Kelowna

This research aims to compare different radiation treatments for men newly diagnosed with low volume oligometastatic prostate cancer, which means having fewer than five bone metastases or non-regional lymph node involvement. The study investigates whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as the standard moderately hypofractionated external beam radiotherapy (EBRT). Secondary goals include evaluating progression-free survival, overall survival, and cost-effectiveness, with the hope that ultrahypofractionation will offer similar or better outcomes with less toxicity and better quality of life. Participants will be randomly assigned to one of four treatment groups: standard EBRT delivering 5500 cGy in 20 fractions over 4 weeks; stereotactic body radiotherapy (SABR) delivering 36.25 Gy in 5 fractions over 2 to 5 weeks; permanent seed implant using Iodine-125 seeds implanted in the prostate; or a single high dose rate brachytherapy implant delivering 19 Gy via catheters. Each treatment is delivered at one of four cancer centers, with centers selecting their preferred alternative to the standard EBRT. During the two-year follow-up, participants will have urinary symptoms monitored at six time points using the International Prostate Symptom Score (IPSS). Other quality of life aspects, including urinary, bowel, and sexual function, will be assessed via questionnaires. Researchers will also track progression-free survival, overall survival, and cost-effectiveness. The total participation involves regular assessments over two years to evaluate the treatments' effects and tolerability.

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness 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 worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

This research focuses on participants with ovarian and breast cancers who have previously been treated with niraparib in GlaxoSmithKline/TESARO-sponsored studies. The aim is to provide continued access to niraparib and to better understand its long-term safety over an extended period. This global extension study involves adult participants who have met the primary objectives in prior clinical trials and are still benefiting from niraparib treatment. Participants will continue to take niraparib orally in the form of tablets or capsules once daily. This open-label, multicenter study allows participants who are judged by their investigators to benefit from ongoing treatment to receive niraparib beyond their initial studies. The treatment focuses on maintaining the therapy rather than comparing it to another drug or placebo. During the study, participants will be regularly monitored for safety through assessments such as adverse events, changes in performance status, blood tests, vital signs, and physical examinations. Researchers will also track the use of other medications. The study collects data for up to five years, ensuring comprehensive long-term safety information while participants adhere to scheduled visits and treatment plans.

Researchers are evaluating the effects of ALN-APP on the progression of cerebral amyloid angiopathy (CAA), a condition affecting blood vessels in the brain. This phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in adults with sporadic CAA and Dutch-type CAA, a genetic form of the disease. The study includes a 24-month double-blind treatment period followed by an optional 18-month open-label extension to further explore the treatment's effects. Participants receive either ALN-APP or a placebo, both administered directly into the spinal canal (intrathecally). The initial 24-month period is conducted in a double-blind manner where neither the participants nor the researchers know who receives the treatment or placebo. After this, participants may join the open-label extension phase where everyone receives ALN-APP. This design helps to monitor the drug's impact over a long period. During the study, participants will undergo brain scans using magnetic resonance imaging (MRI) to measure new microbleeds in the brain, which are a marker of disease progression. Researchers will also monitor safety and drug effects through various assessments. The total participation time, including screening, treatment, and follow-up, can last up to 50 months, allowing for thorough observation of treatment outcomes and safety.

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.