Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) anti...
Who is this study for: Patients with Advanced Cancer and Human Immunodeficiency Virus
Enrollment Status: Recruiting
Publish Date: June 30, 2022
Intervention Type: Drug, Biological
Study Drugs: Cabozantinib, Nivolumab
Study Phase: Phase 1
Summary: This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that has spread to other places in the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolu...
Summary: This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.