Hyde Park

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 elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

This research aims to evaluate HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have previously received at least one systemic anticancer therapy. The study includes participants with various cancers such as melanoma, head and neck squamous cell carcinoma, HER2-negative gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The focus is to assess the treatments safety, tolerability, efficacy, and pharmacokinetics, along with exploring the relationship between HER3 protein expression and treatment response. Participants will receive intravenous infusions of HER3-DXd at a dose of 5.6 mgkg every three weeks Q3W. The trial is designed as a phase 2, multicenter, multicohort, open-label study involving a single treatment group receiving HER3-DXd monotherapy. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The study will also collect tumor tissue samples before treatment to analyze HER3 protein expression. During the study, participants will undergo regular assessments including imaging scans to evaluate tumor response, safety evaluations, laboratory tests, and pharmacokinetic sampling at specified cycles. The primary outcomes include measuring objective response rates and, for prostate cancer participants, the proportion achieving significant decreases in PSA levels. Secondary outcomes cover treatment-emergent adverse events, duration of response, clinical benefit, disease control, progression-free survival, overall survival, and pharmacokinetic parameters. Participants will be followed for up to approximately 27 months to monitor these outcomes.

Snake bites affect thousands of people in Australia each year, with few deaths due to timely medical care and quality first aid. This research investigates and compares two first aid methodsthe Pressure Bandage Immobilisation PBI technique currently recommended in Australia and a simpler Pressure Pad PP technique used internationally. The study aims to determine if the PP method is as effective as PBI in slowing venom movement through the body, which is important for improving first aid guidance. Participants will receive an injection of mock venom in the hand or foot, followed by application of either no first aid, the PBI method, or the PP method. Each technique involves specific bandaging and splinting to immobilize the limb, with pressure carefully controlled around 60mmHg. The study will monitor the flow of the mock venom in each case using nuclear medicine imaging to track its movement through the lymphatic system. During the study, participants will undergo repeated scans to observe how quickly the mock venom reaches regional lymph nodes, with each person experiencing all possible combinations of injection site and first aid method in random order. The primary measure is the time taken for the venom to travel to lymph nodes, monitored over a period spanning a minimum of 12 weeks to a maximum of 18 months. This detailed data will help assess the effectiveness and safety of these first aid techniques to inform future recommendations.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are evaluating the safety, effectiveness, and behavior of Rina-S when used alone in people with locally advanced or metastatic non-small cell lung cancer NSCLC, specifically adenocarcinoma type. The study is a Phase 2, open-label trial involving about 240 participants across multiple countries. It includes participants with or without certain genetic changes in their cancer. The purpose is to understand how well Rina-S works against lung cancer, with no placebo group, and all participants receive the active drug. Participants will receive Rina-S by intravenous infusion as a single treatment. The treatment duration varies, with an average expected around 12 months. Treatment cycles last 3 weeks, and for each cycle, participants may attend between 1 to 5 clinic visits. If the cancer remains stable or improves without serious problems, participants can continue treatment as long as the study is ongoing. Multiple cohorts receive the drug as monotherapy. During the study, participants will attend site visits for various tests including blood draws, heart activity monitoring, and imaging such as X-rays to check treatment safety and effectiveness. Researchers will measure outcomes like tumor response rate, duration of response, disease control, progression-free survival, and overall survival over approximately 3 to 4 years. Pharmacokinetic and immunogenicity assessments will also be done during about 12 months. The total study period lasts until late 2028, with ongoing safety monitoring throughout.