Saint Mande

Researchers are evaluating how well pre-treatment 68Ga-FAPI-46 PET/CT imaging can predict the histological response to neoadjuvant chemo-immunotherapy in patients with early-stage high-risk triple-negative breast cancer (TNBC). This prospective multicenter study focuses on female patients who have not yet been treated and are recommended to receive pembrolizumab combined with chemotherapy as their standard care. The study aims to improve understanding of treatment effectiveness using advanced imaging techniques before therapy begins. Participants will receive neoadjuvant treatment consisting of pembrolizumab 200 mg every three weeks combined first with four cycles of paclitaxel plus carboplatin, followed by four cycles of doxorubicin or epirubicin plus cyclophosphamide. After surgery, patients will continue adjuvant pembrolizumab for nine cycles or until cancer recurrence or unacceptable side effects occur. Each participant will undergo a 68Ga-FAPI-46 PET/CT scan before starting treatment, performed on the same machine as the 18F-FDG PET/CT scan and within 14 days prior to therapy. Throughout the study, researchers will monitor participants using scans and tissue analysis to assess histological response to treatment. They will measure the prediction accuracy through the area under the ROC curve at six months. Patient compliance, informed consent, and health insurance coverage are required for participation. Safety and treatment response will be carefully followed during and after the therapy period.

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

This research aims to evaluate the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis. The study is conducted in France and focuses on understanding how this treatment performs outside of controlled clinical trial settings. Participants in this observational study will be newly starting deucravacitinib as prescribed by their treating clinician. There are no additional study treatments or placebo groups, as the study observes the outcomes of the treatment during routine clinical care. During the study, researchers will assess clinical outcomes including the Physician's Global Assessment (PGA) and the Dermatology Life Quality Index (DLQI) at baseline and at months 4, 12, 18 (optional), and 24. They will also monitor how long participants remain on deucravacitinib treatment, up to 24 months. These evaluations help to measure both the effectiveness and impact on quality of life for participants with plaque psoriasis.

Researchers are evaluating repotrectinib in adults and adolescents with advanced or metastatic solid tumors that have specific gene rearrangements (ALK, ROS1, NTRK1, NTRK2, or NTRK3). The study includes a Phase 1 dose escalation to determine safe dosage levels and side effects, and a Phase 2 expansion to assess the drug's overall response rate in different patient groups. The trial also investigates the drug's effect on liver enzymes in a substudy and measures outcomes like duration of response and survival. The treatment involves oral repotrectinib capsules given to participants. Phase 1 focuses on finding the maximum tolerated dose and recommended dose for Phase 2 by monitoring toxicities within 28 days of dosing. Phase 2 enrolls subjects into six groups based on prior treatments and tumor gene status, including those who are new to ROS1 or TRK targeted therapies and those who have received previous therapies. Each group receives repotrectinib to evaluate its effects in their specific conditions. Participants will undergo assessments including tumor measurements by imaging reviewed independently, laboratory tests, and monitoring for side effects. Researchers will track dose-limiting toxicities, response rates over two to three years, and survival outcomes. Safety and tolerability are closely observed during treatment. The study requires ongoing follow-up, including confirmation of tumor gene status and evaluation of response and progression over time.

Researchers are evaluating the safety and effects of Abrocitinib, a medication given as a tablet once daily, for adults with moderate to severe atopic dermatitis (AD), a long-lasting skin condition causing inflammation, redness, and irritation. This observational cohort study aims to understand how Abrocitinib works in real-life clinical settings and its impact on patients with moderate-to-severe chronic AD who are eligible to receive this treatment. All participants will receive Abrocitinib daily and may continue using medicated topical treatments for their AD at the same time. The study lasts for 24 months, during which participants will visit the study clinic approximately five times, or about once every four to six months. These visits will allow researchers to monitor the effects and safety of the treatment in a real-world context. Participants will be closely observed for changes in their AD severity, specifically looking for improvements measured by the Investigator's Global Assessment (IGA) score at 16 weeks. The study will also assess safety and how patients manage their treatment over time. Overall, the study aims to provide valuable information on how Abrocitinib affects adults with moderate-to-severe atopic dermatitis in everyday clinical practice.

Researchers are evaluating an investigational drug called marlotamig (REGN7075) alone and in combination with cemiplimab, with or without chemotherapy, in adults with advanced solid tumors. The study aims to assess the safety, tolerability, and optimal dosing of marlotamig with cemiplimab, as well as to explore their effectiveness in treating cancer by controlling tumor growth. Additional goals include monitoring side effects, studying how the drugs work in the body, measuring drug levels in the blood, and checking for the development of antibodies against the treatments that might affect their action or cause side effects. Participants may receive marlotamig through intravenous or subcutaneous injection weekly or every three weeks. Cemiplimab is given every three weeks by intravenous infusion or subcutaneous injection, sometimes combined with platinum-based doublet chemotherapy administered intravenously every three weeks. Other drugs like bevacizumab or trifluridine-tipiracil may also be given according to the study plan. Treatment and dosing schedules are carefully followed to find the best approach to manage advanced cancers. During the study, participants will be closely monitored for adverse effects including dose-limiting toxicities, treatment-emergent adverse events, serious events, and laboratory abnormalities for up to five years after the last dose. Researchers will also measure the objective response rate to evaluate how well tumors respond to treatment. Participants undergo regular assessments including biopsies, blood tests, and clinical evaluations to track safety and effectiveness throughout the study and follow-up periods.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

Researchers are evaluating treatments for metastatic clear cell renal cell carcinoma (RCC), a type of kidney cancer. The study compares two combination therapies: immune checkpoint inhibitor with immune checkpoint inhibitor (ICI-ICI) versus immune checkpoint inhibitor with vascular endothelial growth factor receptor tyrosine kinase inhibitor (ICI-VEGFR TKI). The study aims to determine which approach improves overall survival (OS) based on PD-L1 biomarker status. It is a phase III randomized trial enrolling 1250 patients across eight European countries, designed to guide treatment selection using a biomarker-based strategy. The treatments studied include nivolumab and ipilimumab given as intravenous infusions every 21 days in the ICI-ICI group. The ICI-VEGFR TKI group receives pembrolizumab intravenously combined with one of the oral drugs cabozantinib, axitinib, or lenvatinib, taken daily at specified doses. Patients are assigned to treatment arms based on PD-L1 testing results. The trial also involves patient advocacy input and aims to inform clinical guidelines for first-line metastatic RCC therapy. Participants will be monitored throughout the study with evaluations including laboratory tests and performance status assessments. The primary outcome is overall survival measured at the end of the study after 97 months. Additional assessments may include quality of life and patient-reported outcomes. The study requires participants to comply with visits and procedures, and follow-up includes safety and efficacy monitoring to understand the impact of these treatments over time.

Researchers are evaluating whether adding local consolidative radiotherapy to the standard treatment can improve overall survival in patients with metastatic urothelial bladder cancer. The study focuses on patients who have no disease progression and have no more than three remaining distant metastatic lesions after completing first-line systemic therapy. This is a Phase II, multicenter, randomized, open-label trial with a follow-up period of 4 years for each participant. Participants are assigned to receive either standard care alone or standard care combined with consolidative radiotherapy targeting the pelvic area and/or metastatic lesions. Radiotherapy may be combined with previous transurethral resection of bladder tumor as part of the treatment. The study includes patients who have completed 4-6 cycles of first-line systemic therapy, including chemotherapy and/or immunotherapy, and have no progression of disease. Patients who began maintenance therapy are also eligible. During the study, participants will be monitored over 4 years from randomization. Researchers will assess overall survival as the primary outcome. Participants will undergo imaging scans to evaluate metastatic lesions and may be assessed for eligibility for stereotactic body radiotherapy (SBRT) based on dose constraints and prior radiotherapy exposure. The study also involves regular follow-up to monitor disease status and treatment safety.