Kitchener

Researchers are investigating the effects of durvalumab, an immunotherapy drug, on various types of advanced or metastatic solid cancers. The study aims to understand how durvalumab works after patients have discontinued prior checkpoint therapy due to immune-related side effects and to evaluate if prednisone, a steroid, can lessen these side effects when given alongside durvalumab. Another part of the study allows patients from completed Canadian Cancer Trials Group (CCTG) studies to continue treatment with durvalumab, with or without tremelimumab. Participants receive durvalumab through an intravenous infusion of 1500 mg over 60 minutes every four weeks. Some patients will also take prednisone orally during the first two treatment cycles, either at 0.5 mg/kg or 10 mg daily doses, to manage potential immune-related side effects. For patients continuing from previous trials, treatment involves durvalumab with or without tremelimumab according to their prior therapy. The study includes two substudies with treatment periods and safety monitoring lasting up to two years. Throughout the study, participants undergo regular assessments including monitoring for side effects, blood tests to check organ function and blood counts, and imaging to track the presence and size of tumors. Researchers carefully record the number and severity of any adverse events. Patients must be available for treatment and follow-up at the study centers, and all must have provided informed consent. The study also involves collecting tumor tissue when available and uses clinical evaluations to monitor patient health and treatment response over the two-year period.

Researchers are conducting two related studies called RADICAL PC1 and RADICAL PC2 focused on men diagnosed with prostate cancer. RADICAL PC1 follows men within one year of their prostate cancer diagnosis or who have recently started androgen deprivation therapy (ADT). The goal is to understand factors linked to developing cardiovascular disease in these men, especially related to ADT. RADICAL PC2 is a randomized controlled trial within RADICAL PC1 that tests a systematic approach to improving heart health and lifestyle risk factors in this population. The treatments studied include behavioral advice on healthy nutrition, exercise including strength and resistance training, and smoking cessation support if needed. Drug treatments include prescriptions of low to moderate dose statins and ACE inhibitors or angiotensin receptor blockers for controlling blood pressure above 130 mmHg. The intervention targets men newly diagnosed or recently starting ADT, and treatment is personalized based on cardiovascular risk. Participants engage in assessments to monitor heart-related outcomes such as death, heart attacks, strokes, heart failure, or arterial revascularization over 3 to 5 years. The study tracks cardiovascular health and lifestyle factors throughout this period to evaluate the effectiveness of the interventions. Safety and progress are closely monitored to understand impacts on long-term outcomes in men with prostate cancer undergoing ADT.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating a co-payment model aimed at improving access to recommended but unfunded vaccines through community pharmacies in Nova Scotia and Ontario. This pilot project seeks to understand how acceptable and feasible it is for both the public and pharmacy providers to use a co-payment system, which shares vaccine costs between patients, private insurance, and government funding. The study focuses on vaccines such as FluMist Quadrivalent, Shingrix, and RSV vaccines (Abrysvo or Arexvy) that are currently not fully covered by public health programs, potentially limiting their uptake due to cost. The study will be conducted at up to eight community pharmacy sites, four in Nova Scotia and four in Ontario. Each site will be randomly assigned to one of four co-payment steps, ranging from the participant paying 100% of the vaccine cost to paying nothing, with varying shares covered by the study or government. Pharmacy providers will prescribe and administer the vaccines as part of routine care. After vaccination, participants will complete surveys about their satisfaction and perceptions of the co-payment model. Pharmacy providers will also complete online surveys about their experience implementing the model. Participants will be involved in receiving eligible vaccines according to age and health status, such as children for FluMist and adults for Shingrix and RSV vaccines. Surveys will gather demographic data and feedback on the co-payment system. Researchers will assess the acceptability and feasibility of this funding approach over six months, comparing vaccination rates before and during the pilot. This evaluation aims to inform strategies to reduce cost barriers and increase vaccine uptake in community pharmacy settings.

Researchers are investigating treatment options for men with unfavorable risk localized prostate cancer to determine if a shorter, higher-dose radiation therapy called Stereotactic Body Radiation Therapy (SBRT) is as effective as the usual external beam radiation therapy (EBRT) combined with a brachytherapy boost. This phase III randomized trial compares these approaches, both combined with androgen deprivation therapy (ADT), to improve cancer control and reduce recurrence. The study focuses on progression-free survival, measuring the time until biochemical failure, additional treatment, recurrence, progression, or death over 8.6 years. Participants receive one of two radiation treatments: the usual approach involves 46 Gy of EBRT in 23 sessions to the pelvis and prostate plus a low or high-dose brachytherapy boost, or 25 Gy of EBRT in 5 sessions combined with the same boost. The experimental group receives SBRT alone with 25 Gy to the pelvis and 40 Gy to the prostate in 5 sessions. ADT is given based on risk level, lasting 6 months for unfavorable intermediate risk or 24 months for high and very high risk. Treatments start within 12 weeks of enrollment. During the study, participants are monitored through regular assessments including quality of life questionnaires in English, French, or Spanish, and clinical follow-up to document treatment effects, adverse events, and cancer progression. The primary outcome is progression-free survival measured over approximately 8.6 years. Safety and treatment adherence are carefully tracked, and participants must be medically fit for brachytherapy and willing to comply with study procedures and follow-up.

Researchers are evaluating whether two new immunotherapy drugs, botensilimab and balstilimab, can help patients with colorectal cancer that cannot be removed by surgery and is resistant to treatment. The study compares these drugs to the usual supportive care provided to improve quality of life. It also aims to see if these treatments slow tumor growth, shrink tumors, and identify markers in tumors or blood that predict benefits. Safety and how long the body takes to process these drugs are also being studied. Participants will receive either botensilimab and balstilimab or the best supportive care, which focuses on relieving symptoms and improving quality of life. Botensilimab is given as an intravenous infusion at 75 mg every 6 weeks for 4 doses, while balstilimab is given as 450 mg intravenously every 3 weeks. Those receiving supportive care will get treatments to help manage symptoms but not the investigational drugs. During the study, participants will be monitored for overall survival over 34 months. Researchers will assess quality of life, tumor response, and look for biological markers in tissue and blood. Safety will be closely followed, and participants must be available for treatment, follow-up, and completing questionnaires in English or French. The total study duration and treatment timelines are structured to ensure thorough evaluation of outcomes and safety.

Researchers are investigating the best way to use Selective Laser Trabeculoplasty (SLT) therapy for people with glaucoma or ocular hypertension. The study aims to find out if performing SLT at a low energy level is as effective as using the standard energy level. It also evaluates whether repeating low energy SLT once a year can better prevent or delay the need for daily eye drop medications compared to waiting until the effects of the initial SLT wear off before repeating the treatment. Participants will receive SLT treatments at either low energy or standard energy levels. The study compares these two approaches to see which is more effective over time. Some participants will have their low energy SLT repeated annually to assess if this schedule helps in managing their eye condition better than waiting for the treatment effects to diminish before repeating SLT. During the study, participants will be monitored for up to 48 months to track their survival without requiring daily eye drops, with primary outcome measures at 12 and 48 months. Researchers will check eye pressure and overall eye health regularly, ensuring safety and effectiveness of the treatments. Participants need to attend scheduled visits and follow study procedures throughout the study duration, which may include periodic eye exams and assessments.

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.