Spots Global Cancer Trial Database for Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
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Trial Identification
Brief Title: Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Official Title: Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Study ID: NCT03310957
Conditions
Study Description
Brief Summary: This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.
Detailed Description: The primary goal of this study is to evaluate the combination of LV, which targets LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs act through distinct and possibly complementary modes of action. This is a single-arm, open-label, multicenter trial. Patients given LV and pembrolizumab during dose escalation will be monitored for frequency of dose-limiting toxicities to determine a recommended doses for expansion cohorts. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.
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
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center University of California Irvine, Orange, California, United States
University of California Irvine - Newport, Orange, California, United States
Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, United States
The Whittingham Cancer Center / Norwalk Hospital, Norwalk, Connecticut, United States
Helen F. Graham Cancer Center / Christiana Care Health Systems, Newark, Delaware, United States
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States
AdventHealth Cancer Institute, Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
Ingalls Cancer Care / Ingalls Memorial Hospital, Harvey, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center, Maywood, Illinois, United States
University of Maryland, Baltimore, Maryland, United States
Allina Health Cancer Institute, Minneapolis, Minnesota, United States
Saint Luke's Cancer Institute LLC, Kansas City, Missouri, United States
Summit Medical Group, Florham Park, New Jersey, United States
New Mexico Cancer Center, Albuquerque, New Mexico, United States
Weill Cornell Medicine, New York, New York, United States
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Texas Oncology - Baylor Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Houston Memorial City, Houston, Texas, United States
Texas Oncology - San Antonio Medical Center Northeast, San Antonio, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Gynakologisches Zentrum Bonn Friedensplatz, Bonn, Other, Germany
Marien Hospital Bottrop, Bottrop, Other, Germany
Stadtisches Klinikum Dessau, Dessau, Other, Germany
Universitatsklinikum Erlangen, Erlangen, Other, Germany
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung, Essen, Other, Germany
Klinikum Rechts der Isar der Technischen Universitaet Muenchen, Muenchen, Other, Germany
Klinikum der Universitat Munchen, Munchen, Other, Germany
Rotkreuzklinikum Munich, Munich, Other, Germany
Pusan National University Hospital, Busan, Other, Korea, Republic of
CHA Bundang Medical Center, Seongnam, Other, Korea, Republic of
Korea Cancer Center Hospital, Seoul, 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
Hospital del Mar, Barcelona, Other, Spain
Hospital Universitari Vall d'Hebron, Barcelona, Other, Spain
Complejo Hospitalario de Jaen, Jaen, Other, Spain
L'Institut Catala d'Oncologia, L'Hospitalet de Llobregat, Other, Spain
Complejo Hospitalario Universitario La Coruna, La Coruna, Other, Spain
MD Anderson Cancer Center - Madrid, Madrid, Other, Spain
Hospital Ruber Internacional, Madrid, Other, Spain
Hospital Universitario 12 de Octubre, Madrid, Other, Spain
HM Centro Integral Oncologico Clara Campal, Madrid, Other, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcon, Other, Spain
Contact Details
Name: Zejing Wang, MD, PhD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
Name: Kristel Apolinario, PharmD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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