Vina Del Mar

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

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 investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

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 long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

This research aims to evaluate elafibranor, a study drug, compared to a placebo in adults with Primary Biliary Cholangitis PBC and cirrhosis, a liver disease causing bile duct damage and scarring. The trial focuses on whether elafibranor can better prevent worsening of the disease, including progression leading to liver transplant or death, and also assesses long-term safety and symptom impact such as itching and tiredness. Participants will be randomly assigned to take either an 80 mg tablet of elafibranor or a matching placebo tablet once daily, orally, with or without food. This double-blind treatment period can last up to 3.5 years for each participant, with tablets taken at approximately the same time each morning. The study is designed to compare these two groups over the long term. During the study, participants will undergo regular assessments including physical exams, vital signs, electrocardiograms, laboratory tests, and symptom questionnaires at intervals up to 3.5 years. Researchers will measure liver function tests, symptom scales, liver stiffness, and clinical outcomes related to disease progression. Safety is monitored through adverse event tracking and laboratory parameters, with follow-up extending to four weeks after the last dose. Overall participation may last up to 3.5 years.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating AZD8965 in a Phase IIb trial to study its safety, tolerability, and effectiveness in treating Idiopathic Pulmonary Fibrosis IPF. The study compares three doses of AZD8965 to a placebo in participants with IPF, including those who are on stable doses of approved antifibrotic therapies such as nintedanib, pirfenidone, or nerandomilast, as well as those not taking antifibrotic treatment. The trial is randomized, placebo-controlled, double-blind, and parallel-group in design. Participants are assigned to one of four groups placebo, low dose AZD8965, medium dose AZD8965, or high dose AZD8965. The treatment lasts for 24 weeks, during which participants receive their assigned medication. The study includes approximately 360 participants across around 200 sites worldwide. Researchers aim to assess the clinical efficacy of AZD8965 by measuring changes in lung function and study the relationship between dose and outcomes. During the study, participants will undergo various assessments including lung function tests such as forced vital capacity FVC, monitoring for adverse events, and pharmacokinetic analyses of AZD8965. Safety and tolerability are monitored up to 25 weeks. Researchers will also track any serious adverse events and treatment discontinuations. The total participation time covers the 24-week treatment period with scheduled visits to assess the study outcomes and participant health.