Bendigo

Researchers are evaluating the combination of BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in participants with advanced, metastatic, or relapsed small cell lung cancer SCLC and non-small cell lung cancer NSCLC. This multi-part study aims to find safe doses, optimize treatment, assess preliminary effects, and confirm clinical efficacy in different lung cancer groups. The study includes participants with confirmed lung cancer who have measurable disease and meet specific health criteria. Participants will receive intravenous infusions of BNT324 combined with BNT327 in a dose escalation design to establish two recommended dose levels RP2D and RP2D-1. The study has two parts Part 1 focuses on dose finding in NSCLC and SCLC Part 2 compares these doses in treatment-naive and relapsed lung cancer cohorts, with some randomized groups. Additional participants may join at the optimal dose to further evaluate safety and effectiveness. Participants will undergo screening, followed by treatment, safety follow-up, and long-term survival monitoring. Researchers will assess dose-limiting toxicities, adverse events, treatment interruptions, and response rates using standardized criteria. Outcomes include objective response rate, disease control, progression-free survival, duration of response, and overall survival, with evaluations continuing up to 87 months. Safety is closely monitored during and after treatment, and participants health status is regularly assessed.

This trial is focused on adults with cancer who are receiving chemotherapy and experience nausea and vomiting as side effects. Researchers are studying a drug called LY3537021 to see how well it controls these symptoms and to evaluate its safety. The study is a Phase 2, double-blind, placebo-controlled trial designed to better understand the treatment options for chemotherapy-induced nausea and vomiting in this population. Participants are randomly assigned to receive either LY3537021 or a placebo, both given as a subcutaneous injection before chemotherapy. All participants also receive standard anti-nausea treatments, which may be taken orally, intravenously, or through skin patches. The chemotherapy drugs involved include cisplatin or an anthracycline and cyclophosphamide combination. The study treatment is given prior to chemotherapy, and the trial lasts about two months per participant. During the study, participants will be monitored for nausea and vomiting from the time of their chemotherapy infusion through up to five days afterward. Researchers will collect data on symptom control, the need for rescue medications, and drug levels in the body. Participants will complete diaries to track nausea severity. Safety and response to treatment are carefully observed. The study aims to measure how many participants have a complete response to nausea and vomiting during the delayed phase after chemotherapy.

Researchers are evaluating new treatments for acute hypoxemic respiratory failure AHRF, a serious condition that affects millions worldwide each year and carries high risks of death and long-term health problems. This platform trial, called PRACTICAL, uses adaptive methods to test various interventions at different stages, including mechanical ventilation approaches, extracorporeal life support, drugs, and medical devices. The study aims to find better strategies to protect lungs and diaphragm function during ventilation and improve patient outcomes. The trial includes multiple domains studying different treatments or strategies. These include ultra-protective ventilation using extracorporeal carbon dioxide removal, various invasive mechanical ventilation strategies, corticosteroid use in early and extended phases, nebulized furosemide, positive end-expiratory pressure settings during extracorporeal support, fludrocortisone for airspace disease, and inspiratory muscle training. Some domains are observational, collecting data and biomarkers in immunocompromised patients or examining patient-ventilator interactions. Participants will be randomized to different treatment arms or observed, depending on the domain. Participants will undergo assessments including physiological and biological measurements, mechanical ventilation monitoring, and evaluation of clinical outcomes such as mortality, ventilator-free days, organ failure, and long-term cognitive and physical function. Data will be collected daily or at specified time points up to 180 days. The study uses Bayesian adaptive analysis to efficiently evaluate efficacy and safety of interventions. The total participation time varies by domain but includes active treatment periods, follow-up, and feasibility assessments over months to years.

Researchers are investigating treatment options for patients diagnosed with advanced non-small cell lung cancer NSCLC who have a poor prognosis with current therapies. This pilot study aims to evaluate the safety and feasibility of adding stereotactic ablative radiotherapy SABR to the lung tumor before standard systemic therapy in these patients. The study hopes to determine if radiotherapy to the primary lung tumor can be safely delivered before the third cycle of standard systemic therapy and whether this approach is feasible for a larger phase III trial. Participants will be randomly assigned to one of two groups one receiving standard of care SoC systemic therapy alone, and the other receiving radiotherapy to the lung primary tumor prior to the third cycle of SoC systemic therapy. Radiotherapy doses vary based on tumor size and location, and systemic therapy includes chemoimmunotherapy regimens such as Pembrolizumab combined with Carboplatin, Paclitaxel, or Pemetrexed depending on the cancer subtype. Biospecimens will be collected to support future research. During the study, participants will be monitored for radiation toxicity and adverse events through scheduled visits at baseline, radiotherapy if applicable, cycle 3 of systemic therapy, and at 12 and 24 weeks after starting treatment, as well as at disease progression. CT scans will be performed every six weeks to track disease status. The primary outcome is to assess the feasibility of delivering radiotherapy as planned, while secondary outcomes include patient willingness to be randomized, safety, and progression-free survival. The total recruitment period is 18 months, with follow-up extending to 24 months.

Researchers are evaluating the effectiveness of a personalized stepped, multidisciplinary intervention delivered through a virtual multimodal rehabilitation hub for adults undergoing colorectal cancer surgery. The main goal is to reduce postoperative complications within 30 days after surgery compared to usual care. The study also aims to assess differences in quality of life, days spent at home after surgery, quality of recovery, cost-effectiveness, and implementation metrics over time. Participants will be randomly assigned to either the intervention group, which receives usual care plus tailored exercise, nutritional, psychological, nursing support, and group peer support delivered virtually before and after surgery, or the control group, which receives usual care alone. The interventions frequency and duration are adjusted based on individual needs and can last up to 12 months post-surgery. If needed, participants will be provided with devices and internet access to engage in virtual sessions. During the study, participants will be screened and consented before surgery, undergo baseline assessments, and be monitored regularly using standardized tools to evaluate recovery, quality of life, and days at home up to one year after surgery. Safety and data quality will be overseen by an independent monitoring board. The total study duration is approximately five years, and patient-reported outcomes will be carefully documented throughout.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

The trial investigates treatments for bloodstream infection caused by Staphylococcus aureus SAB, which can be life-threatening with a 15-30% death rate within three months. This international, multi-center randomized adaptive platform trial aims to find the best treatment options to reduce mortality within 90 days of infection. The trial adapts over time by assigning more patients to treatments that show better outcomes and removing less effective options. Participants receive various antibiotic treatments depending on their group. These include intravenous vancomycin or daptomycin, flucloxacillin or cloxacillin, cefazolin, or benzylpenicillin, with dosages adjusted for kidney function or illness severity. Some receive adjunctive drugs like clindamycin, and others may switch from intravenous to oral antibiotics if eligible after 7 or 14 days. Additionally, some participants undergo PETCT scans as part of the study. During the study, participants are monitored closely with blood cultures, temperature checks, and clinical assessments to track infection clearance and complications. Researchers measure all-cause mortality at 90 days as the primary outcome, along with other outcomes such as survival at earlier time points, hospital stay length, microbiological treatment failure, serious reactions, and antibiotic use. Safety and health economic data are also collected to evaluate treatments comprehensively throughout the trial.

Researchers are evaluating ORIC-944, a selective small molecule inhibitor targeting PRC2, in patients with metastatic prostate cancer. This open-label, phase 11b study aims to establish the safety and preliminary antitumor activity of ORIC-944 both alone and combined with androgen receptor pathway inhibitors ARPIs. The study involves patients who have progressed after prior ARPI therapies and explores dose escalation and optimization across different patient groups. Participants receive ORIC-944 orally once daily in 28-day continuous cycles either alone or combined with ARPIs such as abiraterone, apalutamide, darolutamide, or enzalutamide. The study has three parts Part I tests ORIC-944 alone Part II tests combinations with ARPIs Part III optimizes dosing of ORIC-944 with ARPIs in separate cohorts. Future combinations with abiraterone or enzalutamide may also be explored. During the study, participants undergo assessments including skin and tumor biopsies and monitoring of organ function and performance status. Researchers measure drug concentrations in the blood, antitumor responses, progression-free survival, and PSA levels. Safety and activity are evaluated over months, with follow-up for up to 36 months. The trial is sponsored by ORIC Pharmaceuticals and runs from 2022 to 2028.

Researchers are evaluating whether the combination of sacituzumab govitecan-hziy SG and pembrolizumab given after surgery is effective and safe compared to the treatment of physicians choice TPC in adults with triple negative breast cancer that remains after surgery and pre-surgical therapy. This phase 3 trial focuses on participants who have residual invasive disease following neoadjuvant therapy and surgery. The study aims to better understand outcomes for this condition where cancer persists despite earlier treatments. Participants are randomly assigned to one of two groups. One group receives SG intravenously at 10 mgkg on Days 1 and 8 of 21-day cycles along with pembrolizumab 200 mg intravenously on Day 1, repeated for up to 8 cycles. The other group receives physicians choice treatment pembrolizumab alone or pembrolizumab combined with oral capecitabine, also given over 8 cycles. Treatment continues until 8 cycles are completed, disease recurrence, unacceptable side effects, or other specified reasons. During the study, participants are monitored for invasive disease-free survival up to 60 months, along with overall survival, distant disease-free survival, recurrence-free survival, and quality of life measures. Safety is assessed through tracking treatment-related adverse events and laboratory tests for up to 38 months plus 30 days. This long-term follow-up helps evaluate the impact of the treatments on disease outcomes and participant well-being.

Researchers are evaluating the effects of two monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced or metastatic solid cancers that cannot be removed by surgery or have spread. These cancers have specific characteristics that may predict how well they respond to immune-based treatments. The study focuses on blocking immune receptors PD-L1 and TIGIT, which tumors use to avoid attack by the immune system, with the goal of reactivating the bodys ability to fight the cancer. Patients who have been screened through specific cancer programs and whose tumors fit the study criteria will join after a 21-day screening period. At the start, patients receive tiragolumab alone, followed by combined tiragolumab and atezolizumab every 21 days. Treatment continues in cycles until it is stopped, with biopsies and imaging done to monitor tumor response. Participants are divided into subgroups based on tumor mutation burden, PD-L1 expression, gene amplification, or tumor-infiltrating lymphocytes. Throughout the study, participants will have biopsies, CT scans, and samples of blood, urine, and stool collected. Follow-up visits and calls will continue after treatment ends to track disease progression and survival for up to 12 months or until death. Researchers will assess progression-free survival at 6 months as the primary outcome, along with tumor response, overall survival, quality of life, and safety measures throughout the study period.