2024
Correlative and spatial biomarker analysis of a phase 1/2b study to evaluate pepinemab in combination with pembrolizumab for first-line treatment of patients with recurrent or metastatic head and neck cancer.
Evans E, Fisher T, Mallow C, Foster A, Leonard J, Chaney M, Mekhail T, Seetharamu N, Steuer C, Saba N, Adkins D, Beck J, Algazi A, Burtness B, Baumgart M, Giampoli E, Hager S, Chay C, Spira A, Zauderer M. Correlative and spatial biomarker analysis of a phase 1/2b study to evaluate pepinemab in combination with pembrolizumab for first-line treatment of patients with recurrent or metastatic head and neck cancer. Journal Of Clinical Oncology 2024, 42: 2603-2603. DOI: 10.1200/jco.2024.42.16_suppl.2603.Peer-Reviewed Original ResearchHead and neck squamous cell carcinomaMyeloid suppressor cellsImmune checkpoint inhibitorsFirst-line treatmentDendritic cellsT cellsB cellsTumor biopsiesLymphoid structuresImmune cellsMetastatic head and neck squamous cell carcinomaActivity of immune checkpoint inhibitorsEfficacy of immune checkpoint inhibitorsSingle-arm open-label studyFirst-line treatment of patientsMetastatic head and neck cancerHead and neck squamous cell carcinoma tumorsImmune checkpoint inhibitor activationOn-treatment tumor biopsiesSuppression of adaptive immunityCD8+ T cellsNeck squamous cell carcinomaHead and neck cancerAnalysis of tumor biopsiesMechanism of immune enhancementA phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).
Colevas A, Chung C, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Worden F, Johnson F, Saba N, Burtness B, Julian R, Bauman J, Jotte R, Seiwert T, Dunn L, Chaney M, Margossian S, Levisetti M, Pai S. A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC). Journal Of Clinical Oncology 2024, 42: 6004-6004. DOI: 10.1200/jco.2024.42.16_suppl.6004.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsMedian OSCheckpoint inhibitorsHLA-A*0201Adverse eventsInterleukin-2Combined cohortHead and neck squamous cell cancerE7-specific T cellsPhase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8First-in-human studyTargeted delivery of cytokinesHLA-A*0201 patientsPhase 2 doseDisease control rateGrade 3 AEsInfusion-related reactionsT-cell engagersSquamous cell cancerDelivery of cytokinesA Phase 1 Dose-escalation and Expansion Study of CUE-101, Given As Monotherapy in 3rd Line and in Combination with Pembrolizumab in 1st Line Recurrent/Metastatic (R/M) HPV16+ Head and Neck Cancer Patients
Colevas A, Chung C, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Burtness B, Johnson F, Julian R, Saba N, Worden F, Dunn L, Seiwert T, Jotte R, Haddad R, Gabrail N, Bauman J, Margossian S, Pai S. A Phase 1 Dose-escalation and Expansion Study of CUE-101, Given As Monotherapy in 3rd Line and in Combination with Pembrolizumab in 1st Line Recurrent/Metastatic (R/M) HPV16+ Head and Neck Cancer Patients. International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e87. DOI: 10.1016/j.ijrobp.2024.01.192.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsHLA-A*0201Phase 1 dose-escalationTumor antigen-specific CD8First-in-human studyHead and neck cancer patientsTargeted delivery of cytokinesHLA-A*0201 patientsHPV16 E7 peptidesRecurrent/metastatic (R/MData cut-offInfusion-related reactionsT-cell engagersDelivery of cytokinesNeck cancer patientsTreatment of patientsPembrolizumab combinationDose escalationEscalating dosesComplete responseMaculopapular rashLeukocyte antigen
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