2022
Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy
Harrington K, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, Hawk N, Ge J, Bidadi B, Swaby R, Burtness B. Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy. International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e43-e44. DOI: 10.1016/j.ijrobp.2021.12.101.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsECOG performance statusPD-L1 inhibitorsM HNSCCDisease progressionRECIST v1.1Monotherapy armPerformance statusPO QDPD-L1 tumor proportion scoreOptimal second-line regimenEnd pointNeck squamous cell carcinomaPrimary end pointSecond-line regimenSecondary end pointsFirst-line treatmentTumor proportion scoreKey eligibility criteriaSquamous cell carcinomaInterim futility analysisMeasurable diseaseSOC chemotherapyMetastatic headUnacceptable toxicity
2014
LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc)
Chow L, Burtness B, Weiss J, Berger R, Eder J, Gonzalez E, Pulini J, Johnson J, Dolled-Filhart M, Emancipator K, Lunceford J, Pathiraja K, Gause C, Cheng J, Seiwert T. LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc). Annals Of Oncology 2014, 25: v1. DOI: 10.1093/annonc/mdu438.32.Peer-Reviewed Original ResearchOverall response ratePD-L1 expressionDrug-related adverse eventsAdverse eventsRECIST v1.1Subsidiary of MerckBristol-Myers SquibbInvestigator reviewAntitumor activityCommon drug-related adverse eventsAdvisory board membershipHigh PD-L1 expressionBoehringer IngelheimMerck SharpGenentech/RochePhase Ib studyPrimary end pointDrug-related deathsMeasurable diseaseMedian OSMedian PFSMetastatic HNCAdvanced HNCUnacceptable toxicityComplete response