2019 GI Symposium: New Phase II/III Trial of Nivolumab in Metastatic Colorectal Cancer
Posted: Tuesday, February 5, 2019
The immune checkpoint inhibitor nivolumab is being tested in a new open-label phase II/III trial in the first-line treatment of metastatic colorectal cancer. conducted by Josep Tabernero, MD, PhD, of the Universitat Autònoma de Barcelona, Spain, and colleagues presented their study design at the 2019 Gastrointestinal Cancers Symposium (Abstract TPS718).
The international multicenter CheckMate-9X8 trial is recruiting an estimated 180 patients with histologically confirmed metastatic colorectal cancer who have had no prior therapy for their metastatic colon cancer. These patients will be randomly assigned to treatment with either the normal standard of care (fluorouracil-containing regiments with oxaliplatin or irinotecan and a biologic agent such as a VEGF inhibitor) or the standard of care with the addition of nivolumab. The primary endpoint for the study will be progression-free survival, which will be assessed by blinded independent central review. In addition, objective response rate, disease control rate, duration of response, and time to response will all serve as secondary endpoints.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.