Coffs Harbour

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 conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are evaluating the effectiveness and safety of pirtobrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on two parts: Part 1 tests three different doses of pirtobrutinib in participants who have had 1 to 3 prior treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have a specific genetic deletion called 17p. This is a phase 2, open-label, randomized study. Pirtobrutinib is given orally to participants in both study parts. Participants in Part 1 receive one of three dose levels, while those in Part 2 receive pirtobrutinib monotherapy. Part 1 participation lasts about 3 years, and Part 2 participation can last up to 2 years. The study compares the effects of different doses and treatment histories to better understand pirtobrutinib’s impact on CLL/SLL. Throughout the study, researchers monitor participants' overall response to treatment from the start up to 3 years. They assess safety and side effects, and participants are required to be able to swallow oral medication and have a performance status that allows them to participate. The study includes regular evaluations to determine how well the treatment controls the disease and to track any adverse events over the course of the study periods.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Multiple myeloma is a cancer affecting plasma cells in the blood, usually found in bones and bone marrow, causing bone pain, fractures, infections, weak bones, and kidney failure. This research aims to evaluate the safety, effectiveness, and how the body processes an investigational drug called Etentamig in adults with multiple myeloma. The study includes participants with newly diagnosed, relapsed, or refractory multiple myeloma and is divided into four substudies to explore different patient groups and treatment combinations. Participants receive Etentamig through intravenous infusions either alone or combined with other treatments such as daratumumab, lenalidomide, dexamethasone, or carfilzomib. The study features dose escalation phases where doses are gradually increased, followed by dose expansion phases where the established doses are administered alone or with other drug combinations. Around 440 adults will join this study, which lasts approximately 130 months and is conducted at about 50 sites worldwide. Throughout the study, participants will attend regular clinic or hospital visits for medical assessments, blood tests, and side effect monitoring. Questionnaires will also be used to evaluate how the treatment affects participants. The primary focus is on tracking adverse events and dose-limiting toxicities over various periods depending on the substudy. This study may require a greater time and treatment commitment compared to standard care, ensuring close monitoring of safety and treatment responses.

Researchers are evaluating how well elritercept works compared to epoetin alfa in treating anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to see if elritercept can reduce the need for RBC transfusions, improve tiredness without transfusions, lower transfusion burden, and enhance quality of life. It also examines the immune response to elritercept and monitors its safety. Participants receive either elritercept or epoetin alfa as subcutaneous injections. The study is a phase 3, multicenter, randomized trial comparing the efficacy and safety of these two drugs. The treatment period lasts through 24 weeks, with each cycle lasting 28 days. Researchers monitor participants for RBC transfusion independence lasting at least 12 weeks and a significant increase in hemoglobin levels. During the study, participants undergo regular assessments including blood tests to measure hemoglobin and other blood counts. Researchers track transfusion needs and quality of life reports. Safety is carefully monitored throughout the trial. Participants are involved from screening through 24 weeks of treatment, with evaluations to measure the effectiveness of the treatments and any side effects.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.