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Brief Title: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Official Title: Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors
Study ID: NCT04032704
Brief Summary: This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.
Detailed Description: This trial is designed to assess the antitumor activity, safety, and tolerability of LV alone and with pembrolizumab, for the treatment of solid tumors. Participants with the following advanced solid tumors will be enrolled: Cohort 1: small cell lung cancer (SCLC) Cohort 2: non-small cell lung cancer-squamous (NSCLC-squamous) Cohort 3: non-small cell lung cancer-nonsquamous (NSCLC-nonsquamous) Cohort 4: head and neck squamous cell carcinoma (HNSCC) Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous) Cohort 6: gastric and gastroesophageal junction (GEJ) adenocarcinoma Cohort 7: castration-resistant prostate cancer (CRPC) Cohort 8: melanoma Participants will continue to receive study treatment until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the sponsor, pregnancy, or death, whichever comes first.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ironwood Cancer & Research Centers - Chandler, Chandler, Arizona, United States
Adventist Health White Memorial, Los Angeles, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Eastern CT Hematology and Oncology Associates, Norwich, Connecticut, United States
GenesisCare USA, Jacksonville, Florida, United States
AdventHealth Cancer Institute, Orlando, Florida, United States
IACT Health, Columbus, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Decatur Memorial Hospital - Illinois, Decatur, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
University of Maryland, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
HealthPartners Institute, Saint Louis Park, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Valley Hospital, The / Luckow Pavilion, Paramus, New Jersey, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Weill Cornell Medicine, New York, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
FirstHealth of the Carolinas, Pinehurst, North Carolina, United States
Gabrail Cancer Center Research, LLC, Canton, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Saint Francis Hospital / Bon Secours - South Carolina, Greenville, South Carolina, United States
Erlanger Oncology and Hematology, Chattanooga, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
UT Health East Texas Hope Cancer Center, Tyler, Texas, United States
Carbone Cancer Center / University of Wisconsin, Madison, Wisconsin, United States
Flinders Medical Centre, Bedford Park, Other, Australia
Townsville Cancer Center, Douglas, Other, Australia
Peninsula and South East Oncology, Frankston, Other, Australia
Central Coast Local Health District (Gosford and Wyong Hospitals), Gosford, Other, Australia
Royal Hobart Hospital, Hobart, Other, Australia
Cabrini, Malvern, Other, Australia
St Vincents Hospital Sydney, Sydney, Other, Australia
Melanoma Institute Australia, Wollstonecraft, Other, Australia
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, Other, Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, Other, Italy
ASL 3 Genovese Villa Scassi Hospital, Genova, Other, Italy
San Luca Hospital, Lucca, Other, Italy
Irccs Irst, Meldola, Other, Italy
Istituto Europeo di Oncologia, Milano, Other, Italy
Niguarda Ca' Granda Hospital, Milan, Other, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Other, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Other, Italy
Policlinico Universitario Agostino Gemelli, Roma, Other, Italy
AOUS Policlinico Le Scotte, Siena, Other, Italy
Dong-A University Hospital, Busan, Other, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Other, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Other, Korea, Republic of
Seoul National University Hospital, Seoul, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Other, Korea, Republic of
Samsung Medical Center, Seoul, Other, Korea, Republic of
Seoul National University Boramae Medical Center, Seoul, Other, Korea, Republic of
Korea University Guro Hospital, Seoul, Other, Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea, Suwon-si, Other, Korea, Republic of
Ajou University Hospital, Suwon-si, Other, Korea, Republic of
Taichung Veterans General Hospital, Taichung, Other, Taiwan
National Cheng-Kung University Hospital, Tainan, Other, Taiwan
National Taiwan University Hospital, Taipei, Other, Taiwan
Taipei Medical University Hospital, Taipei, Other, Taiwan
The Beatson West of Scotland Cancer Centre, Glasgow, Other, United Kingdom
The Royal Marsden Hospital, London, Other, United Kingdom
Sarah Cannon Research Institute UK, London, Other, United Kingdom
UCL Cancer Institute, London, Other, United Kingdom
The Christie NHS Foundation Trust, Manchester, Other, United Kingdom
The Royal Marsden Hospital (Surrey), Sutton, Other, United Kingdom
Name: Brandon Croft, PharmD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR