Abbotsford

Researchers are evaluating two standard doses of the anti-cancer drug bevacizumab combined with chemotherapy in patients with epithelial ovarian cancer that is resistant to platinum-based chemotherapy. This pragmatic, randomized trial aims to compare a lower dose 7.5 mgkg versus a higher dose 15 mgkg of bevacizumab to see if the lower dose is not worse than the higher dose in controlling cancer progression while potentially reducing side effects and treatment costs. Participants will be randomly assigned to receive either 7.5 mgkg or 15 mgkg doses of bevacizumab every three weeks, combined with chemotherapy. The treatment duration will be determined by the treating clinicians based on standard care. The study compares progression-free survival, side effects, quality of life, and drug cost savings between the two dosing groups. During the study, participants will undergo regular CT scans to monitor disease progression, and side effects will be tracked. Quality of life assessments will be conducted during treatment and four weeks after stopping treatment. Researchers will follow participants for up to four years to assess progression-free survival and overall survival, along with treatment response duration and adverse events. Safety and treatment outcomes will be carefully monitored throughout the trial.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are evaluating the effectiveness and safety of combining Dato-DXd with rilvegostomig as an additional treatment compared to standard care in adults with high-risk muscle invasive urothelial carcinoma MIUC who have undergone radical surgery. This Phase III trial focuses on participants with residual disease at high risk of recurrence after surgery. The study aims to see if the new combination improves disease-free survival compared to current standard treatments. Participants are randomly assigned to one of three groups Arm 1 receives Dato-DXd plus rilvegostomig intravenously every three weeks for up to one year Arm 2 receives Dato-DXd alone on the same schedule Arm 3 receives standard care, which includes nivolumab, durvalumab, or a combination of enfortumab vedotin and pembrolizumab, given intravenously at intervals ranging from every two to four weeks for up to a year. Treatment duration and dosing can be adjusted based on tolerance and investigator assessment. During the trial, participants will have visits approximately every three weeks or as per standard care schedules, depending on their assigned group, for up to 12 months of treatment. Researchers will monitor disease recurrence and survival outcomes for up to 78 months from the first participants enrollment. Assessments include clinical evaluations and disease status monitoring to measure disease-free survival and overall survival. Participants will be followed closely to assess safety and effectiveness of the treatments over this extended period.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are evaluating the safety and effectiveness of TORL-1-23 in women with advanced platinum-resistant epithelial ovarian cancer, including primary peritoneal and fallopian tube cancers that express Claudin 6. This Phase 2 study focuses on patients whose cancer has not responded well to platinum-based chemotherapy and aims to understand how this treatment works in this population. The study involves three groups receiving different doses of TORL-1-23 given as an intravenous infusion on Day 1 of every 21-day cycle. Alongside TORL-1-23, participants receive pegfilgrastim by subcutaneous injection on Day 4 of each cycle to support their immune system. Each treatment cycle lasts three weeks, and all participants follow this schedule throughout the study period. Participants will be monitored regularly with scans and lab tests to measure how their cancer responds to treatment, including progression-free survival and overall survival. Safety will be checked by recording side effects and laboratory abnormalities from the start of treatment until 30 days after the last dose. The study will last about 40 months, during which disease progression and other outcomes will be tracked at set intervals to assess the treatments effects.

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.

This research aims to improve the use of Prison Needle Exchange Programs PNEPs in Canadian federal prisons to help people who inject drugs while incarcerated. The study is conducted in nine federal prisons, including five womens prisons where more individuals report injection drug use. The goal is to identify obstacles and supports to increase PNEP adoption and make these programs more sustainable over time. The study uses a step-wedge design with a Type 2 hybrid implementation trial to evaluate how the Network for the Improvement of Addiction Treatment NIATx strategy bundle affects PNEP uptake over 24 months. Nine prisons are divided into three groups that receive the NIATx intervention in staggered intervals every six months. Each group undergoes a control period, a NIATx intervention period, and then a 12-month maintenance phase to assess how well improvements last. Participants include all people incarcerated at the study sites during the intervention period. Researchers will monitor measures such as the effectiveness of program uptake, bloodborne virus care, and enrollment in opioid agonist therapy throughout the intervention. The study includes ongoing observation during and after the intervention to assess program sustainability, with a total study period extending up to 54 months for some groups.

Researchers are evaluating whether adding a treatment called LND101 for Fecal Microbiota Transplant FMT to the usual immunotherapy called Immune Checkpoint Blockade ICB can reduce the chance of advanced melanoma growing or spreading. This Phase II study compares this combination approach with the standard ICB treatment alone for patients with advanced or unresectable melanoma. Immunotherapy activates the immune system to target cancer cells and may slow tumor growth. Participants will receive either standard ICB, which can be a single drug or combination approved for advanced melanoma, or LND101 capsules taken orally after bowel preparation combined with standard ICB. About 40 capsules containing processed fecal material are given 7 days before starting ICB treatment. The choice of ICB regimen is made before enrollment and remains the same during the study. During the study, participants will be monitored for progression-free survival over 4 years, along with overall survival, response to treatment, and any side effects. Researchers will collect blood and stool samples and may analyze tumor tissue if available. Participants will have regular assessments to track disease and safety, and treatment must begin within 14 days after enrollment. The study is randomized without masking, and participants will be followed closely for treatment effects and side effects.