Phase II Study of Avelumab in Patients With Mismatch Repair Deficient and Mismatch Repair Proficient Recurrent/Persistent Endometrial Cancer.
Konstantinopoulos PA, Luo W, Liu JF, Gulhan DC, Krasner C, Ishizuka JJ, Gockley AA, Buss M, Growdon WB, Crowe H, Campos S, Lindeman NI, Hill S, Stover E, Schumer S, Wright AA, Curtis J, Quinn R, Whalen C, Gray KP, Penson RT, Cannistra SA, Fleming GF, Matulonis UA. Phase II Study of Avelumab in Patients With Mismatch Repair Deficient and Mismatch Repair Proficient Recurrent/Persistent Endometrial Cancer. Journal Of Clinical Oncology 2019, 37: 2786-2794. PMID: 31461377, PMCID: PMC9798913, DOI: 10.1200/jco.19.01021.Peer-Reviewed Original ResearchConceptsPhase II studyEndometrial cancerObjective responseII studyMismatch repair-deficient (dMMR) solid tumorsMore mismatch repair proteinsEnd pointData cutoff dateMMRd endometrial cancersPersistent endometrial cancerTissue-agnostic approvalCoprimary end pointsPD-L1 statusPrimary end pointProgression-free survivalPD-L1 expressionPD-L1 inhibitorsCohort of patientsImmune checkpoint blockadeMismatch repair deficientUnacceptable toxicityCheckpoint blockadePatient selectionPolymerase chain reactionImmunohistochemical lossPhase 2, two-group, two-stage study of avelumab in patients (pts) with microsatellite stable (MSS), microsatellite instable (MSI), and polymerase epsilon (POLE) mutated recurrent/persistent endometrial cancer (EC).
Konstantinopoulos P, Liu J, Luo W, Krasner C, Ishizuka J, Gockley A, Buss M, Campos S, Stover E, Wright A, Growdon W, Curtis J, Peralta A, Basada P, Quinn R, Gray K, Penson R, Cannistra S, Fleming G, Matulonis U. Phase 2, two-group, two-stage study of avelumab in patients (pts) with microsatellite stable (MSS), microsatellite instable (MSI), and polymerase epsilon (POLE) mutated recurrent/persistent endometrial cancer (EC). Journal Of Clinical Oncology 2019, 37: 5502-5502. DOI: 10.1200/jco.2019.37.15_suppl.5502.Peer-Reviewed Original ResearchEndometrial cancerObjective responseMicrosatellite InstablePrior therapyPD-L1 negative tumorsProgression-free survival ratesPersistent endometrial cancerPhase 2 studyPD-L1 inhibitorsCo-primary endpointsG3 toxicityG5 toxicityMeasurable diseasePrimary endpointProtocol therapyUnacceptable toxicityPD-L1Negative tumorsImmunohistochemical lossIHC expressionEligibility criteriaMismatch repair proteinsSurvival rateMSS statusCohort