Kelowna

Researchers are evaluating different radiation treatments for men newly diagnosed with low volume oligometastatic prostate cancer, defined as fewer than five bone metastases andor non-regional lymph node involvement. The study aims to compare ultrahypofractionation using stereotactic ablative radiotherapy SABR or brachytherapy with moderately hypofractionated external beam radiotherapy EBRT to see if they are similarly well-tolerated. Secondary goals include assessing progression-free survival, overall survival, and cost-effectiveness. The trial hypothesizes that ultrahypofractionation will provide favorable toxicity profiles and quality of life while maintaining similar or better effectiveness, offering a convenient and cost-effective alternative to standard EBRT. Participants will be randomly assigned to one of four treatment groups standard EBRT delivering 5500 centiGray in 20 fractions over 4 weeks a single outpatient fraction of 19 Gray high dose rate brachytherapy under anesthesia a single outpatient permanent implant of radioactive Iodine-125 seeds delivering 125 Gy under anesthesia or SABR delivering 36.25 Gy in 5 fractions either weekly or every second day. Each treatment center selects its preferred brachytherapy or SABR option to balance enrollment across the four groups. During the study, urinary symptoms will be closely monitored over two years using the International Prostate Symptom Score IPSS at six time points. Additional assessments include quality of life questionnaires focusing on urinary, bowel, and sexual health, as well as biochemical markers, progression monitoring, survival, and cost-effectiveness over up to three years. Participants will complete these evaluations while receiving long-term androgen deprivation therapy and follow-up care to track treatment impact and safety.

Researchers are conducting a randomized controlled trial to study the effects of 6 weeks of blood flow restriction BFR training on immune cell function and energy use in adults living with type 2 diabetes. The study aims to understand how this specific exercise approach impacts immune cells and bioenergetics, focusing on adults aged 19 to 64 years who have type 2 diabetes and engage in less than 150 minutes of moderate to vigorous physical activity weekly. Participants will be randomly assigned to one of two groups regular treadmill walking or treadmill walking with blood flow restriction. Both groups will exercise three times per week for 6 weeks, starting with 21 minutes per session in the first week and increasing to 32 minutes per session for the remaining weeks. The treadmill speed and incline will be set to achieve 40-50% of each participants heart rate reserve. For the BFR group, cuffs will be inflated based on personalized limb occlusion pressure, increasing progressively from 60% to 80% over the 6 weeks, with brief cuff deflations every 10 minutes for safety. Throughout the study, participants will undergo assessments before starting and after completing the 6-week intervention to measure changes in various immune markers, including T-cell oxygen consumption rate and several immune cell expressions. Researchers will monitor these immune and bioenergetic outcomes to understand the exercise effects. The entire study participation lasts for 6 weeks during which participants will attend scheduled exercise sessions and evaluation visits.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

This research aims to provide continued access to niraparib and to further assess its long-term safety in participants with ovarian or breast neoplasms who are currently receiving niraparib treatment within previous GlaxoSmithKlineTESARO-sponsored studies. It focuses on participants who have completed earlier studies where the primary objectives were met and are judged by their doctors to still benefit from niraparib. The study is a phase 2, open-label extension trial designed to monitor treatment continuation and safety over time. Participants will receive niraparib once daily by mouth, following the same dose and schedule as in their previous parent study. Treatment is organized in 90-day cycles and will continue until disease progression, unacceptable side effects, new anticancer therapy unrelated to the parent study, withdrawal, or other reasons for discontinuation occur. The dosing regimen mirrors what was assigned in the prior study, ensuring consistency for each participant. During the study, participants will have regular evaluations to monitor safety and health status for up to five years. These assessments include tracking adverse events, serious side effects, and specific safety concerns, as well as monitoring physical exams, vital signs, blood tests, and medication use. Participants must comply with scheduled visits and treatments while using effective contraception if of childbearing potential. The study duration and follow-up are designed to gather detailed long-term safety information on niraparib treatment.

Researchers are evaluating the effects of ALN-APP on disease progression in adults with sporadic Cerebral Amyloid Angiopathy sCAA and Dutch-type Cerebral Amyloid Angiopathy D-CAA. This Phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in these patient groups. The study is sponsored by Alnylam Pharmaceuticals and includes a randomized, double-blind, placebo-controlled design. Participants will receive multiple doses of ALN-APP or placebo administered intrathecally during a 24-month double-blind treatment period. Those who continue into an optional 18-month open-label extension will receive ALN-APP. The study involves two main periods the initial double-blind treatment phase followed by an optional open-label extension. During the study, participants will undergo brain MRIs to measure new cerebral microbleeds and other brain changes. Researchers will also assess cerebrovascular vasoreactivity using functional MRI and measure amyloid precursor protein levels in cerebrospinal fluid. Safety and adverse events will be monitored throughout the up to 50 months of participation, which includes screening, treatment, and safety follow-up.