title: Immunotherapy of head and neck cancer: Emerging clinical trials from a National Cancer Institute Head and Neck Cancer Steering Committee Planning Meeting.
abstract: Recent advances have permitted successful therapeutic targeting of the immune system in head and neck squamous cell carcinoma (HNSCC). These new immunotherapeutic targets and agents are being rapidly adopted by the oncologic community and hold considerable promise. The National Cancer Institute sponsored a Clinical Trials Planning Meeting to address the issue of how to further investigate the use of immunotherapy in patients with HNSCC. The goals of the meeting were to consider phase 2 or 3 trial designs primarily in 3 different patient populations: those with previously untreated, human papillomavirus-initiated oropharyngeal cancers; those with previously untreated, human papillomavirus-negative HNSCC; and those with recurrent/metastatic HNSCC. In addition, a separate committee was formed to develop integrative biomarkers for the clinical trials. The meeting started with an overview of key immune components and principles related to HNSCC, including immunosurveillance and immune escape. Four clinical trial concepts were developed at the meeting integrating different immunotherapies with existing standards of care. These designs were presented for implementation by the head and neck committees of the National Cancer Institute-funded National Clinical Trials Network. This article summarizes the proceedings of this Clinical Trials Planning Meeting, the purpose of which was to facilitate the rigorous development and design of randomized phase 2 and 3 immunotherapeutic trials in patients with HNSCC. Although reviews usually are published immediately after the meeting is held, this report is unique because there are now tangible clinical trial designs that have been funded and put into practice and the studies are being activated to accrual. Cancer 2017;123:1259-1271. © 2016 American Cancer Society.
authors.affiliation: Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Julie E
authors.initials: JE
authors.lastname: Bauman
authors.affiliation: Department of Medicine, University of California at San Diego, San Diego, California.
authors.forename: Ezra
authors.initials: E
authors.lastname: Cohen
authors.affiliation: Department of Otolaryngology, University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Robert L
authors.identifier: http://orcid.org/0000-0001-6605-2071
authors.initials: RL
authors.lastname: Ferris
authors.affiliation: Department of Medicine, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio.
authors.forename: David J
authors.initials: DJ
authors.lastname: Adelstein
authors.affiliation: Department of Radiation Oncology, Duke Cancer Institute, Durham, North Carolina.
authors.forename: David M
authors.initials: DM
authors.lastname: Brizel
authors.affiliation: Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
authors.forename: John A
authors.initials: JA
authors.lastname: Ridge
authors.affiliation: Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Brian
authors.initials: B
authors.lastname: O'Sullivan
authors.affiliation: Department of Radiation Oncology, Yale Cancer Center, New Haven, Connecticut.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Burtness
authors.affiliation: Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Butterfield
authors.affiliation: Department of Surgery, Ohio State University, Columbus, Ohio.
authors.forename: William E
authors.initials: WE
authors.lastname: Carson
authors.affiliation: Department of Medicine, University of Washington, Seattle, Washington.
authors.forename: Mary L
authors.initials: ML
authors.lastname: Disis
authors.affiliation: Department of Immunology, Earle A. Chiles Research Institute, Portland, Oregon.
authors.forename: Bernard A
authors.initials: BA
authors.lastname: Fox
authors.affiliation: Deparment of Medicine, University of Chicago, Chicago, Illinois.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Gajewski
authors.affiliation: Department of Internal Medicine, Ohio State University, Columbus, Ohio.
authors.forename: Maura L
authors.initials: ML
authors.lastname: Gillison
authors.affiliation: Center for Cancer Research, Bethesda, Maryland.
authors.forename: James W
authors.initials: JW
authors.lastname: Hodge
authors.affiliation: Department of Radiation Oncology-Radiation Therapy, Stanford University, Stanford, California.
authors.forename: Quynh-Thu
authors.initials: QT
authors.lastname: Le
authors.affiliation: Department of Radiation Oncology, University of Colorado, Aurora, Colorado.
authors.forename: David
authors.initials: D
authors.lastname: Raben
authors.affiliation: Department of Otolaryngology, University of Maryland, Baltimore, Maryland.
authors.forename: Scott E
authors.initials: SE
authors.lastname: Strome
authors.affiliation: Cancer Therapeutics Evaluation Program.
authors.forename: Jean
authors.initials: J
authors.lastname: Lynn
authors.affiliation: Cancer Therapeutics Evaluation Program.
authors.forename: Shakun
authors.initials: S
authors.lastname: Malik
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D006258:Head and Neck Neoplasms / Q000175:diagnosis / Q000209:etiology / Q000276:immunology / Q000628:therapy*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D058990:Molecular Targeted Therapy; D054547:National Cancer Institute (U.S.); D009367:Neoplasm Staging; D018579:Patient Selection; D016896:Treatment Outcome; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors
keywords: checkpoint inhibitors; clinical trials; head and neck cancer; human papillomavirus; immunotherapy