Holland

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are evaluating the safety and effects of the medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This type of breast cancer involves cancer cells that grow in response to hormones like estrogen and progesterone but have little or no HER2 protein. The study focuses on people whose breast cancer worsened after treatment with cyclin dependent kinase (CDK) 4/6 inhibitor therapy. The trial is a phase 3, open-label, randomized study comparing PF-07248144 plus fulvestrant to other therapies chosen by doctors. Participants will receive either PF-07248144 tablets daily at home in 28-day cycles combined with fulvestrant injections at the clinic, or the usual treatment of everolimus tablets with endocrine therapy (either exemestane or fulvestrant). The study doctor will help decide the hormone therapy before starting treatment. The trial compares the experiences of those taking PF-07248144 plus fulvestrant with those receiving standard treatments to assess safety and effectiveness. During the study, researchers will monitor participants for disease progression or death, using blinded independent central review based on standard tumor response criteria. The main outcome measure is progression-free survival for up to about 2 years from randomization. Regular assessments, including clinical visits for injections and evaluations, will help track treatment effects and safety throughout the study.

Researchers are evaluating a new medicine called PF-08634404 to see how well it works in adults with colorectal cancer that has spread or returned after previous treatments. This study focuses on whether PF-08634404 combined with approved chemotherapy can help patients compared to another approved medicine called Bevacizumab combined with chemotherapy. The study is a Phase 3, double-blind, randomized trial involving participants who have metastatic colorectal cancer and have not received prior systemic therapy for metastatic disease. Participants will be randomly assigned to one of two groups: one receiving PF-08634404 plus chemotherapy, and the other receiving Bevacizumab plus chemotherapy. Both treatments are given by intravenous infusion in cycles. Participants may continue treatment if it is beneficial and side effects are manageable. Treatments are administered at clinical sites with medical staff monitoring participants during and after each infusion. During the approximately 33-month study, participants will visit the study site regularly for treatment, health checks, and tests. After stopping treatment, there will be a follow-up visit about 30 to 37 days later to assess health and side effects. Participants will also have follow-up every 12 weeks by phone, in person, or through health record reviews to monitor their health status and any new treatments. The main outcomes measured include progression-free survival and overall survival over about 4 years.