Vantoux

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the effectiveness of pioglitazone in improving kidney outcomes for patients with ANCA-associated vasculitis, a condition involving inflammation of small blood vessels that affects the kidneys. This Phase 3 multicenter randomized controlled trial includes patients with biopsy-proven kidney involvement of ANCA vasculitis, aiming to determine if pioglitazone can reduce kidney damage as measured by improvements in proteinuria and serum creatinine levels. Participants will be randomly assigned to receive either pioglitazone (30 mg/day orally) or a placebo for 26 weeks, alongside standard immunosuppressive care which includes rituximab infusions and corticosteroids following a tapered dosing schedule. Rituximab is given at 375 mg/m2 weekly for 4 weeks as induction, then 500 mg every 6 months as maintenance. Biological samples of plasma, serum, and urine will be collected at multiple visits throughout the 52-week follow-up period. Participants will be closely monitored with visits scheduled at weeks 1, 2, 3, 4, 8, 12, 26, 38, and 52, during which assessments will include kidney function tests, proteinuria measurement, and safety evaluations. The primary outcome is defined by a significant decrease in serum creatinine combined with a reduction in urine protein-to-creatinine ratio at 26 weeks. The study also evaluates secondary effects on blood pressure, metabolic changes due to glucocorticoids, vasculitis activity, and the overall safety of pioglitazone in this patient group.

Researchers are evaluating ivonescimab, a bispecific antibody targeting VEGF and PD-1, as a second or third-line treatment for patients with relapsing pleural mesothelioma who have previously received immunotherapy and standard chemotherapy. This is a multicenter, open-label, single-arm phase II study involving about 38 patients. The study aims to assess the disease control rate 12 weeks after starting treatment, with hypotheses set for control rates below 30% versus at least 55%.

Researchers are evaluating the impact of the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring sensor on blood sugar control in people with type 1 diabetes in real-life conditions in France. This non-interventional, multicenter, prospective study aims to assess glycemic control after one year of use, along with participant-reported outcomes like quality of life, treatment satisfaction, fear of low blood sugar, and sleep quality. The study is conducted under post-market clinical follow-up regulations without invasive procedures. Participants will use the mylife CamAPS FX system with the DEXCOM G6 sensor for one year while being monitored by diabetes specialists at 20 centers across France. The study does not involve additional interventions; it is observational, collecting data on system usage patterns such as Boost/Ease-Off mode use, insulin-to-carbohydrate ratios, and alarms. Approximately 125 participants, including 100 adults and 25 minors, will be followed throughout the study period. Participants will have data collected at three time points during the year to monitor changes in time spent in the target blood sugar range. Specialists will also track complications related to the system and gather information through questionnaires about participants' experiences and satisfaction. The study focuses on real-life effectiveness and safety of the device, with continuous monitoring over 12 months after system initiation.

Researchers are conducting a long-term observational study to understand patients with Chronic Obstructive Pulmonary Disease (COPD) who are treated with dupilumab as part of routine care. The study aims to gather information on patient characteristics, safety, and patient-reported outcomes over time. This study includes adults with uncontrolled COPD despite standard treatments and elevated blood eosinophil levels, reflecting real-world use of dupilumab. Participants will be followed for approximately 36 months at up to 50 sites in France. This study is non-interventional, meaning it observes patients receiving dupilumab as prescribed by their doctors without altering treatment. It collects data retrospectively and prospectively from patients newly starting dupilumab under approved guidelines for COPD. During the study, researchers will analyze various baseline and historical clinical data, including demographics, medical history, lung function, symptom patterns, exacerbations, inflammatory markers, comorbidities, and treatment history. Safety and patient-reported measures will also be assessed over the follow-up period. The study will provide detailed descriptive statistics to better characterize this patient population and the long-term outcomes of dupilumab treatment in COPD.

Researchers are evaluating a phase 3 study of pembrolizumab combined with carboplatin and a taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT) in adults with metastatic squamous non-small cell lung cancer. The study aims to determine if adding sac-TMT maintenance to pembrolizumab improves overall survival compared to pembrolizumab alone. Participants have confirmed stage IV squamous NSCLC and measurable disease. All participants first receive an induction phase of four cycles lasting 21 days each. During induction, they receive pembrolizumab every 3 weeks plus carboplatin every 3 weeks, along with either paclitaxel every 3 weeks or weekly nab-paclitaxel. After induction, participants are randomly assigned to continue pembrolizumab maintenance alone or pembrolizumab combined with sac-TMT maintenance. Treatments are given by intravenous infusion. Participants undergo scans to measure tumor response and are monitored for side effects and overall health. Researchers assess overall survival up to about 50 months. Organ function, adverse events, and performance status are regularly evaluated before and during the study. The study includes safety monitoring and follows participants through their treatment and maintenance phases.

Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.

Researchers are evaluating the use of olaparib in adult male patients with metastatic castration-resistant prostate cancer (mCRPC) in a real-world setting across multiple centers in France. This observational longitudinal study aims to understand how olaparib is used in treatment sequences, its effectiveness, safety, and patterns of BRCA genetic testing to help improve future clinical care for this condition. The study includes patients who have started olaparib treatment within the last two months before joining the study or who participated in an early access program funded for olaparib use. Treatment decisions are made by the patients' physicians, and researchers observe and collect data without intervening. The study follows patients for up to 24 months from the start of olaparib treatment to track how long they continue the treatment and other outcomes. Participants will be monitored through their routine medical care, and data will be collected on treatment duration, safety, and BRCA testing patterns. The main outcome measured is the time until patients stop olaparib treatment, observed over a period of up to two years. The study relies on patient records and does not involve additional experimental procedures, focusing on real-life treatment experiences and outcomes.

This research aims to evaluate the safety and performance of the SYMBOL range of medical devices used in total hip arthroplasty (THA) procedures. It focuses on patients undergoing either primary or revision total hip replacements due to various hip conditions, including degenerative hip joint disease, post-traumatic osteoarthritis, hip arthritis, femoral neck fractures, avascular necrosis of the femoral head, or failure of previous joint implants. The study will follow patients for a period of 10 years to assess long-term outcomes. Participants will receive total hip arthroplasty using at least one medical device from the SYMBOL range. The study monitors the survivorship of 13 individual SYMBOL orthopedic components over the 10 years following surgery. Both primary and revision hip replacement procedures are included, and the devices used are those manufactured by DEDIENNE Santé under the SYMBOL range. During the study, patients will be regularly assessed to monitor the performance and safety of the implanted devices. Researchers will track the longevity of the implants and watch for any complications or failures. Participants must be able to read, write, and understand French and will provide informed consent. The study excludes those unable to follow procedures or who have previously participated with a SYMBOL device. The total duration of participation is 10 years post-operation, allowing comprehensive long-term monitoring.