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Brief Title: Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
Official Title: A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT04634825
Brief Summary: This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
University of North Carolina - Lineberger Cancer Center, Chapel Hill, North Carolina, United States
University of Pennsylvania - Abramson Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center- Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Liverpool Hospital, Liverpool, New South Wales, Australia
Monash Health, Medical Oncology Department, Ruse, New South Wales, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Icon Cancer Centre Southport, Southport, Queensland, Australia
Andrew Love Cancer Centre, Barwon Health, Geelong, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Complex Oncology Center Ruse Ltd., Dobrich, , Bulgaria
MHAT Serdica, Panagyurishte, , Bulgaria
MBAL Uni Hospital, Pleven, , Bulgaria
MHAT Nadezhda, Medical Oncology, Sofia, , Bulgaria
UMHAT Tsarisa Yoanna - ISUL, Sofia, , Bulgaria
UMHAT Georgi Stranski Medical Oncology Department, Sofia, , Bulgaria
COC Dobrich, Sofia, , Bulgaria
Bajcsy-Zsilinszky Korhaz, Budapest, , Hungary
Uzsoki Street Hospital, Budapest, , Hungary
Dept of Oncology, University of Debrecen, Debrecen, , Hungary
Dept of Oncology, Bekec County Hosp, Gyula, , Hungary
Dept of Oncology, Tolna County Hospital, Szekszard, , Hungary
The Ewa Pilecka Department of Clinical Oncology, Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
I Clinics of Radiotherapy and Chemiotherapy; The Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice, , Poland
Biokinetica, Jozefow, , Poland
Clinics of Head and Neck Cancer, The Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, , Poland
Complejo Hospitalario Universitario de Badajoz, Badajoz, , Spain
Hospital Universitario Vall D'Hebrón, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario Virgen de la Macarena, Sevilla, , Spain
Communal Non-profit Enterprise "City Clinical Hospital#4" of Dnipro City, Dnipro, , Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology", Oncosurgical Department of Head and Neck, Kharkiv, , Ukraine
Communal Non-profit Enterprise "Regional Clinical Oncology Center of Kirovohrad Regional Council",, Kropyvnytskyi, , Ukraine
Kyiv City Clinical Oncological Centre, Kyiv, , Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary", Sumy, , Ukraine
Communal Nonprofit Enterprise Podilsky Regional Center of Oncology, Vinnytsia, , Ukraine
Name: Ashley L. Ward, MD
Affiliation: MacroGenics
Role: STUDY_DIRECTOR