Belleville

Researchers are conducting a multinational, multicenter observational study to understand the real-world use of garadacimab in patients with hereditary angioedema (HAE). The study includes patients who are newly starting garadacimab treatment as part of their regular clinical care. The main goal is to evaluate the effectiveness of garadacimab by comparing the rate of HAE attacks before and after treatment over a 24-month period, along with assessing safety and quality of life. Participants will receive garadacimab as prescribed by their doctors in routine practice, without any additional interventions from the study. There is one study group consisting of patients treated with garadacimab. Data collection includes information from patient medical records, electronic diaries, and routine clinical visits. Retrospective and prospective data on HAE attacks, prior treatments, safety, and healthcare resource use will be gathered throughout the study. Each participant will be followed for 48 months from the first garadacimab dose. During this time, researchers will collect data through electronic diaries, medical record reviews, and scheduled clinical assessments. Outcome measures include attack rates, adverse event monitoring, angioedema control, and quality-of-life questionnaires. This long-term follow-up helps capture the real-world experience and safety of garadacimab in routine care.

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months (5 years). The study allows prior use of CDK4/6 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patient's randomization.

Researchers are studying the safety and effectiveness of lebrikizumab in adults with perennial allergic rhinitis, a condition involving year-round nasal allergy symptoms. This phase 3 clinical trial aims to assess how well lebrikizumab works when given alongside standard intranasal corticosteroid therapy. The study is sponsored by Eli Lilly and Company and lasts up to 29.5 months for each participant. Participants will receive lebrikizumab or a matching placebo through subcutaneous injections on different schedules, either every 2 weeks, every 4 weeks, or every 8 weeks, combined with ongoing intranasal corticosteroid use. The trial includes multiple treatment groups with random assignment and double-blind masking to compare the effects of lebrikizumab against placebo while all participants continue their background nasal spray therapy. During the study, participants will have their nasal symptoms evaluated at baseline and at various points, including week 16 and week 56, using symptom scores and quality of life questionnaires. Researchers will monitor changes in nasal symptoms, quality of life, and postnasal drip. Safety and any adverse effects will also be tracked throughout the study duration, with follow-up visits and assessments as scheduled.

Researchers are investigating treatments for adults in the US with moderate to severe chronic spontaneous urticaria (CSU) that is not well controlled by second generation H1-antihistamines (sgH1-AHs). The study is a Phase 3b, randomized, double-blind trial comparing remibrutinib, taken orally twice daily, to dupilumab, given as injections every two weeks, both added to standard antihistamine therapy. The trial aims to assess the early effectiveness of these treatments, focusing on improvements within the first four weeks. The trial includes a screening period up to 4 weeks to confirm eligibility, followed by a 12-week core treatment phase where about 400 participants will receive either remibrutinib with placebo injections or dupilumab with placebo tablets, alongside stable sgH1-AH background therapy. Participants can use additional antihistamines as rescue therapy if needed, up to a maximum daily dose. After the core phase, participants may join an optional 12-week open-label extension to receive remibrutinib, depending on its commercial availability. Safety follow-up continues for all participants, with phone calls and visits scheduled up to 24 weeks or longer if the extension continues. During the study, participants will complete daily diaries to track symptoms, and researchers will measure changes in urticaria activity scores at various time points, emphasizing Week 4. Safety and response will be monitored throughout, including phone follow-ups and site visits. Those who do not enter the extension will have safety calls at Weeks 16 and 24, while those in the extension will have continued monitoring until treatment ends or remibrutinib becomes commercially available. The total time involved may extend beyond 24 weeks depending on treatment continuation.

Researchers are evaluating the medicine PF-08046054 compared to the standard treatment docetaxel for adults with non-small cell lung cancer (NSCLC) that has PD-L1 expression of 1% or higher. This study focuses on participants whose cancer has spread or cannot be removed by surgery or treated with radiation, and who have progressed after treatment with PD-L1 or PD-1 inhibitors, platinum chemotherapy, and targeted therapies when applicable. The study is a randomized, phase 3 trial sponsored by Pfizer. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will have an intravenous infusion twice every 21 days, while those in the docetaxel group will receive one infusion every 21 days. Treatment may continue for up to five years if the cancer responds well. The treatments are given in cycles with close monitoring. During the study, participants will visit the clinic regularly for evaluations to monitor their health and response to the study treatments. Researchers will assess overall survival over about five years and track disease progression, response rates, duration of response, and quality of life measures. Safety will be monitored through adverse event reporting for up to 90 days after treatment ends. Additional blood tests will measure drug levels and antibody responses during the first year of treatment.

Researchers are evaluating the safety and effectiveness of atebimetinib combined with a modified schedule of gemcitabine and nab-paclitaxel compared to the standard gemcitabine and nab-paclitaxel treatment in patients with metastatic pancreatic adenocarcinoma. This Phase 3, global, open-label, randomized study aims to see if the new combination improves overall survival when used as the first treatment for this condition. Participants will be randomly assigned to one of two groups: one group will receive atebimetinib as once-daily oral tablets along with biweekly intravenous infusions of gemcitabine and nab-paclitaxel (modified dosing), while the other group will receive the standard weekly intravenous infusions of gemcitabine and nab-paclitaxel for three weeks followed by a one-week break. This treatment period is expected to last up to approximately two years. During the study, participants will be monitored regularly for overall survival, progression-free survival, response rates, disease control, and quality of life using questionnaires. Researchers will also track adverse events and safety throughout. The trial involves assessments like imaging to measure disease and laboratory tests to check organ function. Participation may last up to about two years with ongoing evaluation of treatment effects and patient well-being.

This research aims to evaluate the safety and effectiveness of adjusting fluoropyrimidine (FP) chemotherapy doses based on genetic testing for DPYD variants in cancer patients. The study focuses on patients with cancers such as colorectal, breast, head and neck, and gastrointestinal neoplasms. It compares the occurrence of severe FP-related toxicities in patients with one DPYD gene variant receiving reduced doses against patients with normal DPYD genes receiving standard doses. This prospective treatment study seeks to validate DPYD-guided dosing strategies in a real-world clinical setting. Participants receive treatment in two groups: the control arm receives 100% of standard FP doses according to the BEACON order plan, with dose reductions applied if severe toxicities occur. The experimental arm includes patients with one DPYD variant who start with 50% of the regular FP dose for the first two cycles, with possible dose escalation if tolerated. The chemotherapy drugs studied include Fluorouracil injection and Xeloda (Capecitabine). Throughout the study, participants are monitored for severe fluoropyrimidine-related toxicities (Grade 3 to 5) over a period of up to 24 months. Researchers will also track patterns of dose modifications, such as reductions or escalations. The study involves genetic testing before therapy, regular assessments of treatment response and safety, and follow-up to measure outcomes related to toxicity and treatment adjustments.

Researchers are investigating treatments for pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. Participants must have previously received ribociclib or palbociclib-based therapy and show progression after treatment with an aromatase inhibitor (AI). The study compares the effects of two drug combinations to evaluate their safety, tolerability, and ability to control the cancer. Participants are randomly assigned to receive one of two treatment combinations. One group takes oral lasofoxifene 5 mg daily along with oral abemaciclib 150 mg twice a day. The other group receives intramuscular fulvestrant 500 mg on Days 1, 15, and 29, then monthly thereafter, combined with oral abemaciclib 150 mg twice daily. The study is open-label and conducted across multiple centers. During the trial, participants will be monitored regularly for progression-free survival, objective tumor response, overall survival, clinical benefit, and quality of life using specific questionnaires. Researchers will also assess the duration and time to response, time to chemotherapy, and record any adverse events. The study period for these assessments is approximately three years, ensuring continuous evaluation of treatment effects and safety.

Researchers are studying patients with non-small cell lung cancer (NSCLC) to better understand how the cancer changes on a molecular level during standard treatments. The study aims to track the disease's progress and explore how changes in circulating tumor DNA (ctDNA) might predict cancer recurrence and treatment outcomes. This observational study collects clinical and molecular health data over time from patients receiving usual care. The study involves two groups of patients. The first group includes patients with early-stage NSCLC (Stages I to IIIB) who are treated with surgery and possibly additional therapies before or after surgery. The second group includes patients with advanced stage IV NSCLC receiving first-line immunotherapy, either alone or combined with chemotherapy. Patients will provide blood samples regularly during their routine care to help researchers analyze ctDNA and its changes over time. Participants will be asked to provide tumor samples and give additional blood samples during standard surveillance visits. Researchers will monitor disease-free survival and overall survival over periods up to five years. They will also compare ctDNA testing results with traditional imaging methods used every six months to detect cancer recurrence. The study tracks various outcomes, including treatment patterns and progression-free survival, to gain a detailed understanding of how the disease evolves under standard care.

Researchers are evaluating the effectiveness and safety of Adagrasib (MRTX849) alone and combined with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The study includes a Phase 2 portion focusing on patients with various PD-L1 scores and a Phase 3 portion comparing Adagrasib plus pembrolizumab versus pembrolizumab alone in patients with high PD-L1 levels. This research aims to improve first-line treatment options for advanced NSCLC. The Phase 2 study has three groups: two cohorts with low PD-L1 scores receiving either Adagrasib alone or combined with pembrolizumab, and one cohort with higher PD-L1 scores receiving the combination. In Phase 3, patients are randomly assigned to receive either Adagrasib with pembrolizumab or pembrolizumab alone. Adagrasib is taken orally twice daily, while pembrolizumab is given by intravenous infusion every three weeks. Participants will undergo regular assessments over 22 months for Phase 2 and 36 months for Phase 3, including evaluations of tumor response, safety, quality of life, and drug levels in the blood. Brain imaging is also used to check for metastases. Researchers will monitor progression-free survival, duration of response, and side effects to understand the treatments' impact and tolerability throughout the study period.