Rancho Mirage

Researchers are studying adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) to understand why they choose certain treatments, why some switch to HyQvia from other therapies, and how satisfied they are with these treatments. The study also aims to assess the impact of CIDP on work productivity and daily activities, the signs and symptoms of CIDP, and collect information about any medical problems or side effects during HyQvia treatment. Additionally, it evaluates how effective HyQvia is in routine clinical care and monitors healthcare needs like emergency or hospital visits. This is a non-interventional study where participants receive treatment as determined by their doctors or clinics. Participants include both new users planning to switch to HyQvia within 6 weeks and current users who have recently started HyQvia treatment. Data collection involves medical record reviews, interviews at the start and end of the study, and questionnaires completed by participants. The study does not assign any specific treatment but observes the use of HyQvia in real-world settings. During the study, participants complete questionnaires measuring their treatment preferences, satisfaction, quality of life, disability, and work productivity at multiple times up to 12 months. Researchers also gather clinical information and monitor any side effects or healthcare interventions. Participants must be able to communicate in their local language if they take part in optional interviews. The study tracks outcomes and experiences related to HyQvia use for up to one year or until participants stop treatment or the study.

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

This research evaluates the effects of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. The study is a Phase 3 trial aiming to assess the safety and effectiveness of these treatments. Participants must meet specific CIDP diagnostic guidelines and have shown response to IVIg in the past five years. The study is divided into two parts. In Part A, lasting 24 weeks (6 months), participants receive either empasiprubart with a placebo mimicking IVIg, or IVIg with a placebo mimicking empasiprubart. Following this, Part B lasts 96 weeks (24 months), during which all participants receive empasiprubart. Both treatments are given by intravenous infusion. Placebos are used to maintain blinding in the study. Participants will be monitored for changes in their disease symptoms, particularly focusing on improvements measured by a reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Throughout the study, safety and disease activity will be regularly assessed. The total study duration for participants is up to 120 weeks, including both treatment parts.

Researchers are evaluating the safety and effectiveness of empasiprubart in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This phase 3 study aims to compare empasiprubart with a placebo in treating this condition, which involves nerve inflammation and damage that can cause weakness and disability. Participants include adults with typical CIDP or certain CIDP variants who have active disease and residual disability. The study has two parts: In part A, participants receive either empasiprubart or a placebo through intravenous infusion for 24 weeks (6 months). After this, all participants enter part B, where everyone receives empasiprubart intravenously for an additional 96 weeks (24 months). This design allows researchers to observe both the initial effects compared to placebo and the longer-term outcomes of empasiprubart treatment. Throughout the study, participants will be regularly monitored for treatment effects and safety. The main outcome measured is the reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Researchers will also track any side effects and overall health during the full duration of the study, which can last up to 2.5 years including both parts A and B.

Researchers are evaluating the effectiveness and safety of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Multifocal Motor Neuropathy (MMN). This Phase 3 study includes a double-blinded phase where participants receive either empasiprubart or IVIg, followed by an open-label phase where all receive empasiprubart. The study aims to assess treatment impact over a maximum duration of up to 49 months. Participants receive intravenous infusions of either empasiprubart or IVIg during the double-blinded phase, with matching placebo infusions given to maintain blinding. In the open-label phase, all participants are given empasiprubart infusions. The study carefully monitors treatments and their effects throughout these periods. Participants undergo assessments including measuring changes in grip strength of their most affected hand, using a 3-day moving average at week 24 as the primary outcome. Safety and efficacy are tracked throughout the study duration, with detailed follow-up visits and evaluations to monitor participant response and well-being during the study period.

This research aims to evaluate how well adults with new-onset generalized myasthenia gravis (gMG), who have had symptoms for less than one year, respond to treatment with efgartigimod PH20 SC. The study focuses on adults diagnosed with gMG who are seropositive for AChR antibodies and have moderate disease activity, as indicated by an MG-ADL score of 5 or higher. This phase 4, open-label study seeks to understand clinical outcomes in this specific patient group. Participants will receive subcutaneous injections of efgartigimod PH20 SC during a 51-week treatment period. The study involves a single group design without a comparator, where all enrolled subjects are treated with the study drug. The overall duration for each participant, including screening and follow-up, will be approximately 58 weeks. Throughout the study, researchers will monitor the proportion of participants achieving minimal symptom expression (MSE) of myasthenia gravis within the first 16 weeks of treatment. Participants will undergo assessments to evaluate their disease status and response to therapy over time. Safety and effectiveness will be closely observed during the treatment and follow-up periods to gather comprehensive data on participant outcomes.

Researchers are evaluating the safety and effectiveness of an experimental drug combination, fianlimab and cemiplimab, in adults with advanced or metastatic melanoma, a type of skin cancer. This phase 3 study compares this combination with an approved treatment using relatlimab and nivolumab (Opdualag14). The study also investigates possible side effects, drug levels in the blood, and whether the body produces antibodies that might affect the drugs' performance or safety. Participants receive either fianlimab and cemiplimab together through intravenous (IV) infusions every three weeks or the comparator drugs relatlimab and nivolumab by IV every four weeks. The treatment period is followed closely by researchers who monitor how participants respond to the therapies and how well they tolerate them. During the study, participants undergo regular assessments including scans and laboratory tests to measure tumor response using standardized criteria (RECIST 1.1). Researchers also monitor safety, immune response, and drug levels for up to 72 months. The study requires participants to have measurable melanoma and good organ function, and they are observed for overall treatment effects and side effects throughout the trial.

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 collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.