Kromeriz 1

Researchers are investigating treatments for participants with high-grade non-muscle invasive bladder cancer NMIBC that is unresponsive to Bacillus Calmette-Guerin BCG therapy. This phase 3 trial evaluates the safety and effects of nadofaragene firadenovec, a gene therapy, used alone or combined with chemotherapy or immunotherapy. The study aims to build on earlier findings where over half of participants achieved a complete response in a previous trial. Participants will be randomly assigned to receive one of the following nadofaragene firadenovec alone via intravesical instillation, nadofaragene firadenovec combined with intravesical gemcitabine and docetaxel chemotherapy, or nadofaragene firadenovec combined with intravenous pembrolizumab immunotherapy. The pembrolizumab arm is now closed to new participants, focusing enrollment on the other two arms. Treatments will be administered according to the study protocol to assess their effects on bladder cancer. During the trial, participants will undergo regular evaluations including tumor assessments, pathology staging, and monitoring for disease progression and adverse events for up to 36 months. The main outcomes measured include complete response rates at 3 and 6 months, durability of response, progression to muscle-invasive disease, need for cystectomy, and overall survival. Safety and tolerability will also be closely observed. Participants will be followed throughout the study duration, which extends up to the end of 2030.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

This trial evaluates nadofaragene firadenovec, a gene therapy using interferon alfa-2b amplification, compared with observation in participants with intermediate risk non-muscle invasive bladder cancer IR NMIBC. The study is a phase 3b, randomized, controlled trial aiming to assess treatment effects on recurrence-free survival over 24 months. Participants in the treatment group receive quarterly bladder instillations of nadofaragene firadenovec for 24 months. Disease evaluations occur within two weeks before each treatment instillation. Participants in both groups are followed according to the American Urological AssociationSociety of Urologic Oncology surveillance guidelines, which involve quarterly monitoring during the 24-month treatment period. During the study, participants undergo regular disease assessments, including monitoring for cancer recurrence and safety evaluations over 24 months. The main outcome measured is recurrence-free survival at 24 months. Adverse events and recurrence-free survival at 12 months are also tracked. Participants are monitored closely throughout the treatment and observation periods to evaluate long-term effects and safety.