Neoantigen Cancer Vaccine Clinical Trial Case Study

This case study details a Phase I-II clinical trial managed by Fortrea, focusing on a personalized neoantigen-based vaccine for patients with non-small cell lung cancer, colorectal cancer, and gastroesophageal cancer. The study involved rigorous site selection and extensive training to ensure compliance with inclusion and exclusion criteria, resulting in the recruitment of 30 patients from 12 activated sites across the USA and Australia. Fortrea implemented a comprehensive logistics strategy to manage the complexities of sample collection and drug administration, which included a white-glove approach to project management. The study's success was attributed to effective communication and collaboration between Fortrea and the clinical sites, ensuring timely responses to queries and maintaining a smooth operational flow. Following positive results from the trial, the sponsor advanced the immunotherapy to a Phase II-III trial, showcasing the effectiveness of Fortrea's strategies in managing complex oncology studies.