Mount Waverley

Researchers are evaluating a combination of disitamab vedotin and tucatinib for treating patients with advanced or metastatic breast cancer or gastric cancer that express the HER2 protein. These solid tumors, which arise in organs like the breast or stomach, are challenging to treat once they have spread or grown larger. The trial focuses on patients whose tumors have HER2, a marker that can make the cancer grow and spread faster. The study aims to assess the safety and effectiveness of this drug combination in these cancers. The study includes a dose escalation phase where disitamab vedotin is given intravenously while tucatinib is taken orally twice daily at 300 mg. After determining two appropriate dose levels, the study proceeds to a dose optimization phase to evaluate safety and efficacy in different patient groups based on HER2 expression and cancer type. Following this, an expansion phase will test the treatment in four specific cohorts, including HER2-low and HER2-positive breast and gastric cancers. Participants will have regular assessments including monitoring for side effects, laboratory tests, and scans to evaluate tumor response using RECIST criteria. Safety will be followed for up to approximately five years after the last treatment dose. Key outcomes measured include the number of participants experiencing dose-limiting toxicities, adverse events, laboratory abnormalities, and dose changes. The study also tracks the objective response rate to the treatment over about three years.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN), a study enrolling at least 5,000 men with advanced prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (M0/M1 CRPC). This international cohort will collect data from patients across various countries including Australia, Barbados, Brazil, Canada, and others to better understand differences in care and treatment across academic and community settings worldwide. Participants will receive standard care treatments for metastatic prostate cancer as determined by local practices. The study will collect detailed data at enrollment and during follow-up for a minimum of five years. Blood samples and, when feasible, tumor tissue will be collected at enrollment, at treatment changes, and at one-year follow-up to help identify molecular markers related to treatment response and resistance. During participation, patients will complete patient-reported outcome measures (PROMs) at enrollment and every three months. Physicians will provide questionnaires at enrollment, treatment changes, one-year follow-up, and treatment discontinuation. Researchers will track overall survival, adverse events, comorbidities, treatment changes, and patient quality of life to identify optimal treatment sequences and outcomes for men with advanced prostate cancer.

Researchers are evaluating the effectiveness and safety of a new treatment combination of datopotamab deruxtecan (Dato-DXd) with pembrolizumab compared to pembrolizumab alone in adults with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous type. The study focuses on patients whose tumors have high PD-L1 expression and do not have actionable genomic alterations. This is a Phase 3 trial aiming to improve treatment outcomes for this specific lung cancer group. Participants will be randomly assigned to receive either pembrolizumab alone or Dato-DXd combined with pembrolizumab. Both treatments are given as intravenous infusions every three weeks on Day 1 of each 21-day cycle. The study includes four main periods: Tissue Screening, Screening, Treatment, and Follow-up. The treatment period continues until disease progression or unacceptable side effects occur. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, heart function tests, and biomarker evaluations from tumor tissue samples. Researchers will monitor progression-free survival and overall survival for up to approximately 44 and 71 months respectively. Safety and side effects will be closely followed throughout the study and during the follow-up period to better understand the treatments' effects over time.