2024
Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial
Dzienis M, Cundom J, Fuentes C, Spreafico A, Nordlinger M, Pastor A, Alesi E, Neki A, Fung A, Lima I, Oppelt P, da Cunha G, Burtness B, Franke F, Tseng J, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. Journal Of Clinical Oncology 2024, 42: 2989-2999. PMID: 39038265, PMCID: PMC11361359, DOI: 10.1200/jco.23.02625.Peer-Reviewed Original ResearchBlinded independent central reviewRecurrent/metastatic head and neck squamous cell carcinomaHead and neck squamous cell carcinomaNeck squamous cell carcinomaR/M HNSCCSquamous cell carcinomaRECIST v1.1Cell carcinomaSingle-armStandard-of-care first-line treatmentSafety of first-line pembrolizumabEastern Cooperative Oncology Group performance statusDay 1Treatment-related adverse eventsAlternative chemotherapy combinationsFirst-line pembrolizumabPD-L1 statusMedian follow-upFirst-line therapyIndependent central reviewFirst-line treatmentPhase IV trialChemotherapy combinationsComplete responsePD-L1
2022
A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer.
Chung C, Colevas A, Adkins D, Gibson M, Rodriguez C, Sukari A, Bauman J, Wirth L, Johnson F, Saba N, Burtness B, Dunn L, Seiwert T, Worden F, Muzaffar J, Margossian S, Moniz R, Quayle S, Levisetti M, Pai S. A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. Journal Of Clinical Oncology 2022, 40: 6045-6045. DOI: 10.1200/jco.2022.40.16_suppl.6045.Peer-Reviewed Original ResearchCD8+ T cellsHuman leukocyte antigenT cellsInterleukin-2R/M HNSCCHLA-A*0201Recurrent/metastatic head and neck squamous cell carcinomaTumor antigen-specific T cellsHead and neck squamous cell carcinomaDelivery of interleukin-2Phase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8Neck squamous cell carcinomaFirst-in-human studyAntitumor activityDose-escalation cohortsHLA-A*0201 patientsPhase 2 doseTumor-specific CD8Data cut-offSpecific T cellsFirst-line treatmentSquamous cell carcinomaDose-dependent increase