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Researchers are studying acute pyelonephritis (AP), a common bacterial kidney infection in children, focusing on those aged 1 month to less than 3 years without prior urological malformations. The study compares a short 3-day intravenous (IV) antibiotic treatment alone to a 3-day IV treatment followed by 7 days of oral antibiotics. The goal is to see if the shorter IV-only treatment is as effective at preventing infection recurrence and long-term kidney scarring, while possibly reducing antibiotic resistance and preserving gut microbiota diversity. Participants receive either IV ceftriaxone and/or amikacin once daily for 3 days, or the same 3-day IV treatment followed by 7 days of oral cotrimoxazole or cefixime. The study includes procedures like procalcitonin testing and fecal or rectal swabs collected at several points during and after treatment (day 0, 3, 10 or 17, and 31 or 38) to monitor bacterial presence and gut microbiota changes. Treatment begins after initial confirmation of infection and favorable early response. During the study, children are closely monitored for infection recurrence 28 days after completing antibiotics. Assessments include clinical evaluations, urine cultures, and monitoring for any adverse effects. The total participation covers treatment and follow-up periods to ensure safety and measure outcomes such as infection recurrence and bacterial resistance. This is a Phase 4 open-label randomized trial conducted across multiple centers.

Researchers are studying patients with completely removed non-small cell lung cancer (NSCLC) who have common EGFR mutations (L858R and Del19). The study aims to include broad-panel centralized genetic testing at the start to better understand factors predicting outcomes and resistance to the drug osimertinib when used after surgery. It also investigates the molecular changes linked to cancer returning during or after osimertinib treatment to find better treatment options if the cancer comes back in a metastatic form. The study involves collecting plasma circulating tumor DNA (ctDNA) samples before surgery (optional), 4 to 8 weeks after surgery, before starting any adjuvant chemotherapy or osimertinib treatment, every six months during follow-up, and at relapse. Tumor tissue samples from surgery and optionally at relapse are also collected for molecular analysis. Patients may receive adjuvant chemotherapy if needed before starting osimertinib, which is given with the intent to treat for three years. Participants will be regularly followed every 3 to 6 months according to standard recommendations. Researchers will monitor genetic markers using blood and tissue samples to study cancer relapse and resistance. The main outcome is to assess the feasibility of this molecular monitoring approach over an 18-month period. Safety and long-term follow-up are included, aiming to improve treatment decisions for patients with resected NSCLC and EGFR mutations.

Researchers are evaluating the potential benefits of using neoadjuvant immuno-chemotherapy followed by sequential hypofractionated radiotherapy in patients with unresectable Stage III non-small cell lung cancer (NSCLC) who are elderly or unfit for surgery. This Phase II study aims to compare this approach with the current benefit obtained from maintenance immunotherapy, focusing on improving survival outcomes for this patient group. Participants receive neoadjuvant treatment consisting of three cycles of Carboplatin and Paclitaxel chemotherapy, combined with Cemiplimab immunotherapy over 12 weeks. After completing neoadjuvant therapy, patients undergo curative hypofractionated radiotherapy (55 Gy in 20 fractions). Following radiotherapy, maintenance immunotherapy with Cemiplimab is administered every 3 weeks for up to 12 months. During the study, participants are closely monitored through scheduled visits, laboratory tests, and assessments to evaluate treatment effectiveness and safety. The primary outcome measured is progression-free survival over about 18 months. Researchers also assess patients’ ability to tolerate the treatments and track disease progression. The total study participation includes the neoadjuvant phase, radiotherapy, maintenance therapy, and follow-up assessments.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating the safety and effectiveness of a new drug called EIK1001 combined with Pembrolizumab compared to a placebo with Pembrolizumab as the first treatment for patients with advanced melanoma. This is a multicenter, randomized, double-blind Phase 2/3 study that includes dose optimization and an expansion phase. Participants must have advanced melanoma confirmed by tests and be eligible for standard therapy with Pembrolizumab. The study involves two main treatment groups: one receiving EIK1001, a drug that activates immune receptors (TLR 7/8), along with Pembrolizumab, a PD-1 inhibitor, and the other receiving a placebo plus Pembrolizumab. Treatment will be given as first-line therapy, with detailed dose optimization and expansion parts to determine the best dosing. Prior radiotherapy must be completed at least two weeks before starting the study treatment. Participants will undergo regular assessments including imaging scans like CT or MRI to measure tumor response, laboratory tests to check organ function, and monitoring for side effects. Researchers will follow participants for up to five years to track progression-free survival, overall survival, objective response, and adverse events. Women of childbearing potential will have pregnancy tests and must use contraception during and after the study. The total participation time includes screening, treatment, and long-term follow-up to ensure safety and measure outcomes.

Researchers are comparing two treatments for abdominal aortic aneurysms with a short aortic neck measuring 4 to 15 mm. The study evaluates the safety and performance of EndoVascular Aneurysm Repair (ESAR) using the Endurant II or Endurant IIs endograft combined with the Heli-FX EndoAnchor system, against Fenestrated Endovascular Aneurysm Repair (FEVAR) using customizable fenestrated grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft). This randomized trial aims to determine which approach is better for patients with challenging anatomical features that make standard EVAR unsuitable. Participants receive either the ESAR treatment with the Endurant endograft plus Heli-FX EndoAnchor or the FEVAR treatment with fenestrated endografts from Cook or Terumo. Device selection depends on each patient's anatomy and suitability. Both treatments focus on repairing the aneurysm while accommodating the short neck length and other anatomical criteria. The study follows patients to assess technical success for up to 12 months after the procedure and monitors safety by tracking major adverse events within 30 days post-procedure. During the study, participants undergo detailed anatomical and clinical evaluations to confirm eligibility and suitability for the assigned treatment. Researchers collect imaging and clinical data to evaluate outcomes such as device performance and patient safety. Participants are followed for at least one year to observe treatment effectiveness and any complications. The study requires participants to comply with follow-up visits and assessments as outlined in the protocol to ensure comprehensive monitoring of results.

Researchers are evaluating the safety, tolerability, how the body processes the drugs, and early antitumor effects of new RAS(ON) inhibitors alone or combined with standard treatments in patients with advanced RAS-mutated non-small cell lung cancer (NSCLC) and other solid tumors. This open-label platform Phase 1b/2 study focuses on patients with specific KRAS or RAS mutations, including KRAS G12C and RAS G12D mutations. The study is divided into multiple subprotocols, each targeting different mutations and treatment combinations. The study includes several subprotocols: Subprotocol A tests RMC-6291 alone or with RMC-6236 plus pembrolizumab, with or without chemotherapy, in KRAS G12C-mutated tumors. Subprotocol B evaluates RMC-6236 combined with pembrolizumab, with or without chemotherapy, in RAS-mutated NSCLC. Subprotocol C studies RMC-9805 alone or with RMC-6236 plus other anticancer agents in RAS G12D-mutated NSCLC. Subprotocol D focuses on RMC-9805 in previously treated RAS G12D-mutated NSCLC patients. Subprotocols A, B, and C have two parts: dose exploration and dose expansion, while Subprotocol D has one part. Participants will undergo assessments to monitor safety and drug effects, including tracking side effects up to five years and identifying dose-limiting toxicities within 21 days. Researchers will collect pharmacokinetic data and evaluate antitumor activity. The study involves careful monitoring of organ function and overall health, with various evaluations throughout the treatment periods to understand the optimal dosing and treatment combinations for these mutations.

Researchers are evaluating the effectiveness of tarlatamab compared to standard chemotherapy in patients with advanced, poorly differentiated neuroendocrine carcinomas (NECs) of the lung or gastroenteropancreatic system. This study focuses on patients who have been previously treated and aims to assess overall survival over about 4 years. The trial builds on earlier findings showing tarlatamab's potential benefits in small-cell lung cancer and explores its use in related NECs with specific tumor characteristics. Participants are randomly assigned to receive either tarlatamab at a dose of 10 mg every two weeks or a standard chemotherapy regimen chosen by the investigator. Standard chemotherapy options may include immune checkpoint inhibitors, docetaxel, topotecan for lung NECs, or FOLFOX, FOLFIRI, or alkylating-based chemotherapy for digestive NECs. The study carefully monitors treatments and responses during the treatment period. Throughout the study, participants undergo scheduled visits, laboratory testing, and imaging assessments to track tumor progression and overall health. Researchers collect tumor tissue samples for central review and research purposes. Safety is closely monitored, and participants must meet specific health and laboratory criteria. The main outcome measured is overall survival in patients who receive at least one dose of study treatment, with follow-up lasting approximately four years.