Vantoux

Researchers are evaluating the efficacy and safety 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 progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating the use of pioglitazone to improve kidney outcomes in people with ANCA-associated vasculitis, a condition that affects blood vessels and involves kidney inflammation. This multicenter, randomized controlled trial includes patients with biopsy-confirmed kidney involvement of ANCA vasculitis at diagnosis. The study aims mainly to see if pioglitazone can reduce kidney damage by improving protein levels in urine and serum creatinine. It also examines effects on blood pressure, metabolic changes from steroids, vasculitis activity, and safety in this group of patients. All participants receive standard immunosuppressive treatment combining corticosteroids and rituximab. They are randomly assigned to take either pioglitazone 30 mg daily or a placebo for 26 weeks alongside the standard care. Rituximab is given weekly for four weeks as induction, then re-administered every six months. Participants follow a predefined steroid tapering schedule. Biological samples are collected at multiple points throughout the study for analysis. Participants are followed for a total of 52 weeks with visits scheduled at weeks 1, 2, 3, 4, 8, 12, 26, 38, and 52. During these visits, kidney function, proteinuria, vasculitis activity, quality of life, and safety are assessed through clinical exams, blood and urine tests, and questionnaires. The primary outcome is measured at week 26, and secondary outcomes continue through week 52 to monitor effects and safety of pioglitazone over time.

Researchers are evaluating ivonescimab as a potential treatment for patients with pleural mesothelioma whose cancer has returned after previous immunotherapy and standard chemotherapy. This is an open-label, single-arm phase II study involving about 38 patients who have relapsed after up to two prior lines of treatment, including immunotherapy with nivolumab 1 ipilimumab and standard chemotherapy. The trial aims to assess the disease control rate at 12 weeks after starting treatment with ivonescimab. Participants receive ivonescimab intravenously at a dose of 20 mgkg every three weeks, with a fixed dose of 3200 mg for patients weighing 160 kg or more. Treatment may continue for up to 24 months, or until disease progression, unacceptable side effects, withdrawal of consent, or other reasons for stopping. This study is conducted at approximately 20 centers and is designed as a single-group trial without a placebo or comparator group. During the study, participants will undergo regular assessments including CT scans to measure disease progression and response. Researchers will monitor safety and side effects from the start of treatment through up to 90 days after the last dose. They will also evaluate progression-free survival, overall survival, best response rate, and duration of response over a period of up to about 45 months. Participants are expected to comply with scheduled visits, treatment schedules, and laboratory tests throughout the study.

Researchers are studying the use of the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the Dexcom G6 Continuous Glucose Monitoring sensor in people with type 1 diabetes T1D in France. This observational study aims to evaluate the systems impact on blood sugar control under real-life conditions over one year. It also explores participant experiences related to quality of life, treatment satisfaction, fear of low blood sugar, and sleep quality while tracking any complications related to the system. Participants include both adults and minors starting use of the system as part of their usual diabetes care. The study follows them for 12 months, collecting data on blood sugar control and system usage. There is no experimental treatment given instead, the study observes how the system performs when used in daily life by about 125 participants across multiple centers in France. Throughout the study, participants will complete self-reported questionnaires on quality of life and treatment experience at baseline, 3 months, and 12 months. Blood sugar data is gathered continuously from the glucose monitoring sensor to assess changes in time spent in target ranges and other glucose metrics. Safety is monitored by recording any adverse events related to the system. The study aims to understand how the system affects diabetes management and patient well-being over one year of use.

Researchers are conducting a long-term observational study to understand how dupilumab is used and its effects in patients with Chronic Obstructive Pulmonary Disease COPD who are treated as part of routine care. This study will follow about 350 to 500 participants in multiple sites across France over 36 months, collecting detailed information on patient characteristics, safety, and patient-reported outcomes. The goal is to describe various aspects of COPD and treatment history to better characterize this patient group. Participants in this study are those newly starting dupilumab treatment for COPD, as prescribed by their doctors in line with approved guidelines. The study does not involve any additional treatment but observes the use of dupilumab over time. No placebo or comparator group is included. Data will be collected retrospectively and prospectively, covering medical history before dupilumab initiation and ongoing treatment effects during the 36-month follow-up. Throughout the study, researchers will gather detailed data on demographics, disease characteristics, lung function, exacerbations, comorbidities, and patient-reported assessments such as quality of life and symptom scores. Safety outcomes, including adverse events and reasons for stopping treatment, will be monitored. The study duration for each participant is about 36 months, allowing long-term observation of treatment and disease progression in real-world conditions.

Researchers are evaluating pembrolizumab combined with carboplatin and taxane chemotherapy as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC. This phase 3 trial aims to compare overall survival between patients receiving pembrolizumab with maintenance sacituzumab tirumotecan sac-TMT and those receiving pembrolizumab alone during maintenance therapy. The study explores whether the addition of sac-TMT improves outcomes for patients with this type of lung cancer. Participants first undergo an induction phase of four cycles receiving pembrolizumab every 3 weeks along with carboplatin and either paclitaxel or nab-paclitaxel. After induction, they are randomly assigned to one of two maintenance groups pembrolizumab alone every 6 weeks for up to 96 weeks, or pembrolizumab combined with sac-TMT every 2 weeks until discontinuation criteria are met. The chemotherapy drugs are given intravenously during the induction phase, and maintenance treatments continue intravenously according to assigned groups. Throughout the study, participants will be monitored for overall survival as the primary outcome, with secondary outcomes including progression-free survival, adverse events, treatment discontinuations, and quality of life measures such as dyspnea, cough, and chest pain. Assessments include tumor scans to evaluate disease status, performance status checks, and patient-reported questionnaires on symptoms and health-related quality of life. Participants are followed for up to approximately 79 months to gather comprehensive safety and efficacy data, with ongoing monitoring by the research team.

Researchers are evaluating the effectiveness and safety of two combination treatments for adults with hormone receptor positive HR, human epidermal growth factor receptor 2 negative HER2- locally advanced or metastatic breast cancer that has a PIK3CA mutation. These patients have experienced recurrence or progression after treatment with a CDK46 inhibitor. This Phase 3, open-label, randomized study compares RLY-2608 zovegalisib plus fulvestrant against capivasertib plus fulvestrant to determine which treatment better controls the disease. Participants are assigned to one of two groups one group receives zovegalisib orally twice daily along with fulvestrant administered by injection on specific days during a 28-day treatment cycle the other group receives capivasertib orally twice daily on an intermittent weekly schedule plus fulvestrant injections on the same schedule. Treatment cycles repeat every 28 days. The study is conducted globally at multiple centers and continues until disease progression or other criteria are met. During the study, participants undergo regular assessments including scans reviewed by blinded independent central review to measure progression-free survival, as well as monitoring overall survival, response rates, quality of life questionnaires, and safety evaluations. Blood samples are taken periodically to measure drug levels. The study may last up to approximately 77 months for outcome measurements, with ongoing monitoring for adverse events and quality of life changes throughout this period.

This research investigates GLSI-100 immunotherapy in people with HER2neu positive breast cancer who are at high risk for their cancer returning. It focuses on participants who have completed both neoadjuvant and postoperative adjuvant standard treatments. The study is Phase 3, randomized, double-blinded, and placebo-controlled, involving subjects who are HLA-A*02 positive as well as an open-label group of non-HLA-A*02 positive subjects. The goal is to evaluate the treatments impact on invasive breast cancer-free survival over a median follow-up of 4 years. Participants receive 6 primary immunization injections of GLSI-100 or placebo intradermally once a month for the first 6 months, followed by 5 booster injections spaced 6 months apart, totaling 11 injections over 3 years. There are three groups one receiving placebo 0.9% normal saline, one receiving GLSI-100 immunotherapy in HLA-A*02 positive subjects, and an open-label arm for non-HLA-A*02 positive subjects receiving GLSI-100 under the same schedule. During the study, participants undergo regular monitoring and assessments including invasive disease-free survival, distant disease-free survival, overall survival, and quality of life questionnaires at baseline and up to 36 months. Researchers track safety and treatment effects over a median 4-year follow-up. The study continues until December 2031, aiming to provide comprehensive data on long-term outcomes and quality of life for participants receiving these treatments.

Researchers are conducting a French non-interventional longitudinal multicenter cohort study to evaluate the added value of olaparib for treating patients with metastatic castration-resistant prostate cancer mCRPC in real-world settings. The study aims to assess treatment sequencing, effectiveness, safety, and BRCA testing patterns, helping to inform future clinical practice. This observational study is sponsored by AstraZeneca. The study observes adult male patients who have started olaparib treatment within at least the last two months or who participated in a funded early access program. There are no assigned treatment groups or interventions beyond olaparib use as decided by their physician. Data collection continues up to 32 months to capture treatment patterns and patient characteristics. Participants data on treatment duration, disease progression, therapy sequences, symptomatic skeletal events, and BRCA testing timing will be collected and analyzed up to 24 months from olaparib initiation. Socio-demographic and clinical characteristics of patients and physicians will be gathered at the end of enrollment. The study monitors reasons for dose changes, interruptions, and treatment cessation, ensuring comprehensive real-world evidence about olaparib in mCRPC patients.