Hudson

Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma RCC, a type of kidney cancer that has spread locally or to other parts of the body. This study aims to understand how the medicine works alone or combined with other anticancer treatments, focusing on safety and cancer response. Participants must be adults with advanced RCC who have not yet received treatment for their advanced kidney cancer. Participants will receive PF-08634404 through intravenous infusions either alone or combined with other anticancer medicines such as ipilimumab or axitinib. The study includes different groups receiving these treatments sequentially, with all infusions delivered at clinical sites by medical staff. Treatment and evaluation will continue for up to approximately three years. During the trial, participants will have regular assessments including scans and lab tests to monitor cancer response and safety. Researchers will measure outcomes such as the confirmed objective response rate, adverse events, dose-limiting toxicities, and survival. Pharmacokinetics and immune responses to the study drug will also be tracked. Participants may be followed for up to three years to evaluate treatment effects and safety.

Researchers are evaluating whether a new medicine called PF-08634404, given with chemotherapy, works better than the current standard treatment of pembrolizumab combined with chemotherapy for adults with a type of lung cancer known as non-small cell lung cancer NSCLC. This study focuses on participants with locally advanced or metastatic NSCLC who are not candidates for surgery or curative chemoradiotherapy and have no known actionable genomic alterations. The study is a Phase 3 randomized trial with double-blind masking to compare these treatments. Participants are assigned to one of two parts based on their tumor type those with squamous NSCLC are in Part 1, and those with non-squamous NSCLC are in Part 2. Each participant is randomly placed into one of two treatment groups the experimental group receives PF-08634404 plus chemotherapy, while the control group receives pembrolizumab plus chemotherapy. Treatments are given through intravenous infusions in cycles, followed by maintenance therapy with either PF-08634404 or pembrolizumab, depending on the part of the study. Participants continue treatment as long as it helps and side effects are manageable. During the study, participants attend regular visits for treatment and health assessments. Cancer response is checked every 6 weeks for the first 48 weeks and then every 12 weeks after that. Researchers monitor overall survival, progression-free survival, objective response rates, duration of response, adverse events, lab abnormalities, and quality of life measures. The study includes detailed tracking of drug levels and immune responses. Participation may last up to approximately 39 months, with continuous safety and effectiveness monitoring.