Quint Fonsegrives

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are comparing the length of time participants survive without signs of cancer returning after treatment for high-risk non-muscle-invasive bladder cancer (HR-NMIBC). This Phase 3 study focuses on patients who have received Bacillus Calmette-Guérin (BCG) treatment and have specific FGFR mutations or fusions. The study aims to evaluate and compare disease-free survival between those treated with TAR-210 and those receiving intravesical chemotherapy chosen by the investigator. Participants will receive either TAR-210, a drug administered directly into the bladder, or one of two chemotherapy drugs, Mitomycin C or Gemcitabine, also given intravesically. All visible tumors must be fully removed before randomization. The study includes patients who are either unresponsive to BCG, experienced with BCG, or intolerant to BCG treatment. Participants must not be eligible for or must refuse radical cystectomy surgery. During the study, participants will be monitored for disease-free survival for up to five years. Researchers will perform assessments including urine testing, tumor tissue analysis, and biopsies as needed to confirm eligibility and monitor disease status. Safety, treatment adherence, and patient health status will be regularly evaluated to ensure ongoing suitability for the study.

Researchers are evaluating the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are evaluating the safety and effectiveness of combining JSB462 (luxdegalutamide) at doses of 100 mg and 300 mg once daily with abiraterone, compared to an androgen receptor pathway inhibitor (ARPI) such as abiraterone or enzalutamide in adult men with metastatic hormone-sensitive prostate cancer (mHSPC). This Phase II study aims to select the recommended dose of the combination for further Phase III trials by assessing overall efficacy, safety, tolerability, and pharmacokinetics in participants. Participants receive JSB462 orally every day at either 100 mg or 300 mg doses continuously from randomization until disease progression, unacceptable side effects, death, or decision to stop treatment. Alongside this, abiraterone (1000 mg daily) or enzalutamide (160 mg daily) is also given continuously under the same conditions. The study includes a 28-day screening period, followed by the treatment period and then a 30-day post-treatment safety follow-up. After this, a long-term follow-up phase collects ongoing safety, efficacy, and survival data until the study ends. Throughout the study, participants undergo monitoring for prostate specific antigen (PSA) response, adverse events, dose adjustments, and duration of treatment exposure. Safety visits occur 30 days after treatment stops, and long-term follow-up tracks participant health until study completion. The total participation duration varies depending on individual treatment response and follow-up schedules, with assessments continuing for up to approximately 75 months from randomization.

Researchers are evaluating the use of digital tools in dentistry to improve the detection of dental conditions such as dental caries, plaque, and periodontitis in adults. The study compares the performance of traditional clinical and radiographic examinations performed by practitioners with examinations based on imaging results obtained from digital devices like intraoral scanners, panoramic radiography, and Cone Beam Computed Tomography (CBCT). This observational, descriptive, multicenter study builds on prior research to better understand the advantages of digital imaging in dental care. The study involves a single visit where participating patients undergo a standard oral examination that includes clinical assessment and imaging using digital tools like intraoral scanners and panoramic radiography. CBCT scans may be used when medically justified. These digital tools provide 3D images that may help improve the accuracy and efficiency of dental evaluations. No additional or experimental procedures are introduced, and all imaging methods are commonly used in dental practices. During the visit, dental surgeons will collect clinical and imaging data, including measurements of decayed, missing, or filled teeth using the DMFT index, both clinically and from intraoral scan images. Patients receive information about the study beforehand and may take up to seven days to decide on participation. The study assesses the quality and completeness of dental data collected through these methods to support better diagnosis and treatment planning in routine dental care.

Researchers are evaluating the effectiveness and safety of combining pembrolizumab with capecitabine to improve invasive disease-free survival in patients who have triple negative breast cancer (TNBC) and still have residual disease after receiving neoadjuvant chemotherapy that included pembrolizumab. This Phase II study focuses on patients with localized TNBC who did not achieve a complete pathological response after initial treatment. An additional group of patients treated with pembrolizumab alone as standard care will be observed for comparison. Participants in the experimental group will receive pembrolizumab as an intravenous infusion on Day 1 of each cycle for a total of 9 cycles. Capecitabine tablets will be taken orally at a dose of 1250 mg/m² twice daily on days 1 to 14 of each 21-day cycle, for 8 cycles. Dose adjustments of capecitabine may occur during radiotherapy if needed. Local radiotherapy will be given according to standard practice when indicated. The study will also register data from an external cohort treated with pembrolizumab alone after surgery to compare outcomes. During the study, participants will undergo assessments to monitor their health and response to treatment, including laboratory tests and evaluations of organ and bone marrow function. Researchers will track invasive disease-free survival over 2 years as the primary outcome. Safety will be carefully monitored throughout the treatment period. Participants must comply with study visits and procedures, and the total follow-up will include monitoring for at least 2 years to assess long-term treatment effects and disease status.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Researchers are evaluating treatments for men aged 45 to 75 with favorable intermediate risk prostate cancer. This study compares focal High-Intensity Focused Ultrasound (F-HIFU) with radical prostatectomy (RP) to see which treatment is more cost-effective and provides better quality of life over 24 months. The trial is multicenter and randomized, initially with equal groups but later adjusted to a 2:1 ratio favoring F-HIFU, with follow-up extending to 48 months using health system data to monitor costs, mortality, and cancer control. Participants receive either F-HIFU using the Focal-One4 machine under local or general anesthesia, targeting specific prostate areas, or undergo radical prostatectomy performed by open, laparoscopic, or robot-assisted surgery under general anesthesia. Treatments follow standard procedures at each center, with randomization done up to 2 months before the procedure. During the study, participants will be monitored through medical records and health system data without extra visits. Researchers will assess the cost-effectiveness of treatments based on quality-adjusted life years (QALYs) at 24 months. Safety, cancer control, and mortality will also be tracked up to 48 months. The total participation time includes treatment and long-term follow-up using existing health data sources.