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Brief Title: Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)
Official Title: A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE)
Study ID: NCT04515394
Brief Summary: The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Phoenix, Arizona, United States
Moores Cancer Center, La Jolla, California, United States
University of California, Los Angeles (UCLA), Santa Monica, California, United States
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Mayo Clinic Hospital, Jacksonville, Florida, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Mayo Clinic, Rochester, Minnesota, United States
North Shore-LIJ Monter Cancer Center, Lake Success, New York, United States
Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Scott & White Vasicek Cancer Treatment Center, Temple, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Aurora Cancer Care - Milwaukee West, Wauwatosa, Wisconsin, United States
Antwerp University Hospital, Antwerp, , Belgium
UZ Leuven, Leuven, , Belgium
Universtity Hospital Brno, Brno, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
Dept. of Oncology Faculty Hospital Motol, Prague, , Czechia
Hospital Na Bulovce, Prague, , Czechia
CHU Besançon Hôpital Jean Minjoz, Besancon Cedex, , France
University Hospital of Besançon, Besançon, , France
CHU Estaing, Clermont Ferrand Cedex 1, , France
CHU Estaing, Clermont-Ferrand, , France
CHU Hôpital Henri Mondor, Créteil, , France
Clinique Victor Hugo, Le Mans Cedex 02, , France
Clinique Victor Hugo, Le Mans, , France
CHU de Poitiers, Poitiers, , France
Curie Institute, Saint Cloud, , France
Institut Curie - René-Huguenin Hospital, Saint-Cloud, , France
Istituto Scientifico Romagnolo per lo Studio e la Cura die Tumori, Meldona, , Italy
Fondazione IRCCS - Istituto Tumori Milano, Milan, , Italy
Grande Ospedale Metropolitano Niguarda, Milan, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Istituto Nazionale Tumori, Fondazione G. Pascale Napoli, Napoli, , Italy
UOC Oncoematologia AOU Vanvitelli, Napoli, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chiara, Pisa, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Rome, , Italy
Foundation IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo FG, , Italy
Arkangelsk Clinical Oncological Dyspensary, Arkhangelsk, , Russian Federation
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine, Chelyabinsk, , Russian Federation
Kursk Regional Clinical Oncology Dispensary, Kislino, , Russian Federation
FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhina" of the MoH of the RF, Moscow, , Russian Federation
Limited Liability Company Medicine 24/7, Moscow, , Russian Federation
Russian Cancer research center n.a. N.N. Blokhin, Moscow, , Russian Federation
Omsk Regional Oncology Dispensary, Omsk, , Russian Federation
LLC Clinica UZI 4D, Pyatigorsk, , Russian Federation
Pavlov First Saint Petersburg State Medical University, St. Petersburg, , Russian Federation
Tomsk National Research Medical Center, Tomsk, , Russian Federation
MKMC Medical City, Tyumen, , Russian Federation
SAHI Republican Clinical Oncology Dispensary, Ufa, , Russian Federation
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
VHIO Valle de Hebron Instituto de Oncologia, Barcelona, , Spain
H.U. Ramon y Cajal, Madrid, , Spain
HM-CIOCC, Madrid, , Spain
Hospital de Madrid Norte Sanchinarro, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital UNiversitario La Paz, Madrid, , Spain
H.U.Marqués de Valdecilla, Santander, , Spain
HUVirgen del Rocio, Sevilla, , Spain
Consorcio Hospital General Universitario de Valencia, Valencia, , Spain
Bristol Oncology Centre, Bristol, , United Kingdom
Beatson WJSCC, Glasgow, , United Kingdom
Guy's & St Thomas' NHS Foundation Trust, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR