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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 evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage (stage I and II) classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments: some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

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 studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase II/III trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.

Researchers are evaluating the effects of combining two drugs, cabozantinib and nivolumab, in treating patients with advanced melanoma or squamous cell head and neck cancer that has spread to nearby tissues, lymph nodes, or distant parts of the body. This phase II study aims to understand how well patients can be grouped based on tumor biomarkers, specifically tumor mutational burden and tumor inflammation signature, and to see if these markers influence how the cancer responds to treatment. Participants receive nivolumab through an intravenous infusion on the first day of each 28-day cycle, while cabozantinib is taken orally every day. Treatment cycles continue for up to two years unless the cancer worsens or side effects become unacceptable. During the study, patients undergo CT or MRI scans and blood sample collections. Tumor biopsies are done at screening and optionally during follow-up. After treatment ends, patients are followed every 12 weeks for one year, then every six months for up to three years. Throughout the trial, researchers monitor tumor response, including shrinkage or stabilization, and assess safety and side effects. They measure how quickly biomarker results can be obtained, overall response rates, disease control, progression-free survival, and overall survival. Additional analyses aim to identify biomarkers that predict response and side effects. Participants are regularly evaluated through scans, blood tests, and biopsies to track their health and treatment effects over time.

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients' medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

Researchers are evaluating treatments for younger patients with intermediate risk acute myeloid leukemia (AML) in this phase II MyeloMATCH trial. The study compares three treatment approaches: cytarabine with daunorubicin, cytarabine with daunorubicin plus venetoclax, and venetoclax with azacitidine. The goal is to determine if adding venetoclax improves the elimination of leukemia cells by measuring undetectable residual disease after treatment. Participants are randomly assigned to one of three treatment groups. The first group receives daunorubicin intravenously on days 2-4, cytarabine intravenously continuously on days 2-8, and venetoclax orally once daily on days 1-11, with possible reinduction cycles based on bone marrow assessments. The second group receives azacitidine intravenously or subcutaneously on days 1-7 or days 1-5 and 8-9 and venetoclax orally daily for 28 days, repeating cycles every 28 days for two cycles. The third group receives daunorubicin intravenously on days 1-3 and cytarabine intravenously continuously on days 1-7, with possible reinduction based on bone marrow results. Treatment continues unless disease progresses or unacceptable side effects occur. Participants undergo bone marrow aspirations and blood sample collections during the study and as needed. After treatment, follow-up visits occur at 4 weeks, then every 3 months for a year, every 6 months for the second year, and yearly afterward. Researchers measure the rate of undetectable measurable residual disease, treatment toxicities, remission rates, event-free survival, relapse-free survival, overall survival, and responses related to genetic findings. The total study duration includes treatment and long-term follow-up up to 10 years.

Researchers are evaluating the addition of a stem cell transplant with melphalan after chemotherapy with daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) compared to Dara-VCD chemotherapy alone for patients newly diagnosed with amyloid light chain (AL) amyloidosis. This phase III trial aims to assess outcomes such as major organ deterioration progression-free survival, overall survival, organ response rates, and quality of life. The study also investigates minimal residual disease negativity and treatment-related side effects. Participants initially receive induction therapy with Dara-VCD drugs over a series of 28-day cycles, including daratumumab and hyaluronidase-fihj subcutaneously, bortezomib subcutaneously, cyclophosphamide orally or intravenously, and dexamethasone orally or intravenously. After induction, those with a partial response or better are randomized to one of two consolidation arms: either continued Dara-VCD chemotherapy or high-dose melphalan chemotherapy followed by autologous stem cell transplant. Following consolidation, patients receive maintenance daratumumab and hyaluronidase-fihj therapy every 28 days for up to 18 cycles, unless the disease progresses or unacceptable toxicity occurs. Throughout the study, participants undergo multiple assessments including CT, MRI, or PET-CT scans, fat pad biopsies, echocardiography, bone marrow aspiration and biopsies, and blood and urine sample collections at regular intervals. Patient-reported outcomes related to physical function, fatigue, and symptoms are collected using standardized questionnaires. After completing study treatment, patients are followed up every 3 to 6 months for up to 4 years to monitor progression and overall health.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating the efficacy and safety of tozorakimab, a drug administered under the skin, in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb study is designed as a double-blind, placebo-controlled trial to find the right dose range of tozorakimab for this group. The study aims to better understand how tozorakimab may impact asthma control and reduce severe asthma attacks in this population. Participants will be randomly assigned to one of three groups: one receiving a lower dose of tozorakimab, another receiving a higher dose or placebo, and a third group receiving placebo injections. All treatments are given by subcutaneous injection. The study will last for 26 to 52 weeks, during which the participants will be closely monitored for asthma exacerbations and lung function changes. This includes assessing how well tozorakimab is tolerated and how it affects asthma symptoms and quality of life. During the study, participants will undergo regular assessments including lung function tests, questionnaires about asthma control and quality of life, and blood tests to measure drug levels and immune response. Researchers will track the annual rate of severe asthma flare-ups as the main outcome. Safety will be monitored throughout the study period, and participants will be followed for up to one year. The study is designed to ensure participants receive careful observation and support while contributing valuable information about tozorakimab’s potential use in asthma treatment.