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Brief Title: A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
Official Title: An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors
Study ID: NCT05091346
Brief Summary: The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California, Los Angeles, Los Angeles, California, United States
University of California, Irvine Health, Orange, California, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
SCRI Florida Cancer Specialists East, West Palm Beach, Florida, United States
Emory University, Atlanta, Georgia, United States
Barbara Ann Karmanos Cancer Center, Detroit, Michigan, United States
Rutgers cancer Institute of NJ, New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Providence Medical Center, Portland, Oregon, United States
Sarah Cannon Cancer Care in Nashville, Nashville, Tennessee, United States
Hôpital de la Croix Rousse, Lyon, , France
Eisai Trial Site 4, Chiba-shi, , Japan
Eisai Trial Site 6, Fukuoka, , Japan
Eisai Trial Site 1, Kashiwa, , Japan
Eisai Trial Site 3, Osaka, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Sapporo-Kosei General Hospital, Sapporo shi, , Japan
Eisai Trial Site 5, Shizouka, , Japan
Eisai Trial Site 2, Tokyo, , Japan
Eisai Trial Site 7, Tokyo, , Japan
Hospital Regional Universitario de Malaga, Malaga, Avenida Carolos Haya S/n, Spain
Hospital Clínico San Carlos, Madrid, Calle Profesor Martín Lagos, Spain
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Complejo Asistencial Universitario de Salamanca, Salamanca, Paseo De San Vicente, 58 - 182, Spain
Hospital Universitario de Badajoz, Badajoz, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario de la Paz, Madrid, , Spain
Consorcio Hospital General Universitario de Valencia, Valencia, , Spain
The Royal Marsden NHS Foundation Trust - The Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Imperial College London, London, , United Kingdom
Royal Free Hospital NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom