Phase Ib/II Regorafenib (multikinase inhibitor) plus Lorigerlimab (PD-1/CTLA-4 bispecific) Neoadjuvant Trial for lung-limited mCRC

This Phase Ib/II study from MD Anderson Cancer Center is evaluating neoadjuvant treatment in patients with resectable, lung-limited metastatic colorectal cancer harboring pMMR/MSS tumors. Patients receive oral Regorafenib, a multikinase inhibitor, plus intravenous Lorigerlimab, a bispecific antibody targeting PD-1 and CTLA-4, every four weeks. The trial aims to provide initial data supporting a novel systemic treatment approach and subsequent registration study for this CRC subset; surgery ± peri-op chemo is typical and IO has underperformed in pMMR/MSS—this combo aims to “warm up” tumors pre-resection.