La Rochelle

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are creating a national, prospective cohort to study children with idiopathic nephrotic syndrome (INS), a rare kidney disease. The goal is to collect detailed data on patients treated in pediatric nephrology centers across France, Reunion Island, Mayotte, and eventually other French overseas territories. This structured follow-up aims to better understand the disease's characteristics and provide a foundation for future clinical trials. The study involves enrolling pediatric patients diagnosed with INS and systematically collecting clinical, biological, psychological, and social data. Biological samples such as blood, urine, hair, and nails will be gathered at disease onset before immunosuppressive treatment begins. Data will be recorded through medical records from hospital visits and consultations, supplemented by annual telephone interviews for patients without active disease. Quality of life, treatment adherence, and aesthetic impact questionnaires will also be collected and integrated into a secure database. Participants will be followed over at least two years, with data collected regularly by clinical research staff. This includes medical validation of clinical information, annual telephone follow-ups, and questionnaire assessments. The study's primary outcome is the number and characteristics of included cases over two years. This ongoing monitoring will support future nested studies and improve understanding of pediatric INS outcomes and management.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are evaluating whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. This Phase 3 study compares zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The goal is to see if the new combination improves progression-free survival. Participants receive treatments through intravenous infusions of study drugs including zilovertamab vedotin, rituximab or its biosimilar, cyclophosphamide, doxorubicin, and vincristine, along with oral prednisone or prednisolone as per approved guidelines. Some may receive rescue medication such as granulocyte colony-stimulating factor (G-CSF) if needed. The study is open-label and conducted across multiple centers. During the study, participants are closely monitored for how long they live without their disease worsening, with follow-up up to approximately 50 months. Assessments include imaging scans like PET to evaluate disease status, heart function tests, and regular evaluations of overall health and side effects. Safety is monitored throughout, and researchers measure progression-free survival as the primary outcome to determine the effectiveness of the treatments.

Researchers are evaluating the clinical benefits of combining physiological pacing with atrioventricular node ablation in patients who have Heart Failure with preserved Ejection Fraction (HFpEF) and well-controlled permanent atrial fibrillation. The study aims to determine if this approach, which regularizes heart rate and avoids the harmful effects of right ventricular apical pacing, can reduce mortality and hospitalizations related to heart failure compared to standard drug treatment. This trial addresses a significant health issue affecting older adults, as HFpEF and atrial fibrillation often occur together and lead to poor outcomes. Participants in the intervention group will undergo implantation of a pacemaker lead targeting the heart's conduction system, using a specific Medtronic lead or an alternative if needed. They will also receive atrioventricular node ablation via a catheter procedure to regulate heart rhythm. The pacemaker will be programmed to maintain a steady heart rate of 75 beats per minute. The control group will continue with optimized medication for heart rate control. Participants will be randomly assigned to one of these two groups. During the 24-month study, participants will visit the clinic at 3, 12, and 24 months after randomization for checkups and tests. Researchers will monitor the time until participants experience either death from any cause or hospitalization due to heart failure or need for intravenous diuretics. These assessments will help evaluate the safety and effectiveness of the treatments over two years of follow-up.

Researchers are studying motor skills and their psycho-physiological connections in children diagnosed with Autism Spectrum Disorder (ASD). This study aims to measure and analyze motor performance in three main areas: general motor skills like posture and walking, fine motor skills such as graphic and pointing tasks, and oculomotor skills involving visual orientation and control. The research also compares motor performance with clinical characteristics, cognitive and social profiles, and comorbid conditions like ADHD. Participants will undergo various tests to assess their motor abilities. These include biomechanical analysis for gross motor skills and eye movement recording using an eye-tracking system called Tobii Pro TX300. The study also involves completing self and caregiver questionnaires. The measurements are automated and standardized to capture detailed motor patterns and performance. During the study, children's motor skills will be quantitatively evaluated at baseline and at a 3-month follow-up. Assessments include fine motor tasks, general motor skills analyzed biomechanically, and oculomotor control measured via eye tracking. Researchers will monitor changes and relationships between motor abilities and other clinical features. The total participation includes initial testing and a follow-up after three months to measure outcomes and safety.

Age is a major risk factor for developing cognitive disorders and neurodegenerative diseases. Cognitive disorders are known to occur during phases of bipolar disorder, and these impairments increase significantly after age 65. Drug treatments have limited effects, so researchers are evaluating a cognitive stimulation program adapted specifically for elderly patients with bipolar disorder to address these challenges. Bipolar disorder is a leading cause of disability worldwide, and cognitive impairments in attention, memory, and executive function greatly affect quality of life and risk of relapse. This study compares the adapted cognitive stimulation program to usual care involving psychiatric consultations and sometimes home nursing. Participants receiving cognitive stimulation attend weekly sessions that include sensory stimulation, language and imagination exercises, attention improvement, memory and intellectual structuring activities, social communication skills, and temporal-spatial orientation tasks. The program consists of multiple types of sessions aimed at enhancing various cognitive skills important for daily life and social interaction. This behavioral approach is designed to support cognitive function in bipolar patients over 65 years old. During the study, participants are assessed at baseline and after three months, with the main measurement being the score on the Frontal Assessment Battery (FAB) to evaluate executive function. The study involves ongoing monitoring of cognitive symptoms and treatment effects, with participation lasting at least three months. Researchers will evaluate how the cognitive stimulation influences residual cognitive symptoms compared to standard psychiatric care.

Researchers are studying acute hidrosadenitis by creating a group of patients to better understand its different clinical forms and phenotypes. This study aims to improve knowledge about the disease's natural history, identify severe forms, and explore environmental factors that may contribute to the disease becoming chronic. The study plans to follow participants for about three years to gather this information. This is an observational study without any interventional treatments involved. Participants diagnosed with acute hidrosadenitis are followed over time to collect data related to their condition. The study focuses on characterizing the disease to support the development of appropriate therapeutic approaches based on different phenotypes. Participants will be monitored throughout the study period with assessments aimed at describing disease progression and identifying various clinical types. Researchers will collect information on the severity and environmental influences related to the disease's chronic nature. The total participation time averages three years, during which data are gathered to help define suitable care and follow-up strategies.