Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412.
Jean-Pascal H MachielsYungan TaoBarbara BurtnessMakoto TaharaLisa LicitraDanny RischinJohn WaldronChristian SimonVincent GregoireKevin HarringtonGustavo Vasconcelos AlvesIane Pinto Figueiredo LimaYoann PointreauBrett G M HughesSercan AksoyMarcin HetnalJoy Y GeHolly BrownJonathan ChengBehzad BidadiLillian L SiuPublished in: Future oncology (London, England) (2020)
Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment, including chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy. The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials. For patients with locally advanced disease, Phase Ib data on the use of pembrolizumab in combination with chemoradiation have shown the approach to be safe and feasible. We describe here the design and rationale for KEYNOTE-412, a randomized, double-blind, Phase III trial investigating pembrolizumab or placebo administered concurrently with CRT and as maintenance treatment in patients with locally advanced HNSCC. Clinical Trial Registration: NCT03040999 (ClinicalTrials.gov).
Keyphrases
- locally advanced
- phase iii
- clinical trial
- rectal cancer
- double blind
- phase ii
- squamous cell carcinoma
- open label
- neoadjuvant chemotherapy
- radiation therapy
- placebo controlled
- phase ii study
- advanced non small cell lung cancer
- study protocol
- stem cells
- small cell lung cancer
- heart failure
- minimally invasive
- acute coronary syndrome
- machine learning
- randomized controlled trial
- artificial intelligence
- combination therapy
- bone marrow
- coronary artery disease
- chronic pain
- pain management
- electronic health record
- mesenchymal stem cells
- tyrosine kinase
- percutaneous coronary intervention
- coronary artery bypass