Kitchener

Researchers are evaluating the effects of durvalumab, an immunotherapy drug, on various advanced solid tumors in adults who previously stopped prior immunotherapy due to immune-related side effects. This phase II study also investigates whether prednisone, a steroid, can reduce side effects when given with durvalumab. Additionally, the study allows patients from completed Canadian Cancer Trials Group CCTG studies to continue treatment with durvalumab with or without tremelimumab. Participants receive durvalumab at a dose of 1500 mg intravenously every 4 weeks. Prednisone may be given orally in the first two cycles at specific doses to manage side effects. Patients previously enrolled in other CCTG trials may continue durvalumab treatment, sometimes combined with tremelimumab. The study uses a factorial design and randomized allocation to evaluate these treatments over a period of up to two years. Participants undergo screening and regular follow-ups to monitor side effects and treatment response. Assessments include laboratory tests, imaging to document disease status, and evaluation of immune-related adverse events. Researchers measure the number and severity of side effects and the effectiveness of corticosteroids in preventing recurrent immune-related events. The study also collects tumor samples for correlative studies. Treatment begins promptly after enrollment, and patients are followed for up to two years to assess safety and continued treatment outcomes.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

This research aims to explore the acceptability and feasibility of a co-payment model for recommended but unfunded vaccines in community pharmacies in Nova Scotia and Ontario. Many vaccines recommended by Canadas National Advisory Committee on Immunization are not publicly funded, which may limit vaccine uptake due to cost barriers. The study evaluates whether sharing vaccine costs between patients, private insurers, and the government can improve access and increase vaccination rates. The study involves a pilot of four different co-payment steps at up to eight community pharmacy sites, with each site randomly assigned to one step. These steps range from patients paying the full vaccine cost to full coverage by the study, with varying government and participant cost shares for vaccine and administration fees. Vaccines included are FluMist Quadrivalent, Shingrix, and Abrysvo or Arexvy RSV vaccines. Pharmacy providers will administer vaccines as part of routine care during the study. Participants will receive vaccines at reduced costs based on the assigned co-payment model and complete online surveys about their experiences and satisfaction. Pharmacy providers will also complete surveys about implementing the model. Researchers will track vaccine administration numbers before and during the pilot. The study will run for up to 30 months, with primary outcomes measured over 6 months, focusing on the models acceptability and feasibility among the public and providers.

This clinical trial investigates treatment options for men with unfavourable risk localized prostate cancer. Researchers are comparing a newer radiation method called Stereotactic Body Radiation Therapy SBRT, which uses higher doses over fewer sessions with special equipment, against the standard external beam radiation combined with a brachytherapy boost. The study aims to find out if SBRT is as effective as the standard approach in controlling prostate cancer progression. Participants will receive either the standard treatment involving external beam radiation to the pelvis and prostate plus a brachytherapy boost, combined with hormone therapy, or the experimental SBRT treatment delivering higher radiation doses in fewer sessions. Adjuvant androgen deprivation therapy ADT will be given according to risk level, lasting 6 months for intermediate risk and 24 months for high or very high risk. Treatments are assigned randomly to compare outcomes between groups. Throughout the study, participants will be monitored for cancer progression, side effects, and quality of life using questionnaires and medical assessments for up to 8.6 years. Researchers will track progression-free survival, PSA response, metastasis-free survival, and overall survival, as well as participant-reported tolerability and economic outcomes. Safety will be assessed continuously to understand how well participants tolerate the treatments over time.

Researchers are evaluating whether low energy selective laser trabeculoplasty SLT is as effective as standard energy SLT for treating glaucoma and ocular hypertension. The study aims to determine if repeating low energy SLT once a year can better prevent or delay the need for daily eye drop medications compared to waiting for the effects of standard SLT to wear off before repeating it. This is a phase 3 randomized clinical trial sponsored by the University of Pittsburgh. Participants initially receive either standard energy SLT, where energy levels are adjusted to produce champagne bubbles every 2nd or 3rd spot during a 360-degree treatment, or low energy SLT, delivering 100 spots at 0.4 mJ per spot with energy adjustments based on bubble formation. After 12 months, eligible participants are randomized to either annual repeat low energy SLT or as-needed repeat standard energy SLT. One treatment arm was discontinued following an interim analysis. Throughout the study, participants are monitored at regular intervals up to 48 months to track outcomes such as 12-month and 48-month treatment survival, mean intraocular pressure IOP at multiple time points, and occurrence of IOP spikes. The study involves assessments of eye pressure and glaucoma progression, with follow-up visits scheduled to observe long-term effects and safety. Total participation may extend up to four years, including repeated evaluations and treatments.

Researchers are evaluating a new medicine called NNC6019-0001 for people with transthyretin amyloid cardiomyopathy ATTR-CM, a condition that affects the heart and leads to heart failure. This Phase 3 study compares NNC6019-0001 with a placebo to see if it can reduce the risk of heart-related death and illness. Participants will continue their usual heart treatments throughout the study. Participants will receive either NNC6019-0001 or a matching placebo through intravenous IV infusion. Both groups may also continue their standard heart failure treatments as advised by their doctors. The study is randomized and blinded so that neither participants nor researchers know who receives the medicine or placebo. Treatment and follow-up will last up to about 4 years. During the study, participants will have regular assessments including heart function tests, questionnaires about heart failure symptoms and quality of life, and walking tests to measure physical ability. Researchers will monitor heart-related events such as hospitalizations and urgent visits for heart failure, as well as death from cardiovascular causes. Safety labs and biomarker tests will be done. The main outcome is a combination of cardiovascular deaths and recurrent heart problems measured from the start to the end of the study.

Researchers are conducting a randomized, open-label phase 3 clinical trial to compare the effectiveness and safety of two treatment combinations with docetaxel alone in people with advanced or metastatic non-small cell lung cancer NSCLC who have developed resistance to immune checkpoint inhibitor therapy. The study includes two groups one receiving N-803 plus tislelizumab and docetaxel, and the other receiving N-803 plus a prior failed checkpoint inhibitor and docetaxel. The trial explores how these combinations perform compared to docetaxel by itself in this specific patient population. Participants are divided into two cohorts and randomized to either the experimental treatments or docetaxel monotherapy. Treatments are given in repeated 3-week cycles. In cohort A, N-803, tislelizumab, and docetaxel are given during the first two cycles, followed by N-803 and tislelizumab alone from cycle 3 onward until the study ends. In cohort B, N-803, the prior failed checkpoint inhibitor, and docetaxel are administered in the first two cycles, then N-803 with the prior checkpoint inhibitor continue from cycle 3 onward. The control groups in both cohorts receive docetaxel alone every 3 weeks. Participants will attend regular study visits aligned with the treatment cycles, during which researchers will assess overall survival and monitor safety. The main measurement focuses on comparing survival between the experimental and control arms over approximately 12 months. The study involves follow-up visits and safety monitoring throughout the treatment period. The trial is sponsored by ImmunityBio, Inc. and plans to enroll adults aged 18 to 90 with confirmed stage IV NSCLC who meet specific health and treatment history criteria.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.