Viewing posts categorised under: Immunotherapy

Guidelines for the Evaluation of Immune Therapy Activity

In a previous article, we discussed therapies that might affect the cancer-immunity cycle. Today’s article continues that discussion by reviewing the guidelines for the evaluation of immune therapy activity in solid tumors. These guidelines were published in 2009 in Clinical Cancer Research in Guidelines for the Evaluation of the Immune Therapy Activity in Solid Tumors: […]

Therapies That Might Affect the Cancer-Immunity Cycle

In the last five years we’ve seen a major increase, not only in immunotherapy trials in oncology, but also in immunotherapy approvals. It’s an exciting time to be working with the immune system! Medelis has been managing immunotherapy studies in oncology since 2008. We work directly with sponsors on the development of clinical strategy (protocol, endpoints, […]

Monitoring irAEs and SAEs in Oncology Immunotherapy Studies

In a previous post, we discussed site selection for cancer immunotherapy studies and the key areas of difference between an immunotherapy study and a traditional cancer study. Since serious adverse events (SAEs) in oncology immunotherapy studies are critical to the outcome of the study, and are very different from most SAEs in standard cancer treatments, […]

Site Selection for Cancer Immunotherapy Studies

Rapid advances in cancer immunotherapy treatments have fueled a tremendous investment in this promising area of research. While sponsors and investigators rush to get immunotherapy treatments (such as checkpoint inhibitors, adoptive cell transfer, therapeutic antibodies and immune system modulators) into the clinic, it’s important not to overlook the operational considerations associated with cancer immunotherapy studies. […]