Richards Bay

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared to placebo plus CDK4/6i and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. It aims to assess treatment outcomes in the first-line setting for this specific breast cancer type. Participants will be assigned to receive either oral inavolisib once daily or a matching oral placebo once daily. All participants will also receive a CDK4/6 inhibitor on either Days 1-21 or Days 1-28 of each 28-day cycle, along with daily oral letrozole. This randomized, double-blind study will compare these two treatment combinations to monitor differences in disease progression and safety. Throughout the study, researchers will evaluate progression-free survival from the time of randomization until disease progression or death, up to 7 years. Participants will undergo assessments including tumor measurements by RECIST criteria, performance status evaluations, and monitoring of blood and organ function before treatment begins. Safety and efficacy will be closely observed during treatment, aiming to provide detailed long-term data on the study therapies.

Researchers are evaluating the safety and effectiveness of a new drug called EIK1001 combined with Pembrolizumab compared to a placebo with Pembrolizumab as the first treatment for patients with advanced melanoma. This is a multicenter, randomized, double-blind Phase 2/3 study that includes dose optimization and an expansion phase. Participants must have advanced melanoma confirmed by tests and be eligible for standard therapy with Pembrolizumab. The study involves two main treatment groups: one receiving EIK1001, a drug that activates immune receptors (TLR 7/8), along with Pembrolizumab, a PD-1 inhibitor, and the other receiving a placebo plus Pembrolizumab. Treatment will be given as first-line therapy, with detailed dose optimization and expansion parts to determine the best dosing. Prior radiotherapy must be completed at least two weeks before starting the study treatment. Participants will undergo regular assessments including imaging scans like CT or MRI to measure tumor response, laboratory tests to check organ function, and monitoring for side effects. Researchers will follow participants for up to five years to track progression-free survival, overall survival, objective response, and adverse events. Women of childbearing potential will have pregnancy tests and must use contraception during and after the study. The total participation time includes screening, treatment, and long-term follow-up to ensure safety and measure outcomes.