Hyde Park

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have been previously treated with at least one systemic anticancer therapy. This phase 2 proof-of-concept study includes participants with various cancers such as melanoma, squamous cell carcinoma of the head and neck, HER2-negative gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The study aims to assess the safety, tolerability, efficacy, and pharmacokinetics of HER3-DXd, as well as the relationship between HER3 protein expression in tumor tissue and treatment response. Participants receive HER3-DXd as an intravenous infusion at a dose of 5.6 mg/kg every 21 days on Day 1 of each cycle. The study is organized into multiple cohorts based on tumor type, with treatment continuing until disease progression, unacceptable toxicity, withdrawal, or other specified reasons. HER3 protein expression and its association with treatment outcomes are also investigated. Throughout the study, participants undergo regular assessments including tumor response evaluations according to RECIST v1.1 criteria, radiographic imaging, and laboratory tests. For prostate cancer participants, prostate-specific antigen (PSA) levels are monitored each cycle. Safety and tolerability are closely observed up to approximately 27 months. Participants provide tumor tissue samples either from archival or fresh biopsies before treatment initiation. The overall study duration includes screening, treatment cycles, and follow-up for disease progression or other outcomes.

Snake bites affect thousands of Australians annually, but deaths are rare due to effective first aid and medical care. Current first aid methods in Australia use a pressure bandage immobilisation (PBI) technique, but questions have arisen about its effectiveness and potential harm when applied incorrectly. This research compares PBI with a simpler pressure pad (PP) technique used in other countries to see which better slows venom movement through the lymphatic system, providing important information to improve snake bite first aid. The study involves 24 healthy volunteers who will receive an injection of mock venom in their hand or foot. Participants will be assigned to receive either the PBI method, applying an elastic bandage at about 60mmHg pressure over the entire limb with immobilisation, the PP method using a pressure pad secured with an elastic bandage at similar pressure and immobilisation, or no first aid (control). Splints or slings will be used to immobilise the limb. Pressure accuracy is confirmed with specialized "smart" bandages and pressure measurement devices. Participants will be monitored using gamma camera imaging to track how quickly the mock venom reaches regional lymph nodes over a period lasting from 12 weeks up to 18 months. The study will assess the effectiveness of each first aid technique in slowing venom flow, aiming to provide evidence that could lead to improved recommendations for snake bite treatment in Australia. Safety and proper application of methods will be closely observed throughout the study.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.