Abstract
ObjectivesManaging advanced endometrial cancer (EC) after platinum therapy remains a challenge. Retifanlimab is an investigational humanized monoclonal antibody against programmed cell death 1 (PD-1) with demonstrated efficacy in advanced tumors, including EC.MethodsPOD1UM-204 is a phase 2, multicenter, nonrandomized, open-label, umbrella study in women ≥18 years of age, with histologically confirmed advanced/metastatic EC which progressed on/after platinum-based chemotherapy, ECOG performance status ≤1, at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors v1.1, and baseline tumor tissue. Approximately 220 patients enroll into 4 treatment Groups: A—CPI-naive MSI-H EC receiving retifanlimab monotherapy (up to 100 patients); B—CPI-naive dMMR or POLE-positive EC receiving retifanlimab monotherapy (up to 40 patients); D—EC with activating fibroblast growth factor receptor (FGFR1, 2 or 3) mutations or alterations outside of the kinase domain and regardless of prior CPI treatment receiving retifanlimab plus pemigatinib (up to 40 patients); F—CPI-experienced MSI-H EC receiving retifanlimab, INCAGN02385 (LAG-3 inhibitor), and INCAGN02390 (TIM-3 inhibitor) (up to 40 patients). The primary endpoint is ORR of retifanlimab by independent central review (ICR) in Group A. Secondary endpoints include additional efficacy measures (DOR, DCR and PFS by ICR, and overall survival) in Group A; determining clinical activity (ORR by investigator) in Groups B, D and F; and safety and tolerability of retifanlimab in combination with other agents.ResultsTrial in progress: there are no available results at the time of submission.ConclusionsTrial in progress: there are no available conclusions at the time of submission.