedure using a pre-pectoral method. This study compares breast reconstruction using an Acellular Dermal Matrix device called Cortiva Tissue Matrix with reconstruction performed without this matrix. The trial is non-randomized and aims to assess outcomes in women 22 years or older undergoing immediate breast reconstruction after mastectomy. Participants will be assigned to one of two groups breast reconstruction with the Cortiva Tissue Matrix device or reconstruction without the Acellular Dermal Matrix. Both groups will undergo a two-stage breast reconstruction using the pre-pectoral technique following nipple or skin-sparing mastectomy. The study is conducted across multiple centers and does not involve masking or blinding. During the study, participants will be monitored for major adverse events and health-related quality of life over 12 months. Additional assessments include changes in quality of life at one and two years, procedure-related and device-related adverse events at three months, one year, and two years, and histopathology evaluation during the second stage of the procedure. The trial lasts for up to two years, with ongoing safety and quality of life follow-ups.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

Researchers are studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase IIIII trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating the addition of olaparib, a targeted therapy that blocks the PARP enzyme involved in DNA repair, in patients with pancreatic cancer who have had surgery to remove their tumor and carry a mutation in BRCA1, BRCA2, or PALB2. This phase II trial aims to determine if olaparib can improve relapse-free survival compared to placebo after chemotherapy completion. The study also explores overall survival and differences based on mutation type and chemotherapy received. Participants are randomly assigned to one of two groups. One group receives oral olaparib twice daily for 28-day cycles, up to 12 cycles, while the other group receives a placebo on the same schedule. Throughout treatment, patients undergo CT or MRI scans and blood collection. After treatment, patients are followed for up to 10 years with regular visits to monitor health and disease status. During the study, participants complete imaging scans and blood tests to assess disease progression and treatment effects. Researchers track relapse-free survival from the time of randomization until disease recurrence or death, with assessments extending up to 44 months. Safety and survival outcomes are monitored for up to 10 years. Follow-up visits occur 30 days after treatment and then every 4 months in the first year, followed by every 6 months for years 2 through 10.

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.

Eating disorders, especially binge-spectrum disorders, have become a serious concern on college campuses, with a significant rise in cases since the COVID-19 pandemic. This research aims to evaluate a mobile health guided self-help program called Building Healthy Eating and Self-Esteem Together for University Students BEST-U compared to present-centered therapy PCT in university students with binge eating disorders. The study will explore how these treatments reduce binge eating and improve related symptoms, focusing on mechanisms like dietary restraint and weightshape concerns. The study compares two behavioral interventions the BEST-U program, which delivers 15 brief modules via a smartphone app over 12 weeks combined with weekly 25-30 minute coaching sessions, and PCT, a therapy focusing on coping with daily life stressors and improving interpersonal connections. BEST-U includes evidence-based skills from Cognitive Behavioral Therapy and Dialectical Behavior Therapy, while PCT serves as a comparator addressing emotional triggers for binge eating. Participants receive these treatments in a randomized, single-blind design. Participants will be university students aged 18 to 65 with binge-spectrum eating disorders who have access to a smartphone. They will be assessed through surveys measuring binge eating and eating disorder symptoms at baseline, weekly during the 12-week intervention, and at 3- and 6-month follow-ups. Additional assessments will track impairment, anxiety, depression, and mood symptoms. The study also explores factors influencing response to treatment and barriers to implementing BEST-U across campuses, with the total participation lasting up to six months after treatment.

Researchers are evaluating treatment options for patients with nasal and paranasal sinus squamous cell carcinoma that can be surgically removed. This phase II randomized trial compares chemotherapy given before surgery and radiation therapy to surgery and radiation therapy alone. The study aims to see if giving chemotherapy first can shrink tumors and help preserve important nearby structures like the skull base and orbit, while also looking at overall survival and progression-free survival. Participants are randomly assigned to one of two groups. One group has surgery followed by radiation therapy, with additional chemotherapy if certain risk factors are found after surgery. The other group receives chemotherapy first, then surgery, followed by radiation therapy with possible additional chemotherapy. Chemotherapy drugs studied include docetaxel, cisplatin, and carboplatin, all given through intravenous infusions. Radiation therapy is delivered using image-guided intensity-modulated radiation therapy IMRT daily for several weeks. During the study, participants undergo scans like MRI and PETCT to assess tumor response and help predict outcomes. They are monitored regularly for side effects and treatment effects, with follow-up visits every three months for up to two years and then every six months up to five years. Researchers also collect data on tobacco use and its impact on treatment outcomes. The main outcomes measured are the rate of preserving the skull base and orbit and overall survival over five years.

Researchers are evaluating whether adding chemotherapy to immunotherapy with pembrolizumab improves overall survival compared to pembrolizumab alone in older adults with advanced non-small cell lung cancer NSCLC stages IIIB-IV. This phase III trial focuses on patients aged 70 and above with tumors expressing PD-L1 at 1-49 and without certain genetic mutations. The study aims to assess survival, progression-free survival, response rates, toxicity, and quality of life in this vulnerable population. Participants are randomized into two groups. One group receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. The other group receives pembrolizumab plus a chemotherapy regimen chosen by the investigator, given intravenously on specific schedules repeating every 21 days for four cycles, followed by the same pembrolizumab maintenance. Imaging with MRI, CT, andor PET scans is performed at baseline and throughout the trial. During the trial, patients undergo regular evaluations including imaging studies, laboratory tests, and quality of life questionnaires. Follow-up visits occur every three months for up to two years after treatment and then every six months up to five years. Researchers measure overall survival, disease progression, treatment response, adverse events, and patient-reported quality of life. The study also explores safety, tolerability, geriatric assessments, and correlations between gut microbes and outcomes.