Bambang

Researchers are evaluating the safety and effectiveness of combining trastuzumab deruxtecan (T-DXd) with rilvegostomig compared to standard treatments in patients with advanced HER2-expressing biliary tract cancer who have not received prior therapy. This phase 3 study focuses on patients with locally advanced or metastatic disease and aims to measure overall survival and safety outcomes. Participants will receive one of the following treatments: the experimental combination of T-DXd and rilvegostomig by intravenous infusion, T-DXd alone, or a standard care regimen consisting of gemcitabine, cisplatin, and durvalumab given intravenously. The study includes a safety run-in period to assess tolerability of the combination, followed by a randomized phase where patients receive assigned treatments. Each treatment cycle lasts 21 days. During the study, participants will be closely monitored through clinical assessments, laboratory tests, and imaging to evaluate tumor response and safety. Researchers will track overall survival from the time of treatment initiation until death from any cause, with follow-up estimated up to 50 months. Additional assessments include performance status, organ function, and tumor tissue analysis to confirm HER2 expression and other markers. Safety and side effects will be continuously evaluated throughout the study.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.