Spots Global Cancer Trial Database for A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours
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Trial Identification
Brief Title: A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours
Official Title: An Open Label Phase Ib Dose Finding Study of BI 836880 in Combination With Ezabenlimab to Characterize Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer and in Other Solid Tumors
Study ID: NCT03468426
Study Description
Brief Summary: This study has 2 parts. The first part was open to adults with advanced non-small cell lung cancer. The second part was open also to adults with other types of advanced cancer of the lung, brain, skin, and liver. After early encouraging results, more people with liver cancer can now take part in the study. The participants get a combination of two medicines called BI 836880 and ezabenlimab. BI 836880 is a type of an antibody that blocks new blood vessel formation. New blood vessels are needed by the tumour to continue growing. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor). The purpose of the first part of the study was to find out the highest dose of the BI 836880 that the participants can tolerate in combination with BI 754091. After the best dose of BI 836880 for the combination with ezabenlimab was found, it is used in the second part of the study. The purpose of the second part is to see whether the combination of BI 836880 and BI 754091 is able to make tumours shrink. The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of BI 836880 and ezabenlimab every 3 weeks. The doctors also regularly check the general health of the participants.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Peninsula & South Eastern Oncology Group, Frankston, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
CTR Georges-François Leclerc, Dijon, , France
HOP Timone, Marseille, , France
INS Curie, Paris, , France
CTR Eugène Marquis, Rennes, , France
HOP Nord Laennec, Saint-Herblain, , France
HOP Civil, Strasbourg, , France
Universitätsklinikum Augsburg, Augsburg, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsklinikum Frankfurt, Frankfurt am Main, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
University Clinical Center, Gdansk, Gdansk, , Poland
Mandziuk Slawomir Specialist Medical Practice, Lublin, , Poland
European Health Center Otwock, Otwock, , Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan, Poznan, , Poland
Dom Lekarski S.A., Szczecin, , Poland
JSC "Group of Companies "Medsi", Moscow, , Russian Federation
SBHI "Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncological)", St. Petersburg, , Russian Federation
State Budget Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary", Volgograd, , Russian Federation
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital ClĂnic de Barcelona, Barcelona, , Spain
Hospital ClĂnico de Valencia, Valencia, , Spain
NCKUH, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, Dnipropetrovks, , Ukraine
Kyiv City Clinical Oncological Center, Kyiv, , Ukraine
Medical and Preventive Treatment Inst. Volyn Regional, Lutsk, Lutsk, , Ukraine
Vinnytsia Regional Clinical Oncological Dispensary, Vinnytsia, , Ukraine
Royal Free Hospital, London, , United Kingdom
Contact Details
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