Temple

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating real-world patient characteristics, treatment methods, and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the United States and Europe. The study includes patients receiving mavacamten, other treatments, or no treatment due to intolerance or treatment failure. The US sub-study focuses on safety of mavacamten, while the European sub-study assesses both safety and effectiveness of mavacamten in everyday care. Participants may receive mavacamten or standard treatments like beta blockers, non-dihydropyridine calcium channel blockers, or disopyramide as prescribed by their doctors. The study observes these groups over time in routine clinical settings without altering their care. The study includes two main groups based on treatment type and monitors outcomes up to five years. Participants undergo evaluations including echocardiograms, heart function assessments using New York Heart Association (NYHA) class, left ventricular outflow tract gradient measurements, and patient-reported health questionnaires. Researchers also track heart failure events, arrhythmias, major cardiovascular events, hospitalizations, mortality, and biomarkers like NT-proBNP and cardiac troponin. Follow-up varies by region, lasting up to 18 months in Europe and up to 5 years in the United States.

Researchers are comparing two treatments, niraparib and temozolomide (TMZ), in adults with newly diagnosed glioblastoma multiforme (GBM) that has an unmethylated MGMT promoter. This Phase 3 trial aims to find out if niraparib can improve overall survival compared to the current standard treatment, TMZ. The trial will enroll 450 adult participants and is sponsored by the Ivy Brain Tumor Center. Participants will be randomly assigned to receive either niraparib or TMZ. Niraparib is taken orally once daily starting with radiation therapy (RT) for 6 to 7 weeks and continued as an adjuvant treatment until cancer progression or discontinuation. The TMZ group receives the drug daily during RT, followed by a rest period and then up to 6 cycles of adjuvant TMZ. Radiation therapy is given as standard care to 60 Gy in 30 fractions. During the study, participants will complete scheduled visits and keep a diary to record medication use. Researchers will monitor overall survival over 24 months as the primary outcome. Secondary measures include progression-free survival, response rates, quality of life assessments, neurocognitive function tests, and tracking of adverse events. Safety and treatment effects will be closely observed throughout the trial period, which continues until March 2028.

This research aims to evaluate the persistence of immune response and the safety of revaccination with an adjuvanted Respiratory Syncytial Virus (RSV) vaccine in adults aged 18 years and older who have received lung or kidney transplants. Participants are individuals undergoing chronic immunosuppressive therapy who previously received one or two doses of the adjuvanted RSVPreF3 vaccine in a prior study. The study focuses on assessing immune responses separately for those who had one or two initial doses and collectively for safety analysis. Participants will receive an additional dose of the adjuvanted RSVPreF3 vaccine administered by injection into the muscle at the start of this study. The study groups include those who received one dose (IC_1) and those who received two doses (IC_2) in the prior study. Revaccination occurs at the first visit (Day 1), and participants will be monitored through scheduled visits to assess immune response and safety. During the study, participants will have multiple visits at Day 1, Day 31, and Day 180 to measure specific immune markers, including RSV-A and RSV-B neutralizing antibody levels. Safety evaluations include monitoring for side effects and adverse events from the day of revaccination up to one year. Participants will complete diaries and questionnaires, and their health will be regularly assessed to track immune response persistence and any related safety concerns.

Researchers are investigating the best way to combine chemotherapy and radiation therapy for patients aged 3 to 29 years with localized non-germinomatous germ cell tumors (NGGCT) in the brain. This phase II trial aims to optimize treatment based on how well the tumor responds to initial chemotherapy, with the goal of reducing spinal cord relapses and adjusting therapy for better disease control. The study also compares different radiation types and examines cognitive and physical effects in children and young adults with NGGCT. Participants first receive induction chemotherapy consisting of carboplatin, etoposide, and ifosfamide over six cycles every 21 days. Based on tumor response, patients are assigned to one of two plans: Plan A involves whole ventricular plus spinal canal irradiation (WVSCI), delivered daily for 6 weeks, while Plan B includes high-dose chemotherapy with stem cell transplant followed by radiation therapy to the whole brain and spine. Some patients may undergo second-look surgery depending on tumor response before continuing treatment. Throughout the study, participants undergo MRI scans, collection of cerebrospinal fluid and blood samples, and questionnaires assessing cognitive, social, and behavioral functioning. Researchers monitor tumor response, progression-free survival, overall survival, and patterns of disease recurrence for up to 10 years. Safety and side effects are also evaluated to better understand long-term outcomes of these treatment approaches.

Researchers are evaluating treatments for participants with KRAS/NRAS and BRAF wild-type colorectal cancer that is recurrent, unresectable, or metastatic. The study compares the length of time participants remain disease-free and overall survival when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. All participants have previously received chemotherapy, and the study is a randomized, open-label phase 3 trial sponsored by Janssen Research & Development, LLC. Participants are assigned to one of two groups. One group receives amivantamab combined with the FOLFIRI chemotherapy regimen, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with FOLFIRI. Treatments are given in 28-day cycles and continue until the disease progresses or other reasons require stopping treatment. During the study, participants undergo regular assessments including imaging to monitor disease status and response to treatment. Researchers measure progression-free survival, overall survival, response rates, duration of response, and quality of life through questionnaires. Safety is monitored by tracking adverse events and laboratory test changes. The primary outcomes are evaluated up to about 2 years for progression-free survival and over 4 years for overall survival, with several secondary outcomes assessed up to the same longer timeframe.

This research aims to compare progression-free survival in adult participants with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. The study evaluates two first-line treatment approaches: amivantamab combined with chemotherapy versus cetuximab combined with chemotherapy. This is a Phase 3 randomized, open-label trial assessing outcomes for this specific cancer type. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles of either mFOLFOX6 (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin) or FOLFIRI (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan hydrochloride). The other group receives cetuximab combined with the same chemotherapy options. Each treatment cycle lasts 28 days, and participants continue treatment until disease progression or other stopping criteria are met. During the study, participants will undergo regular assessments including imaging scans reviewed by a blinded independent committee to measure progression-free survival up to 4 years and 2 months. Additional outcomes such as overall survival, response rates, duration of response, and quality of life will be monitored for up to over 7 years. Safety is tracked through adverse event reporting and laboratory tests. Participants' symptoms and functioning will also be evaluated using quality of life questionnaires throughout the study period.

Researchers are evaluating disitamab vedotin, alone or combined with pembrolizumab, to treat HER2-expressing urothelial cancer that has either spread locally and cannot be removed or has metastasized throughout the body. This phase 2 clinical trial aims to assess how well these treatments work and how safe they are for participants with this type of advanced cancer. The study includes several groups receiving either disitamab vedotin alone given intravenously every two weeks or in combination with pembrolizumab administered intravenously on the first day of each six-week cycle. Different cohorts represent variations in prior treatment history and tumor HER2 expression levels. The trial also includes specific cohorts in Japan and evaluates both monotherapy and combination therapy approaches, with treatment continuing for about two years. Participants will undergo regular assessments including tumor measurements by imaging using standardized criteria, monitoring for side effects, laboratory tests, heart function evaluations, and analysis of drug levels in the body. Safety and response to treatment will be tracked during the treatment period lasting up to two years, with an overall study duration of about three years to observe outcomes such as survival and disease control.

Researchers are evaluating the use of belimumab, in addition to standard therapy, for adults with interstitial lung disease (ILD) linked to connective tissue diseases (CTDs) such as rheumatoid arthritis and systemic lupus erythematosus. ILD causes lung inflammation and stiffness, leading to symptoms like shortness of breath and fatigue, and is a leading cause of death in people with these conditions. The study aims to see if belimumab can stabilize or improve lung function and symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both alongside their usual standard therapy. Belimumab is administered subcutaneously, and the study is designed as a phase 3, double-blind, placebo-controlled trial. The treatment period lasts 52 weeks, during which lung function and symptoms will be closely monitored. Participants will have assessments including lung function tests measuring forced vital capacity, symptom questionnaires, and imaging scans at the start and after 52 weeks. Researchers will also track safety by monitoring adverse events and hospitalizations related to respiratory issues. The overall study duration includes these evaluations up to 52 weeks to understand the treatment's impact on lung disease progression and patient well-being.

Researchers are evaluating the safety and effectiveness of plixorafenib in people with advanced or metastatic solid tumors, including primary central nervous system tumors, that have specific BRAF gene alterations. The study focuses on participants with BRAF fusions or rare BRAF V600 mutations in tumors like melanoma, thyroid cancer, or recurrent CNS tumors. This is a Phase 2 trial aiming to understand how well plixorafenib works in these cancer types. Participants receive plixorafenib as oral tablets continuously in 3-week cycles. The dose may be increased as tolerated and treatment continues until the disease progresses, unacceptable side effects occur, or other reasons lead to stopping. The study includes different groups based on tumor types and BRAF mutation status, including unresectable solid or CNS tumors with BRAF fusions, recurrent CNS tumors with BRAF V600E mutations, and advanced rare non-CNS solid tumors with BRAF V600E mutations. During the trial, participants will have scans and tests before starting treatment to assess tumor changes. Researchers will monitor tumor response, duration of response, progression-free survival, overall survival, and treatment side effects for up to four years. Blood samples will be taken to study how the drug is processed in the body. Participants will be closely followed throughout the study to evaluate the drug's effects and safety.