Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
NCT ID: NCT03310957
Last Updated: 2025-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
185 participants
INTERVENTIONAL
2018-02-27
2024-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LV + pembrolizumab
LV + pembrolizumab
ladiratuzumab vedotin
Given into the vein (IV; intravenously)
Pembrolizumab
IV infusion every 3 weeks
Interventions
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ladiratuzumab vedotin
Given into the vein (IV; intravenously)
Pembrolizumab
IV infusion every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part D only: Tumor tissue PD-L1 Combined Positive Score \<10 expression.
* Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
* At least 6 months since prior treatment with curative intent and recurrence
* At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Able to provide biopsy tissue for biomarker analysis
* Meet baseline laboratory data criteria
Exclusion Criteria
* Pre-existing neuropathy of at least Grade 2
* History of carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off corticosteroids.
* Received prior radiotherapy within 2 weeks of start of study treatment or have not adequately recovered from prior radiotherapy
* Active autoimmune disease requiring systemic treatment within the past 2 years
* History of interstitial lung disease
* Current pneumonitis or history of pneumonitis requiring steroids
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Zejing Wang, MD, PhD
Role: STUDY_DIRECTOR
Seagen Inc.
Kristel Apolinario, PharmD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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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 - DFW
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
Rotkreuzklinikum Munich
Munich, Other, Germany
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
München, Other, Germany
Klinikum der Universitat Munchen
München, , Germany
Pusan National University Hospital
Busan, Other, South Korea
CHA Bundang Medical Center
Seongnam, Other, South Korea
Korea Cancer Center Hospital
Seoul, Other, South Korea
Seoul National University Hospital
Seoul, Other, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Other, South Korea
Samsung Medical Center
Seoul, Other, South Korea
Complejo Hospitalario Universitario La Coruna
A Coruña, Other, Spain
Hospital del Mar
Barcelona, Other, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Other, Spain
Complejo Hospitalario de Jaen
Jaén, Other, Spain
L'Institut Catala d'Oncologia
L'Hospitalet de Llobregat, 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 Alarcón, Other, Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KEYNOTE 721
Identifier Type: OTHER
Identifier Source: secondary_id
2017-002289-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MK-3475-721
Identifier Type: OTHER
Identifier Source: secondary_id
SGNLVA-002
Identifier Type: -
Identifier Source: org_study_id
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