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Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Researchers are evaluating the combination of nivolumab and blinatumomab compared to blinatumomab alone in children and young adults aged 1 to under 31 years with first relapse of CD19 B-cell acute lymphoblastic leukemia B-ALL, including patients with Down syndrome. This phase II trial aims to compare event-free survival after reinduction and consolidation therapy, assess safety and tolerability, and explore various outcomes such as remission rates and toxicity, with follow-up up to 10 years after enrollment. Participants receive treatments based on their assigned groups and arms, involving cycles of immunotherapy including blinatumomab, nivolumab, dexamethasone, methotrexate, and other chemotherapy drugs given by various routes such as intravenous infusion, intrathecal injection, and oral administration. Treatment cycles repeat every 36 or 37 days for up to two cycles, with some groups receiving radiation therapy or maintenance chemotherapy afterward. Patients with high white blood cell counts or specific disease locations may receive pre-immunotherapy treatments. Throughout the study, participants undergo lumbar punctures, bone marrow biopsies and aspirations, and collection of blood, urine, and cerebrospinal fluid for monitoring. Researchers measure outcomes such as minimal residual disease negative remission rates and event-free survival. After completing treatment, participants are followed every three months for one year to monitor their health and any long-term treatment effects.

Researchers are investigating the treatment outcomes of subcutaneous anifrolumab 120 mg given once weekly as add-on therapy to antimalarials, with or without glucocorticoids GCs, in patients with systemic lupus erythematosus SLE who have not previously received immunosuppressants or biologic therapies and are not in low disease activity status at enrollment. This Phase 3, multinational, open-label study aims to better understand remission rates, including DORIS remission, and the ability to taper and withdraw chronic GCs in this patient group. Participants will receive anifrolumab administered subcutaneously once weekly for 52 weeks using an autoinjector pen. The study includes a screening period of up to 35 days before treatment starts. For patients on higher doses of GCs at baseline, a structured tapering protocol will be followed from week 5 to week 40, aiming to reduce GC doses to 5 mgday and potentially withdraw GCs completely after sustained remission. After week 40, no further GC dose reductions will occur. An additional 12-week safety follow-up is planned for participants who discontinue anifrolumab after week 52. During the study, participants will undergo regular assessments including clinical evaluations, quality of life and fatigue questionnaires, and laboratory tests to monitor disease activity and remission status. Researchers will measure outcomes such as attainment and duration of DORIS remission, low disease activity, flare incidence, and changes in GC use. Safety will be monitored throughout treatment and in the follow-up period. The total study duration for participants is approximately 69 weeks, including screening, treatment, and safety follow-up.

Researchers are evaluating how well the 20-valent pneumococcal conjugate vaccine 20vPnC works against pneumonia caused by seven new types of the Streptococcus pneumoniae bacteria. This study focuses on adults aged 65 years and older who are hospitalized with pneumonia confirmed by chest imaging. The study aims to compare the presence of pneumonia caused by these specific bacteria types in people vaccinated with 20vPnC versus those with pneumonia caused by other bacteria or strains. This observational study involves adults 65 years and older hospitalized with radiologically-confirmed community-acquired pneumonia RADCAP. Participants will provide a urine sample for testing pneumococcal bacteria using BinaxNOW and specific urinary antigen detection assays UAD-1 and UAD-2. Cases are identified by detection of the seven additional bacteria types in 20vPnC beyond the previous 13-valent vaccine, while controls include other pneumonia cases without these serotypes. No treatment is given as part of the study. Participants will be involved for about 1 to 2 days for urine sample collection and providing medical history. Researchers will collect detailed information on illness and hospital stay up to 30 days through medical record review. The main outcome measured is the effectiveness of 20vPnC against pneumonia caused by the seven additional bacterial types over approximately 55 months. Other clinical features and pneumonia types will also be reviewed during this period.

This trial investigates monitoring and treatment options for patients with low risk and standard risk metastatic germ cell tumors, which are cancers that start in the cells that produce sperm or eggs. The study aims to find out if active surveillance after surgical removal of low risk tumors can maintain high survival rates, and whether carboplatin or cisplatin chemotherapy works better for treating standard risk tumors in children, adolescents, and young adults. Patients with low risk tumors undergo observation after surgery and may transfer to a standard risk treatment arm if the tumor recurs. Those with standard risk tumors are randomly assigned to receive one of two chemotherapy regimens one containing carboplatin, bleomycin, and etoposide, or the other containing cisplatin, bleomycin, and etoposide. Treatments are given intravenously in cycles every 21 days for up to 3 or 4 cycles depending on the group. Throughout the study, patients have imaging scans, blood tests, tumor biopsies, and pulmonary function tests to monitor response and side effects. Participants are followed closely during treatment and afterward with regular check-ups including CT, MRI, and chest X-rays, as well as blood sample collections. Follow-up visits occur every 2 months for the first year, then every 3-6 months up to 2 years, every 6 months for years 3 to 5, and annually up to 10 years. Researchers measure overall survival, event-free survival, hearing loss, body composition, tumor markers, and patient-reported outcomes related to hearing and neuropathy. This long-term monitoring helps assess the effects and safety of chemotherapy and surveillance strategies.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab compared to paclitaxel and ramucirumab alone in patients with advanced stomach or esophageal adenocarcinoma. This phase IIIII trial aims to see if nivolumab improves progression-free survival and overall survival in these patients. Nivolumab is an immunotherapy monoclonal antibody that may help the immune system attack cancer, while ramucirumab may prevent tumor blood vessel growth, and paclitaxel stops cancer cells from dividing. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, combined with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives only ramucirumab and paclitaxel on the same schedule without nivolumab. Treatment cycles continue unless the disease worsens or side effects become unacceptable. During the study, patients undergo CT scans and MRI imaging, and may optionally provide blood samples. Throughout the trial, participants are monitored with regular imaging and optional blood tests. After treatment ends, patients have follow-up visits at 30, 60, and 90 days, then every six months for up to three years. Researchers assess progression-free survival, overall survival, response rates, disease control, safety, and quality of life using questionnaires and patient-reported symptoms. This comprehensive monitoring helps evaluate treatment effects and patient well-being over time.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.