Saint John

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

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 combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating treatments for newly diagnosed multiple myeloma in patients who cannot undergo autologous stem cell transplantation. This Phase 3 study compares two drug combinations belantamab mafodotin with lenalidomide and dexamethasone BRd versus daratumumab with lenalidomide and dexamethasone DRd. The goal is to see if BRd extends progression-free survival and improves minimal residual disease negative status compared to DRd. Participants receive either BRd or DRd treatment, continuing until disease progression, death, unacceptable side effects, withdrawal, or study end. Both treatment arms involve the administration of lenalidomide and dexamethasone alongside either belantamab mafodotin or daratumumab. Treatment duration may last up to approximately seven years. During the study, participants will undergo regular assessments including monitoring disease progression, response to treatment, and side effects. Measurements include progression-free survival, overall survival, and the number achieving minimal residual disease negative status. Quality of life questionnaires and blood tests will also be conducted. Safety monitoring includes eye exams and tracking adverse events throughout the study duration.

Researchers are studying an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. The trial is a Phase 3, open-label, randomized study comparing odronextamab to rituximab combined with different chemotherapy regimens, which represent the current standard treatment. The study aims to evaluate the safety, tolerability, and how well odronextamab works compared to standard care, including side effects, drug levels in the blood, antibody development against the drug, and quality of life impacts. The study has two parts Part 1 is a non-randomized safety run-in where all participants receive odronextamab alone to assess safety and tolerability. In Part 2, participants are randomly assigned to one of two groups one receiving odronextamab followed by maintenance therapy with odronextamab, and the other receiving rituximab combined with chemotherapy followed by rituximab maintenance. Chemotherapy regimens include CHOP, CVP, or bendamustine, administered as per protocol. Participants will be monitored regularly for treatment side effects, drug concentrations, and immune responses for up to 5 years. Researchers will assess responses using imaging and other tests at multiple time points, including complete response at 30 months and progression-free survival up to 5 years. Quality of life and physical function will also be evaluated using standardized questionnaires. Safety and adverse events will be tracked for up to 2 years, ensuring comprehensive follow-up throughout the study duration.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

This trial investigates treatment options for adults aged 16 to 69 with early-stage classical Hodgkin lymphoma, specifically stage I or II supradiaphragmatic disease without mediastinal bulk or B symptoms. The study compares two chemotherapy regimens ABVD and A2VD, using a PET response-adapted design to adjust therapy based on treatment response. It is a phase III, randomized, open-label trial conducted internationally and sponsored by University College London and Canadian Cancer Trials Group. Participants will be randomly assigned to receive either ABVD chemotherapy doxorubicin, bleomycin, vinblastine, and dacarbazine or A2VD chemotherapy doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support. After two 28-day cycles, a PET-CT scan will assess response using the Deauville score to guide further treatment. Patients with scores 1-3 receive one more cycle those with score 4 receive two more cycles followed by involved site radiotherapy patients with score 5 discontinue trial treatment and receive alternative therapy as determined by their clinician. Throughout the study, participants undergo PET-CT scans and clinical assessments to monitor treatment response and safety. They will be followed for at least five years post-treatment to evaluate progression-free survival and other outcomes such as event-free survival, overall survival, and incidence of second cancers or cardiovascular disease. Safety and toxicity are monitored from treatment start until 30 days after completion. The overall study period extends until 2032.

Researchers are evaluating a new monitoring strategy for patients who develop a new left bundle branch block LBBB after undergoing transcatheter aortic valve implantation TAVI. This study compares an electrophysiology-based algorithmic approach with the standard clinical follow-up using 30-day transcutaneous cardiac monitoring. The goal is to determine if the electrophysiology method better reduces the combined risk of syncope, hospitalization, and death in these patients. Participants who are 18 years or older and have no pacemaker will be randomly assigned to one of two groups. One group will have an electrophysiology study before hospital discharge and receive a pacemaker if certain electrical delays are detected. The other group will have at least 72 hours of ECG monitoring in hospital followed by 30 days of transcutaneous cardiac monitoring using a device that continuously records heart rhythms. During the study, participants will be monitored for cardiovascular hospitalizations, episodes of syncope, emergency visits, and death over 12 months. Researchers will also assess procedural complications, atrioventricular blocks, and cost-effectiveness of the electrophysiology-guided approach. The study involves regular evaluations and cardiac monitoring to track heart events and overall safety throughout the 12-month period.

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.