Amphoe Mueang Khon Kaen

Researchers are studying new treatment options for people with high-risk non-muscle invasive bladder cancer HR NMIBC, including cases with carcinoma in situ CIS. HR NMIBC affects the lining of the bladder but has not spread to muscle or beyond. The study aims to learn if adding intismeran autogene V940 to the standard Bacillus Calmette-Guerin BCG immunotherapy can improve outcomes by helping the immune system attack the cancer more effectively. Participants are divided into groups receiving different treatments. One group Cohort A receives both intismeran autogene via intramuscular injection every 3 weeks for 9 doses and BCG instillations weekly in specific weeks over about 75 weeks. Another group receives only BCG following the same weekly schedule. A third group Cohort B receives intismeran autogene alone every 3 weeks for 9 doses. The study evaluates these treatments over several years. During the study, participants will have regular treatments and follow-up visits where researchers will monitor cancer progression, recurrence, and survival for up to approximately 5 years. Assessments include event-free survival, recurrence-free survival, overall survival, response rates, time to cystectomy, and safety outcomes such as adverse events and treatment discontinuation. The study is randomized and open-label, with detailed long-term monitoring planned.

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are investigating whether adding intismeran autogene to pembrolizumab after surgery helps people with non-small cell lung cancer NSCLC stay cancer-free longer compared to pembrolizumab with a placebo. This study focuses on participants whose tumors did not fully respond to treatment before surgery. It is a phase 3 trial aiming to evaluate treatment options for resectable stage II to IIIB N2 NSCLC patients who did not achieve a complete pathological response after neoadjuvant therapy. Participants receive neoadjuvant treatment with pembrolizumab and chemotherapy drugs such as cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel, given by intravenous infusion every three weeks for up to four cycles. After surgery, participants receive adjuvant treatment with pembrolizumab every six weeks combined with either intismeran autogene or placebo by intramuscular injection every three weeks, for up to seven and nine doses respectively. During the study, participants undergo treatment cycles, surgery, and follow-up assessments. Researchers evaluate disease-free survival over approximately 97 months and monitor overall survival, metastasis-free survival, quality of life, physical and role functioning, and adverse events up to around 129 months. The study includes regular evaluations and safety monitoring to understand the impact of these treatments on long-term outcomes and participant well-being.

Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. This study aims to see if V181 can reduce the number of dengue infections caused by any of the four dengue virus types, regardless of whether participants have had dengue before. The trial is a phase 3, randomized, double-blind, placebo-controlled study sponsored by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive a single 0.5 mL dose of either the V181 vaccine or a placebo by subcutaneous injection on Day 1. About 3600 participants are included in the Reactogenicity and Immunogenicity Subset, which will be monitored for safety and immune response for 28 days after vaccination. A smaller group of about 620 participants from this subset will be followed for up to 5 years to assess long-term immune response using specific virus neutralization tests. During the study, participants will be monitored for adverse events, vaccine reactions, and dengue infections, including severity and hospitalization rates, up to 5 years after vaccination. Safety assessments include tracking medically attended and serious adverse events. Immune responses will be measured by antibody levels and seroconversion rates. Participants will have scheduled visits during the first month postvaccination and ongoing follow-ups for several years to evaluate the vaccines long-term effects and protective benefits.

Researchers are investigating the effects of vericiguat compared to a placebo in children with heart failure caused by left ventricular systolic dysfunction. This study aims to see if vericiguat is better than a placebo at lowering levels of a heart failure marker called NT-proBNP over 16 weeks. The trial includes a base period and an optional extension period to further evaluate safety and long-term effects. During the base period, participants receive vericiguat orally once daily either as tablets in doses of 2.5 mg, 5 mg, or 10 mg, or as a suspension of 0.2 mgmL or 1 mgmL for up to 52 weeks. Another group receives a placebo in matching forms and schedules. After completing the base period, eligible participants may join the extension period, where they continue to receive vericiguat under similar dosing for additional monitoring. Participants will undergo regular assessments, including measuring NT-proBNP levels at baseline, Week 16, and Week 52 during the base period, as well as monitoring heart events and adverse effects. In the extension period, safety is tracked for up to 8 years, including adverse events and reasons for stopping the study drug. Pharmacokinetics of vericiguat are also studied through blood sampling at scheduled weeks. The total participation time may extend over several years for those in the extension phase.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating pembrolizumab combined with carboplatin and taxane chemotherapy as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC. This phase 3 trial aims to compare overall survival between patients receiving pembrolizumab with maintenance sacituzumab tirumotecan sac-TMT and those receiving pembrolizumab alone during maintenance therapy. The study explores whether the addition of sac-TMT improves outcomes for patients with this type of lung cancer. Participants first undergo an induction phase of four cycles receiving pembrolizumab every 3 weeks along with carboplatin and either paclitaxel or nab-paclitaxel. After induction, they are randomly assigned to one of two maintenance groups pembrolizumab alone every 6 weeks for up to 96 weeks, or pembrolizumab combined with sac-TMT every 2 weeks until discontinuation criteria are met. The chemotherapy drugs are given intravenously during the induction phase, and maintenance treatments continue intravenously according to assigned groups. Throughout the study, participants will be monitored for overall survival as the primary outcome, with secondary outcomes including progression-free survival, adverse events, treatment discontinuations, and quality of life measures such as dyspnea, cough, and chest pain. Assessments include tumor scans to evaluate disease status, performance status checks, and patient-reported questionnaires on symptoms and health-related quality of life. Participants are followed for up to approximately 79 months to gather comprehensive safety and efficacy data, with ongoing monitoring by the research team.

Researchers are studying treatments for non-small cell lung cancer NSCLC in patients who have an EGFR mutation and whose disease has progressed after EGFR tyrosine kinase inhibitor TKI therapy. This trial compares the investigational drug Izalontamab Brengitecan BMS-986507 with platinum-based chemotherapy combinations including carboplatin or cisplatin plus pemetrexed. The study is a randomized phase 23 trial designed to evaluate these treatments in this specific group of lung cancer patients. Participants will receive one of several study treatments Izalontamab Brengitecan given at specified doses on scheduled days, or platinum-based chemotherapy with either carboplatin or cisplatin combined with pemetrexed. The trial includes multiple experimental and active comparator arms to assess the therapies effects following prior EGFR TKI treatment failure. Treatment schedules and doses are specified for each drug as part of the trial interventions. During the trial, participants will be monitored for several outcomes including progression-free survival assessed by established criteria over up to three years, as well as overall survival up to five years. Other measures include objective response, disease control rate, duration and time to response. Safety and organ function will also be evaluated. The study involves regular assessments and follow-up visits to collect these data over the course of the trial.