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Brief Title: A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Official Title: A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Study ID: NCT04196283
Brief Summary: The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The University of Chicago Medical Center /ID# 217196, Chicago, Illinois, United States
Norton Cancer Institute /ID# 216179, Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer In /ID# 214050, Detroit, Michigan, United States
Nebraska Methodist Hospital /ID# 215786, Omaha, Nebraska, United States
Atlantic Health System /ID# 216159, Morristown, New Jersey, United States
Roswell Park Comprehensive Cancer Center /ID# 215882, Buffalo, New York, United States
Vanderbilt Ingram Cancer Center /ID# 214040, Nashville, Tennessee, United States
MD Anderson Cancer Center /ID# 214041, Houston, Texas, United States
Centre Antoine Lacassagne - Nice /ID# 215706, Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 215657, Marseille CEDEX 05, Bouches-du-Rhone, France
Hopital Saint-Andre /ID# 215702, Bordeaux, Gironde, France
Institut Curie /ID# 215653, Paris CEDEX 05, Ile-de-France, France
Universitaetsklinikum Erlangen /ID# 214196, Erlangen, Bayern, Germany
Universitaetsklinikum Leipzig /ID# 214200, Leipzig, Sachsen, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197, Berlin, , Germany
The Chaim Sheba Medical Center /ID# 215229, Ramat Gan, Tel-Aviv, Israel
Rambam Health Care Campus /ID# 215231, Haifa, , Israel
Gastroenterology Institute, Division of Medicine /ID# 215862, Jerusalem, , Israel
Antoni van Leeuwenhoek /ID# 215291, Amsterdam, Noord-Holland, Netherlands
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Fuenlabrada /ID# 214263, Fuenlabrada, Madrid, Spain
Hospital Clinic de Barcelona /ID# 214264, Barcelona, , Spain
Hospital Universitario 12 de Octubre /ID# 214198, Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 214110, Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 214109, Malaga, , Spain
Hospital Clinico Universitario de Valencia /ID# 221401, Valencia, , Spain
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR