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Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

Researchers are evaluating the effectiveness and safety of combining divarasib and pembrolizumab compared to pembrolizumab with pemetrexed and carboplatin or cisplatin for first-line treatment in adults with KRAS G12C-mutated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This phase III study focuses on patients who have not received prior systemic treatment for this type of lung cancer and aims to provide new options for this specific mutation. Participants are randomly assigned to one of two groups. One group receives an oral daily dose of divarasib along with pembrolizumab given by intravenous infusion every three weeks. The other group receives pembrolizumab combined with pemetrexed and either carboplatin or cisplatin, also administered intravenously every three weeks. Treatments continue according to the study schedule to assess how well each combination works and their safety profiles. Throughout the study, participants will be closely monitored for progression-free survival and overall survival for up to approximately five years. Additional assessments include tumor response, quality of life related to lung cancer symptoms, duration of response, and side effects reported by patients. Safety is also tracked by recording adverse events and their impact on daily activities. This comprehensive monitoring helps researchers understand the full effects of the treatments over time.

Researchers are evaluating the antitumor activity of amivantamab combined with lazertinib or with chemotherapy in participants who have common EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 2b open-label study aims to understand how well these combinations work as first-line or second-line treatments for this type of lung cancer. Participants will be assigned to one of two groups: one group will receive amivantamab combined with lazertinib orally in 28-day cycles, and the other group will receive amivantamab combined with platinum-based chemotherapy (carboplatin and pemetrexed) given by intravenous infusion in 21-day cycles. Treatment will continue until disease progression, withdrawal, death, or investigator decision to stop treatment. During the study, participants will undergo regular assessments including monitoring for progression-free survival up to 4 years and 6 months. Additional evaluations include tracking dose changes, adverse events, overall survival, response rates, and time to treatment discontinuation. Safety and clinical outcomes will be closely observed throughout the treatment period and follow-up.

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with zanubrutinib compared to zanubrutinib with placebo in adults who have relapsed or refractory mantle cell lymphoma (MCL). This phase 3 randomized, double-blind study aims to determine if sonrotoclax plus zanubrutinib can improve outcomes for patients who have received prior treatments including anti-CD20 monoclonal antibodies or chemoimmunotherapy. The trial is sponsored by BeOne Medicines and includes patients with measurable disease and adequate organ function. Participants are randomly assigned to one of two groups: one receives sonrotoclax plus zanubrutinib taken orally, and the other receives a placebo plus zanubrutinib, also taken orally. Treatment continues under blinded conditions to compare the effects of the study drug combination versus placebo. The study includes multiple outcome measures such as progression-free survival, overall survival, response rates, and quality of life assessments over periods ranging from about 41 to 92 months. During the trial, participants will undergo regular assessments including tumor evaluations, laboratory tests, and quality of life questionnaires using specific tools like the EORTC-QLQ-NHL-HG29 and EORTC-QLQ-C30. Safety is closely monitored from the first dose until 30 days after the last dose. The study spans several years, allowing researchers to track long-term outcomes and treatment-emergent side effects while participants continue follow-up visits according to the study schedule.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicine's effects and patient health throughout the trial.

Researchers are investigating the long-term safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy in people with heart failure. This global study combines both past and future patient data to observe how CCM therapy, delivered through Impulse Dynamics devices, performs in real-world settings over extended periods. The goal is to better understand CCM therapy's impact on heart failure outcomes and any related device or procedure complications. The study includes patients who have already received or will receive CCM therapy using Impulse Dynamics systems, including future technologies like CCM-D. It is a single-arm observational study without experimental treatment groups, following patients for at least five years after their therapy. Patients are grouped into prospective, retrospective, and hybrid cohorts based on when they receive or received the CCM therapy. Participants will be monitored through regular follow-ups to assess hospitalization rates and length of stay due to heart failure, safety regarding device-related complications, and various clinical outcomes such as mortality, functional capacity, and heart remodeling. Additional evaluations include quality of life measurements using the Kansas City Cardiomyopathy Questionnaire and assessments of therapy compliance. The study duration allows detailed observation of CCM therapy effects and patient health over several years, up to at least five years.

Researchers are evaluating whether adding chemotherapy to immunotherapy with pembrolizumab improves overall survival compared to pembrolizumab alone in older adults with advanced non-small cell lung cancer (NSCLC) stages IIIB-IV. This phase III trial focuses on patients aged 70 and above with tumors expressing PD-L1 at 1-49% and without certain genetic mutations. The study aims to assess survival, progression-free survival, response rates, toxicity, and quality of life in this vulnerable population. Participants are randomized into two groups. One group receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. The other group receives pembrolizumab plus a chemotherapy regimen chosen by the investigator, given intravenously on specific schedules repeating every 21 days for four cycles, followed by the same pembrolizumab maintenance. Imaging with MRI, CT, and/or PET scans is performed at baseline and throughout the trial. During the trial, patients undergo regular evaluations including imaging studies, laboratory tests, and quality of life questionnaires. Follow-up visits occur every three months for up to two years after treatment and then every six months up to five years. Researchers measure overall survival, disease progression, treatment response, adverse events, and patient-reported quality of life. The study also explores safety, tolerability, geriatric assessments, and correlations between gut microbes and outcomes.

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the player's skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the user's performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.